Pflanzenwissen.
Mit Herkunft.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2, 3
Well-established use                                                      Traditional use

With regard to the marketing authorisation
application of Article 10(a) of Directive
2001/83/EC

Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl), folium (senna leaf)

i) Herbal substance

Not applicable.

ii) Herbal preparations

Comminuted herbal substance or herbal
preparations thereof, standardised



3. Pharmaceutical form
Well-established use                                                      Traditional use

Standardised comminuted herbal substance as
herbal tea for oral use.

Standardised herbal preparations in liquid or solid
dosage forms for oral use.

The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                      Traditional use

Herbal medicinal product for short-term use in



2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.

3 The material complies with the Ph. Eur. monograph (ref.: 0206).




European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl) 0F, folium
EMA/HMPC/625849/2015                                                                                                                 Page 3/10
Well-established use                                             Traditional use

cases of occasional constipation.


4.2. Posology and method of administration 4

Well-established use                                             Traditional use

Posology

Adolescents over 12 years of age, adults, elderly
Single dose:

Herbal preparation equivalent to 10 – 30 mg
hydroxyanthracene derivatives, calculated as
sennoside B (photometric method) to be taken
once daily at night. The correct individual dose is
the smallest required to produce a comfortable
soft-formed motion.

The use in children under 12 years of age is
contraindicated (see section 4.3
Contraindications).

The pharmaceutical form must allow lower
dosages.

Duration of use

Not to be used for more than 1 week. Usually it is
sufficient to take this medicinal product up to two
to three times during that week.

If the symptoms persist during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

See also section 4.4 Special warnings and
precautions for use.

Method of administration

Oral use

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

Hypersensitivity to the active substance.

Cases of intestinal obstructions and stenosis,
atony, appendicitis, inflammatory bowel diseases
(e.g. Crohn’s disease, ulcerative colitis),

4 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate

preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl) 0F, folium
EMA/HMPC/625849/2015                                                                                            Page 4/10
Well-established use                                            Traditional use

abdominal pain of unknown origin, severe
dehydration state with water and electrolyte
depletion.

Pregnancy and lactation (see section 4.6 and
5.3).

Children under 12 years of age.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                             Traditional use

Long-term use of stimulant laxatives should be
avoided, as use for more than a brief period of
treatment may lead to impaired function of the
intestine and dependence on laxatives. If laxatives
are needed every day the cause of the
constipation should be investigated. Senna leaf
preparations should only be used if a therapeutic
effect cannot be achieved by a change of diet or
the administration of bulk forming agents.

Patients taking cardiac glycosides, antiarrhythmic
medicinal products, medicinal products inducing
QT-prolongation, diuretics, adrenocorticosteroids
or liquorice root, have to consult a doctor before
taking senna leaf preparations concomitantly.

Like all laxatives, senna leaf preparations should
not be taken by patients suffering from faecal
impaction and undiagnosed, acute or persistent
gastro-intestinal complaints, e.g. abdominal pain,
nausea and vomiting, unless advised by a doctor,
because these symptoms can be signs of potential
or existing intestinal blockage (ileus).

When preparations containing senna leaf
preparations are administered to incontinent
adults, pads should be changed more frequently
to prevent extended skin contact with faeces.

Patients with kidney disorders should be aware of
possible electrolyte imbalance.

If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

For liquid dosage forms containing ethanol the
appropriate labelling for ethanol, taken from the


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl) 0F, folium
EMA/HMPC/625849/2015                                                                  Page 5/10
Well-established use                                             Traditional use

‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’, must
be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                             Traditional use

Hypokalaemia (resulting from long-term laxative
abuse) potentiates the action of cardiac glycosides
and interacts with antiarrhythmic medicinal
products. Concomitant use with diuretics,
adrenocorticosteroids and liquorice root may
enhance loss of potassium.

Undesirable effects

4.8. Undesirable effects

Well-established use                                             Traditional use

Hypersensitivity:

Hypersensitivity reactions (pruritus, urticaria, local
or generalised exanthema) may occur.

Gastrointestinal disorders:

Senna leaf preparations may produce abdominal
pain and spasm and passage of liquid stools, in
particular in patients with irritable colon. However,
these symptoms may also occur generally as a
consequence of individual overdosage. In such
cases dose reduction is necessary.

Furthermore, chronic use may cause pigmentation
of the intestinal mucosa (pseudomelanosis coli),
which usually recedes when the patient stops
taking the preparation.

Kidney and urinary tract symptoms:

Long term use may lead to water and electrolyte
imbalance and may result in albuminuria and
haematuria.

Yellow or red-brown (pH dependent)
discolouration of urine by metabolites, which is
not clinically significant, may occur during the
treatment.

The frequencies are not known.

If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be
consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2, 3
Well-established use                                                      Traditional use

With regard to the marketing authorisation
application of Article 10(a) of Directive
2001/83/EC

Senna alexandrina Mill. (Cassia senna L., Cassia
angustifolia Vahl) fructus (senna pods)

i) Herbal substance

Not applicable

ii) Herbal preparations

Comminuted herbal substance or herbal
preparations thereof, standardised



3. Pharmaceutical form
Well-established use                                                      Traditional use

Standardised comminuted herbal substance as
herbal tea for oral use.

Standardised herbal preparations in liquid or solid
dosage forms for oral use.

The pharmaceutical form should be described by
the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                      Traditional use

Indication 1)



2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.

3 The material complies with the Ph. Eur. monograph (ref.: 0207 and or 0208).




European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl)0F, fructus
EMA/HMPC/228761/2016                                                                                                                 Page 3/11
Well-established use                                             Traditional use

Herbal medicinal product for short-term use in
cases of occasional constipation.

Indication 2)

Herbal medicinal product for bowel cleansing prior
to clinical procedures requiring bowel preparation.


4.2. Posology and method of administration 4

Well-established use                                             Traditional use

Posology

Indication 1)

Adolescents over 12 years of age, adults, elderly

Single dose:

Herbal preparations equivalent to 10 – 30 mg
hydroxyanthracene derivatives, calculated as
sennoside B (photometric method) to be taken
once daily at night. The correct individual dose is
the smallest required to produce a comfortable
soft-formed motion.

The use in children under 12 years of age is
contraindicated (see section 4.3
Contraindications).

The pharmaceutical form must allow lower
dosages.

Indication 2)

Adolescents over 12 years of age, adults, elderly

Single dose:

Herbal preparations equivalent to 150 mg
hydroxyanthracene derivatives, calculated as
sennoside B (photometric method) in the
beginning of the afternoon of the day before the
intended examination. A glass of water should be
added. The use in children under 12 years of age
is contraindicated (see section 4.3
Contraindications).

Duration of use




4 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate

preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl)0F, fructus
EMA/HMPC/228761/2016                                                                                            Page 4/11
Well-established use                                             Traditional use

Indication 1)

Not to be used for more than 1 week. Usually it is
sufficient to take this medicinal product up to two
to three times during that week.

If the symptoms persist during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

See also section 4.4 Special warnings and
precautions for use.

Indication 2)

Single use only according to instructions specified.

(Example: The preparation starts with a three
days diet of clear fluids, the herbal preparation is
to be applied between 14:00-16:00h of the day
before the examination followed by a glass of
water and drinking 2 l of clear fluids until bedtime.
No solid food intake until examination.)

Method of administration

Indications 1) and 2)

Oral use

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

Hypersensitivity to the active substance.

Cases of intestinal obstructions and stenosis,
atony, appendicitis, inflammatory bowel diseases
(e.g. Crohn’s disease, ulcerative colitis),
abdominal pain of unknown origin, severe
dehydration state with water and electrolyte
depletion.

Pregnancy and lactation (see section 4.6 and 5.3)

Children under 12 years of age.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                             Traditional use

Long-term use of stimulant laxatives should be
avoided, as use for more than a brief period of


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl)0F, fructus
EMA/HMPC/228761/2016                                                                  Page 5/11
Well-established use                                             Traditional use

treatment may lead to impaired function of the
intestine and dependence on laxatives. If laxatives
are needed every day the cause of the
constipation should be investigated. Senna pod
preparations should only be used if a therapeutic
effect cannot be achieved by a change of diet or
the administration of bulk forming agents.

Patients taking cardiac glycosides, antiarrhythmic
medicinal products, medicinal products inducing
QT-prolongation, diuretics, adrenocorticosteroids
or liquorice root, have to consult a doctor before
taking senna pods concomitantly.

Like all laxatives, senna pods should not be taken
by patients suffering from faecal impaction and
undiagnosed, acute or persistent gastro-intestinal
complaints, e.g. abdominal pain, nausea and
vomiting, unless advised by a doctor, because
these symptoms can be signs of potential or
existing intestinal blockage (ileus).

When preparations containing senna pods are
administered to incontinent adults, pads should be
changed more frequently to prevent extended skin
contact with faeces.

Patients with kidney disorders should be aware of
possible electrolyte imbalance.

If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist
should be consulted.

For liquid dosage forms containing ethanol the
appropriate labelling for ethanol, taken from the
‘Guideline on excipients in the label and package
leaflet of medicinal products for human use’, must
be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                             Traditional use

Hypokalaemia (resulting from long-term laxative
abuse) potentiates the action of cardiac glycosides
and interacts with antiarrhythmic medicinal
products. Concomitant use with diuretics,
adrenocorticosteroids and liquorice root may


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl)0F, fructus
EMA/HMPC/228761/2016                                                                  Page 6/11
Well-established use                                             Traditional use

enhance loss of potassium.

Undesirable effects

4.8. Undesirable effects

Well-established use                                             Traditional use

Hypersensitivity:

Hypersensitivity reactions may occur.

Gastrointestinal disorders:

Senna pods may produce abdominal pain and
spasm and passage of liquid stools, in particular in
patients with irritable colon. However, these
symptoms may also occur generally as a
consequence of individual over-dosage. In such
cases dose reduction is necessary.

Furthermore, chronic use may cause pigmentation
of the intestinal mucosa (pseudomelanosis coli),
which usually recedes when the patient stops


European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia
angustifolia Vahl)0F, fructus
EMA/HMPC/228761/2016                                                                  Page 7/11
Well-established use                                             Traditional use

taking the preparation.

Kidney and Urinary tract symptoms:

Long term use may lead to water and electrolyte
imbalance and may result in albuminuria and
haematuria.

Yellow or red-brown (pH dependent)
discolouration of urine by metabolites, which is
not clinically significant, may occur during the
treatment.

The frequencies are not known.

If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be
consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2,3
Well-established use                                                Traditional use

                                                                    With regard to the registration application of
                                                                    Article 16d(1) of Directive 2001/83/EC as
                                                                    amended

                                                                    Sideritis scardica Griseb.; Sideritis clandestina
                                                                    (Bory & Chaub.) Hayek, Sideritis raeseri Boiss. &
                                                                    Heldr.; Sideritis syriaca L., herba (ironwort)

                                                                    i) Herbal substance

                                                                    Not applicable

                                                                    ii) Herbal preparations

                                                                    Comminuted herbal substance



3. Pharmaceutical form
Well-established use                                                Traditional use

                                                                    Comminuted herbal substance as herbal tea for
                                                                    oral use.

                                                                    The pharmaceutical form should be described by
                                                                    the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                Traditional use

                                                                    Indication 1)

                                                                    Traditional herbal medicinal product used for the

2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
  Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a
monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State


European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina
(Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba
EMA/HMPC/39453/2015                                                                                                  Page 3/7
Well-established use                                                Traditional use

                                                                    relief of cough associated with cold.

                                                                    Indication 2)

                                                                    Traditional herbal medicinal product used for the
                                                                    relief of mild gastrointestinal discomfort.

                                                                    The product is a traditional herbal medicinal
                                                                    product for use in specified indications exclusively
                                                                    based upon long-standing use.


