Pflanzenwissen.
Mit Herkunft.

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

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


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

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

                                                                Origanum majorana, herba (Majoram)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Comminuted herbal substance

                                                                Extract 4 (ratio of herbal substance to extraction
                                                                solvent 1:5), extraction solvents ethanol 96%
                                                                V/V and white petroleum jelly.



3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

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

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




2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
3
  The material complies with the monograph Majoranae herba in Farmakopea Polska X, 2014.
4
  The preparation is described in the Farmakopea Polska (1995), two parts of comminuted Origanum majorana L., herba is
moistened with one part of ethanol 96% and then warm extracted with ten parts of white petroleum jelly until ethanol
evaporation.


European Union herbal monograph on Origanum majorana L., herba
EMA/HMPC/166517/2015                                                                                                Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

                                                                 Indication 1)

                                                                 Traditional herbal medicinal product used for the
                                                                 symptomatic relief of mild spasmodic gastro-
                                                                 intestinal complaints such as bloating and
                                                                 flatulence.

                                                                 Indication 2)

                                                                 Traditional herbal medicinal product used for
                                                                 relief of irritated skin around the nostrils.

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


4.2. Posology and method of administration 5

 Well-established use                                            Traditional use

                                                                 Posology

                                                                 Indication 1)

                                                                 Adults and elderly

                                                                 a) Herbal tea: 2-4 g of the comminuted herbal
                                                                 substance in 150 ml of boiling water as a herbal
                                                                 infusion, once to twice daily before meal.

                                                                 Daily dose: 2-8 g

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

                                                                 Indication 2)

                                                                 b) Children 1-11 years, adolescents and adults

                                                                 Small amount of the preparation spread around
                                                                 nostrils, 2 to 4 times daily

                                                                 The use in children under 1 year of age is not
                                                                 recommended (see section 4.4 ‘Special warnings
                                                                 and precautions for use’).




5
  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 Origanum majorana L., herba
EMA/HMPC/166517/2015                                                                                             Page 4/7
 Well-established use                                            Traditional 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 1 week
                                                                 during the use of the medicinal product, a doctor
                                                                 or a qualified health care practitioner should be
                                                                 consulted

                                                                 Method of administration

                                                                 Preparation a)

                                                                 Oral use

                                                                 Preparation b)

                                                                 Cutaneous use

Contraindications

4.3. Contraindications

 Well-established use                                        Traditional use

                                                             Hypersensitivity to the active substance or to
                                                             other plants of the Lamiaceae family.

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                            Traditional use

                                                                 Indication 1)
                                                                 The use in children and adolescents under 18
                                                                 years of age has not been established due to lack
                                                                 of adequate data.

                                                                 Indication 2)
                                                                 The use in children under 1 year of age has not
                                                                 been established due to lack of adequate data.
                                                                 The deep penetration
                                                                 of the ointment inside nostril should be
                                                                 avoided, as it can reduce the activity of the
                                                                 ciliary epithelium.

                                                                 If signs of skin infection are observed during the
                                                                 use of the medicinal product, a doctor or a
                                                                 qualified health care practitioner should be


European Union herbal monograph on Origanum majorana L., herba
EMA/HMPC/166517/2015                                                                                             Page 5/7
 Well-established use                                            Traditional use

                                                                 consulted.

                                                                 Eye contact with unwashed hands after the
                                                                 application may potentially cause irritation.

                                                                 Indication 1) and 2)

                                                                 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 registration application of
                                                                 Article 16d(1) of Directive 2001/83/EC

                                                                 Orthosiphon aristatus (Blume) Miq. var.
                                                                 aristatus, folium (Java tea)

                                                                 i) Herbal substance

                                                                 Not applicable

                                                                 ii) Herbal preparations

                                                                 a) Comminuted herbal substance

                                                                 b) Powdered herbal substance

                                                                 c)   Liquid extract (DER 1:1), extraction solvent
                                                                      ethanol 25% m/m

                                                                 d) Dry extract (DER 5-7:1), extraction solvent
                                                                      water

                                                                 e) Dry extract (DER 8-12:1), extraction solvent
                                                                      ethanol 60% V/V

                                                                 f)   Dry extract (DER 7-8:1), extraction solvent
                                                                      ethanol 70% V/V

                                                                 g) Dry extract (DER 5-7:1), extraction solvent
                                                                      ethanol 30% V/V



3. Pharmaceutical form
 Well-established use                                            Traditional use

                                                                 Comminuted herbal substance as herbal tea for
                                                                 oral use.

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



1 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 1229).

