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 1,2
Well-established use                                            Traditional use

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

Plantago afra L. (Plantago psyllium L.) or Plantago
indica L. (Plantago arenaria Waldstein and
Kitaibel), semen (psyllium seed)

i) Herbal substance
    Ripe, whole, dry seeds

ii) Herbal preparations
    Powdered herbal substance



3. Pharmaceutical form
Well-established use                                            Traditional use

Herbal substance for oral use; herbal preparation
in 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)
Herbal medicinal product for the treatment of
habitual constipation.

Indication 2)
Herbal medicinal product in conditions in which


1
 The material complies with the Eur. Ph. monograph monograph (ref.: 01/2008:0858).
2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.



Community herbal monograph on Plantago afra L. et Plantago indica L., semen
EMA/HMPC/599747/2012                                                                                               Page 3/11
Well-established use                                            Traditional use

easy defecation with soft stool is desirable, e.g. in
cases of painful defecation after rectal or anal
surgery, anal fissures and haemorrhoids.


4.2. Posology and method of administration

Well-established use                                            Traditional use

Posology

Adolescents, adults and elderly

Daily dose
25 - 40 g herbal substance/herbal preparation in
3 single doses

Children from 6 to 12 years of age

Daily dose
12 - 25 g herbal substance/herbal preparation in
3 single doses

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

Duration of use

If the constipation does not resolve within 3 days,
a doctor or a pharmacist should be consulted.

See section 4.4 ‘Special warnings and precautions
for use.’

Method of administration

A sufficient amount of liquid (water, milk, fruit
juice or similar aqueous liquid) should always be
taken e.g. 30 ml of water per 1 g of herbal
substance.

The medicinal product can be mixed with the
liquids and then swallowed or taken and then
swallowed with sufficient quantity of liquid.
Adequate fluid intake has to be maintained.

The product should be taken during the day at
least ½ to 1 hour before or after intake of other
medicines, not immediately prior to bed-time.

The effect starts 12 - 24 hours later.




Community herbal monograph on Plantago afra L. et Plantago indica L., semen
EMA/HMPC/599747/2012                                                              Page 4/11
Well-established use                                            Traditional use

Powder formulations:

When preparing the product for administration, it
is important to try to avoid inhaling any of the
powder in order to minimise the risk of
sensitisation to the active ingredient.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

Hypersensitivity to the active substance (for
powder formulations add: See section 4.4 ‘Special
warnings and precautions for use’).

Patients with a sudden change in bowel habit that
persists for more than 2 weeks.

Undiagnosed rectal bleeding and failure to
defecate following the use of a laxative.

Patients suffering from abnormal constrictions in
the gastro-intestinal tract, with diseases of the
oesophagus and cardia, potential or existing
intestinal blockage (ileus), paralysis of the
intestine or megacolon.

Patients who have difficulty in swallowing or any
throat problems.

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 below
6 years of age due to insufficient data on efficacy.
Laxative bulk producers should be used before
using other purgatives if change of nutrition is not
successful.

A sufficient amount of liquid should always be
taken e.g. 30 ml of water per 1 g of herbal
substance.

Psyllium seed should not be used by patients with
faecal impaction and symptoms such as
abdominal pain, nausea and vomiting unless
advised by a doctor because these symptoms can
be signs of potential or existing intestinal blockage
(ileus).




Community herbal monograph on Plantago afra L. et Plantago indica L., semen
EMA/HMPC/599747/2012                                                              Page 5/11
Well-established use                                            Traditional use


If abdominal pain occurs or in cases of any
irregularity of faeces, the use of psyllium seed
should be discontinued and medical advice must
be sought.

When taken with inadequate fluid amounts, bulk
forming agents can cause obstruction of the
throat and oesophagus with choking and intestinal
obstruction. Symptoms can be chest pain,
vomiting, or difficulty in swallowing or breathing.

The treatment of debilitated patients and / or
elderly patients requires medical supervision.

In order to decrease the risk of gastrointestinal
obstruction (ileus) psyllium seed should be used
together with medicinal products known to inhibit
peristaltic movement (e.g. opioids) only under
medical supervision.

Powder formulations:

Warning on hypersensitive reactions

In individuals with continued occupational contact
to powder of psyllium seeds (i.e. healthcare
workers, caregivers) allergic sensitisation may
occur due to inhalation, this is more frequent in
atopic individuals. This sensitisation usually leads
to hypersensitivity reactions which could be
serious (see 4.8 ‘Undesirable effects’).

It is recommended to assess clinically the possible
sensitisation of individuals at risk and, if justified,
to perform specific diagnostic tests.

In case of proven sensitisation leading to
hypersensitivity reactions, exposure to the
product should be stopped immediately and
avoided in the future (see 4.3 ‘Contraindications’).

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

Enteral absorption of concomitantly administered
medicines such as minerals, vitamins (B 12),
cardiac glycosides, coumarin derivatives,
carbamazepine and lithium may be delayed. For
this reason the product should not be taken ½ to



Community herbal monograph on Plantago afra L. et Plantago indica L., semen
EMA/HMPC/599747/2012                                                              Page 6/11
Well-established use                                            Traditional use

1 hour before or after intake of other medicinal
products.

Diabetic patients should take psyllium seeds only
under medical supervision because adjustment of
anti-diabetic therapy may be necessary.

Use of psyllium seed concomitantly with thyroid
hormones requires medical supervision because
the dose of the thyroid hormones may have to be
adjusted.

Undesirable effects

4.8. Undesirable effects

Well-established use                                            Traditional use

Flatulence may occur with the use of the product,
with generally disappears in the course of the
treatment. Abdominal distension and risk of
intestinal or oesophageal obstruction and faecal
impaction may occur, particularly if swallowed
with insufficient fluid. The frequency is not known.

Psyllium seed contains potent allergens. The
exposure to these allergens is possible through



Community herbal monograph on Plantago afra L. et Plantago indica L., semen
EMA/HMPC/599747/2012                                                              Page 7/11
Well-established use                                            Traditional use

oral administration, contact with the skin and, in
the case of powder formulations, also by
inhalation. As a consequence to this allergic
potential, individuals exposed to the product can
develop hypersensitivity reactions such as rhinitis,
conjunctivitis, bronchospasm and in some cases,
anaphylaxis. Cutaneous symptoms such as
exanthema and/or pruritus have also been
reported. Special attention should be given to
individuals manipulating the powder formulations
routinely (see 4.4 ‘Special warnings and
precautions for use’). The frequency is 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 1,2
Well-established use                                            Traditional use

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

                                                                Quercus robur L., Quercus petraea (Matt.) Liebl.
                                                                and Quercus pubescens Willd., cortex (oak bark)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                     a) Comminuted herbal substance

                                                                     b) Powdered herbal substance

                                                                     c)   Dry extract (DER 5.0-6.5:1), extraction
                                                                          solvent ethanol 50% m/m



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as a herbal tea for
                                                                oral use or as a decoction preparation for
                                                                oromucosal or cutaneous use.