                                                                             4
4.2. Posology and method of administration

Well-established use                                                Traditional use

                                                                    Posology

                                                                    Adults and elderly

                                                                    Indication 1) and 2)

                                                                    Single dose:

                                                                    Herbal tea: 2-4 g of the comminuted herbal
                                                                    substance in 150-200 ml of water as a herbal
                                                                    infusion 2-3 times daily
                                                                    Daily dose up to 12 g

                                                                    The use in children and adolescents under 18
                                                                    years of age is not recommended (see section 4.4
                                                                    ‘Special warnings and precautions for use’).

                                                                    Duration of use

                                                                    Indication 1)

                                                                    If the symptoms persist longer than 1 week,
                                                                    during the use of the medicinal product, a doctor
                                                                    or a qualified health care practitioner should be
                                                                    consulted.

                                                                    Indication 2)

                                                                    If the symptoms persist longer than 2 weeks
                                                                    during the use of the medicinal product, a doctor
                                                                    or a qualified health care practitioner should be
                                                                    consulted.

                                                                    Method of administration

                                                                    Oral use


4
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina
(Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba
EMA/HMPC/39453/2015                                                                                               Page 4/7

Contraindications

4.3. Contraindications

Well-established use                                                Traditional use

                                                                    Hypersensitivity to the active substance and to
                                                                    other plants of the Lamiaceae (Labiatae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                                Traditional use

                                                                    The use in children and adolescents under 18
                                                                    years of age has not been established due to lack
                                                                    of adequate data.

                                                                    If the symptoms worsen during the use of the
                                                                    medicinal product, a doctor or a qualified health
                                                                    care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                                Traditional use

                                                                    None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                                Traditional use

                                                                    None known

                                                                    If adverse reactions occur, a doctor or a qualified


European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina
(Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba
EMA/HMPC/39453/2015                                                                                              Page 5/7
Well-established use                                                Traditional use

                                                                    health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC

                                                                Silybum marianum (L.) Gaertn., dried fruit
                                                                (milk thistle)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance for herbal tea

                                                                b) Powdered herbal substance

                                                                c)    Dry extract (DER 20-70:1), extraction
                                                                      solvent acetone

                                                                d) Dry extract (DER 30-40:1), extraction
                                                                      solvent ethanol 96% (V/V)

                                                                e) Dry extract (DER 20-35:1), extraction
                                                                      solvent ethyl acetate

                                                                f)    Dry extract (DER 26-45:1), extraction
                                                                      solvent ethyl acetate

                                                                g) Dry extract (DER 36-44:1), extraction
                                                                      solvent ethyl acetate

                                                                h) Dry extract (DER 20-34:1), extraction
                                                                      solvent methanol 90% (V/V)

                                                                i)    Soft extract (DER 10-17:1), extraction
                                                                      solvent ethanol 60% (V/V)



3. Pharmaceutical form
    Well-established use                                        Traditional use


1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
    The material complies with the Ph. Eur. monograph (ref.: 1860).



European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus
EMA/HMPC/294187/2013                                                                                                Page 3/7
 Well-established use                                          Traditional use

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.

                                                               Herbal preparations in solid or liquid dosage
                                                               forms for oral use.

                                                               The pharmaceutical form should be described by
                                                               the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                          Traditional use

                                                               Traditional herbal medicinal product for the
                                                               symptomatic relief of digestive disorders,
                                                               sensation of fullness and indigestion and to
                                                               support the liver function, after serious
                                                               conditions have been excluded by a medical
                                                               doctor.

                                                               The product is a traditional herbal medicinal
                                                               product for use in the specified indication
                                                               exclusively based upon long-standing use.


4.2. Posology and method of administration 3

 Well-established use                                          Traditional use

                                                               Posology
                                                               Adults and elderly
                                                               a) Comminuted herbal substance for herbal tea
                                                               Single dose: 3-5 g in 100 ml of boiling water, 2-
                                                               3 times daily, before meals
                                                               b) Powdered herbal substance
                                                               Single dose: 300 mg–600 mg, 2-3 times daily
                                                               Daily dose: up to 1800 mg, before meals

                                                               c) Dry extract (DER 20-70:1), extraction solvent
                                                               acetone
                                                               Single dose: 82-239 mg, 2-3 times daily
                                                               Daily dose: up to 478 mg, before meals

                                                               d) Dry extract (DER 30-40:1), extraction solvent
                                                               ethanol 96% (V/V)
                                                               Single dose: 200 mg
                                                               Daily dose: 200 mg

3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus
EMA/HMPC/294187/2013                                                                                             Page 4/7
 Well-established use                                          Traditional use

                                                               e) Dry extract (DER 20-35:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 162.5-250 mg, 3-4 times daily

                                                               f) Dry extract (DER 26-45:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 123-208.3 mg, 3-4 times daily

                                                               g) Dry extract (DER 36-44:1), extraction solvent
                                                               ethyl acetate
                                                               Single dose: 173.0-186.7 mg, 3 times daily

                                                               h) Dry extract (DER 20-34:1), extraction solvent
                                                               methanol 90% (V/V)
                                                               Single dose: 70 mg, 3 times daily

                                                               i) Soft extract
                                                               Single dose: 392 mg 2 times daily

                                                               The use in children and adolescents under 18
                                                               years of age is not recommended (see section
                                                               4.4 ‘Special warnings and precautions for use’)

                                                               Duration of use

                                                               If the symptoms persist longer than 2 weeks
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Oral use

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

                                                               Hypersensitivity to the active substance and to
                                                               plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                          Traditional use

                                                               The use in children and adolescents under 18
                                                               years of age has not been established due to lack
                                                               of adequate data.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a qualified health
                                                               care practitioner should be consulted. If icterus
                                                               or a change in colour of urine or stool appears,



European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus
EMA/HMPC/294187/2013                                                                                        Page 5/7
 Well-established use                                          Traditional use

                                                               the medical doctor should be consulted
                                                               immediately.

                                                               For tinctures and extracts containing ethanol, the
                                                               appropriate labelling for ethanol, taken from the
                                                               ‘Guideline on excipients in the label and package
                                                               leaflet of medicinal products for human use’,
                                                               must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                          Traditional use

                                                               None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                          Traditional use

                                                               Mild gastrointestinal symptoms such as dry
                                                               mouth, nausea, upset stomach, gastric irritation
                                                               and diarrhoea may occur; headache; allergic
                                                               reactions (dermatitis, urticaria, skin rash,
                                                               pruritus, anaphylaxis, asthma) may occur. The
                                                               frequency is not known.

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.




European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus
EMA/HMPC/294187/2013                                                                                          Page 6/7

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1, 2
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended

                                                                Sisymbrium officinale (L.) Scop., herba (hedge
                                                                mustard)

                                                                i) Herbal substance

                                                                    Not applicable.

                                                                ii) Herbal preparations


                                                                a) Dry extract (DER 3.5-5.5:1), extraction solvent
                                                                    water

                                                                b) Dry extract (DER 6-8:1), extraction solvent
                                                                    water



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparations in solid dosage form for
                                                                oromucosal use.

                                                                Herbal preparation in liquid dosage form for oral
                                                                use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.




1
  The material complies with the French Pharmacopoeia monograph (Pharmacopée française 1998 Érysimum, Sisymbrium
officinale)
2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba
EMA/HMPC/280193/2013                                                                                                 Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                             Traditional use

                                                                 Traditional herbal medicinal product for the relief
                                                                 the symptoms of throat irritation such as
                                                                 hoarseness and dry cough.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                             Traditional use

                                                                 Posology

                                                                 Single dose

                                                                 Oromucosal use

                                                                 Adolescents, adults and elderly
                                                                 a) Dry extract (DER 3.5-5.5:1), extraction solvent
                                                                    water: 10 mg, 10 – 12 times daily

                                                                 b) Dry extract (DER 6-8:1), extraction solvent
                                                                    water: 7.5 - 10 mg, 10 - 12 times daily


                                                                 Children 6 - 11 years of age
                                                                 a) Dry extract (DER 3.5-5.5:1), extraction solvent
                                                                    water: 10 mg, 5 - 6 times daily

                                                                 b) Dry extract (DER 6-8:1), extraction solvent
                                                                    water: 7.5 - 10 mg, 5 - 6 times daily

                                                                 The oromucosal use in children under 6 years of
                                                                 age is not recommended (see section 4.4 ‘Special
                                                                 warnings and precautions for use’).

                                                                 Tablet/lozenge to dissolve in the mouth without
                                                                 chewing.

                                                                 Oral use

                                                                 Adolescents, adults and elderly
                                                                 b) Dry extract (DER 6-8:1), extraction solvent
                                                                    water: 82.5 mg, 3 - 4 times daily


                                                                 Children 3 - 11 years of age
                                                                 b) Dry extract (DER 6-8:1), extraction solvent
                                                                    water: 27.5 mg, 3 - 4 times daily

                                                                 The oral use in children under 3 years of age is not

European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba
EMA/HMPC/280193/2013                                                                                           Page 3/6
Well-established use                                            Traditional use

                                                                recommended (see section 4.4 ‘Special warnings
                                                                and precautions for use’).

                                                                Duration of use

                                                                If the symptoms persist longer than 1 week
                                                                during the use of the medicinal product, a doctor
                                                                or a qualified health care practitioner should be
                                                                consulted.

                                                                Method of administration

                                                                Oromucosal use.

                                                                Oral use.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

                                                                Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                            Traditional use

                                                                If the symptoms worsen during the use of the
                                                                medicinal product, a doctor or a qualified health
                                                                care practitioner should be consulted.

                                                                If dyspnoea, fever or purulent sputum occurs, a
                                                                doctor or a qualified health care practitioner
                                                                should be consulted immediately.


                                                                Herbal preparations a) and b)

                                                                The oromucosal use in children under 6 years of
                                                                age is not recommended because of the
                                                                pharmaceutical form (solid dosage form) and due
                                                                to lack of adequate data.

                                                                Herbal preparation b)

                                                                The oral use in children under 3 years of age is
                                                                not recommended due to lack of adequate data
                                                                and because medical advice should be sought.




European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba
EMA/HMPC/280193/2013                                                                                         Page 4/6

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                             Traditional use

                                                                 Not reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                             Traditional use

                                                                 None known.

                                                                 If adverse reactions occur, a doctor or a qualified
                                                                 health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2,3
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Glycine max (L.) Merr., oleum raffinatum (soya-
                                                                bean oil, refined)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Soya-bean oil, refined



3. Pharmaceutical form
    Well-established use                                        Traditional use

                                                                Herbal preparations in liquid dosage forms for
                                                                use as a bath additive.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Traditional herbal medicinal product used for the
                                                                symptomatic relief of dry skin conditions
                                                                associated with mild recurrent eczema.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication



2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
    The material complies with the Ph. Eur. monograph (ref.: 1473).



European Union herbal monograph on Glycine max (L.) Merr., oleum raffinatum
EMA/HMPC/338914/2016                                                                                                Page 3/7
 Well-established use                                           Traditional use

                                                                exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                           Traditional use

                                                                Posology

                                                                Liquid preparations containing 70‒90% of soya-
                                                                bean oil as bath additive 2‒3 times per week

                                                                Adolescents, adults and elderly

                                                                Full bath (approximately 100‒150 l): 15‒45 ml

                                                                Partial bath (approximately 25‒50 l): 5‒15 ml

                                                                Partial bath (approximately 5 l): 1‒2.5 ml

                                                                Shower bath with direct application on skin:
                                                                20 ml

                                                                In particularly dry skin, 2‒3 times the above
                                                                quantities can be used.

                                                                Infants and children

                                                                Children’s bath (approximately 50 l): 20 ml

                                                                Children’s bath (approximately 25 l): 2.5‒10 ml

                                                                In particularly dry skin, 2‒3 times the above
                                                                quantities can be used.