European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium
EMA/HMPC/486551/2020                                                                                               Page 3/7
 Well-established use                                            Traditional use

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



4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                            Traditional use

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

                                                                 a) Herbal tea: 2-3 g comminuted herbal
                                                                      substance in 150 ml of boiling water as a
                                                                      herbal infusion

                                                                 Daily dose: 6-12 g

                                                                 b) Powdered herbal substance

                                                                 Single dose: 500-750 mg
                                                                 Daily dose: 1000-1500 mg

                                                                 c)   Liquid extract (DER 1:1), extraction solvent
                                                                      ethanol 25% m/m

                                                                 Single dose: 2 g
                                                                 Daily dose: 2-4 g

                                                                 d) Dry extract (DER 5-7:1), extraction solvent
                                                                      water

                                                                 Single dose: 360 mg
                                                                 Daily dose: 1080-1440 mg

                                                                 e) Dry extract (DER 8-12:1), extraction solvent
                                                                      ethanol 60% V/V

                                                                 Single dose: 200-400 mg



European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium
EMA/HMPC/486551/2020                                                                                           Page 4/7
 Well-established use                                            Traditional use

                                                                 Daily dose: 600-1200 mg

                                                                 f)   Dry extract (DER 7-8:1), extraction solvent
                                                                      ethanol 70% V/V

                                                                 Single dose: 280 mg
                                                                 Daily dose: 840 mg

                                                                 g) Dry extract (DER 5-7:1), extraction solvent
                                                                      ethanol 30% V/V

                                                                 Single dose: 200 mg
                                                                 Daily dose: 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.

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

Contraindications

4.3. Contraindications

 Well-established use                                            Traditional use

                                                                 Hypersensitivity to the active substance.

                                                                 Conditions where a 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

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

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


European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium
EMA/HMPC/486551/2020                                                                                          Page 5/7
 Well-established use                                            Traditional use

                                                                 doctor or a qualified health care practitioner
                                                                 should be consulted.

                                                                 For liquid 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 as
                                                                amended

                                                                Passiflora incarnata L., herba (Passion flower)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                    a) Comminuted herbal substance

                                                                    b) Powdered herbal substance

                                                                    c)    Liquid extract (DER 1:8) extraction
                                                                          solvent ethanol 25% V/V

                                                                    d) Liquid extract (DER 1:8) extraction
                                                                          solvent ethanol 45% V/V

                                                                    e) Liquid extract (DER 1:3.6) extraction
                                                                          solvent ethanol 60% V/V

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

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

                                                                    h) Liquid extract (DER 1:3.8-4.3) extraction
                                                                          solvent ethanol (96% V/V) + glycerol
                                                                          (85% m/m) + Water (11.8 + 1 + 7.9)

                                                                    Dried extracts corresponding to the tea and
                                                                    liquid extracts above.




1
    The material complies with the Eur.Ph.monograph (ref. 01/2005:1364)
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 Passiflora incarnata L., herba
EMA/HMPC/669740/2013                                                                                                Page 3/7
3. Pharmaceutical form
Well-established use                                           Traditional use

                                                               Comminuted herbal substance as herbal tea for
                                                               oral use.

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

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



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                           Traditional use

                                                               Traditional herbal medicinal product for relief of
                                                               mild symptoms of mental stress and to aid sleep.

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


4.2. Posology and method of administration 3

Well-established use                                           Traditional use

                                                               Posology

                                                               Adolescents, adults and elderly

                                                               Single dose

                                                               ii) Herbal preparations
                                                                   a) Herbal tea: 1-2 g of the comminuted
                                                                      herbal substance in 150 ml of boiling
                                                                      water as a herbal infusion, 1-4 times daily

                                                                   b) Powdered herbal substance:
                                                                      0.5-2g, 1-4 times daily
                                                                   c)   Liquid extract: 2-4 ml, up to 4 times daily

                                                                   d) Liquid extract: 2 ml, up to 3 times daily

                                                                   e) Liquid extract: 1 ml, 3-5 times daily

                                                                   f)   Liquid extract: 0.5-2 ml, up to 4 times
                                                                        daily

                                                                   g) Liquid extract: 2 ml up to 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 Passiflora incarnata L., herba
EMA/HMPC/669740/2013                                                                                             Page 4/7
Well-established use                                           Traditional use

                                                                   h) Liquid extract: 0.3-0.4 ml,

                                                                       adults 3-5 times daily;
                                                                       adolescents 3 times daily

                                                                   Doses of dried extracts corresponding to the
                                                                   posologies of tea and liquid extracts above.



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

                                                               Duration of use

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

                                                               Method of administration

                                                               Oral use.

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.

                                                               For liquid 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.




Community herbal monograph on Passiflora incarnata L., herba
EMA/HMPC/669740/2013                                                                                         Page 5/7

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                           Traditional use

                                                               None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                           Traditional use

                                                               None known.

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

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

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


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

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

                                                                Paullinia cupana Kunth ex H.B.K. var. sorbilis
                                                                (Mart.) Ducke, semen (guarana seed)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Powdered herbal substance.