                                                                Herbal preparation in solid or liquid dosage forms
                                                                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. no 01/2008:1887).
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.

Community herbal monograph on Quercus robur L., Quercus petraea.(Matt.) Liebl.,
Quercus pubescens Willd., cortex
EMA/HMPC/3203/2009                                                                                                  Page 2/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Indication 1)

                                                                Traditional herbal medicinal product for
                                                                symptomatic treatment of mild diarrhoea.

                                                                Indication 2)

                                                                Traditional herbal medicinal product for
                                                                symptomatic treatment of minor inflammation of
                                                                the oral mucosa or skin.

                                                                Indication 3)

                                                                Traditional herbal medicinal product for
                                                                symptomatic relief of itching and burning
                                                                associated with haemorrhoids, after serious
                                                                conditions have been excluded by a medical
                                                                doctor.

                                                                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, elderly

                                                                Indication 1)

                                                                     a) 3 g comminuted herbal substance in 250
                                                                          ml of water, three times daily.

                                                                     b) 1 g powdered herbal substance in
                                                                          capsules/tablets for oral use, three times
                                                                          daily.

                                                                     c)   Dry extract: 140 mg, 4 times daily.

                                                                Indication 2)

                                                                     a) Decoction for oromucosal use: 20 g/L.

                                                                Indications 2) and 3)

                                                                     b) Decoction for bath preparation: 5 g
                                                                          comminuted herbal substance/1L to be
                                                                          added to the bath (bath duration 20


Community herbal monograph on Quercus robur L., Quercus petraea.(Matt.) Liebl.,
Quercus pubescens Willd., cortex
EMA/HMPC/3203/2009                                                                                              Page 3/7
Well-established use                                            Traditional use

                                                                          minutes).

                                                                One full or partial bath daily.

                                                                Topical rinses or poultices several 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

                                                                Indication 1)

                                                                Not to be used for more than 3 days.

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

                                                                Indications 2) and 3)

                                                                Not to be used for more than 1 week.

                                                                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.

                                                                Cutaneous use.

                                                                Oromucosal use.

                                                                Anorectal use.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

                                                                Hypersensitivity to the active substance.
                                                                Use as bath additive:
                                                                Open wounds, large skin and mucosa injuries
                                                                and infection of the skin and mucosa.




Community herbal monograph on Quercus robur L., Quercus petraea.(Matt.) Liebl.,
Quercus pubescens Willd., cortex
EMA/HMPC/3203/2009                                                                                             Page 4/7

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 is not recommended due to lack of
                                                                adequate data.

                                                                Indication 1)

                                                                If recurrent diarrhoea or bloody stools occur, a
                                                                doctor or a qualified health care practitioner
                                                                should be consulted.

                                                                Indications 2) and 3)

                                                                Hot bathes should not be used in case of febrile or
                                                                infectious illnesses, in heart insufficiency and
                                                                hypertension.

                                                                Indication 3)

                                                                If rectal bleeding occurs during the treatment of
                                                                haemorrhoids a doctor 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

                                                                Indication 1)

                                                                Internal absorption of concomitantly administered
                                                                medicine may be delayed. For this reason, the
                                                                product should be taken 1 hour or more before or
                                                                after intake of other medicinal products.

Undesirable effects

4.8. Undesirable effects

Well-established use                                            Traditional use

                                                                Allergic reactions have been reported. 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 marketing authorisation                     With regard to the registration application of
application of Article 10(a) of Directive                      Article 16d(1) of Directive 2001/83/EC.
2001/83/EC.

Rhamnus purshiana DC. (Frangula purshiana
(D.C.) A. Gray), cortex (cascara bark)

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 comminuted herbal substance or
herbal preparations in solid or liquid dosage forms
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 with the Ph. Eur. monograph (ref .: 0105)



European Union herbal monograph on Rhamnus purshiana DC. cortex
EMA/HMPC/726270/2016                                                                                               Page 3/10
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                         Traditional use

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


4.2. Posology and method of administration3

Well-established use                                         Traditional use

Posology

Adolescents, adults, elderly

Single dose:

Herbal preparations equivalent to 10-30 mg
hydroxyanthracene derivatives, calculated as
cascaroside A, to be taken once daily at night.

The correct individual dose is the smallest
required to produce a comfortable soft-formed
motion.

Herbal tea: amount of comminuted herbal
substance (equivalent to not more than 30 mg
hydroxyanthracene derivatives) in 150 ml of
boiling water as herbal infusion.

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.




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 Rhamnus purshiana DC. cortex
EMA/HMPC/726270/2016                                                                                           Page 4/10
Well-established use                                         Traditional 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),
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. Cascara bark
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 cascara bark concomitantly.

Like all laxatives, cascara bark 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 cascara bark preparations are administered



European Union herbal monograph on Rhamnus purshiana DC. cortex
EMA/HMPC/726270/2016                                                           Page 5/10
Well-established use                                         Traditional use

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
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:

Cascara bark 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 frequency is not known.

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




European Union herbal monograph on Rhamnus purshiana DC. cortex
EMA/HMPC/726270/2016                                                           Page 7/10

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 marketing authorisation                      With regard to the registration application of
application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC.
2001/83/EC.

Rheum palmatum L. or Rheum officinale Baillon or
their hybrids or a mixture of these two species
and/or their hybrids, radix (rhubarb root)

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.




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.: 0291)


European Union herbal monograph on Rheum palmatum L. and Rheum officinale
Baillon, radix
EMA/HMPC/113700/2019                                                                                                Page 3/10
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                         Traditional use

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


4.2. Posology and method of administration3

Well-established use                                         Traditional use

Posology

Adolescents, adults, elderly

Single dose:

Herbal preparation equivalent to 20-30 mg
hydroxyanthracene derivatives, calculated as
rhein, to be taken once daily at night.

The correct individual dose is the smallest
required to produce a comfortable soft-formed
motion.

Herbal tea: amount of comminuted herbal
substance (equivalent to not more than 30 mg
hydroxyanthracene derivatives) in 150 ml of
boiling water as herbal infusion.

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



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 Rheum palmatum L. and Rheum officinale
Baillon, radix
EMA/HMPC/113700/2019                                                                                           Page 4/10
Well-established use                                         Traditional use

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 colon 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
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. Rhubarb
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 rhubarb root concomitantly.