                                                                Duration of use

                                                                Duration of bath:

                                                                Adolescents, adults and elderly

                                                                Maximum 20 minutes

                                                                Infants and children

                                                                A few minutes

                                                                If the symptoms persist during the use of the
                                                                medicinal product, a doctor or a qualified health
                                                                care practitioner should be consulted.

                                                                Method of administration

                                                                Use as bath additive.

                                                                Bath temperature:

                                                                Do not exceed 36 °C.




European Union herbal monograph on Glycine max (L.) Merr., oleum raffinatum
EMA/HMPC/338914/2016                                                                                          Page 4/7

Contraindications

4.3. Contraindications

    Well-established use                                       Traditional use

                                                               Hypersensitivity to the active substance, soya,
                                                               peanut and to other plants of the Fabaceae
                                                               (legume) family and to birch pollen. 4

                                                               Full baths are contraindicated in cases of open
                                                               wounds, large skin injuries, acute skin diseases,
                                                               high fever, severe infections, severe circulatory
                                                               disturbances and cardiac insufficiency.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

    Well-established use                                        Traditional use

                                                                If the symptoms worsen during the use of the
                                                                medicinal product, a doctor or a qualified health
                                                                care practitioner should be consulted.

                                                                Eye contact may cause keratitis and should be
                                                                avoided. In cases of accidental eye contact, the
                                                                eye should be rinsed immediately with cold
                                                                water. If eye irritation remains, a doctor or a
                                                                qualified health care practitioner should be
                                                                consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

    Well-established use                                        Traditional use

                                                                None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                Skin rashes and hypersensitivity reactions have
                                                                been reported. The frequency is not known.

                                                                Accidental eye contact may cause keratitis (see
                                                                section 4.4 ‘Special warnings and precautions for
                                                                use’).

                                                                If other adverse reactions not mentioned above
                                                                occur, a doctor or a qualified health care
                                                                practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended

                                                                Solanum dulcamara L., stipites (woody nightshade
                                                                stem)


                                                                i) Herbal substance
                                                                Not applicable.


                                                                ii) Herbal preparations
                                                                Comminuted herbal substance.


3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance for infusion or
                                                                decoction preparation for cutaneous use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Traditional herbal medicinal product for the
                                                                symptomatic relief of mild recurrent eczema.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication
                                                                exclusively based upon long-standing use.



1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
   The herbal substance consists of dried 2 to 3 years old stems of the plant, harvested in spring prior to leaf development
or in the late autumn after leaves have dropped.

Community herbal monograph on Solanum dulcamara L., stipites
EMA/HMPC/734361/2011                                                                                                  Page 2/5
4.2. Posology and method of administration 3

Well-established use                                           Traditional use

                                                               Posology

                                                               Adults and elderly

                                                               Comminuted herbal substance for infusion or
                                                               decoction preparation for cutaneous use:
                                                               1-2 g of the comminuted herbal substance in
                                                               250 ml of water 1-5 times daily.


                                                               The use in children and adolescents under 18
                                                               years of age is not recommended (see section 4.4
                                                               ‘Special warnings and precautions for use’).

                                                               Duration of use

                                                               If the symptoms persist longer than 2 weeks
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Cutaneous use.

                                                               The infusion/decoction (at room temperature) is
                                                               applied on the afflicted area with a clean dressing.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

                                                               Hypersensitivity to the active substance.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

                                                               The use in children and adolescents under 18
                                                               years of age has not been established due to lack
                                                               of adequate data.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a qualified health
                                                               care practitioner should be consulted.




3
  For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

Community herbal monograph on Solanum dulcamara L., stipites
EMA/HMPC/734361/2011                                                                                             Page 3/5

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                           Traditional use

                                                               None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               None known.

                                                               If adverse reactions occur, a doctor or a qualified
                                                               health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1.         NAME OF THE MEDICINAL PRODUCT

To be specified for the individual finished product.


2.         QUALITATIVE AND QUANTITATIVE COMPOSITION 1,2

Well-established use                                                       Traditional use

                                                                           With regard to the registration application of
                                                                           Article 16d(1) of Directive 2001/83/EC as
                                                                           amended

                                                                           Solidago virgaurea L., herba
                                                                           (European goldenrod)

                                                                           i) Herbal substance
                                                                              Not applicable.

                                                                           ii) Herbal preparations
                                                                               - Comminuted herbal substance
                                                                               - Liquid extract (1:1) prepared with
                                                                                 ethanol/water 25% v/v
                                                                               - Tincture (1:5 v/v) prepared with
                                                                                 ethanol/water 45% v/v
                                                                               - Dry extract (5-7:1) prepared with
                                                                                 ethanol/water 30 – 60% v/v


3.         PHARMACEUTICAL FORM

Well-established use                                                       Traditional use

                                                                           Herbal preparation in solid or liquid dosage forms
                                                                           or herbal tea for oral use.

                                                                           The pharmaceutical form should be described by
                                                                           the European Pharmacopoeia full standard term.




1
    The material complies with the Ph. Eur. monograph (ref. 01/2006:1893).
2
    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.

                                                             © EMEA 2008                                                                     2/5
4.     CLINICAL PARTICULARS

4.1.   Therapeutic indications

Well-established use                           Traditional use

                                               Traditional herbal medicinal product to increase
                                               the amount of urine - as adjuvant in treatment of
                                               minor urinary complaints.

                                               The product is a traditional herbal medicinal
                                               product for use in specified indications
                                               exclusively based upon long-standing use.

4.2.   Posology and method of administration

Well-established use                           Traditional use

                                               Posology

                                               Adults and adolescents

                                               Single dose
                                               - Comminuted herbal substance for preparation
                                                  of an infusion: 3-5 g, 2-4 times daily
                                               - Liquid extract: 0.5-2 ml, 3 times daily
                                               - Tincture: 0.5-2 ml, 3 times daily
                                               - Dry extract: 350-450 mg, 3 times daily

                                               The use in children under 12 years of age is not
                                               recommended (see also 4.4. ‘Special warnings
                                               and precautions for use’).

                                               Duration of use

                                               The herbal substance is traditionally used over a
                                               period of 2 up to 4 weeks.

                                               If the symptoms persist during the use of the
                                               medicinal product, a doctor or a qualified health
                                               care practitioner should be consulted.

                                               Method of administration

                                               Oral use.
                                               For extracts, ensure appropriate fluid intake.




                                      © EMEA 2008                                               3/5

Contraindications

4.3.   Contraindications

Well-established use                              Traditional use

                                                  Hypersensitivity to the active substance or to
                                                  plants of the Asteraceae (Compositae) family.

                                                  Conditions where a reduced fluid intake is
                                                  recommended, e.g. severe cardiac or renal
                                                  diseases.

Special warnings and precautions for use

4.4.   Special warnings and precautions for use

Well-established use                              Traditional use
                                                  The use is not recommended in children under the
                                                  12 years of age because of the lack of available
                                                  experience.

                                                  If complaints of symptoms such as fever, dysuria,
                                                  spasms or blood in the urine occur during the use
                                                  of the medicinal product, a doctor or a qualified
                                                  health care professional should be consulted.

                                                  Concomitant treatment with synthetic diuretics is
                                                  not recommended.

                                                  For tinctures and extracts containing ethanol the
                                                  appropriate labelling for ethanol, taken from the
                                                  ‘Guideline on excipients in the label and package
                                                  leaflet of medicinal products for human use’,
                                                  must be included.

Interactions with other medicinal products and other forms of interaction

4.5.   Interactions with other medicinal products and other forms of interaction

Well-established use                                  Traditional use

                                                      None reported.

Undesirable effects

4.8.   Undesirable effects

Well-established use                         Traditional use

                                             Hypersensitivity reactions or gastrointestinal
                                             disorders may occur. The frequency is not known.

                                             If other adverse reactions not mentioned above
                                             occur, a doctor or a qualified health care
                                             practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1,2
 Well-established use                                           Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC

                                                                Herbal tea combinations containing several
                                                                herbal substances out of the following list:
                                                                    Achillea millefolium L., herba
                                                                    Artemisia absinthium L., herba

                                                                    Centaurium erythraea Rafn. s.l., herba
                                                                    Cichorium intybus L., radix

                                                                    Gentiana lutea L., radix
                                                                    Marrubium vulgare L., herba

                                                                    Menyanthes trifoliata L., folium
                                                                    Taraxacum officinale Weber ex Wigg., radix
                                                                    cum herba

                                                                i) Herbal substance

                                                                    Not applicable




1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
2 The material complies with the respective monographs in Ph. Eur.




European Union herbal monograph on Species amarae
EMA/HMPC/44543/2018                                                                                                  Page 3/9
                                                                                                                                                                          combination (excl.
                                                                                   Gentianae radix
                                                Centaurii herba
                          Absinthii herba




                                                                                                      Marrubii herba




                                                                                                                       Millefolii herba




                                                                                                                                                         Taraxaci radix
                                                                                                                                          Menyanthidis
                                                                  Cichorii radix




                                                                                                                                                                          excipients)
                                                                                                                                                         cum herba



                                                                                                                                                                          Range in a
                                                                                                                                          folium
 Absinthii herba                                             +                                  +                  +                  +          +                                  10-50%

 Centaurii herba                            +                                  +                +                  +                  +          +              +                   10-50%

 Cichorii radix                                              +                                  +                  +                                                                     22%

 Gentianae radix                            +                +                 +                                   +                  +          +              +                   10-33%

 Marrubii herba                             +                +                 +                +                                                                                   22-33%

 Menyanthidis folium                        +                +                                  +                                     +                                             11-50%

 Millefolli herba                           +                +                                  +                                                +                                  10-54%
 Taraxaci radix cum
 herba
                                                             +                                  +                                                                                   10-35%

 A + indicates the evidence of traditional medicinal use of a certain combination.

 Out of these documented combinations the combination partners for an application for a traditional
 herbal medicinal product may be chosen.

 The number of active substances in a herbal tea combination should be limited to a maximum of 4.
 Further herbal substances may be added as excipients. Their number, amount and function should
 be justified.

 The far right column indicates the traditional amount of the herbal substance in the combinations.
 The calculation is based on those combination partners only, which contribute to the plausibility of
 efficacy. The amount in a traditional herbal medicinal product should be within this range. The sum
 of active ingredients should end up with 100%. Excipients are not considered in this range.



3. Pharmaceutical form
 Well-established use                                                                                Traditional use

                                                                                                     Comminuted herbal substances as herbal tea for
                                                                                                     oral use.

                                                                                                     The pharmaceutical form should be described by
                                                                                                     the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                                                                Traditional use

                                                                                                     Traditional herbal medicinal product used for
                                                                                                     temporary loss of appetite.

                                                                                                     The product is a traditional herbal medicinal



European Union herbal monograph on Species amarae
EMA/HMPC/44543/2018                                                                                                                                                                            Page 4/9
 Well-established use                                         Traditional use

                                                              product for use in the specified indication
                                                              exclusively based upon long-standing use.


4.2. Posology and method of administration3

 Well-established use                                         Traditional use

                                                              Posology

                                                              Adults and elderly

                                                              Combinations containing (among other active
                                                              ingredients) Absinthii herba, Centaurii herba or
                                                              Gentianae radix

                                                              Adolescents, adults and elderly

                                                              Combinations containing none of the above-
                                                              mentioned herbal substances

                                                              Herbal tea: 2 g of the herbal tea combination in
                                                              150 ml of boiling water as an herbal infusion 3
                                                              times daily.

                                                              Depending on the herbal substances included:

                                                              The use in children and adolescents under 18
                                                              years of age is not recommended (see section
                                                              4.4 ‘Special warnings and precautions for use’).

                                                              or

                                                              The use in children under 12 years of age is not
                                                              recommended (see section 4.4 ‘Special warnings
                                                              and precautions for use’).

                                                              Duration of use

                                                              If the symptoms persist longer than 2 weeks
                                                              during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
                                                              consulted.

