Draft Community Herbal Monograph On Camellia Sinensis (L.) Kuntze, Non Fermentatum Folium
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
12 March 2013
EMA/HMPC/283630/2012
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Camellia sinensis (L.) Kuntze, non fermentatum folium, green tea leaf
BG (bälgarski): 3eneH Man
CS (Cestina): Cajovnikovy list nefermentovany
DA (dansk): Gr0n te
DE (Deutsch): Grünteeblätter
EL (ellinika): KapeÀÀiaç (Te'iaç) Tgç aiviKijç 9ÙÀÀ0
npàaivo
EN (English): Green tea ES (espanol): Té verde, hoja de ET (eesti keel): roheline tee FI (suomi): vihreätee FR (français): Thé vert (feuille de)
HU (magyar): Zöld tea levél IT (italiano):
LT (lietuviq kalba): Kininiq arbatmedziq nefermentuoti lapai
LV (latviesu valoda): Tejas kruma nefermentetas lapas
MT (malti): Te ahdar NL (nederlands): Groene thee PL (polski): Lisc herbaty chinskiej niefermentowany (herbata zielona)
PT (portugués): Chá, folha nao fermentada RO (romana): Frunza de ceai verde SK (slovencina): Cajovníkovy list, nefermentovany
SL (slovenscina): nefermentirani list cajevca SV (svenska): Te IS (íslenska):
NO (norsk): Gr0nn te_
Draft
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Discussion in Working Party on Community monographs and Community list (MLWP) |
March 2012 September 2012 January 2013 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
12 March 2013 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 July 2013 |
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Rediscussion in Working Party on Community monographs and Community list (MLWP) | |
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Adoption by Committee on Herbal Medicinal Products (HMPC) |
Keywords
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© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1,2
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Well-established use |
Traditional use |
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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
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Well-established use |
Traditional use |
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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
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Well-established use |
Traditional use |
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Traditional herbal medicinal product for relief of fatigue and sensation of weakness. |
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, current edition
|
Well-established use |
Traditional use |
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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 administration1
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Well-established use |
Traditional use |
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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. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance(s). Gastric and duodenal ulcers, cardiovascular disorders such as hypertension and arrhythmia, hyperthyroidism. |
4.4. Special warnings and precautions for use
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Well-established use |
Traditional use |
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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. |
4.5. Interactions with other medicinal products and other forms of interaction
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Well-established use |
Traditional use |
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Caffeine containing preparations reduce sedative action and increase side effects caused by sympathomimetic drugs. |
4.6. Fertility, pregnancy and lactation
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Well-established use |
Traditional use |
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No fertility data available. Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. |
4.7. Effects on ability to drive and use machines
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Well-established use |
Traditional use |
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No studies on the effect on the ability to drive and use machines have been performed. |
4.8. Undesirable effects
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Well-established use |
Traditional use |
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None known. If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted. |
4.9. Overdose
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Well-established use |
Traditional use |
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Overdose (quantities corresponding to more than 300 mg caffeine or 5 cups of tea as a beverage) can lead to restlessness, tremor, and elevated reflex excitability. The first signs of poisoning are vomiting and abdominal spasm. |
5. Pharmacological properties
5.1. Pharmacodynamic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
5.2. Pharmacokinetic properties
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. Caffeine crosses the placenta and is distributed in breast milk. |
5.3. Preclinical safety data
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Well-established use |
Traditional use |
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Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless necessary for the safe use of the product. Adequate tests on reproductive toxicity and carcinogenicity have not been performed. |
6. Pharmaceutical particulars
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Well-established use |
Traditional use |
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Not applicable. |
7. Date of compilation/last revision
12 March 2013
Page 6/5
Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium
EMA/HMPC/283630/2012
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).