Like all laxatives, rhubarb root 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


European Union herbal monograph on Rheum palmatum L. and Rheum officinale
Baillon, radix
EMA/HMPC/113700/2019                                                           Page 5/10
Well-established use                                         Traditional use

be signs of potential or existing intestinal blockage
(ileus).

When rhubarb root 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
‘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:

Rhubarb root 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
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
treatment.

The frequency is not known.

If other adverse reactions not mentioned above


European Union herbal monograph on Rheum palmatum L. and Rheum officinale
Baillon, radix
EMA/HMPC/113700/2019                                                           Page 7/10
Well-established use                                         Traditional use

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 1
 Well-established use                                             Traditional use

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

                                                                  Rhodiola rosea L., rhizoma et radix (Arctic
                                                                  rhizome and root)

                                                                  i) Herbal substance

                                                                  Not applicable

                                                                  ii) Herbal preparations

                                                                  Dry extract (DER 1.5-5:1), extraction solvent
                                                                  ethanol 67-70% (V/V) 2



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Herbal preparations in 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

                                                                 Traditional herbal medicinal product for the
                                                                 relief of symptoms of stress, such as fatigue and
                                                                 exhaustion.

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


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

quality guidance.
2 A narrow DER to be specified for an individual medicinal product.




European Union herbal monograph on Rhodiola rosea L., rhizoma et radix
EMA/HMPC/24177/2023
                                                                                                                     Page 3/6
4.2. Posology and method of administration

 Well-established use                                            Traditional use

                                                                 Posology

                                                                 Adults and Elderly

                                                                 Single dose: 144-200 mg
                                                                 Dosage frequency: 1-2 times daily
                                                                 Daily dose: 144 - 400 mg

                                                                 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.

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

                                                                  No clinically relevant interactions have been
                                                                  observed.




European Union herbal monograph on Rhodiola rosea L., rhizoma et radix
EMA/HMPC/24177/2023
                                                                                                              Page 4/6

Undesirable effects

4.8. Undesirable effects

 Well-established use                                            Traditional use

                                                                 Nervous system disorders: Headache. The
                                                                 frequency is not known.

                                                                 Gastrointestinal disorders: Nausea, abdominal
                                                                 pain, diarrhoea. The frequency is not known.

                                                                 Skin and subcutaneous tissue disorders: Skin
                                                                 rash, itching. 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

                                                                Ribes nigrum L., folium (blackcurrant leaf)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                  a)    Comminuted herbal substance
                                                                  b)    Dry extract (DER 7:1), extraction solvent
                                                                        water
                                                                  c)    Powdered herbal substance


3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Herbal preparations in 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)

                                                                Traditional herbal medicinal product for the
                                                                relief of minor articular pain.


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.: 2528).


European Union herbal monograph on Ribes nigrum L., folium
EMA/HMPC/745353/2016                                                                                                 Page 3/7
 Well-established use                                        Traditional use

                                                             Indication 2)

                                                             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

                                                             Adults and elderly

                                                             Indication 1)

                                                             a) Comminuted herbal substance

                                                             Single dose: 2 to 4 g of the comminuted herbal
                                                             substance in 200 ml of boiling water as a herbal
                                                             infusion 3 times daily.

                                                             Daily dose: 6-12 g.

                                                             b) Dry extract (DER 7:1)

                                                             Single dose: 170 mg of dry extract (7:1, water),
                                                             1-3 times daily.

                                                             Daily dose: 170-510 mg.

                                                             c) Powdered herbal substance

                                                             Single dose: 340 mg of powdered herbal
                                                             substance, 3-5 times daily.

                                                             Daily dose: 1020-1700 mg.

                                                             Indication 2)

                                                             b) Dry extract (DER 7:1)

                                                             Single dose: 170 mg of dry extract (7:1, water),
                                                             1-3 times daily.

                                                             Daily dose: 170-510 mg.

                                                             c) Powdered herbal substance

                                                             Single dose: 340 mg of powdered herbal

                                                             substance 3-5 times daily




European Union herbal monograph on Ribes nigrum L., folium
EMA/HMPC/745353/2016                                                                                       Page 4/7
 Well-established use                                        Traditional use

                                                             Daily dose: 1020-1700 mg.

                                                             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 4 weeks
                                                             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

                                                             Indications 1) and 2)

                                                             Oral use

Contraindications

4.3. Contraindications

 Well-established use                                        Traditional use

                                                             Hypersensitivity to the active substance.

                                                             Indication 2)

                                                             Conditions where reduced fluid intake is
                                                             recommended (e.g. severe cardiac or renal
                                                             disease).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                        Traditional use

                                                             Indications 1) and 2)

                                                             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.

                                                             Indication 1)

                                                             Articular pain accompanied by swelling of joints,


European Union herbal monograph on Ribes nigrum L., folium
EMA/HMPC/745353/2016                                                                                      Page 5/7
 Well-established use                                        Traditional use

                                                             redness or fever, should be examined by a
                                                             doctor.

                                                             Indication 2)

                                                             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.

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

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.




European Union herbal monograph on Ribes nigrum L., folium
EMA/HMPC/745353/2016                                                                                        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 composition 2,3
Well-established use                                            Traditional use

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

Ricinus communis L., oleum (castor oil)

i) Herbal substance

Not applicable

ii) Herbal preparation

Fatty oil obtained from seeds of Ricinus communis
L. by cold expression



3. Pharmaceutical form
Well-established use                                            Traditional use

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

Laxative for short term use in cases of occasional
constipation.




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 (Ricini oleum virginale (ref.: 0051) or Ricini oleum raffinatum (ref.:
2367))


European Union herbal monograph on Ricinus communis L., oleum
EMA/HMPC/572974/2014                                                                                                 Page 2/6
4.2. Posology and method of administration

Well-established use                                            Traditional use

Posology

Adults and elderly

Daily dose: 2-5 g (2.1-5.3 ml) as a single dose

Normally it is sufficient to take this medicinal
product up to 2-3 times a week.

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

Use for more than 1 week requires medical
supervision.

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

Method of administration

Oral use

The onset time of defecation varies between 2-6
hours.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

Hypersensitivity to the active substance.

Cases of intestinal obstructions and stenosis,
atony, appendicitis, inflammatory colon 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 5.3)




European Union herbal monograph on Ricinus communis L., oleum
EMA/HMPC/572974/2014                                                              Page 3/6

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                            Traditional use

Long-term use of laxatives should be avoided. If
laxatives are needed every day the cause of
constipation should be investigated.

If stimulant laxatives are taken for longer than a
brief period, this may lead to impaired function of
the intestine. Castor oil should only be used if a
therapeutic effect cannot be achieved by a change
of diet or the administration of bulk forming
agents.