                                                              Method of administration

                                                              Oral use

                                                              To be taken 30 minutes before meals.

Contraindications

4.3. Contraindications

 Well-established use                                        Traditional use


3 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate

preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Species amarae
EMA/HMPC/44543/2018                                                                                              Page 5/9
 Well-established use                               Traditional use

                                                    All combinations:

                                                    Hypersensitivity to the active substances.

                                                    Combinations containing Millefolii herba or
                                                    Cichorii radix:

                                                    Additionally: Hypersensitivity to other plants of
                                                    the Asteraceae (Compositae) family.

                                                    Combinations containing Taraxaci radix cum
                                                    herba:

                                                    Additionally: Hypersensitivity to other plants of
                                                    the Asteraceae (Compositae) family.

                                                    Obstructions of bile ducts, cholangitis, liver
                                                    diseases, gallstones, active peptic ulcer and any
                                                    other biliary diseases.
                                                    Combinations containing Absinthii herba:
                                                    Additionally: Hypersensitivity to other plants of
                                                    the Asteraceae (Compositae) family. Obstruction
                                                    of the bile duct, cholangitis or liver disease.

                                                    Combinations containing Centaurii herba:

                                                    Additionally: Peptic ulcer.

                                                    Combinations containing Marrubii herba:

                                                    Additionally: Hypersensitivity to other plants of
                                                    the Lamiaceae (Labiatae) family. Obstruction of
                                                    the bile duct, cholangitis, liver disease, ileus

                                                    Combinations containing Menyanthidis folium:

                                                    Additionally: Patients with active gastric or
                                                    duodenal ulcer.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                               Traditional use

                                                    Depending on the herbal substances included:

                                                    The use in children and adolescents under 18
                                                    years of age has not been established due to lack
                                                    of adequate data.

                                                    or

                                                    The use in children under 12 years of age has not
                                                    been established due to lack of adequate data.

                                                    Combinations containing Absinthii herba:



European Union herbal monograph on Species amarae
EMA/HMPC/44543/2018                                                                                   Page 6/9
 Well-established use                               Traditional use

                                                    Additionally: Patients with gallstones and any
                                                    other biliary disorders should consult a doctor
                                                    before using Absinthii herba preparations.

                                                    Combinations containing Marrubii herba:

                                                    Additionally: Patients with active peptic ulcer,
                                                    gallstones and any other biliary disorders should
                                                    consult a doctor before using Marrubii herba
                                                    preparations.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                               Traditional use

                                                    None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                               Traditional use

                                                    For an individual combination the combined
                                                    information regarding undesirable effects taken
                                                    from the European Union herbal monographs for
                                                    the single ingredients have to be used.

                                                    If other adverse reactions occur, a doctor or a
                                                    qualified health care practitioner should be
                                                    consulted.




European Union herbal monograph on Species amarae
EMA/HMPC/44543/2018                                                                                Page 7/9

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1, 2
 Well-established use                                         Traditional use

                                                              With regard to the registration application of Article
                                                              16d(1) of Directive 2001/83/EC

                                                              Herbal tea combinations containing several herbal
                                                              substances out of the following list:

                                                                Achillea millefolium L., herba, flos

                                                                Aloysia citrodora Paláu (syn. Aloysia triphylla
                                                                (L’Hér.) Kuntze; Verbena triphylla L’Hér.; Lippia
                                                                citriodora Kunth), folium (Verbenae citriodorae
                                                                folium)

                                                                Althaea officinalis L., radix

                                                                Artemisia absinthium L., herba

                                                                Carum carvi L., aetheroleum, fructus

                                                                Centaurium erythraea Rafn. s.l., herba

                                                                Cinnamomum verum J. S. Presl, (Cinnamomum
                                                                zeylanicum Nees), cortex

                                                                Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D.
                                                                Dietrich), rhizoma

                                                                Foeniculum vulgare Miller subsp. vulgare var.
                                                                dulce (Mill.) Batt. & Trab., fructus

                                                                Foeniculum vulgare Miller subsp. vulgare var.
                                                                vulgare, fructus

                                                                Fumaria officinalis L., herba

                                                                Gentiana lutea L., radix

                                                                Glycyrrhiza glabra L.; Glycyrrhiza inflata Bat.;
                                                                Glycyrrhiza uralensis Fisch., radix

                                                                Hypericum perforatum L., herba

                                                                Marrubium vulgare L., herba



1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
2 The material complies with the respective monographs in the Ph. Eur.




European Union herbal monograph on Species digestivae
EMA/HMPC/180400/2018                                                                                                Page 5/16
 Well-established use                                   Traditional use

                                                         Matricaria recutita L., flos

                                                         Melissa officinalis L., folium

                                                         Mentha x piperita L., folium

                                                         Menyanthes trifoliata L., folium

                                                         Peumus boldus Molina, folium

                                                         Pimpinella anisum L., fructus

                                                         Rosmarinus officinalis L. folium

                                                         Salvia officinalis L., folium

                                                         Taraxacum officinale Weber ex Wigg., radix cum
                                                         herba

                                                        i) Herbal substance

                                                        Not applicable.

                                                        ii) Herbal preparations

                                                        Combinations of the comminuted herbal substances
                                                        (see combinations table below)




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                                                                                                                                                                                                                                                                                                                                                                           Menyanthidis folium




                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Taraxaci radix cum
                                                                                                                                                                                                                                                                                                                                                                                                 Millefolli herba/flos
                                                                                                                                                  Cinnamomi cortex




                                                                                                                                                                                                                                                                                                                                                       Menthae piperitae




                                                                                                                                                                                                                                                                                                                                                                                                                                           Salviae officinalis
                                                                                                                                                                                                                                                                                                                                                                                                                         Rosmarini herba
                                                                                                                                                                                                                                           Gentianae radix
                                                                                                                                                                                                                          Fumariae herba




                                                                                                                                                                                                                                                                              Liquiritiae radix
                                                                                                                                Centaurii herba




                                                                                                                                                                                                                                                                                                                   Matricariae flos
                                      Aloysiae folium




                                                                                                                                                                                                       Foeniculi dulcis
                                                                                                                                                                                     Foeniculi amari
                    Absinthii herba




                                                                                                                                                                                                                                                                                                  Marrubii herba
                                                                                                                                                                                                                                                             Hyperici herba
                                                            Althaeae radix




                                                                                                                                                                                                                                                                                                                                      Melisae folium
                                                                                                                                                                     xanthorrhizae
                                                                                                                Carvi fructus
                                                                                 Anisi fructus


                                                                                                 Boldi folium




                                                                                                                                                                       Curcumae
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Range in




                                                                                                                                                                        rhizoma


                                                                                                                                                                                        fructus


                                                                                                                                                                                                          fructus




                                                                                                                                                                                                                                                                                                                                                                                                                                                 folium
                                                                                                                                                                                                                                                                                                                                                            herba




                                                                                                                                                                                                                                                                                                                                                                                                                                                                       herba
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      combination
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         (excl.
                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       excipients)




Absinthii herba                                                                                                                  +                 +                                                                                        +                                                                                          +                    +                                                        +                                                                 10-50%

Aloysiae folium                                         +                    +                                                                                                                                                                                                                                                                                                                                                                                                           10%
                                                                                                                                                                                                                                                                                                                    +                                       +                                                             +
Althaeae radix                                      +                             +                                                                                                      +                                                                                     +                                    +                                       +                                                                                                                            10%
Anisi fructus                                       +        +                                                   +               +                                                       +                                                                                                                          +                  +                                                                             +    +                                                            10-40%

Boldi folium                                                                                                                                                                                                                                                                                       +                +                                                                      +                                                                          +                10-32%




                                                                                                                                                                                                                                                                                                                                                         +
                                                                                                                                                                                                                                 +
                                                                                                                                                                                                                                                                                                                                                                                                                          +
Carvi fructus                                                                     +                                                                                      +               +                                                                                                                          +                                       +                                                        +                                                +                10-40%
Centaurii herba      +                                                                                                                             +                                     +                                                  +                 +                                                     +                                       +                                                        +    +                                           +                10-35%
Cinnamomi
cortex               +                                                                                                           +                                                                                                          +                                                                                                                                                                                                                                            10%
Curcumae
xanthorrhizae                                                                                                    +                                                                                                                                                                                                                                                                                                   +                                                +                15-20%




                                                                                                                                                                                                                                                                                                                                                          +
rhizoma
Foeniculi amari
fructus                                                                           +                              +               +                                                                                                                                                                                  +                                       +                                +                       +                                                                 14-40%
Foeniculi dulcis
fructus                                                      +                                                                   +                                                                                                                            +                +                                    +                                       +                                                                                                                          10-22%
Fumariae herba                                                                                    +                                                                                                                                                                                                                                                         +                                +                            +                                           +                  13%
Gentianae radix      +                                                                                                           +                 +                                                       +                                                                   +                                    +                                                                                                +                                                +                10-30%
Hyperici herba                                                                                                                                                                                                                                                                                                                                                                                                                                                                           10%
                                                                                                                                 +                                                       +                                                                                                                          +                                       +
Liquiritiae radix                                                                                                                                                                                                                                                                                                                                                                                                                                                                      10-35%
                                                             +                                                                                                                           +                                                                                                                          +                                       +                                                        +                          +
Marrubii herba                                                                                                                                                                                                                                                                                                                                                                                                                                                                           25%
                                                                                                  +                                                                                                                                                                                                                 +                                       +                                                                                                         +
Matricariae flos                                    +                                                                                                                                                                                                                                                                                                                                        +                                                                                         10-40%
                                                             +                                                   +               +                                                       +                                                                                                                                             +                    +                                                        +    +
Melissae folium                                                                                                                                                                                                                                                                                                                                                                                                      +                                                                 10-35%
                     +                                                            +                                                                                                      +                                                                                                                          +
Menthae                                             +                                                                                                                                                                                                                                                                                                                                        +
                     +                                       +                    +               +              +               +                                       +               +                                 +                                  +                +                                                                                                                                     +    +                     +                     +                10-40%




                                                                                                                                                                                                                                                                                                  +

                                                                                                                                                                                                                                                                                                                   +

                                                                                                                                                                                                                                                                                                                                      +
piperitae herba
Menyanthidis
folium                                                                                            +                                                                                                                        +                                                                                                                                +                                                             +                                           +                  11%
Millefolii
herba/flos                                                   +                    +               +              +               +                                                       +                                                                                     +                                    +                  +                    +                                                                                                                          10-50%




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Rosmarini herba
                         +            +      +                               +                           +           +    +                      +     10-16%
Salviae
officinalis folium
                                                                                              +          +           +                                  10%
Taraxaci radix
cum herba
                                             +          +                    +                                       +    +           +                19-25%




A + indicates the evidence of traditional medicinal use of a certain combination.

Out of these documented combinations the combination partners for an application for a traditional herbal medicinal product may be chosen.

The number of active substances in an herbal tea combination is recommended to be limited to a maximum of 4. Further herbal substances may be added as
excipients. Their number, amount and function should be justified.

The very right row indicates the traditional amount of the herbal substance in the combinations. The calculation is based on those combination partners only,
which contribute to the plausibility of the traditional medicinal use. The amount in a traditional herbal medicinal product should be within this range. The sum
of active ingredients should end up with 100%. Excipients are not considered in this range.




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3. Pharmaceutical form
 Well-established use                                         Traditional use

                                                              Comminuted herbal substances as herbal tea
                                                              for oral use.

                                                              The pharmaceutical form should be described
                                                              by the European Pharmacopoeia full standard
                                                              term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                         Traditional use

                                                              Traditional herbal medicinal product used for
                                                              the symptomatic relief of mild dyspeptic /
                                                              gastrointestinal disorders including bloating and
                                                              flatulence.

                                                              The product is a traditional herbal medicinal
                                                              product for use in the specified indication
                                                              exclusively based upon long-standing use.


