Draft Community Herbal Monograph On Potentilla Erecta (L.) Raeusch., Rhizoma
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
11 March 2010 EMA/HMPC/5513/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Potentina erecta (L.) Raeusch., rhizoma
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Potentina erecta (L.) Raeusch., Tormentillae rhizoma; tormentil
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Discussion in Working Party on Community monographs and Community list (MLWP) |
January 2010 March 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
11 March 2010 |
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End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu |
15 August 2010 |
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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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BG (bälgarski): |
LT (lietuviq. kalba): |
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CS (cestina): |
LV (latviesu valoda): |
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DA (dansk): |
MT (malti): |
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DE (Deutsch): Tormentillwurzelstock, Blutwurz |
NL (nederlands): |
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EL (ellinika): |
PL (polski): |
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EN (English): |
PT (português): |
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ES (espanol): |
RO (romàna): |
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ET (eesti keel): |
SK (slovencina): |
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FI (suomi): |
SL (slovenscina): |
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FR (français): |
SV (svenska): |
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HU (magyar): |
IS (islenska): |
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IT (italiano): |
NO (norsk): |
An agency of the European Union
Community herbal monograph on Potentina erecta (L.) Raeusch., rhizoma
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 Potentilla erecta (L.) Raeusch., rhizoma (tormentil) i) Herbal substance not applicable ii) Herbal preparations a) Comminuted herbal substance b) Tincture (ratio drug : extraction solvent 1:5), extraction solvent ethanol 70% v/v 1 2 3 c) Tincture (ratio drug : extraction solvent 1:5), extraction solvent ethanol 45% v/v d) Liquid extract (DER 1:1), extraction solvent ethanol 25% v/v e) Dry extract (DER 3.5-4.5:1), extraction solvent ethanol 60% v/v |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Comminuted herbal substance as herbal tea for oral use. Comminuted herbal substance for infusion or decoction preparation for oromucosal use. Herbal preparations a), c), d) and e) in liquid dosage forms for oral use. Herbal preparation b) in liquid dosage forms for oromucosal 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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Indication 1) Traditional herbal medicinal product for symptomatic treatment of mild diarrhoea. Indication 2) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the oral mucosa. 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 Indication 1 (oral use) a) Comminuted herbal substance: As infusion: single dose 1.4-4 g, several times daily up to a maximum daily dose of 12 g comminuted herbal substance. |
As decoction: single dose 1.4-3 g, several times daily up to a maximum daily dose of 6 g comminuted herbal substance.
b) Single dose: 1-2 ml in water; 3 times daily.
c) Single dose 2-4 ml, 3 times daily.
d) Single dose 2-4 ml, 3 times daily.
e) Single dose 400 mg, 3 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').
Adults and elderly Indication 2 (oromucosal use)
a) Comminuted herbal substance:
As infusion: 1.3 - 2 g per 100 ml of water.
As decoction: 0.8 - 3 g per 100 ml of water.
Rinse the mouth several times daily.
b) Single dose: 1-5 ml per 150 ml of water.
Rinse the mouth several 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
Indication 1:
If the symptoms persist longer than 3 days 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
Indication 1:
Oral use.
Indication 2:
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Well-established use |
Traditional use |
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Oromucosal 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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Indication 1: If recurrent diarrhoea or bloody stools occur a doctor or a qualified health care practitioner should be consulted. Indications 1 and 2: 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. For tinctures 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. |
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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Indication 1: Internal absorption of concomitantly administered medicine may be delayed. For this reason the product should be taken 1 hour or more before or after intake of other medicinal products. Indication 2: None reported. |
4.6. 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. |
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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Indication 1: Mild stomach complains with the symptoms nausea and vomiting may occur in sensitive patients. The frequency is not known. If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. Indication 2: 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. Adequate 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
11 March 2010
Page 7/7
Community herbal monograph on Potentilla erecta (L.) Raeusch., rhizoma
EMA/HMPC/5513/2010
The material complies with the Ph. Eur. monograph (ref.: 01/2008: 1478).
The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
The tincture complies with the Eur. Ph. monograph (ref.: 01/2008: 1895).