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

If the symptoms worsen during the use of the
medicinal product, a doctor or a pharmacist
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

Hypokalaemia (resulting from long-term laxative
abuse) potentiates the action of cardiac glycosides
and interacts with antiarrhythmic medicinal
products.

Concomitant use with diuretics, adrenal
corticosteroids and liquorice root may enhance
loss of potassium.

Concomitant use of antihistamines may reduce
the laxative action of castor oil.

Undesirable effects

4.8. Undesirable effects

Well-established use                                            Traditional use

Nausea, vomiting, abdominal pain and severe
diarrhoea may occur. The frequency is not known.
In such cases dose reduction is necessary.

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 1, 2
Well-established use                                              Traditional use

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

                                                                  Rosa gallica L., Rosa centifolia L., Rosa
                                                                  damascena Mill., flos (Rose flower)

                                                                  i) Herbal substance

                                                                  Dried petals

                                                                  ii) Herbal preparations

                                                                  Comminuted herbal substance



3. Pharmaceutical form
Well-established use                                              Traditional use

                                                                  Herbal substance or comminuted herbal substance
                                                                  for infusion preparation for oromucosal or
                                                                  cutaneous use.

                                                                  The pharmaceutical form should be described by
                                                                  full standard term.



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                               Traditional use

                                                                   Indication 1)

                                                                   Traditional herbal medicinal product used for mild
                                                                   inflammations of the oral and pharyngeal mucosa.




1
 The material complies with the monograph in the Ph. Fr. XI edition (Rose pâle 1989; Rose rouge 1989).
2
 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.


Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos
EMA/HMPC/137299/2013                                                                                                Page 2/6
Well-established use                                               Traditional use

                                                                   Indication 2)

                                                                   Traditional herbal medicinal product used for relief
                                                                   of minor skin inflammation.

                                                                   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 3

Well-established use                                               Traditional use

                                                                   Posology

                                                                   Indication 1)

                                                                   Adolescents, adults and elderly

                                                                   Single dose

                                                                   Herbal substance or comminuted herbal substance
                                                                   for infusion preparation for oromucosal use:
                                                                   1 – 2 g of the herbal substance or comminuted
                                                                   herbal substance in 200 ml of boiling water

                                                                   As a mouth rinse, 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’).



                                                                   Indication 2)

                                                                   Adolescents, adults and elderly

                                                                   Single dose

                                                                   Herbal substance or comminuted herbal substance
                                                                   for infusion preparation for cutaneous use:
                                                                   1 – 2 g of the herbal substance or comminuted
                                                                   herbal substance in 200 ml of boiling water

                                                                   Apply on the affected area, up to 3 times daily, in
                                                                   the form of a wet, impregnated dressing.

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


Community herbal monograph on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos
EMA/HMPC/137299/2013                                                                                             Page 3/6
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.

                                                                   Method of administration

                                                                   Cutaneous use.
                                                                   Oromucosal 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

                                                                   Indications 1) and 2)

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

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

                                                                Rosmarinus officinalis L., aetheroleum (rosemary
                                                                oil)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Essential oil



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 for the relief
                                                                of minor muscular and articular pain and in minor
                                                                peripheral circulatory disorders.

                                                                The product is a traditional herbal medicinal
                                                                product for use in specified indications



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.: 01/2008:1846).




European Union herbal monograph on Rosmarinus officinalis L., aetheroleum
EMA/HMPC/513893/2021                                                                                                 Page 3/6
 Well-established use                                           Traditional use

                                                                exclusively based upon long-standing use.


4.2. Posology and method of administration

 Well-established use                                           Traditional use

                                                                Posology

                                                                Adults, elderly

                                                                6-10% in semi-solid dosage forms, 2-3 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 4 weeks
                                                                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.

                                                                Do not apply to broken or irritated skin.

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 the
                                                                lack of adequate data.

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

                                                                Articular pain accompanied by swelling of joint,
                                                                redness or fever should be examined by a doctor.

                                                                If there is inflammation of the skin or
                                                                subcutaneous induration, ulcers, sudden swelling



European Union herbal monograph on Rosmarinus officinalis L., aetheroleum
EMA/HMPC/513893/2021                                                                                         Page 4/6
 Well-established use                                           Traditional use

                                                                of one or both legs particularly associated with
                                                                redness and heat, cardiac or renal insufficiency,
                                                                or a sudden sharp pain in the leg when at rest, a
                                                                doctor should be consulted.

                                                                Contact with eyes should be avoided. Should not
                                                                be applied near mucous membranes.

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

                                                                Immune system disorders: Hypersensitivity
                                                                (contact dermatitis). The frequency is not known.

                                                                Respiratory, thoracic and mediastinal disorders:
                                                                Hypersensitivity (asthma). 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 Rosmarinus officinalis L., aetheroleum
EMA/HMPC/513893/2021                                                                                         Page 5/6

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

                                                                 Rosmarinus officinalis L., folium (rosemary leaf)

                                                                 i) Herbal substance

                                                                 Whole or fragmented, dried leaf

                                                                 ii) Herbal preparations

                                                                 Comminuted herbal substance



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Comminuted herbal substance as herbal tea for
                                                                 oral use and use as 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

                                                                 Indication 1)

                                                                 Traditional herbal medicinal product for the
                                                                 symptomatic relief of dyspepsia and mild
                                                                 spasmodic disorders of the gastrointestinal tract.

                                                                 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.: 01/2013:1560).




European Union herbal monograph on Rosmarinus officinalis L., folium
EMA/HMPC/513940/2021                                                                                                 Page 4/8
 Well-established use                                            Traditional use

                                                                 Traditional herbal medicinal product for the relief
                                                                 of minor muscular and articular pain and in minor
                                                                 peripheral circulatory disorders.

                                                                 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)

                                                                 Adolescents, adults, elderly

                                                                 Oral use:
                                                                 Single dose: 1-2 g in 150-250 ml of boiling water
                                                                 as herbal tea, 2-3 times daily
                                                                 Daily dose: 2-6 g

                                                                 Indication 2)

                                                                 Adolescents, adults, elderly

                                                                 Use as bath additive:
                                                                 50 g either as decoction (in 1 l of boiling water)
                                                                 or direct in the bath. Usage should be 2-3 times
                                                                 a week, if necessary 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

                                                                 Indication 1)
                                                                 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.

                                                                 Indication 2)
                                                                 If the symptoms persist longer than 4 weeks
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted.

                                                                 Method of administration

                                                                 Indication 1)



European Union herbal monograph on Rosmarinus officinalis L., folium
EMA/HMPC/513940/2021                                                                                          Page 5/8
 Well-established use                                            Traditional use

                                                                 Oral use.