4.2. Posology and method of administration 3

 Well-established use                                          Traditional use

                                                               Posology

                                                               Adults and Elderly

                                                               Combinations containing (among other active
                                                               ingredients) Absinthii herba, Anisi fructus,
                                                               Boldi folium, Carvi fructus, Centaurii herba,
                                                               Cinnamomi cortex, Curcumae xanthorrhizae
                                                               rhizoma, Fumariae herba, Gentianae radix,
                                                               Hyperici herba, Liquiritiae radix, Melissae
                                                               folium, Menyanthidis trifoliatae folium, Millefolii
                                                               herba, Rosmarini herba, Salviae officinalis
                                                               folium or Taraxaci radix cum herba:

                                                               Herbal tea: 1.5-2 g of the herbal tea
                                                               combination in 150 ml of boiling water as an
                                                               herbal infusion 3 times daily.

                                                               For combinations with Anisi fructus: see
                                                               section 6 for content of estragole.


3 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate

preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).

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 Well-established use                                   Traditional use

                                                        Adolescents, Adults and Elderly

                                                        Combinations containing Verbenae citriodorae
                                                        folium, Althaeae radix, Foeniculi amari fructus,
                                                        Marrubii herba, Matricariae flos or Menthae
                                                        piperitae herba:

                                                        Herbal tea: 1.5-2 g of the herbal tea
                                                        combination in 150 ml of boiling water as an
                                                        herbal infusion 1-2 times daily.

                                                        For combinations with Foeniculi amari fructus
                                                        and/or Foeniculi dulci fructus: see section 6 for
                                                        content of estragole.

                                                        Depending on the herbal substances included:

                                                        The use in children and adolescents under 18
                                                        years of age is not recommended (see section
                                                        4.4 ‘Special warnings and precautions for use’).

                                                        or

                                                        The use in children under 12 years of age is
                                                        not recommended (see section 4.4 ‘Special
                                                        warnings and precautions for use’).

                                                        Duration of use

                                                        If the symptoms persist longer than 2 weeks
                                                        during the use of the medicinal product, a
                                                        doctor or a qualified health care practitioner
                                                        should be consulted.

                                                        Combinations containing Foeniculi amari
                                                        fructus and/or Foeniculi dulci fructus and/or
                                                        Anisi fructus:

                                                        Not to be used for more than 2 weeks.

                                                        Method of administration

                                                        Oral use.

Contraindications

4.3. Contraindications

 Well-established use                                   Traditional use

                                                        All combinations:

                                                        Hypersensitivity to the active substances.

                                                        Combinations containing Absinthii herba,
                                                        Matricariae flos, Millefolii herba or Taraxaci
                                                        radix cum herba:

                                                        Additionally: Hypersensitivity to other plants of

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 Well-established use                                   Traditional use

                                                        the Asteraceae family.

                                                        Combinations containing Anisi fructus, Carvi
                                                        fructus Foeniculi amari fructus or Foeniculi dulci
                                                        fructus:

                                                        Additionally: Hypersensitivity to other plants of
                                                        the Apiaceae family (fennel, anise, celery,
                                                        coriander and dill).

                                                        Combinations containing Verbenae citriodorae
                                                        folium:

                                                        Additionally: Hypersensitivity to other plants of
                                                        the Verbenaceae family.

                                                        Combinations containing Marrubii herba:

                                                        Additionally: Hypersensitivity to other plants of
                                                        the Lamiaceae family.

                                                        Combinations containing Menyanthidis
                                                        trifoliatae folium:

                                                        Additionally: Active gastric or duodenal ulcer.

                                                        Combinations containing Absinthii herba, Boldi
                                                        folium, Fumariae herba, Marrubii herba,
                                                        Rosmarini herba or Taraxaci radix cum herba:

                                                        Additionally: Obstruction of the bile duct,
                                                        cholangitis, liver disease, gallstones and any
                                                        other biliary disorders.

                                                        Combinations containing Centaurii herba;
                                                        Gentianae radix or Taraxaci radix cum herba:

                                                        Additionally: Peptic ulcer.

                                                        Combinations containing Anisi fructus, Foeniculi
                                                        amari fructus or Foeniculi dulci fructus:

                                                        Additionally: Hypersensitivity to anethole.

                                                        Combinations containing Carvi fructus:

                                                        Additionally: Hypersensitivity to mugwort or to
                                                        birch.

                                                        Combinations containing Cinnamomi cortex:

                                                        Additionally: Hypersensitivity to Peru balsam.

                                                        Combinations containing Menthae piperitae
                                                        herba:

                                                        Additionally: Hypersensitivity to menthol.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                   Traditional use

                                                        Depending on the herbal substances included:


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 Well-established use                                   Traditional use

                                                        The use in children and adolescents under 18
                                                        years of age has not been established due to
                                                        lack of adequate data.

                                                        or

                                                        The use in children under 12 years of age has
                                                        not been established due to lack of adequate
                                                        data.

                                                        Combinations containing Anisi fructus, Foeniculi
                                                        amari fructus or Foeniculi dulci fructus:

                                                        The use in children under 12 years of age has
                                                        not been established due to lack of adequate
                                                        data for safety assessment (see section 5.3
                                                        regarding preclinical safety related to the
                                                        content of estragole).

                                                        Combinations containing Absinthii herba, Carvi
                                                        fructus, Curcumae xanthorrhizae rhizoma,
                                                        Marrubii herba or Menthae piperitae herba:

                                                        Gallstones, liver disease, cholangitis and any
                                                        other biliary disorders.

                                                        Combinations containing Althaeae radix:

                                                        Not to be taken ½ to 1 h before or after intake
                                                        of other medicinal products.

                                                        Combinations containing Liquiritiae radix:

                                                        Hypertension, cardiac rhythm disorders, kidney
                                                        diseases, liver or cardiovascular disorders or
                                                        hypokalaemia. Concomitant use with diuretics,
                                                        cardiac glycosides, corticosteroids, stimulant
                                                        laxatives or other medications which may
                                                        aggravate electrolyte imbalance is not
                                                        recommended.

                                                        Combinations containing Marrubii herba:

                                                        Active peptic ulcer.

                                                        Combinations containing Menthae piperitae
                                                        herba:

                                                        Patients with gastro-oesophageal reflux
                                                        (heartburn).

                                                        Combinations containing Taraxaci radix cum
                                                        herba:

                                                        Patients with renal failure and/or diabetes,
                                                        and/or heart failure because of possible risks

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 Well-established use                                   Traditional use

                                                        due to hyperkalaemia.

                                                        If the symptoms worsen during the use of the
                                                        medicinal product, a doctor or a qualified health
                                                        care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                   Traditional use

                                                        All combinations except those containing
                                                        Liquiritiae radix and/or Matricariae flos:

                                                        None reported.

                                                        Combinations containing Liquiritiae radix:

                                                        Not to use concomitantly with diuretics, cardiac
                                                        glycosides, corticosteroids, stimulant laxatives or
                                                        other medications which may aggravate
                                                        electrolyte imbalance.

                                                        Combinations containing Matricariae flos:

                                                        For patients after renal transplantation taking
                                                        high doses for longer periods (about 2 months)
                                                        interactions based on effects on CYP450 have
                                                        been reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                   Traditional use

                                                        Combinations containing Absinthii herba,
                                                        Althaeae radix, Carvi fructus, Centaurii herba,
                                                        Cinnamomi cortex, Fumariae herba, Liquiritiae
                                                        radix, Melissae folium, Marrubii herba or Salviae
                                                        officinalis folium:

                                                        None known.

                                                        If adverse reactions occur, a doctor or a qualified
                                                        health care practitioner should be consulted.

                                                        Combinations containing Anisi fructus:

                                                        Allergic reactions to aniseed affecting the skin or
                                                        the respiratory system have been reported. The
                                                        frequency is not known.

                                                        Combinations containing Boldi folium:

                                                        Hypersensitivity (anaphylaxis) has been
                                                        reported.

                                                        The frequency is not known

                                                        Combinations containing Foeniculi fructus or
                                                        Rosmarini herba:

                                                        Allergic reactions affecting the skin, or the
                                                        respiratory system may occur. The frequency is
                                                        not known.

                                                        Combinations containing Curcumae



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 Well-established use                                   Traditional use

                                                        xanthorrhizae rhizoma:

                                                        Mild gastrointestinal symptoms such as dry
                                                        mouth, flatulence and gastric irritation may
                                                        occur. The frequency is not known.

                                                        Combinations containing Gentianae radix:

                                                        Gastrointestinal disorders have been observed.
                                                        The frequency was uncommon.

                                                        In rare cases, tachycardia and pruritus have
                                                        been reported.

                                                        Headache may occur. The frequency is not
                                                        known.

                                                        Combinations containing Hyperici herba:

                                                        Gastrointestinal disorders, allergic skin
                                                        reactions, fatigue and restlessness may occur.
                                                        The frequency is not known.

                                                        Fair-skinned individuals may react with
                                                        intensified sunburn-like symptoms under intense
                                                        sunlight.

                                                        Combinations containing Matricariae flos:

                                                        Hypersensitivity reactions including severe
                                                        allergic reaction (dyspnoea, Quincke’s disease,
                                                        vascular collapse, anaphylactic shock) following
                                                        mucosal contact with liquid chamomile
                                                        preparations have been reported. The frequency
                                                        is not known.

                                                        Combinations containing Menthae piperitae
                                                        herba:

                                                        The gastro-oesophageal reflux may worsen, and
                                                        heartburn may increase. The frequency is not
                                                        known.

                                                        Combinations containing Millefolii herba:

                                                        Hypersensitivity reactions of the skin have been
                                                        reported. The frequency is not known.

                                                        Combinations containing Taraxaci radix cum
                                                        herba:

                                                        Epigastric pain and hyperacidity may occur. The
                                                        frequency is not known.

                                                        Allergic reactions may occur. The frequency is
                                                        not known.

                                                        If other adverse reactions not mentioned above
                                                        occur, a doctor or a qualified health care
                                                        practitioner should be consulted.




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Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1,2,3
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC

                                                                Herbal tea combinations containing several
                                                                herbal substances out of the following list:
                                                                    Arctostaphylos uva-ursi (L.) Spreng., folium
                                                                    Agropyron repens (L.) P. Beauv., rhizoma
                                                                    Betula pendula Roth and/or Betula pubescens
                                                                    Ehrh., folium
                                                                    Equisetum arvense L., herba

                                                                    Ilex paraguariensis St. Hilaire, folium
                                                                    Juniperus communis L., galbulus (synonym:
                                                                    Juniperus communis L., pseudo-fructus)

                                                                    Levisticum officinale Koch, radix
                                                                    Ononis spinosa L., radix

                                                                    Orthosiphon stamineus Benth., folium
                                                                    Phaseolus vulgaris L., fructus sine semine

                                                                    Polygonum aviculare L., herba
                                                                    Solidago virgaurea L., herba

                                                                    Urtica dioica L. and Urtica urens L., herba,
                                                                    folium

                                                                i) Herbal substance

                                                                    Not applicable

    Traditional use

    ii) Herbal preparations

    Combinations of the comminuted herbal substances.




1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
  The material complies with the respective monographs in Ph. Eur.
3
  Detailed specifications for the herbal substance shall be given by references to bibliographic sources in absence of a
monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State.


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 Well-established use                                                                                                                        Traditional use




                                                     Graminis rhizoma


                                                                        Juniperi galbulus




                                                                                                                                                                                                                                          Uvae ursi folium
                                                                                                                                                                                                    Solidaginis virg.
                                                                                                                                                              Phaseoli fructus



                                                                                                                                                                                 Polygoni avicul.