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 symptoms
                                                                of fatigue and sensation of weakness.

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



1
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance.
2
   The material complies with the Ph. Fr. monograph ‘guarana, graine de’ (1997).

Community herbal monograph on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen
EMA/HMPC/897344/2011                                                                                                  Page 2/5
4.2. Posology and method of administration

Well-established use                                            Traditional use

                                                                Posology

                                                                Adults and elderly

                                                                Single dose: 450 mg, up to 5 times daily

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

                                                                Duration of use

                                                                If the symptoms persist longer than 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.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

                                                                Hypersensitivity to the active substance.

                                                                Gastric and duodenal ulcers, cardiovascular
                                                                disorders such as hypertension and
                                                                arrhythmias, hyperthyroidism.

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.

                                                                Not recommended before bedtime as it may
                                                                cause sleep disturbances.




Community herbal monograph on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen
EMA/HMPC/897344/2011                                                                                          Page 3/5

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                            Traditional use

                                                                Persons taking MAO-inhibitor drugs should use
                                                                Paulliniae semen with caution.

                                                                Caffeine containing preparations reduce
                                                                sedative action and increase side effects caused
                                                                by sympathomimetic drugs.

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 composition1, 2
 Well-established use                                           Traditional use

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

                                                                Pelargonium sidoides DC and/or Pelargonium
                                                                reniforme Curt., radix (pelargonium root)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                    a) Liquid extract (DER 1:8-10), extraction
                                                                         solvent ethanol 11% (m/m)

                                                                    b) Dry extract (DER 4-25:1), extraction
                                                                         solvent ethanol 11% (m/m)

                                                                    c)   Dry extract (DER 4-7:1), extraction
                                                                         solvent ethanol 14% (V/V)



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

                                                                Traditional herbal medicinal product for the


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.: 2264).




European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix
EMA/HMPC/648100/2022                                                                                                           Page 4/8
 Well-established use                                           Traditional use

                                                                symptomatic treatment 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

 Well-established use                                           Traditional use

                                                                Posology

                                                                Herbal preparation a)

                                                                Adolescents over the age of 12 years, adults
                                                                and elderly

                                                                Single dose: 1.4 ml, 3 times daily
                                                                Daily dose: 4.2 ml

                                                                Children between 6-12 years

                                                                Single dose: 0.9 ml, 3 times daily
                                                                Daily dose: 2.7 ml

                                                                Children between 3 and 5 years

                                                                Single dose: 0.4 ml, 3 times daily
                                                                Daily dose: 1.2 ml

                                                                Herbal preparations b) and c)

                                                                Adolescents over the age of 12 years, adults
                                                                and elderly

                                                                Single dose: 20 mg, 3 times daily
                                                                Daily dose: 60 mg

                                                                Children between 6-12 years

                                                                Single dose: 13.3 mg, 3 times daily; or 20 mg,
                                                                2 times daily
                                                                Daily dose: 40 mg

                                                                Children between 3 and 5 years

                                                                Single dose: 6.67 mg, 3 times daily
                                                                Daily dose: 20 mg

                                                                Herbal preparation a)

                                                                The use in children under 3 years of age is not
                                                                recommended (see section 4.4 ‘Special
                                                                warnings and precautions for use’).

                                                                Herbal preparations b) and c)



European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix
EMA/HMPC/648100/2022                                                                                              Page 5/8
 Well-established use                                           Traditional use

                                                                The herbal preparations should be given to
                                                                children under 6 years only in liquid dosage
                                                                forms.

                                                                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.

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 oral use in children under 3 years of age is
                                                                not recommended because of concerns
                                                                requiring medical advice.

                                                                Hepatotoxicity and hepatitis cases were
                                                                reported in association with the administration
                                                                of the medicinal product. In case signs of
                                                                hepatotoxicity occur, the administration of the
                                                                medicinal product should be stopped
                                                                immediately, and a medical 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.

                                                                For liquid 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.




European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix
EMA/HMPC/648100/2022                                                                                                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,
                                                                (anaphylactic reaction). The frequency is not
                                                                known.

                                                                Skin and subcutaneous tissue disorders: Rash,
                                                                pruritus, urticaria, angioedema. The frequency
                                                                is not known.

                                                                Respiratory, thoracic and mediastinal disorders:
                                                                Nasal bleeding. The frequency is not known.

                                                                Gastrointestinal disorders: Diarrhoea, epigastric
                                                                pain, nausea, vomiting, gingival bleeding. The
                                                                frequency is not known.

                                                                Hepatobiliary disorders: Hepatotoxicity,
                                                                hepatitis. 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 Pelargonium sidoides DC; Pelargonium reniforme Curt., radix
EMA/HMPC/648100/2022                                                                                                Page 7/8

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

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


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

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

                                                                Phaseolus vulgaris L., fructus sine semine (green
                                                                bean pod)

                                                                i) Herbal substance

                                                                Not applicable.