                                                                 Indication 2)
                                                                 Use as bath additive.
                                                                 Recommended bath temperature is 35 – 38°C,
                                                                 for 10 to 20 minutes.

Contraindications

4.3. Contraindications

 Well-established use                                            Traditional use

                                                                 Hypersensitivity to the active substance.

                                                                 Do not apply to broken or irritated skin.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

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

                                                                 Oral use
                                                                 The use in children under 12 years of age is not
                                                                 recommended due to lack of adequate data.

                                                                 Obstruction of bile duct, cholangitis, liver disease,
                                                                 gallstones and any other biliary disorders that
                                                                 require medical supervision.

                                                                 Use as bath additive
                                                                 The use in children under 12 years of age is not
                                                                 recommended due to lack of adequate data and
                                                                 because medical advice should be sought.

                                                                 Articular pain accompanied by swelling of joint,
                                                                 redness or fever should be examined by a doctor.

                                                                 If there is inflammation of the skin or
                                                                 subcutaneous induration, ulcers, sudden swelling
                                                                 of one or both legs particularly associated with
                                                                 redness and heat, cardiac or renal insufficiency,
                                                                 or a sudden sharp pain in the leg when at rest, a
                                                                 doctor should be consulted.

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




European Union herbal monograph on Rosmarinus officinalis L., folium
EMA/HMPC/513940/2021                                                                                           Page 6/8

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

                                                                 Immune system disorders: Hypersensitivity
                                                                 (contact dermatitis). 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

                                                                Rubus idaeus L., folium (raspberry leaf)

                                                                i) Herbal substance
                                                                Not applicable.


                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Dry extract (DER 4:1): extraction solvent water



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use and for infusion preparation for
                                                                oromucosal use.

                                                                Herbal preparations in solid dosage form 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 for the
                                                                symptomatic relief of minor spasm associated with

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. Fr. monograph ‘Ronce - Rubus’ (Ph. Fr. XI edition).

Community herbal monograph on Rubus idaeus L., folium
EMA/HMPC/44211/2012                                                                                                  Page 3/6
Well-established use                                          Traditional use

                                                              menstrual periods.

                                                              Indication 2)

                                                              Traditional herbal medicinal product for the
                                                              symptomatic treatment of mild inflammation in
                                                              the mouth or throat.

                                                              Indication 3)

                                                              Traditional herbal medicinal product for the
                                                              symptomatic treatment of mild diarrhoea.

                                                              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 3

Well-established use                                          Traditional use

                                                              Posology

                                                              Indication 1)

                                                              Adults

                                                              Single dose

                                                              Dry extract: 113-226 mg, up to 3 to 4 times daily.
                                                              To be taken after meals.

                                                              Indication 2)

                                                              Adults and elderly

                                                              Single dose

                                                              Comminuted herbal substance for infusion
                                                              preparation for oromucosal use: 1.5-8 g of the
                                                              comminuted herbal substance in 150 ml of boiling
                                                              water, 3 times daily.

                                                              Use as a gargle.

                                                              Indication 3)

                                                              Adults and elderly

                                                              Single dose

                                                              Herbal tea: 1.5-8 g of the comminuted herbal
                                                              substance in 150 ml of boiling water as a herbal
                                                              infusion, 3 times daily.


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 Rubus idaeus L., folium
EMA/HMPC/44211/2012                                                                                              Page 4/6
Well-established use                                    Traditional use

                                                        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

                                                        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 3)

                                                        If the symptoms persist longer than 3 days during
                                                        the use of the medicinal product, a doctor or a
                                                        qualified health care practitioner should be
                                                        consulted

                                                        Method of administration

                                                        Indication 1)

                                                        Oral use.

                                                        Indication 2)

                                                        Oromucosal use.

                                                        Indication 3)

                                                        Oral 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

                                                        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.




Community herbal monograph on Rubus idaeus L., folium
EMA/HMPC/44211/2012                                                                                    Page 5/6

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

                                                        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.

                                                                  Ruscus aculeatus L., rhizoma (Butcher’s broom).

                                                                  i) Herbal substance

                                                                  Not applicable

                                                                  ii) Herbal preparations

                                                                  a) Powdered herbal substance

                                                                  b) Dry extract (DER 2.5-6.5:1); extraction
                                                                  solvent: water

                                                                  c) Dry extract (DER 5-8.5:1); extraction solvent:
                                                                  ethanol 80% V/V

                                                                  d) Dry extract (DER 6-9:1); extraction solvent:
                                                                  ethanol 96% V/V



3. Pharmaceutical form
Well-established use                                              Traditional use

                                                                  Herbal substance or herbal preparation in solid
                                                                  dosage forms 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 with the Ph. Eur. monograph (ref.: 1847).



European Union herbal monograph on Ruscus aculeatus L., rhizoma
EMA/HMPC/188804/2017                                                                                                Page 3/3
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                              Traditional use

                                                                  Indication 1)

                                                                  Traditional herbal medicinal product to relieve
                                                                  symptoms of discomfort and heaviness of legs
                                                                  related to minor venous circulatory disturbances.

                                                                  Indication 2)

                                                                  Traditional herbal medicinal product for
                                                                  symptomatic relief of itching and burning
                                                                  associated with haemorrhoids, after serious
                                                                  conditions have been excluded by a medical
                                                                  doctor

                                                                  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)

                                                                  a) Powdered herbal substance

                                                                  Adults:

                                                                  Single dose: 350 mg, 3 times daily

                                                                  b) Dry extract (DER 2.5-6.5:1); extraction
                                                                  solvent: water

                                                                  Adults:

                                                                  Single dose: 150 to 200 mg,

                                                                  Daily dose to maximum 450 mg

                                                                  c) Dry extract (DER 5.0-8.5:1), extraction
                                                                  solvent, ethanol 80% (V/V)

                                                                  Adults:

                                                                  Single dose: 86 mg, 1-2 times daily

                                                                  d) Dry extract (DER 6-9:1); extraction solvent:
                                                                  ethanol 96 % V/V

                                                                  Adults:



European Union herbal monograph on Ruscus aculeatus L., rhizoma
EMA/HMPC/188804/2017                                                                                           Page 4/4
Well-established use                                              Traditional use

                                                                  Single dose: 45 mg, 2 times daily

                                                                  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.

                                                                  There is no relevant use in children and
                                                                  adolescents.

                                                                  Indication 2)

                                                                  a) Powdered herbal substance

                                                                  Adults:

                                                                  Single dose: 350 mg, 3 times daily.