                                                                                                                                                                                                                        Urticae herba /
                   Betulae folium




                                                                                                                            Ononidis radix
                                    Equiseti herba




                                                                                                                                              Orthosiphonis
                                                                                            Levistici radix


                                                                                                              Mate folium
                                                                                                                                                                                                                                                             Range in a




                                                                                                                                              folium




                                                                                                                                                                                                                        folium
                                                                                                                                                                                 herba



                                                                                                                                                                                                    herba
                                                                                                                                                                                                                                                             combination
                                                                                                                                                                                                                                                             (excl.
                                                                                                                                                                                                                                                             excipients)
 Betulae
 folium                               +                   +                 +                   +                +              +               +                    +              +                 +                     +                   +             10–57%
 Equiseti
 herba                 +                                  +                 +                   +                +              +               +                    +                                +                     +                   +             10–61%
 Graminis
 rhizoma               +              +                                     +                                                   +               +                                                                                               +             10–25%
 Juniperi
 galbulus              +              +                   +                                     +                               +               +                                                     +                                                       10–50%

 Levistici radix       +              +                                     +                                                   +                                                                                                                             20–33%

 Mate folium           +              +                                                                                                         +                    +                                                                          +               10%
 Ononidis
 radix                 +              +                   +                 +               +                                                   +                                   +                                       +                   +             10–50%
 Orthosiphonis
 folium                +              +                   +                 +                                    +              +                                    +                                +                                         +             10–50%
 Phaseoli
 fructus               +              +                                                                          +                              +                                                                                               +             10–20%
 Polygoni avic.
 herba                 +                                                                                                        +                                                                                           +                   +               12%
 Solidaginis
 virg. herba           +              +                                     +                                                                   +                                                                                               +             18–29%
 Urticae
 herba/folium          +              +                                                                                         +                                                   +                                                           +             11–22%
 Uvae ursi
 folium                +              +                   +                                                      +              +               +                    +              +                 +                     +                                 20–50%

 A + indicates the evidence of traditional medicinal use of a certain combination.

 Out of these documented combinations the combination partners for an application for a traditional
 herbal medicinal product may be chosen.

 The number of active substances in a herbal tea combination should be limited to a maximum of 4.
 Further herbal substances may be added as excipients. Their number, amount and function should
 be justified.

 The very right row indicates the traditional amount of the herbal substance in the combinations. The
 calculation is based on those combination partners only, which contribute to the plausibility of
 efficacy. The amount in a traditional herbal medicinal product should be within this range. The sum
 of active ingredients should end up with 100%. Excipients are not considered in this range.



3. Pharmaceutical form
 Well-established use                                                                                                                        Traditional use

                                                                                                                                             Comminuted herbal substances as herbal tea for
                                                                                                                                             oral use.

                                                                                                                                             The pharmaceutical form should be described by
                                                                                                                                             the European Pharmacopoeia full standard term.




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4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                     Traditional use

                                                             Traditional herbal medicinal product to increase
                                                             the amount of urine to achieve flushing of the
                                                             urinary tract as an adjuvant in minor urinary
                                                             complaints.

                                                             The product is a traditional herbal medicinal
                                                             product for use in the specified indication
                                                             exclusively based upon long-standing use.


4.2. Posology and method of administration4

    Well-established use                                     Traditional use

                                                             Posology

                                                             Adults and Elderly

                                                                  Combinations containing (among other active
                                                                  ingredients) Juniperi galbulus, Levistici radix,
                                                                  Mate folium, Orthosiphonis folium, Phaseoli
                                                                  fructus or Uvae ursi folium

                                                             Adolescents, Adults and Elderly

                                                                  Combinations containing none of the above
                                                                  mentioned herbal substances

                                                             Herbal tea: 1.5–2 g of the herbal tea
                                                             combination in 150 ml of boiling water as an
                                                             herbal infusion 3–4 times daily.

                                                             Depending on the herbal substances included:

                                                             The use in children and adolescents under 18
                                                             years of age is not recommended (see section
                                                             4.4 ‘Special warnings and precautions for use’).

                                                             or

                                                             The use in children under 12 years of age is not
                                                             recommended (see section 4.4 ‘Special warnings
                                                             and precautions for use’).

                                                             Duration of use

                                                             If the symptoms persist longer than 2 weeks
                                                             during the use of the medicinal product, a doctor
                                                             or a qualified health care practitioner should be

4
 For guidance on herbal substance/herbal preparation administered as a herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


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 Well-established use                                   Traditional use

                                                        consulted.

                                                        Method of administration

                                                        Oral use

Contraindications

4.3. Contraindications

 Well-established use                                   Traditional use

                                                        All combinations:

                                                            Hypersensitivity to the active substances.
                                                            Conditions where a reduced fluid intake is
                                                            recommended (e.g. severe cardiac or renal
                                                            disease).

                                                        Combinations containing Betulae folium:

                                                            Additionally: Hypersensitivity to birch pollen.

                                                        Combinations containing Levistici radix:

                                                            Additionally: Hypersensitivity to other plants
                                                            of the Apiaceae family or to anethole.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                   Traditional use

                                                        Depending on the herbal substances included:

                                                            The use in children and adolescents under 18
                                                            years of age has not been established due to
                                                            lack of adequate data.

                                                            or

                                                            The use in children under 12 years of age
                                                            has not been established due to lack of
                                                            adequate data.

                                                        If urinary tract complaints worsen or symptoms
                                                        such as fever, dysuria, spasm, or blood in the
                                                        urine occur during the use of medicinal product,
                                                        a doctor or a qualified health care practitioner
                                                        should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                   Traditional use




European Union herbal monograph on Species diureticae
EMA/HMPC/224755/2016                                                                                  Page 6/9
 Well-established use                                   Traditional use

                                                        None reported

Undesirable effects

4.8. Undesirable effects

 Well-established use                                   Traditional use

                                                        For an individual combination the combined
                                                        information regarding undesirable effects taken
                                                        from the European Union herbal monographs for
                                                        the single ingredients have to be used.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition1,2
Well-established use                                          Traditional use

                                                              With regard to the registration application of Article
                                                              16d(1) of Directive 2001/83/EC

                                                              Herbal tea combinations containing 2, 3 or 4 herbal
                                                              substances out of the following list:

                                                              Humulus lupulus L., flos

                                                              Lavandula angustifolia Mill., flos

                                                              Melissa officinalis L., folium

                                                              Passiflora incarnata L., herba

                                                              Valeriana officinalis L., radix

                                                              i) Herbal substance

                                                              Not applicable

                                                              ii) Herbal preparations

                                                              Combinations of the comminuted herbal substances




1
  The declaration of the active substance(s) for an individual finished product s hould be in accordance with relevant herbal
quality guidance.
2
  The material complies with the respective monographs in Ph. Eur.


European Union herbal monograph on Species sedativae
EMA/HMPC/438183/2017                                                                                                 Page 3/7
                                                                                                                                          combination (excl.
                                                                                                         Passiflorae herba
                            Valerianae radix




                                                                                     Lavandulae flos
                                                 Melissae folium




                                                                                                                                                               excipients)
                                                                                                                             Range in a
                                                                     Lupuli flos
Amount of
Valerianae radix
in combination                  -              15-57%              15-57%          15-57%              33-57%                 15-57%

with:
Amount of
Melissae folium
in combination           11-30%                      -             11-30%          11-30%              27-57%                 11-57%

with:
Amount of Lupuli
flos in
combination              15-43%                15-43%                  -           15-40%              21-36%                 15-43%

with:
Amount of
Lavandulae flos
                         15-36%                15-36%              15-30%                -                    -               15-36%
in combination
with:
Amount of
Passiflorae herba
in combination           11-34%                11-34%              11-28%                -                    -               11-34%

with:

The grey shaded fields indicate combinations with evidence of traditional medicinal use.

Out of these documented combinations the combination partners for an application for a traditional
herbal medicinal product may be chosen.

The number of active substances in an herbal tea combination should be limited to a maximum of 4.
Further herbal substances may be added as excipients.

The far right column indicates the traditional amount of the herbal substance in the combinations. The
calculation is based on those combination partners only, which contribute to the plausibility of efficacy.
The amount in a traditional herbal medicinal product should be within this range. The sum of active
ingredients should end up with 100%. Excipients are not considered in this range.

Usually, the sum of all excipients should not exceed 30% in the final combination and no more than 3
excipients should be used (see also Regulatory Q&A on herbal medicinal products,
EMA/HMPC/345132/2010 Rev. 4).



3. Pharmaceutical form
Well-established use                                                   Traditional use


European Union herbal monograph on Species sedativae
EMA/HMPC/438183/2017                                                                                                                           Page 4/7
Well-established use                                         Traditional use

                                                             Comminuted herbal substances as herbal tea for
                                                             oral use.

                                                             The pharmaceutical form should be described by
                                                             the European Pharmacopoeia full standard term.



4. Clinical particulars
4.1. Therapeutic indications

Well-established use                                         Traditional use

                                                             Traditional herbal medicinal product for relief of
                                                             mild symptoms of mental stress and to aid sleep.
                                                             The product is a traditional herbal medicinal
                                                             product for use in the specified indication
                                                             exclusively based upon long-standing use.



4.2. Posology and method of administration 3

Well-established use                                         Traditional use

                                                             Posology

                                                             Adolescents, Adults and Elderly

                                                             Herbal tea: 1.5–4 g of the herbal tea combination
                                                             in 150 ml of boiling water as a herbal infusion 3–4
                                                             times daily, the last dose before going to bed.

                                                             The use in children under 12 years of age is not
                                                             recommended (see section 4.4 ‘Special warnings
                                                             and precautions for use’).

                                                             Duration of use

                                                             If the symptoms persist longer than 2 weeks
                                                             during the use of the medicinal product, a doctor
                                                             or a qualified health care practitioner should be
                                                             consulted.

                                                             Method of administration

                                                             Oral use




3
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).



European Union herbal monograph on Species sedativae
EMA/HMPC/438183/2017                                                                                           Page 5/7

Contraindications

4.3. Contraindications

Well-established use                                   Traditional use

                                                       Hypersensitivity to the active substances.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                   Traditional use

                                                       The use in children under 12 years of age has not
                                                       been established due to lack of adequate data.

                                                       If the symptoms worsen during the use of the
                                                       medicinal product, a doctor or a qualified health
                                                       care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                   Traditional use

                                                       None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                   Traditional use

                                                       None known

                                                       In herbal tea combinations containing Valeriana
                                                       officinalis L., radix, gastrointestinal symptoms
                                                       (e.g. nausea, abdominal cramps) may occur. The


European Union herbal monograph on Species sedativae
EMA/HMPC/438183/2017                                                                                Page 6/7
Well-established use                                   Traditional use

                                                       frequency is not known.

                                                       If adverse reactions occur, a doctor or a qualified
                                                       health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2,3
 Well-established use                                            Traditional use

                                                                 With regard to the registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC as
                                                                 amended

                                                                 Symphytum officinale L., radix (comfrey root)

                                                                 i) Herbal substance
                                                                 Not applicable.

                                                                 ii) Herbal preparations
                                                                 Liquid extract prepared by extraction with
                                                                 ethanol 65% (V/V) followed by partial
                                                                 evaporation and adjustment to a DER 2:1



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal preparations in semi-solid dosage forms
                                                                 for cutaneous use.

                                                                 The pharmaceutical form should be described by
                                                                 the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

                                                                 Traditional herbal medicinal product used for the
                                                                 symptomatic relief of minor sprains and bruises.

                                                                 The product is a traditional herbal medicinal
                                                                 product for use in the specified indication
                                                                 exclusively based upon long-standing use.


2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
3 Detailed specification for the herbal substance shall be given by refences to bibliographic sources in absence of a

monograph in the European Pharmacopoeia.