                                                                ii) Herbal preparations

                                                                Comminuted herbal substance



3. Pharmaceutical form
Well-established use                                            Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

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



4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                            Traditional use

                                                                Traditional herbal medicinal product used to
                                                                increase the amount of urine to achieve flushing
                                                                of the urinary tract as an adjuvant in minor
                                                                urinary tract complaints.
                                                                The product is a traditional herbal medicinal
                                                                product for use in the specified indication
                                                                exclusively based upon long-standing use.

2
  The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal
quality guidance
3
  The material complies with DAC 1986

Community herbal monograph on Phaseolus vulgaris L., fructus sine semine
EMA/HMPC/317319/2012                                                                                                 Page 2/5
4.2. Posology and method of administration 4

Well-established use                                            Traditional use

                                                                Posology

                                                                Adults and elderly

                                                                Single dose

                                                                Herbal tea: 2.5 g of the comminuted herbal
                                                                substance in 150 ml of boiling water as a herbal
                                                                infusion, 2 - 6 times daily.

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

                                                                Duration of use

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

                                                                Method of administration

                                                                Oral use.

Contraindications

4.3. Contraindications

Well-established use                                            Traditional use

                                                                Hypersensitivity to the active substance.

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 because of
                                                                lack of data.

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

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                            Traditional use

                                                                None reported.

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

Community herbal monograph on Phaseolus vulgaris L., fructus sine semine
EMA/HMPC/317319/2012                                                                                             Page 3/5

Undesirable effects

4.8. Undesirable effects

Well-established use                                            Traditional use

                                                                None known.

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

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

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


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

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

                                                                   Pilosella officinarum Vall., herba cum radice
                                                                   (Mouse-ear hawkweed)

                                                                   i) Herbal substance

                                                                   Not applicable

                                                                   ii) Herbal preparations

                                                                       a) Comminuted herbal substance

                                                                       b) Powdered herbal substance



3. Pharmaceutical form
    Well-established use                                           Traditional use

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

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



4. Clinical particulars

4.1. Therapeutic indications

    Well-established use                                           Traditional use

                                                                   Traditional herbal medicinal product used for the
                                                                   relief of symptoms associated with minor urinary
                                                                   tract complaints in addition to the general


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. Fr. monograph (Piloselle)



European Union herbal monograph on Pilosella officinarum Vall. (syn Hieracium
pilosella L.), herba cum radice
EMA/HMPC/493453/2023
                                                                                                                     Page 3/6
 Well-established use                                             Traditional use

                                                                  recommendation of a sufficient fluid intake to
                                                                  increase the amount of urine.

                                                                  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 4

 Well-established use                                             Traditional use

                                                                  Posology

                                                                  Adults and elderly

                                                                  a) Herbal tea

                                                                  Single dose: 2-4 g of the comminuted herbal
                                                                  substance in 250 ml of boiling water as an herbal
                                                                  infusion, 3 times daily.

                                                                  b) Powdered herbal substance:

                                                                  Single dose: 200-520 mg, 2-4 times daily. Daily
                                                                  dose: 560 mg up to 1300 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(s) and
                                                                 to other plants of the Asteraceae (Compositae)
                                                                 family.




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

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


European Union herbal monograph on Pilosella officinarum Vall. (syn Hieracium
pilosella L.), herba cum radice
EMA/HMPC/493453/2023
                                                                                                                 Page 4/6

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

                                                                  Because adequate fluid intake is required during
                                                                  treatment Pilosella officinarum Vall., herba cum
                                                                  radice is not recommended for patients with
                                                                  conditions where reduced fluid intake is advised.

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.




European Union herbal monograph on Pilosella officinarum Vall. (syn Hieracium
pilosella L.), herba cum radice
EMA/HMPC/493453/2023
                                                                                                                 Page 5/6
 Well-established use                                             Traditional use

                                                                  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
application of Article 10(a) of Directive
2001/83/EC as amended

Plantago ovata Forssk. (P. ispaghula Roxb.),
semen (ispaghula seed)
i) Herbal substance
   Dried ripe 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
easy defecation with soft stool is desirable, e.g. in
cases of painful defecation after rectal or anal

1
 The material complies with the Eur. Ph. monograph monograph (ref.: 01/2008:1333).
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 ovata Forssk., semen
EMA/HMPC/304390/2012                                                                                               Page 4/10
Well-established use                                          Traditional use

surgery, anal fissures and haemorrhoids.


4.2. Posology and method of administration

Well-established use                                          Traditional use

Posology
Adolescents, adults and elderly

Daily dose
8 - 40 g herbal substance/herbal preparation in
2 - 3 single doses
Children from 6 to 12 years of age

Daily dose
4 - 25 g herbal substance/herbal preparation in
2 – 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.

