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 as
                                                                amended

                                                                Camellia sinensis (L.) Kuntze, non fermentatum
                                                                folium (green tea leaf)

                                                                i) Herbal substance

                                                                  Whole dried leaf.

                                                                ii) Herbal preparations

                                                                   a) Comminuted herbal substance

                                                                   b) Powdered herbal substance



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.
                                                                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
                                                                fatigue and sensation of weakness.



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 French Pharmacopoeia monograph,2010

Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium
EMA/HMPC/283630/2012                                                                                                 Page 3/5
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 3

Well-established use                                           Traditional use

                                                               Posology

                                                               Adults and elderly

                                                               a) Herbal tea

                                                               1.8 – 2.2 g of whole or comminuted herbal
                                                               substance in 100 – 150 ml of boiling water as a
                                                               herbal infusion, 3 – 5 times daily.

                                                               b) powdered herbal substance

                                                               Single dose:

                                                               390 mg, 3 times daily (up to 5 times if necessary)

                                                               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(s).

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




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 Camellia sinensis (L.) Kuntze, non fermentatum folium
EMA/HMPC/283630/2012                                                                                             Page 4/5

Special warnings and precautions for use

4.4. Special warnings and precautions for use

Well-established use                                           Traditional use

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

                                                               Not recommended before bedtime as it may cause
                                                               sleep disturbances.

                                                               If symptoms worsen during the use of the
                                                               medicinal products a doctor or a qualified health
                                                               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

                                                               Caffeine containing preparations reduce actions of
                                                               sedative substances 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.




Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium
EMA/HMPC/283630/2012                                                                                        Page 5/5