European Union herbal monograph on Symphytum officinale L., radix
EMA/HMPC/572846/2009                                                                                                    Page 2/7
4.2. Posology and method of administration

 Well-established use                                           Traditional use

                                                                Posology

                                                                Adults and elderly:

                                                                Single dose for semi-solid dosage forms (10%
                                                                liquid extract):
                                                                apply a thin layer, 2 times a daily

                                                                The use in children and adolescents under 18
                                                                years of age is not recommended (see section
                                                                4.4 ’Special warnings and precaution for use’).

                                                                Duration of use

                                                                Not to be used for more than 10 days.

                                                                If the symptoms persist during the use of the
                                                                medicinal product, a doctor or a qualified health
                                                                care practitioner should be consulted.

                                                                Method of administration

                                                                Cutaneous use.

Contraindications

4.3. Contraindications

 Well-established use                                          Traditional use

                                                               Hypersensitivity to the active substance(s).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                           Traditional use

                                                                Not to be applied to broken or irritated skin.

                                                                Avoid contact with the eyes or mucous
                                                                membranes.

                                                                If the symptoms worsen during the use of the
                                                                medicinal product, a doctor or a qualified health
                                                                care practitioner should be consulted.

                                                                The use in children and adolescents under 18
                                                                years of age has not been established due to
                                                                lack of adequate data.




European Union herbal monograph on Symphytum officinale L., radix
EMA/HMPC/572846/2009                                                                                          Page 3/7

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                           Traditional use

                                                                None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                None known.

                                                                If adverse reactions occur, a doctor or a qualified
                                                                health care practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC as
                                                                amended


                                                                Taraxacum officinale Weber ex Wigg., folium
                                                                (dandelion leaf)


                                                                i) Herbal substance

                                                                    Not applicable.


                                                                ii) Herbal preparations


                                                                a) Dried leaves, comminuted
                                                                b) Liquid extract (DER 1:1),
                                                                   extraction solvent ethanol 25% (V/V)
                                                                c) Expressed juice 2 from fresh leaves



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparations in liquid dosage forms for oral
                                                                use.

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.




1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2 The material complies, when dried, with Ph. Eur. monograph on herbal drugs.

Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium
EMA/HMPC/579636/2008                                                                                                 Page 2/6
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

                                                               Traditional herbal medicinal product to increase
                                                               the amount of urine to achieve flushing of the
                                                               urinary tract as an adjuvant in minor urinary
                                                               complaints.

                                                               The product is a traditional herbal medicinal
                                                               product for use in the specified indication
                                                               exclusively based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                           Traditional use

                                                               Posology

                                                               Adolescents, adults and elderly
                                                               a) Comminuted herbal substance:
                                                                  Single dose 4-10 g as an infusion,
                                                                  3 times daily

                                                               b) Liquid extract:
                                                                  Single dose 4-10 ml,
                                                                  3 times daily

                                                               c)   Expressed juice from fresh leaves:
                                                                    Single dose 5-10 ml,
                                                                    2 times daily

                                                               The use in children under 12 years of age is not
                                                               recommended (see section 4.4 ‘Special warnings
                                                               and precautions for use’).

                                                               Duration of use

                                                               If the symptoms persist longer than 2 weeks
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Oral use.

                                                               To ensure an increase of the amount of urine,
                                                               adequate fluid intake is required during treatment.




Community herbal monograph on Taraxacum officinale Weber ex Wigg., folium
EMA/HMPC/579636/2008                                                                                         Page 3/6

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

                                                              Hypersensitivity to the active substance or to
                                                              plants of the Asteraceae (Compositae) family.

                                                              Obstructions of bile ducts, cholangitis, liver
                                                              diseases, gallstones, active peptic ulcer and any
                                                              other biliary diseases.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

                                                               The use in patients with renal failure and/or
                                                               diabetes, and/or heart failure should be avoided
                                                               because of possible risks due to hyperkalemia.

                                                               The use in children under 12 years of age has not
                                                               been established due to lack of adequate data.

                                                               If complaints or symptoms such as fever, dysuria,
                                                               spasms or blood in urine occur during the use of
                                                               the medicinal product, a doctor or a qualified
                                                               health care practitioner should be consulted.

                                                               For extracts containing ethanol, the appropriate
                                                               labelling for ethanol, taken from the ‘Guideline on
                                                               excipients in the label and package leaflet of
                                                               medicinal products for human use’, must be
                                                               included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                           Traditional use

                                                               None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               Allergic reactions may occur. The frequency is not
                                                               known.

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2, 3
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Taraxacum officinale F.H. Wigg., radix
                                                                (dandelion root).

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                a) Comminuted dried root

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol

                                                                c) Juice from fresh root

                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V



3. Pharmaceutical form
    Well-established use                                        Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparations in liquid dosage form for
                                                                oral use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.


2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant
herbal quality guidance.
3
    The material complies with the Ph. Eur. monograph (ref.: 1852).



European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                          Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product used for the
                                                                relief of symptoms related to mild digestive
                                                                disorders (such as feeling of abdominal fullness,
                                                                flatulence, and slow digestion).

                                                                Indication 2)

                                                                Traditional herbal medicinal product for
                                                                temporary loss of appetite.

                                                                Indication 3)

                                                                Traditional herbal medicinal product to increase
                                                                the amount of urine to achieve flushing of the
                                                                urinary tract as an adjuvant in minor urinary
                                                                complaints.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indications
                                                                exclusively based upon long-standing use.


4.2. Posology and method of administration 4

    Well-established use                                        Traditional use

    Posology                                                    Posology

                                                                Adolescents, adults and elderly

                                                                Indications 1), 2) and 3)

                                                                a) Comminuted herbal substance for
                                                                     decoction: single dose of 1-5 g in 150 ml of
                                                                     water, 2-3 times daily

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol: single dose
                                                                     5 ml, diluted in small volume of water, 3
                                                                     times daily

                                                                Indication 1) and 3)

                                                                c)   Juice from fresh root: single dose 4-8 ml, 3
                                                                     times daily


4
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                           Page 4/8
 Well-established use                                           Traditional use



                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V: single dose 2-8 ml, 3
                                                                     times daily

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V: single dose 5-10 ml, 3
                                                                     times daily

                                                                The use in children under 12 years of age is not
                                                                recommended (see section 4.4 ‘Special
                                                                warnings and precautions for use’).

                                                                Duration of use

                                                                If the symptoms persist longer than 2 weeks
                                                                during the use of the medicinal product, a
                                                                doctor or a qualified health care practitioner
                                                                should be consulted.

                                                                Method of administration

                                                                Oral use.

                                                                Indication 2)

                                                                Preparations are to be taken ½ hour before
                                                                meal.

                                                                Indication 3)

                                                                To ensure an increase of the amount of urine,
                                                                adequate fluid intake is required during
                                                                treatment (see section 4.4. Special warnings
                                                                and precautions for use).

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance or to
                                                                plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                           Traditional use

                                                                Indication 1), 2) and 3)

                                                                Due to possible stimulation on bile secretion,
                                                                dandelion root is not recommended in case of


European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                         Page 5/8
 Well-established use                                           Traditional use

                                                                obstruction of the bile duct, cholangitis, liver
                                                                disease, gallstones and any other biliary
                                                                diseases.

                                                                The use in children under 12 years of age has
                                                                not been established due to lack of adequate
                                                                data.

                                                                Indication 3)

                                                                If complaints or symptoms such as fever,
                                                                dysuria, spasms or blood in urine occur during
                                                                the use of the medicinal product, a doctor or a
                                                                qualified health care practitioner should be
                                                                consulted.

                                                                Because adequate fluid intake is required during
                                                                treatment (see section 4.2. Posology and
                                                                method of administration), dandelion root is not
                                                                recommended for patients with conditions
                                                                where reduced fluid intake is advised by a
                                                                medical doctor.

                                                                For preparations containing ethanol, the
                                                                appropriate labelling for ethanol, taken from the
                                                                ‘Guideline on excipients in the label and
                                                                package leaflet of medicinal products for human
                                                                use’, must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                           Traditional use

                                                                None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                Allergic reactions may occur. The frequency is
                                                                not known.

                                                                If other adverse reactions not mentioned above
                                                                occur, a doctor or a qualified health care
                                                                practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 2, 3
    Well-established use                                        Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Taraxacum officinale F.H. Wigg., radix
                                                                (dandelion root).

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                a) Comminuted dried root

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol

                                                                c) Juice from fresh root

                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V



3. Pharmaceutical form
    Well-established use                                        Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparations in liquid dosage form for
                                                                oral use.

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.


2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant
herbal quality guidance.
3
    The material complies with the Ph. Eur. monograph (ref.: 1852).



European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                          Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                        Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product used for the
                                                                relief of symptoms related to mild digestive
                                                                disorders (such as feeling of abdominal fullness,
                                                                flatulence, and slow digestion).

                                                                Indication 2)

                                                                Traditional herbal medicinal product for
                                                                temporary loss of appetite.

                                                                Indication 3)

                                                                Traditional herbal medicinal product to increase
                                                                the amount of urine to achieve flushing of the
                                                                urinary tract as an adjuvant in minor urinary
                                                                complaints.

                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indications
                                                                exclusively based upon long-standing use.


4.2. Posology and method of administration 4

    Well-established use                                        Traditional use

    Posology                                                    Posology

                                                                Adolescents, adults and elderly

                                                                Indications 1), 2) and 3)

                                                                a) Comminuted herbal substance for
                                                                     decoction: single dose of 1-5 g in 150 ml of
                                                                     water, 2-3 times daily

                                                                b) Expressed juice (DER 1:1) from fresh root
                                                                     subjected to a steam of ethanol: single dose
                                                                     5 ml, diluted in small volume of water, 3
                                                                     times daily

                                                                Indication 1) and 3)

                                                                c)   Juice from fresh root: single dose 4-8 ml, 3
                                                                     times daily


4
 For guidance on herbal substance/herbal preparation administered as herbal tea or as infusion/decoction/macerate
preparation, please refer to the HMPC ‘Glossary on herbal teas’ (EMA/HMPC/5829/2010 Rev.1).


European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                           Page 4/8
 Well-established use                                           Traditional use



                                                                d) Liquid extract (DER 1:1), extraction solvent
                                                                     ethanol 30% V/V: single dose 2-8 ml, 3
                                                                     times daily

                                                                e) Tincture (ratio of herbal substance to
                                                                     extraction solvent 1:5), extraction solvent
                                                                     ethanol 45% V/V: single dose 5-10 ml, 3
                                                                     times daily

                                                                The use in children under 12 years of age is not
                                                                recommended (see section 4.4 ‘Special
                                                                warnings and precautions for use’).

                                                                Duration of use

                                                                If the symptoms persist longer than 2 weeks
                                                                during the use of the medicinal product, a
                                                                doctor or a qualified health care practitioner
                                                                should be consulted.

                                                                Method of administration

                                                                Oral use.

                                                                Indication 2)

                                                                Preparations are to be taken ½ hour before
                                                                meal.

                                                                Indication 3)

                                                                To ensure an increase of the amount of urine,
                                                                adequate fluid intake is required during
                                                                treatment (see section 4.4. Special warnings
                                                                and precautions for use).

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance or to
                                                                plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                           Traditional use

                                                                Indication 1), 2) and 3)

                                                                Due to possible stimulation on bile secretion,
                                                                dandelion root is not recommended in case of


European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix
EMA/HMPC/475726/2020                                                                                         Page 5/8
 Well-established use                                           Traditional use

                                                                obstruction of the bile duct, cholangitis, liver
                                                                disease, gallstones and any other biliary
                                                                diseases.

                                                                The use in children under 12 years of age has
                                                                not been established due to lack of adequate
                                                                data.

                                                                Indication 3)

                                                                If complaints or symptoms such as fever,
                                                                dysuria, spasms or blood in urine occur during
                                                                the use of the medicinal product, a doctor or a
                                                                qualified health care practitioner should be
                                                                consulted.

                                                                Because adequate fluid intake is required during
                                                                treatment (see section 4.2. Posology and
                                                                method of administration), dandelion root is not
                                                                recommended for patients with conditions
                                                                where reduced fluid intake is advised by a
                                                                medical doctor.