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.


Community herbal monograph on Plantago ovata Forssk., semen
EMA/HMPC/304390/2012                                                            Page 5/10

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.

Ispaghula 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).

If abdominal pain occurs or in cases of any
irregularity of faeces, the use of ispaghula 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.


Community herbal monograph on Plantago ovata Forssk., semen
EMA/HMPC/304390/2012                                                            Page 6/10
Well-established use                                          Traditional use

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

In order to decrease the risk of gastrointestinal
obstruction (ileus) ispaghula 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 Plantago ovata seeds or husks (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
1 hour before or after intake of other medicinal
products.

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

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


Community herbal monograph on Plantago ovata Forssk., semen
EMA/HMPC/304390/2012                                                            Page 7/10

Undesirable effects

4.8. Undesirable effects

Well-established use                                          Traditional use

Flatulence may occur with the use of the product,
which 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.

Ispaghula contains potent allergens. The exposure
to these allergens is possible through 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


Community herbal monograph on Plantago ovata Forssk., semen
EMA/HMPC/304390/2012                                                            Page 8/10
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 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 ovata Forssk. (P. ispaghula Roxb.),
seminis tegumentum (ispaghula husk)

i) Herbal substance
    Episperm and collapsed adjacent layers
    removed from the 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 (ref.: 01/2008:1334).
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 ovata Forssk., seminis tegumentum
EMA/HMPC/199774/2012                                                                                               Page 3/11
Well-established use                                         Traditional use

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

Indication 3)
Herbal medicinal product in patients to whom an
increased daily fibre intake may be advisable e.g.
as an adjuvant in constipation predominant
irritable bowel syndrome, as an adjuvant to diet in
hypercholesterolemia (see section 4.4 Special
warnings and precautions for use and section 5.1
Pharmacodynamic properties).


4.2. Posology and method of administration

Well-established use                                         Traditional use

Posology
Indication 1) and 2)
Adolescents, adults and elderly
Daily dose
7 – 11 g herbal substance/herbal preparation in
1 – 3 single doses

Children from 6 to 12 years of age
Daily dose
3 – 8 g herbal substance/herbal preparation in
1 – 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’).

Indication 3)
Adolescents, adults and elderly
Daily dose
7 – 20 g herbal substance/herbal preparation in
1 – 3 single doses

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 during the use of the
medicinal product longer than 3 days, a doctor or
a pharmacist should be consulted (see section 4.4



Community herbal monograph on Plantago ovata Forssk., seminis tegumentum
EMA/HMPC/199774/2012                                                           Page 4/11
Well-established use                                         Traditional use

‘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.

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.




Community herbal monograph on Plantago ovata Forssk., seminis tegumentum
EMA/HMPC/199774/2012                                                           Page 5/11

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                         Traditional use

Indication 1) and 2)
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.

Indication 3)
The use is not recommended in children below
12 years of age due to insufficient data on
efficacy.

Indication 1), 2), 3)
A sufficient amount of liquid should always be
taken e.g. 30 ml of water per 1 g of herbal
substance.

Ispaghula husk 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).

If abdominal pain occurs or in cases of any
irregularity of faeces, the use of ispaghula husk
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) ispaghula husk 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 Plantago ovata seeds or husks (i.e.
healthcare workers, caregivers) allergic


Community herbal monograph on Plantago ovata Forssk., seminis tegumentum
EMA/HMPC/199774/2012                                                           Page 6/11
Well-established use                                         Traditional use

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’).

Indication 3)
The use of ispaghula husk as an adjuvant to diet
in hypercholesterolemia requires medical
supervision.

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
1 hour before or after intake of other medicinal
products.

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

Use of ispaghula husk 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,
which 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.

Ispaghula contains potent allergens. The exposure
to these allergens is possible through 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.




Community herbal monograph on Plantago ovata Forssk., seminis tegumentum
EMA/HMPC/199774/2012                                                           Page 8/11

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

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


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

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

                                                                Polygonum aviculare L., herba (Knotgrass herb)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Comminuted herbal substance



3. Pharmaceutical form
 Well-established use                                           Traditional use

                                                                Comminuted herbal substance as herbal tea for
                                                                oral use.

                                                                Comminuted herbal substance for decoction
                                                                preparation 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 used for the
                                                                relief of symptoms of common cold.



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.: 1885)


European Union herbal monograph on Polygonum aviculare L., herba
EMA/HMPC/143658/2015                                                                                                 Page 3/7
 Well-established use                                          Traditional use

                                                               Indication 2)

                                                               Traditional herbal medicinal product used for
                                                               symptomatic treatment of minor inflammations
                                                               in the mouth or the throat.

