Pflanzenwissen.
Mit Herkunft.

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

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


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

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

                                                                Trigonella foenum-graecum L., semen
                                                                (fenugreek)

                                                                i) Herbal substance

                                                                As defined in the Ph. Eur. monograph.

                                                                ii) Herbal preparations

                                                                a) Comminuted herbal substance

                                                                b) Powdered herbal substance

                                                                c)   Dry extract (DER 4:1), extraction solvent:
                                                                     ethanol 20% V/V

                                                                d) Soft extract (DER 5-6:1), extraction solvent:
                                                                     ethanol 60% V/V



3. Pharmaceutical form
 Well-established use                                           Traditional use

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

                                                                Herbal preparations in solid dosage forms for
                                                                oral use.

                                                                Herbal substance or powdered herbal substance
                                                                for infusion for cutaneous use.

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




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

quality guidance.
2 The material complies with the Ph. Eur. monograph (ref.: 1323).




European Union herbal monograph on Trigonella foenum-graecum L., semen
EMA/HMPC/179591/2018                                                                                                 Page 3/8
4. Clinical particulars

4.1. Therapeutic indications

 Well-established use                                         Traditional use

                                                              Indication 1)

                                                              Traditional herbal medicinal product used for
                                                              temporary loss of appetite.

                                                              Indication 2)

                                                              Traditional herbal medicinal product used for the
                                                              symptomatic treatment of minor inflammations
                                                              of the skin.

                                                              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 3

 Well-established use                                         Traditional use

                                                              Posology

                                                              Adults and elderly

                                                              Indication 1)

                                                              i) Herbal substance

                                                              Herbal tea: 1-6 g daily of the herbal substance
                                                              in 250 ml of boiling water, before meals

                                                              ii) Herbal preparations

                                                              a) Comminuted herbal substance

                                                              Comminuted herbal substance: 1-2 g with
                                                              liquid, 3 times daily, before meals

                                                              Macerate: 0.5 g comminuted herbal substance
                                                              macerated in 150 ml cold water for 3 hours;
                                                              strain. Drink 3 times daily

                                                              b) Powdered herbal substance

                                                              Single dose: 380-1100 mg, 3 times daily

                                                              Daily dose: 1140-3300 mg

                                                              c) Dry 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).>


European Union herbal monograph on Trigonella foenum-graecum L., semen
EMA/HMPC/179591/2018                                                                                             Page 4/8
 Well-established use                                         Traditional use

                                                              Single dose: 295 mg, 2 times daily

                                                              Daily dose: 590 mg

                                                              d) Soft extract

                                                              Single dose: 500 mg, 2 times daily

                                                              Daily dose: 1 g

                                                              Indication 2)

                                                              Herbal substance or powdered herbal substance
                                                              for infusion for cutaneous use: 50 g in 250 ml of
                                                              water, 2-3 times daily.

                                                              The still warm infusion is used in cataplasm over
                                                              the affected areas.

                                                              Indication 1) and 2)

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

                                                              Duration of use

                                                              Indication 1)

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

                                                              Method of administration

                                                              Indication 1)

                                                              Oral use.

                                                              Indication 2)

                                                              Cutaneous use.




European Union herbal monograph on Trigonella foenum-graecum L., semen
EMA/HMPC/179591/2018                                                                                         Page 5/8

Contraindications

4.3. Contraindications

 Well-established use                                         Traditional use

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

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 safety data.

                                                               Oral use
                                                               Due to a possible hypoglycaemic effect of
                                                               fenugreek, close monitoring of glycaemic control
                                                               should be considered in patients treated for
                                                               diabetes mellitus.

                                                               For extracts containing ethanol, the appropriate
                                                               warning for ethanol, taken from the ‘Annex to
                                                               the European Commission guideline on
                                                               excipients in the labelling 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

                                                              Oral use
                                                              Gastrointestinal disorders: flatulence, diarrhoea
                                                              may occur.
                                                              Nervous system disorders: dizziness may occur.
                                                              The frequency is not known.

                                                              Oral use and cutaneous use
                                                              Allergic reactions have been reported after local
                                                              application (facial angioedema, wheezing) or
                                                              ingestion (asthma, allergic rhinitis). The
                                                              frequency is not known.

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