                                                                For preparations containing ethanol, the
                                                                appropriate labelling for ethanol, taken from the
                                                                ‘Guideline on excipients in the label and
                                                                package leaflet of medicinal products for human
                                                                use’, must be included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

 Well-established use                                           Traditional use

                                                                None reported.

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                Allergic reactions may occur. The frequency is
                                                                not known.

                                                                If other adverse reactions not mentioned above
                                                                occur, a doctor or a qualified health care
                                                                practitioner should be consulted.

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition 1, 2
Well-established use                                          Traditional use

                                                              With regard to the registration application of
                                                              Article 16d(1) of Directive 2001/83/EC as
                                                              amended.

                                                              Taraxacum officinale Weber ex Wigg., radix cum
                                                              herba (dandelion root with herb).

                                                              i) Herbal substance

                                                                 Not applicable.

                                                              ii) Herbal preparations

                                                              a) Comminuted dried root with herb
                                                              b) Dry extract (DER 5.6-8.4:1),

                                                                 extraction solvent ethanol 60% (V/V)
                                                              c) Liquid extract (DER 1:0.9-1.1),

                                                                 extraction solvent ethanol 30% (V/V)
                                                              d) Liquid extract (DER 0.75:1),

                                                                 extraction solvent ethanol 30% (m/m)
                                                              e) Expressed juice (DER 1:0.5-0.8) from

                                                                 fresh flowering Taraxaci radix cum herba 3



3. Pharmaceutical form
Well-established use                                          Traditional use

                                                              Herbal preparations in solid or liquid dosage forms
                                                              for oral use.

                                                              Comminuted herbal substance as herbal tea for
                                                              oral use.

                                                              The pharmaceutical form should be described by

1
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant
herbal quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 1851).

3 The material, when dried, complies with the Ph. Eur. monograph.

Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum
herba
EMA/HMPC/212895/2008                                                                                         Page 3/7
Well-established use                                          Traditional use

                                                              the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                          Traditional use

                                                              Indication a)

                                                              Traditional herbal medicinal product for the relief
                                                              of symptoms related to mild digestive disorders
                                                              (such as feeling of abdominal fullness, flatulence,
                                                              and slow digestion) and temporary loss of
                                                              appetite.

                                                              Indication b)

                                                              Traditional herbal medicinal product to increase
                                                              the amount of urine to achieve flushing of the
                                                              urinary tract as an adjuvant in minor urinary
                                                              complaints.

                                                              The product is a traditional herbal medicinal
                                                              product for use in specified indications exclusively
                                                              based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                          Traditional use

                                                              Posology

                                                              Adolescents, adults and elderly
                                                              Indication a)

                                                              a) Comminuted dried root with herb,
                                                                   3-4 g as a decoction or 4-10 g as an infusion
                                                                   up to 3 times daily
                                                              b) 1 coated tablet, 300 mg dry extract,
                                                                   2 times daily or
                                                                   1-2 coated tablets, 150 mg dry extract each,
                                                                   3 times daily
                                                              c)   Liquid extract 90 drops
                                                                   (90 drops = 3.15 ml = 3.31 g),
                                                                    3 times daily
                                                              d) Liquid extract 35 drops
                                                                   (35 drops = ca. 1 ml = 1 g),
                                                                    3 times daily
                                                              e) Expressed juice from fresh flowering Taraxaci

Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum
herba
EMA/HMPC/212895/2008                                                                                       Page 4/7
Well-established use                                          Traditional use

                                                                   radix cum herba
                                                                   Single dose 10 ml, 3 times daily


                                                              Indication b)

                                                              a) Comminuted dried root with herb,
                                                                   3-4 g as a decoction or 4-10 g as an infusion
                                                                   up to 3 times daily

                                                              The use in children under 12 years of age is not
                                                              recommended (see section 4.4 ‘Special warnings
                                                              and precautions for use’).

                                                              Duration of use

                                                              If the symptoms persist longer than 2 weeks
                                                              during the use of the medicinal product, a doctor
                                                              or a qualified health care practitioner should be
                                                              consulted.

                                                              Method of administration

                                                              Oral use.
                                                              Indication b)
                                                              To ensure an increase of the amount of urine,
                                                              adequate fluid intake is required during treatment.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

                                                              Hypersensitivity to the active substance or to
                                                              plants of the Asteraceae (Compositae) family.

                                                              Obstructions of bile ducts, cholangitis, liver
                                                              diseases, gallstones, active peptic ulcer and any
                                                              other biliary diseases.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                          Traditional use

                                                              The use in patients with renal failure and/or
                                                              diabetes, and/or heart failure should be avoided
                                                              because of possible risks due to hyperkalemia.

                                                              The use in children under 12 years of age has not
                                                              been established due to lack of adequate data.

                                                              If complaints or symptoms such as fever, dysuria,
                                                              spasms or blood in urine occur during the use of

Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum
herba
EMA/HMPC/212895/2008                                                                                           Page 5/7
Well-established use                                          Traditional use

                                                              the medicinal product, a doctor or a qualified
                                                              health care practitioner should be consulted.

                                                              For extracts containing ethanol, the appropriate
                                                              labelling for ethanol, taken from the ‘Guideline on
                                                              excipients in the label and package leaflet of
                                                              medicinal products for human use’, must be
                                                              included.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                          Traditional use

                                                              None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

                                                              Epigastric pain and hyperacidity may occur. The
                                                              frequency is not known.

                                                              Allergic reactions may occur. The frequency is not
                                                              known.

                                                              If other adverse reactions not mentioned above
                                                              occur, a doctor or a qualified health care
                                                              practitioner should be consulted.




Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum
herba
EMA/HMPC/212895/2008                                                                                       Page 6/7

Originalkontext vor Abschnitt 4.3, einschließlich der Angaben zu Zubereitungen und Anwendung. Buchstaben und Nummern der Zubereitungen werden in den Sicherheitsabschnitten wieder aufgegriffen.

1. Name of the medicinal product
To be specified for the individual finished product.


2. Qualitative and quantitative composition2, 3
Well-established use                                            Traditional use

                                                                With regard to the registration application of
                                                                Article 16d(1) of Directive 2001/83/EC.

                                                                Thymus vulgaris L. or Thymus zygis L. or a
                                                                mixture of both species, aetheroleum (thyme oil)

                                                                i) Herbal substance

                                                                    Not applicable

                                                                ii) Herbal preparations

                                                                    Essential oil



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Herbal preparations in liquid dosage forms for oral
                                                                use (Indication 1) and in liquid or semi-solid
                                                                dosage forms for cutaneous use and use as a bath
                                                                additive (Indication 2).

                                                                The pharmaceutical form should be described by
                                                                the European Pharmacopoeia full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product used as an
                                                                expectorant in cough associated with cold.
                                                                Indication 2)


2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal

quality guidance.
3 The material complies with the Ph. Eur. monograph (ref.: 1374)



European Union herbal monograph on Thymus vulgaris L., Thymus zygis L.,
aetheroleum
EMA/HMPC/59032/2017                                                                                                  Page 3/8
Well-established use                                           Traditional use

                                                               Traditional herbal medicinal product for the relief
                                                               of symptoms in coughs and colds.

                                                               The product is a traditional herbal medicinal
                                                               product for use in specified indications exclusively
                                                               based upon long-standing use.


4.2. Posology and method of administration

Well-established use                                           Traditional use

                                                               Posology
                                                               Indication 1)

                                                               Adults and elderly

                                                               Oral use:

                                                               Single dose: 0.2-0.25 ml, 3-5 times daily

                                                               Daily dose: 0.6-1.25 ml

                                                               The oral use in children and adolescents under 18
                                                               years of age is not recommended (see 4.4 ‘Special
                                                               warnings and precaution for use’).
                                                               Indication 2)

                                                               Adults and elderly

                                                               Cutaneous use: in liquid and semi-solid dosage
                                                               forms in concentrations up to 10%; apply up to 3
                                                               times daily.

                                                               Use as bath additive: 0.007-0.025 g per litre.

                                                               Adolescents

                                                               Use as bath additive: 0.007-0.025 g per litre.

                                                               Children 6-12 years

                                                               Use as bath additive: 0.0035-0.017 g per litre.

                                                               Children 3-6 years

                                                               Use as bath additive: 0.0017-0.0082 g per litre.

                                                               One bath every day or every second day.

                                                               The cutaneous use in children and adolescents
                                                               under 18 years of age is not recommended (see
                                                               4.4 ‘Special warnings and precaution for use’).

                                                               The use as bath additive in children under 3
                                                               years of age is not recommended (see 4.4 ‘Special
                                                               warnings and precaution for use’).

European Union herbal monograph on Thymus vulgaris L., Thymus zygis L.,
aetheroleum
EMA/HMPC/59032/2017                                                                                         Page 4/8
Well-established use                                           Traditional use

                                                               Duration of use
                                                               Indications 1) and 2)

                                                               If the symptoms persist longer than 1 week during
                                                               the use of the medicinal product, a doctor or a
                                                               qualified health care practitioner should be
                                                               consulted.
                                                               Indication 2)

                                                               Duration of a bath: 10-20 minutes

                                                               Method of administration

                                                               Indication 1)

                                                               Oral use

                                                               Indication 2)

                                                               Cutaneous use: Apply on the chest and the back.

                                                               Use as bath additive: recommended temperature
                                                               of bath 35-38°C.

Contraindications

4.3. Contraindications

Well-established use                                           Traditional use

                                                               Hypersensitivity to the active substance.

                                                               Use as bath additive:
                                                               Full hot baths are contraindicated in cases of
                                                               large skin injuries and open wounds, acute skin
                                                               diseases, high fever, severe infections, severe
                                                               circulatory disturbances and cardiac failure.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

                                                               Indication 1)

                                                               The use in children and adolescents under 18
                                                               years of age is not recommended due to lack of
                                                               adequate data.

                                                               When dyspnoea, fever or purulent sputum occurs,
                                                               a doctor or a qualified health care practitioner
                                                               should be consulted.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a qualified health
                                                               care practitioner should be consulted.


European Union herbal monograph on Thymus vulgaris L., Thymus zygis L.,
aetheroleum
EMA/HMPC/59032/2017                                                                                            Page 5/8
Well-established use                                           Traditional use

                                                               Indication 2)

                                                               Use as bath additive:

                                                               When dyspnoea, fever or purulent sputum occurs,
                                                               a doctor or a qualified health care practitioner
                                                               should be consulted.

                                                               The use in children under 3 years of age is not
                                                               recommended because medical advice should be
                                                               sought and due to lack of adequate data.

                                                               In cases of hypertension, a full bath should be
                                                               used with caution.

                                                               Cutaneous use:

                                                               Thyme oil should not be applied to the face
                                                               particularly in the nasal area of babies and infants
                                                               under the age of 2 years because of the risk of a
                                                               laryngospasm.

                                                               When dyspnoea, fever or purulent sputum occurs,
                                                               a doctor or a qualified health care practitioner
                                                               should be consulted.

                                                               The use in children and adolescents under 18
                                                               years of age is not recommended due to lack of
                                                               adequate data.

                                                               If the symptoms worsen during the use of the
                                                               medicinal product, a doctor or a qualified health
                                                               care practitioner should be consulted.

Interactions with other medicinal products and other forms of interaction

4.5. Interactions with other medicinal products and other forms of
interaction

Well-established use                                           Traditional use

                                                               None reported

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               Indication 1)

                                                               Hypersensitivity reactions have been observed.
                                                               The frequency is not known.
                                                               Indication 2)

                                                               Hypersensitivity reactions and skin irritation have
                                                               been observed. The frequency is not known.

                                                               If other adverse reactions not mentioned above
                                                               occur, a doctor or a qualified health care
                                                               practitioner should be consulted.