                                                                  b) Dry extract (DER 2.5-6.5:1); extraction
                                                                  solvent: water

                                                                  Adults:

                                                                  Single dose: 150 to 200 mg

                                                                  Daily dose to maximum 450 mg

                                                                  c) Dry extract (DER 5.0-8.5:1), extraction
                                                                  solvent, ethanol 80% (V/V)

                                                                  Adults:

                                                                  Single dose: 86 mg, 1-2 times daily

                                                                  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.

                                                                  The use in children and adolescents is not
                                                                  recommended (see section 4.4 special warnings
                                                                  and precaution for use).

                                                                  Method of administration

                                                                  Oral use

Contraindications

4.3. Contraindications

Well-established use                                              Traditional use

                                                                  Hypersensitivity to the active substance(s).




European Union herbal monograph on Ruscus aculeatus L., rhizoma
EMA/HMPC/188804/2017                                                                                             Page 5/5

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.

                                                                  Indication 1)

                                                                  If there is inflammation of the skin or
                                                                  subcutaneous induration, ulcers, sudden swelling
                                                                  of one or both legs, cardiac or renal insufficiency,
                                                                  a doctor should be consulted.

                                                                  Indication 2)

                                                                  If rectal bleeding occurs a doctor 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.

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 marketing authorisation                      With regard to the registration application of
application of Article 10(a) of Directive                       Article 16d(1) of Directive 2001/83/EC as
2001/83/EC as amended                                           amended

Serenoa repens, fructus (saw palmetto, fruit)                   Serenoa repens, fructus (saw palmetto, fruit)

i) Herbal substance                                             i) Herbal substance

Not applicable.                                                 Not applicable.

ii) Herbal preparation                                          ii) Herbal preparations

a) Soft extract (DER 7-11:1) 3, extraction                      a) Soft extract (DER 7.5-14.3:1), extraction
                                                                   solvent: ethanol 90% to 96% m/m
    solvent: hexane



3. Pharmaceutical form
Well-established use                                            Traditional use

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

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



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

Herbal medicinal product for the symptomatic                    Traditional medicinal product for the relief of lower
treatment of benign prostatic hyperplasia.                      urinary tract symptoms related to benign prostatic
                                                                hyperplasia, after serious conditions have been
                                                                excluded by a doctor.

                                                                The product is a traditional herbal medicinal


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.: 1848).
3
  Containing 92% of fatty acids (free or esterified) and 2% of an unsaponifiable part.


European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
EMA/HMPC/280079/2013                                                                                                 Page 2/5
Well-established use                                           Traditional use

                                                               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                                                       Posology

Adults and elderly                                             Adults and elderly

a) 320 mg once daily or 160 mg 2 times daily.                  a) 320 mg once daily.

There is no relevant indication for women,                     There is no relevant indication for women,
children and adolescents.                                      children and adolescents.

Duration of use                                                Duration of use
Long-term use is possible (see section 4.4 ‘Special            Long-term use is possible (see section 4.4 ‘Special
warnings and precautions for use’).                            warnings and precautions for use’).
If the symptoms persist during the use of the                  If the symptoms persist during the use of the
medicinal product, a doctor or a pharmacist                    medicinal product, a doctor or a qualified health
should be consulted.                                           care practitioner should be consulted.

Method of administration                                       Method of administration

Oral use.                                                      Oral use.

Contraindications

4.3. Contraindications

Well-established use                                          Traditional use

Hypersensitivity to the active substance.                     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 complaints worsen or if symptoms such as                    If complaints worsen or if symptoms such as
fever, spasms or blood in the urine, painful                   fever, spasms or blood in the urine, painful
urination, or urinary retention occur during the               urination, or urinary retention occur during the
use of the medicinal product, a doctor or a                    use of the medicinal product, a doctor or a
pharmacist should be consulted.                                qualified healthcare 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

A few cases of suspected interactions with                     A few cases of suspected interactions with
warfarin have been reported. Increased INR-                    warfarin have been reported. Increased INR-


European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus
EMA/HMPC/280079/2013                                                                                          Page 3/5
Well-established use                                           Traditional use

values have been described.                                    values have been described.

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

Gastro-intestinal disorders                                    Gastro-intestinal complaints
Common: abdominal pain                                         Uncommon: nausea, vomiting, diarrhoea,
Uncommon: nausea                                               abdominal pain (especially when taken on an
                                                               empty stomach).
Hepatobiliary disorders
Uncommon: increase of transaminases or gamma-                  Immune system disorders
glutamyltransferases                                           Allergic or hypersensitivity reactions may occur.
                                                               The frequency is not known.
Skin and subcutaneous tissue disorders
Uncommon: skin rash
                                                               Nervous system disorders
Endocrine disorders                                            Headache may occur. The frequency is not known.
Uncommon: reversible gynecomastia
                                                               If other adverse reactions occur, a doctor or a
Nervous system disorders
                                                               qualified health care practitioner should be
Common: headache
                                                               consulted.
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 3, 4
Well-established use                                              Traditional use

With regard to the marketing authorisation                        With regard to the registration application of
application of Article 10(a) of Directive                         Article 16d(1) of Directive 2001/83/EC
2001/83/EC
                                                                  Salix [various species including S. purpurea L., S.
Salix [various species including S. purpurea L., S.               daphnoides Vill., S. fragilis L.], whole or
daphnoides Vill., S. fragilis L.], whole or                       fragmented dried bark
fragmented dried bark
                                                                  i) Herbal substance
i) Herbal substance
                                                                  Not applicable
Not applicable
                                                                  ii) Herbal preparations
ii) Herbal preparations
                                                                    a) Comminuted herbal substance
  a) Dry extract (8-14:1) extraction solvent
                                                                    b) Powdered herbal substance
        ethanol 70% V/V, 15% total salicin 5.
                                                                    c)   Dry extract (DER 8-20:1) extraction solvent
                                                                         water 6

                                                                    d) Dry extract (DER 16-23:1) extraction
                                                                         solvent water

                                                                    e) Liquid extract (DER 1:1), extraction solvent
                                                                         ethanol 25% V/V

                                                                    f)   Tincture (1:5), extraction solvent ethanol
                                                                         25% V/V



3. Pharmaceutical form
Well-established use                                              Traditional use

Quantified herbal preparation in solid dosage                     Herbal preparation in solid or liquid dosage form,
form.                                                             or as herbal tea for oral use.


3
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
4
  The material complies with the Ph. Eur. monograph (ref. 1583)
5
  15% total salicin represents an average value. The exact range should be established for each finished product on the
basis of the manufacturer’s specifications in accordance with the relevant herbal quality guidance.
6
  The DER should be specified for the specific product by the registration holder.