                                                               Indication 3)

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

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


4.2. Posology and method of administration 4

 Well-established use                                          Traditional use

                                                               Posology

                                                               Adolescents, adults and elderly

                                                               Indication 1)
                                                               Single dose:
                                                               Herbal tea: 1.5-2 g of the comminuted herbal
                                                               substance in 150 mL of boiling water as a herbal
                                                               infusion 3-4 times daily.
                                                               Daily dose: 4.5-8 g

                                                               Indication 2)
                                                               Single dose:
                                                               Comminuted herbal substance for decoction
                                                               preparation for oromucosal use: 1.5 g of the
                                                               comminuted herbal substance in 200-250 mL of
                                                               water 4-5 times daily for gargling of the
                                                               mouth and throat.
                                                               Daily dose: 6-7.5 g

                                                               Indication 3)
                                                               Single dose:
                                                               Herbal tea: 3 g of the comminuted herbal
                                                               substance in 200 mL of water as a decoction
                                                               2 times daily.
                                                               Daily dose: 6 g



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


European Union herbal monograph on Polygonum aviculare L., herba
EMA/HMPC/143658/2015                                                                                             Page 4/7
 Well-established use                                          Traditional use

                                                               Indication 1), 2) and 3)
                                                               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) 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 2 weeks
                                                               during the use of the medicinal product, a doctor
                                                               or a qualified health care practitioner should be
                                                               consulted.

                                                               Method of administration

                                                               Indication 1) and 3)
                                                               Oral use

                                                               Indication 2)
                                                               Oromucosal use

Contraindications

4.3. Contraindications

 Well-established use                                         Traditional use

                                                              Hypersensitivity to the active substance(s).

                                                              Indication 3)
                                                              Conditions where reduced fluid intake is
                                                              recommended (e.g. severe cardiac diseases).

Special warnings and precautions for use

4.4. Special warnings and precautions for use

 Well-established use                                          Traditional use

                                                               Indication 1), 2) and 3)
                                                               The use in children under 12 years of age has
                                                               not been established due to lack of adequate
                                                               data.

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


European Union herbal monograph on Polygonum aviculare L., herba
EMA/HMPC/143658/2015                                                                                         Page 5/7
 Well-established use                                          Traditional use

                                                               Indication 3)
                                                               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 Polygonum aviculare L., herba
EMA/HMPC/143658/2015                                                                                         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

Well-established use                                             Traditional use

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

                                                                 Polypodium vulgare L., rhizoma
                                                                 (polypody rhizome)

                                                                 i) Herbal substance
                                                                    Not applicable

                                                                 ii) Herbal preparations
                                                                     Comminuted herbal substance for tea
                                                                     preparation


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.




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

                                                        © EMEA 2008                                                              5
                                                                                                                               2/5
4.     CLINICAL PARTICULARS

4.1.   Therapeutic indications

Well-established use                           Traditional use

                                               a) Traditional herbal medicinal product used as
                                                  an expectorant in cough and cold.

                                               b) Traditional herbal medicinal product for
                                                  short-term use in cases of occasional
                                                  constipation.

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

4.2.   Posology and method of administration

Well-established use                           Traditional use

                                               Posology

                                               Adolescents over 12 years of age, adults, elderly

                                               Indication a)
                                               Comminuted herbal substance for tea preparation.
                                               Dried polypody rhizome: 4-5 g 3- 4 times daily

                                               Indication b)
                                               Comminuted herbal substance for tea preparation
                                               Dried polypody rhizome: 14-30 g daily

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

                                               Duration of use

                                               Not to be taken 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.

Contraindications

4.3.   Contraindications

Well-established use                           Traditional use

                                               Hypersensitivity to the active substance.




                                         © EMEA 2008                                             5
                                                                                               3/5

Special warnings and precautions for use

4.4.   Special warnings and precautions for use

Well-established use                              Traditional use

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

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

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                  Traditional use

                                                      None reported.

Undesirable effects

4.8.   Undesirable effects

Well-established use                                  Traditional use

                                                      Indication a)
                                                      Mild laxative effect when used in cough and cold.
                                                      The frequency is not known.

                                                      Indication b)
                                                      None 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

                                                                   Primula veris L. and/or Primula elatior (L.) Hill,
                                                                   flos (Primula flower)

                                                                   i) Herbal substance

                                                                   Not applicable

                                                                   ii) Herbal preparations

                                                                       A) Liquid extract (DER 1:1), extraction solvent
                                                                            ethanol 25% v/v

                                                                       B) Comminuted herbal substance




3. Pharmaceutical form
Well-established use                                               Traditional use

                                                                   Comminuted herbal substance as herbal tea for
                                                                   oral use.

                                                                   Other 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 the relevant
herbal quality guidance.
2
  The material complies with the Deutscher Arzneimittel Codex (DAC 2006).


Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos
EMA/HMPC/136582/2012                                                                                                 Page 3/7
4. Clinical particulars

4.1. Therapeutic indications

Well-established use                                                Traditional use

                                                                    Traditional herbal medicinal product used as an
                                                                    expectorant in cough associated with 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, elderly



                                                                    Herbal preparations:

                                                                    A) Liquid extract:
                                                                        Single dose: 1-3 ml, up to 3 times daily
                                                                        Maximum daily dose 6 ml

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

                                                                    B) Comminuted herbal substance

                                                                    Herbal tea: 1 g of the comminuted herbal
                                                                    substance in 150 ml of boiling water as a herbal
                                                                    infusion 3 times daily.

                                                                    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).


Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, flos
EMA/HMPC/136582/2012                                                                                               Page 4/7

Contraindications

4.3. Contraindications

Well-established use                                               Traditional use

                                                                   Hypersensitivity to the active substance or to
                                                                   other Primula species.

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.

                                                                    Caution is recommended in patients with gastritis
                                                                    or gastric ulcer.

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

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

Interactions with other medicinal products and other forms of interaction

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

Well-established use                                                Traditional use

                                                                    None reported.

Undesirable effects

4.8. Undesirable effects

Well-established use                                                Traditional use

                                                                    Allergic reactions may occur. The frequency is not
                                                                    known.

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

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

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


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

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

                                                                   Primula veris L. and/or Primula elatior (L.) Hill,
                                                                   radix (Primula root)

                                                                   i) Herbal substance

                                                                   Not applicable

                                                                   ii) Herbal preparations

                                                                        A) Dry extract (DER 3-9:1), extraction
                                                                             solvent ethanol 40-50 % v/v

                                                                        B) Liquid extract (DER 1:1), extraction
                                                                             solvent ethanol 70 % v/v

                                                                        C) Liquid extract (DER 1:2.0-2.5), extraction
                                                                             solvent ethanol 70% v/v

                                                                        D) Tincture (ratio of herbal substance to
                                                                             extraction solvent 1:5), extraction solvent
                                                                             ethanol 70 % v/v

                                                                        E) Soft extract (DER 5-10:1), extraction
                                                                             solvent water

                                                                        F) Soft extract (DER 1-4:1), extraction
                                                                             solvent ethanol 20-55% v/v

                                                                        G) Soft extract (DER 6-10:1), extraction
                                                                             solvent methanol, water, ammonia
                                                                             solution 10% (50.0:49.5:0.5)

                                                                        H) Soft extract (DER 6-10:1), extraction
                                                                             solvent methanol 50%

                                                                        I)   Comminuted herbal substance



1
 The material complies with the Eur. Ph. monograph (ref. 01/2008:1364 corrected 6.0)
2
 The declaration of the active substance(s) for an individual finished product should be in accordance with the relevant
herbal quality guidance.


Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, radix
EMA/HMPC/104095/2012                                                                                                Page 3/3
3. Pharmaceutical form
Well-established use                                               Traditional use

                                                                   Comminuted herbal substance as herbal tea for
                                                                   oral use.

                                                                   Other herbal preparations in liquid and 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 used as an
                                                                   expectorant in cough associated with 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, elderly



                                                                   Herbal preparations A (according to ÖAB 4), B, C,
                                                                   D, G:

                                                                    A) Dry extract (according to ÖAB with DER 3-
                                                                         3.5:1):
                                                                         Single dose: 0.1 – 0.2 g, 3 times daily

                                                                    B) Liquid extract:
                                                                         Single dose: 0.5 g, 3 times daily

                                                                    C) Liquid extract:
                                                                         Single dose: 0.6 g, 4 times daily

                                                                    D) Tincture:
                                                                         Single dose: 0.5 – 1 g, 3 times daily
                                                                   G) Soft extract:

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).
4
  Austrian pharmacopoeia (current edition)


Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, radix
EMA/HMPC/104095/2012                                                                                               Page 4/4
Well-established use                                               Traditional use

                                                                       Single dose: 22.5 mg, 3 times daily

                                                                   Herbal preparations A (different DER to ÖAB), E,
                                                                   F, H:

                                                                   Single dose equivalent to 0.2 – 0.5 g herbal
                                                                   substance (depending on the actual DER), 3 times
                                                                   daily

                                                                   Herbal preparation I:

                                                                   Herbal tea: 0.2 – 0.5 g of the comminuted herbal
                                                                   substance in 150 ml of boiling water as a herbal
                                                                   infusion 3 times daily.



