Draft Community Herbal Monograph On Aesculus Hippocastanum L., Cortex
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
13 September 2011
EMA/HMPC/354156/2011
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Aesculus hippocastanum L., cortex
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Aesculus hippocastanum L., cortex; Hippocastani cortex; Horse chestnut bark
BG (balgarski): flwB KecTeH, Kopa CS (cestina): kura kastanu koñského DA (dansk): Hestekastanjebark DE (Deutsch): Rosskastanienrinde EL (elliniká): OÀoiôç innoKaoTavéaç EN (English): Horse chestnut bark ES (espanol): Castaño de Indias, corteza de ET (eesti keel): hobukastanikoor FI (suomi):
FR (français): Marronnier d'Inde (écorce de) HU (magyar):
IT (italiano): Ippocastano corteccia
LT (lietuviq. kalba):
LV (latviesu valoda): Zirgkastaga miza MT (malti):
NL (nederlands): Paardenkastanje
PL (polski): Kora kasztanowca
PT (portugues): Castanheiro-da-india, casca
RO (romana): scoar^ä de castan
SK (slovencina): List pagastanu
SL (slovenscina): skorja navadnega divjega
kostanja
SV (svenska): Hästkastanj, bark IS (fslenska):
NO (norsk): Hestekastanjebark_
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Discussion in Working Party on Community monographs and Community list (MLWP) |
May 2011 July 2011 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
September 2011 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 February 2012 |
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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, 2011. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Aesculus hippocastanum L., cortex
1. Name of the medicinal product
To be specified for the individual finished product.
2. Qualitative and quantitative composition1
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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 Aesculus hippocastanum L., cortex (horse chestnut bark) i) Herbal substance Not applicable. ii) Herbal preparations Powdered herbal substance |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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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 |
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Indication 1) Traditional herbal medicinal product for relief of symptoms of discomfort and heaviness of legs |
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Well-established use |
Traditional use |
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related to minor venous circulatory disturbances. Indication 2) Traditional herbal medicinal product for symptomatic relief of itching and burning associated with haemorrhoids, after serious conditions have been excluded by a medical doctor. The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use. |
4.2. Posology and method of administration
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Well-established use |
Traditional use |
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Posology Adults and elderly Single dose: 275 mg, 3 to 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. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance. |
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. |
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Well-established use |
Traditional use |
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Indication 1) If there is inflammation of the skin, thrombophlebitis, varicosis or subcutaneous induration, ulcers, sudden swelling of one or both legs, cardiac or renal insufficiency, a doctor should be consulted. Indication 2) If rectal bleeding occurs, a doctor should be consulted. |
4.5. Interactions with other medicinal products and other forms of interaction
|
Well-established use |
Traditional use |
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None reported. |
4.6. Fertility, pregnancy and lactation
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Well-established use |
Traditional use |
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Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended. No fertility data available. |
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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No case of overdose has been reported. |
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. |
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. Tests on reproductive toxicity, genotoxicity 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
13 September 2011
Community herbal monograph on Aesculus hippocastanum L., cortex
EMA/HMPC/354156/2011
Page 5/5
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.