European Union herbal monograph on Salix [various species including S. purpurea L.,
S. daphnoides Vill., S. fragilis L.], cortex
EMA/HMPC/80630/2016                                                                                                 Page 5/11
Well-established use                                              Traditional use

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



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                              Traditional use

Herbal medicinal product used for the short-term                  Indication 1)
treatment of low back pain.
                                                                  Traditional herbal medicinal product used for the
                                                                  relief of minor articular pain.

                                                                  Indication 2)

                                                                  Traditional herbal medicinal product used for the
                                                                  relief of fever associated with common cold.

                                                                  Indication 3)

                                                                  Traditional herbal medicinal product used for
                                                                  headache.

                                                                  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 7

Well-established use                                              Traditional use

Posology                                                          Posology

Adults and elderly                                                Adults and elderly

Single dose: 393 mg to 786 mg up to 2 times                       Indication 1), 2) and 3)
daily
                                                                   a) Herbal tea: 1-3 g of the comminuted herbal
Daily dose: 393 to 1572 mg                                             substance in 150 ml of boiling water as an
                                                                       herbal infusion 3 times daily.
The use in children and adolescents under 18
years of age is contraindicated (see section 4.3.                 Decoction: 4 g of the comminuted herbal
‘Contraindications’).                                             substance pour with 1 cup (200 ml) of water and
                                                                  boil covered for 15 minutes. Let stand for 15
Duration of use
                                                                  minutes, strain. Drink after meals, 3 times a day a
If the pain or symptoms persist during the first                  glass of warm, freshly prepared decoction.
week of use of the medicinal product, a doctor or
                                                                   b) Powdered herbal substance: 260-500 mg 3-8
a pharmacist should be consulted.
                                                                       times daily.


7
  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 Salix [various species including S. purpurea L.,
S. daphnoides Vill., S. fragilis L.], cortex
EMA/HMPC/80630/2016                                                                                             Page 6/11
Well-established use                                              Traditional use

Not to be used for more than 4 weeks.                              To be taken after meals. It is advised to take with
                                                                   larger quantity of hot water.
Method of administration
                                                                   c)   Dry aqueous extract (8-20:1): 600 mg twice
Oral use
                                                                        daily

                                                                   d) Dry aqueous extract (16-23:1): 480 mg twice
                                                                        daily

                                                                   e) Liquid extract 1-3 ml, three times daily

                                                                   f)   Tincture (1:5): 15-24 ml per day

                                                                  The use in children and adolescents under 18
                                                                  years of age is contraindicated (see section 4.3
                                                                  ‘Contraindications’).

                                                                  Duration of use

                                                                  Indication 1)

                                                                  Not to be used for more than 4 weeks.

                                                                  Indication 2)

                                                                  If the symptoms persist longer than 3 days during
                                                                  the use of the medicinal product, a doctor or a
                                                                  qualified health care practitioner should be
                                                                  consulted.

                                                                  Indication 3)

                                                                  If the symptoms persist longer than one day
                                                                  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.                        Hypersensitivity to the active substance.

Hypersensitivity to salicylates or to other NSAIDs               Hypersensitivity to salicylates or to other
(e.g. history of angioedema, bronchial spasm, or                 NSAIDs (e.g. history of angioedema, bronchial
chronic urticaria in response to salicylates or to               spasm, or chronic urticaria in response to
other NSAIDs).                                                   salicylates or to other NSAIDs).

Asthma due to sensitivity to salicylates.                        Asthma due to sensitivity to salicylates.

Active peptic ulcer disease.                                     Active peptic ulcer disease.



European Union herbal monograph on Salix [various species including S. purpurea L.,
S. daphnoides Vill., S. fragilis L.], cortex
EMA/HMPC/80630/2016                                                                                            Page 7/11
Well-established use                                             Traditional use

Third trimester of pregnancy (see section 4.6                    Third trimester of pregnancy (see section 4.6
Pregnancy and lactation).                                        Pregnancy and lactation).

Glucose-6-phosphate dehydrogenase deficiency.                    Glucose-6-phosphate dehydrogenase deficiency.

Children and adolescents under 18 years of age                   Children and adolescents under 18 years of age
due to the risk of Reye’s syndrome.                              due to the risk of Reye’s syndrome.

Severe liver or renal dysfunction.                               Severe liver or renal dysfunction,

Coagulation disorders.                                           Coagulation disorders.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                              Traditional use

Concomitant use with salicylates and other                        The product is not intended to be used in case of
NSAIDs is not recommended without medical                         acute arthritis as this condition requires medical
advice.                                                           advice.

If the symptoms worsen during the use of the                      If fever exceeds 39°C, persists or is associated
medicinal product, a doctor or a pharmacist                       with severe headache or if symptoms worsen
should be consulted.                                              during the use of the medicinal product, a doctor
                                                                  should be consulted.

                                                                  Concomitant use with salicylates and other
                                                                  NSAIDs is not recommended without medical
                                                                  advice.

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

                                                                  For tinctures, 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

Willow bark may increase the effects of                           Willow bark may increase the effects of

anticoagulants such as coumarin derivatives.                      anticoagulants such as coumarin derivatives.




European Union herbal monograph on Salix [various species including S. purpurea L.,
S. daphnoides Vill., S. fragilis L.], cortex
EMA/HMPC/80630/2016                                                                                           Page 8/11

Undesirable effects

4.8. Undesirable effects

Well-established use                                              Traditional use

Allergic reactions such as rash, pruritis, urticaria,             Allergic reactions such as rash, pruritis, urticaria,
asthma, exanthema and gastrointestinal                            asthma, exanthema and gastrointestinal
symptoms such as, nausea, vomiting, abdominal                     symptoms such as, nausea, vomiting, abdominal
pain, diarrhea, dyspepsia, heartburn, may occur.                  pain, diarrhea, dyspepsia, heartburn, may occur.
The frequency is not known.                                       The frequency is not known.

If other adverse reactions not mentioned above                    If other adverse reactions not mentioned above
occur, a doctor or a pharmacist should be                         occur, a doctor or a pharmacist should be
consulted.                                                        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
                                                                   Salvia officinalis L., folium, (sage leaf)

                                                                   i) Herbal substance

                                                                      Not applicable

                                                                   ii) Herbal preparations

                                                                   a) Comminuted herbal substance

                                                                   b) Liquid extract (DER 1:1), extraction solvent
                                                                   ethanol 70% V/V

                                                                   c) Dry extract (DER 4-7:1), extraction solvent
                                                                   water

                                                                   d) Liquid extract (DER 1:3.5-5), extraction
                                                                   solvent ethanol 31.5% V/V

                                                                   e) Liquid extract (DER 1:4-5) extraction solvent
                                                                   ethanol 50% V/V

                                                                   f) Liquid extract (DER 1:4-6), extraction solvent
                                                                   liquor wine:ethanol 96% V/V (38.25:61.75 m/m)

                                                                   g) Tincture (ratio of herbal substance to
                                                                   extraction solvent 1:10) extraction solvent
                                                                   ethanol 70% V/V



3. Pharmaceutical form
    Well-established use                                           Traditional use

                                                                   Comminuted herbal substance as herbal tea for
                                                                   oral use.