                                                                   Children between 4 and 12 years of age
                                                                   Herbal preparations C, D, F:
                                                                   C) Liquid extract
                                                                       4-12 years of age
                                                                       Single dose 0.33 g, 3 times daily
                                                                   D) Tincture
                                                                       4-12 years of age
                                                                       Single dose 0.3 – 0.5 ml, 3 times daily
                                                                   F) Soft extract
                                                                       4-6 years of age
                                                                       Single dose 0.12 g, 3 times daily
                                                                       6-12 years of age
                                                                       Single dose 0.12 g, 3-4 times daily


                                                                   Herbal preparations A, B, E, G, H, I:

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



                                                                   Herbal preparations C, D, F:

                                                                   The use in children under 4 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, a
                                                                   doctor or a qualified health care practitioner
                                                                   should be consulted.




Community herbal monograph on Primula veris L. and/or Primula elatior (L.) Hill, radix
EMA/HMPC/104095/2012                                                                                             Page 5/5
Well-established use                                               Traditional use

                                                                   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

                                                                   Herbal preparations A, B, E, G, H, I:

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

                                                                   Herbal preparations C, D, F:

                                                                   The use in children under 4 years of age is not
                                                                   recommended because medical advice should be
                                                                   sought.

                                                                   All herbal preparations:

                                                                   Caution is recommended in patients with gastritis
                                                                   or gastric ulcer.

                                                                   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.

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 .

                                                                Prunus africana (Hook f.) Kalkm., cortex
                                                                (pygeum africanum bark)

                                                                i) Herbal substance

                                                                Not applicable

                                                                ii) Herbal preparations

                                                                Soft extract (DER 114-222:1), extraction
                                                                solvent: chloroform; (stabilised by 1.2% of
                                                                ethanol >99.9%)



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 lower urinary tract symptoms related to
                                                                benign prostatic hyperplasia after serious
                                                                conditions have been excluded by a medical
                                                                doctor.


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.: 1886)


European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex
EMA/HMPC/680626/2013                                                                                                 Page 2/5
 Well-established use                                           Traditional use

                                                                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

                                                                Single dose: 50 mg

                                                                Daily dose: 100 mg

                                                                There is no relevant use in children and
                                                                adolescents under 18 years of age and women.

                                                                Duration of use

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

                                                                Method of administration

                                                                Oral use

Contraindications

4.3. Contraindications

 Well-established use                                           Traditional use

                                                                Hypersensitivity to the active substance.

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
                                                                fever, spasms or blood in the urine, painful
                                                                urination or urinary retention occur during the
                                                                use of the medicinal product, 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

                                                                None reported




European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex
EMA/HMPC/680626/2013                                                                                           Page 3/5

Undesirable effects

4.8. Undesirable effects

 Well-established use                                           Traditional use

                                                                Rarely: digestive disorders (nausea, constipation
                                                                or diarrhoea).

                                                                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

                                                                     Prunus avium L., and/or Prunus cerasus L.,
                                                                     peduncle (cherry stalks)

                                                                     i) Herbal substance

                                                                     Not applicable.

                                                                     ii) Herbal preparations

                                                                     Comminuted herbal substance.



3. Pharmaceutical form
   Well-established use                                              Traditional use

                                                                     Herbal preparation as herbal tea for oral use.

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


4. Clinical particulars

4.1. Therapeutic indications

   Well-established use                                               Traditional use
                                                                     Traditional herbal medicinal product used for the
                                                                     relief of symptoms associated with minor urinary
                                                                     tract complaints in addition to the general
                                                                     recommendation of a sufficient fluid intake to
                                                                     increase the amount of urine.
                                                                     The product is a traditional herbal medicinal
                                                                     product for use in the specified indication
                                                                     exclusively based upon long-standing use.


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

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

monograph in the European Pharmacopoeia, a national pharmacopoeia or national codex currently used officially in a
Member State.

European Union herbal monograph on Prunus avium L.; Prunus cerasus L., peduncle
EMA/HMPC/379866/2023                                                                                                  Page 3/6
4.2. Posology and method of administration 4

    Well-established use                                            Traditional use

                                                                   Posology

                                                                   Adults and Elderly

                                                                   2-6 g of comminuted herbal substance in 200 mL
                                                                   water as an infusion or decoction.

                                                                   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

                                                                   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 urinary tract complaints worsen and symptoms
                                                                    such as fever, dysuria, spasm, or blood in the urine
                                                                    occur during the use of medicinal product, a doctor
                                                                    or a qualified health care practitioner should be
                                                                    consulted.
                                                                    Because adequate fluid intake is required during
                                                                    treatment (see section 4.2. Posology and method of
                                                                    administration), Prunus avium L. and/or Prunus
                                                                    cerasus L., peduncle is not recommended for
                                                                    patients with conditions where reduced fluid intake
                                                                    is advised by a medical doctor.


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

European Union herbal monograph on Prunus avium L.; Prunus cerasus L., peduncle
EMA/HMPC/379866/2023                                                                                             Page 4/6
                                                                    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.