                                                                   Comminuted herbal substance for infusion


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.: 1370)


European Union herbal monograph on Salvia officinalis L., folium
EMA/HMPC/277152/2015                                                                                                 Page 3/9
    Well-established use                                           Traditional use

                                                                   preparation for oromucosal or cutaneous use.

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

                                                                   Herbal preparations in liquid or semi-solid dosage
                                                                   forms for cutaneous use or for oromucosal 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 for relief of
                                                                   mild dyspeptic complaints such as heartburn and
                                                                   bloating.

                                                                   Indication 2)
                                                                   Traditional herbal medicinal product for relief of
                                                                   excessive sweating.

                                                                   Indication 3)
                                                                   Traditional herbal medicinal product for relief of
                                                                   inflammations in the mouth or the throat.

                                                                   Indication 4)
                                                                   Traditional herbal medicinal product for relief of
                                                                   minor skin inflammations.

                                                                   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 administration3

    Well-established use                                           Traditional use

                                                                   Posology
                                                                   Adults and elderly

                                                                   Indication 1)

                                                                   a) Comminuted herbal substance

                                                                   Herbal tea: 1-2 g of the comminuted herbal
                                                                   substance in 150 ml boiling water as herbal

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 Salvia officinalis L., folium
EMA/HMPC/277152/2015                                                                                             Page 4/9
 Well-established use                                              Traditional use

                                                                   infusion 3 times daily.

                                                                   c) Dry extract (DER 4-7:1)

                                                                   320 mg daily divided in 3-4 doses

                                                                   d) Liquid extract (DER 1:3.5-5)

                                                                   0.5 ml in water 3 times daily.

                                                                   f) Liquid extract (DER 1:4-6)

                                                                   0.43 ml 3 times daily

                                                                   g) Tincture

                                                                   2-3 ml 3 times daily

                                                                   Indication 2)

                                                                   a) Comminuted herbal substance

                                                                   Herbal tea: 2 g of comminuted herbal substance
                                                                   in 150 ml boiling water as herbal infusion.

                                                                   c) Dry extract (DER 4-7:1)

                                                                   80-160 mg 3 times daily

                                                                   d) Liquid extract (DER 1:3.5-5)

                                                                   0.5-1 ml in some liquid 3 times daily.

                                                                   For night sweat: 1.5 ml in some liquid 1 hour
                                                                   directly before bedtime.

                                                                   e) Liquid extract (DER 1:4.5)

                                                                   2 ml 3 times daily

                                                                   Indication 3)

                                                                   a) Comminuted herbal substance:

                                                                   2.5 g comminuted herbal substance in 100 ml
                                                                   boiling water as an infusion. The infusion is used
                                                                   warm for gargle 3 times daily.

                                                                   b) Liquid extract (DER 1:1)

                                                                   250 mg gel containing 20% liquid extract for
                                                                   oromucosal use. Apply on affected regions and
                                                                   massage gently up to 5 times daily.

                                                                   d) Liquid extract (DER 1:3.5-5)

                                                                   0.5 ml in 150 ml warm water for gargle 3 times
                                                                   daily.




European Union herbal monograph on Salvia officinalis L., folium
EMA/HMPC/277152/2015                                                                                             Page 5/9
 Well-established use                                              Traditional use

                                                                   f) Liquid extract (DER 1:4-6)

                                                                   0.65 ml in 150 ml water for rinse or gargle 3
                                                                   times daily.

                                                                   g) Tincture

                                                                   5-10 ml in a glass of water for rinse or gargle
                                                                   several times daily. Undiluted tincture is applied
                                                                   locally on the affected regions once daily.

                                                                   Indication 4)

                                                                   a) Comminuted herbal substance

                                                                   2.5 g of the comminuted herbal substance in 100
                                                                   ml water as herbal infusion to be applied on the
                                                                   affected area of the skin 2-4 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

                                                                   Indications 1)

                                                                   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.

                                                                   Indication 2)

                                                                   Long-term use is possible (see section 4.4
                                                                   ‘Special warnings and precautions for use’).

                                                                   If the symptoms do not improve within 6 weeks
                                                                   of use of the medicinal product, a doctor or a
                                                                   qualified health care practitioner should be
                                                                   consulted.

                                                                   Indication 3)

                                                                   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 4)

                                                                   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.




European Union herbal monograph on Salvia officinalis L., folium
EMA/HMPC/277152/2015                                                                                              Page 6/9
 Well-established use                                              Traditional use

                                                                   Method of administration

                                                                   Indication 1) and 2)

                                                                   Oral use

                                                                   Indication 3)

                                                                   Oromucosal use

                                                                   Indication 4)

                                                                   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

                                                                   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.

                                                                   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

                                                                   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

                                                                Sambucus nigra L., flos (elder flower)

                                                                i) Herbal substance

                                                                      As defined in the Ph. Eur. monograph.

                                                                ii) Herbal preparations

                                                                      a) Comminuted herbal substance.

                                                                      b) Liquid extract (DER 1:1), extraction
                                                                           solvent: ethanol 25 % V/V

                                                                      c)   Tincture (1:5) extraction solvent: ethanol
                                                                           25 % V/V



3. Pharmaceutical form
Well-established use                                            Traditional use



                                                                Herbal substance or comminuted herbal substance
                                                                as herbal tea for oral use.

                                                                Herbal preparations in liquid dosage forms 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 with the Ph. Eur. Monograph (ref.: 1217).



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EMA/HMPC/611512/2016                                                                                                Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                          Traditional use

                                                              Traditional herbal medicinal product used for the
                                                              relief of early symptoms of common cold.

                                                              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

                                                              a) Single dose:

                                                                   Herbal tea: 2-5 g of the herbal substance or
                                                                   comminuted herbal substance in 150 ml
                                                                   boiling water as a herbal infusion three times
                                                                   daily.

                                                                   Herbal tea: 3-6 g of the comminuted herbal
                                                                   substance in 200 ml water as a decoction
                                                                   divided in 2 single doses daily.

                                                              b)   Single dose: 2-5 ml three times daily

                                                              c)   Single dose: 10-25 ml three 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 1 week
                                                              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 Sambucus nigra L., flos
EMA/HMPC/611512/2016                                                                                             Page 4/7

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 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.

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

                                                             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

                                                             None known

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