Draft Community Herbal Monograph On Urtica Dioica L., Urtica Urens L., Folium
European Medicines Agency Evaluation of Medicines for Human Use
London, 8 May 2008 Doc. Ref. EMEA/HMPC/508015/2007
COMMITTEE ON HERBAL MEDICINAL PRODUCTS
(HMPC)
DRAFT
COMMUNITY HERBAL MONOGRAPH ON URTICA DIOICA L., URTICA URENS L.,
FOLIUM
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DISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP) |
October 2007 January 2008 May 2008 |
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ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION |
8 May 2008 |
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END OF CONSULTATION (DEADLINE FOR COMMENTS) |
15 September 2008 |
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REDISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP) | |
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ADOPTION BY HMPC |
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged
Comments should be provided using this template to hmpc.secretariat@emea.europa.eu Fax: +44 20 75 23 70 51
KEYWORDS
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Urtica dioica L.; Urtica urens L.; Urticae folium; nettle leaf
COMMUNITY HERBAL MONOGRAPH ON URTICA DIOICA L., URTICA URENS L., 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 marketing authorisation application of Article 10(a) of Directive 2001/83/EC as amended |
With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended |
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Urtica dioica L., Urtica urens L. or a mixture of the two species, folium (nettle leaf) | |
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i) Herbal substance whole or cut dried leaves | |
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ii) Herbal preparations A) liquid extract (1:5) prepared with 96% ethanol: water: wine 16.5% (V/V) (1.65:1.35:7) B) dry extract (4.7-6:1), extraction solvent: water C) dry extract (5-10:1), extraction solvent: water D) dry extract (8-10:1), extraction solvent: ethanol 50% (V/V) |
3. PHARMACEUTICAL FORM
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Well-established use |
Traditional use |
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The pharmaceutical form should be described by the European Pharmacopoeia full standard term. | |
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Herbal substance or herbal preparation in solid or liquid dosage forms or as an herbal tea for oral | |
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use |
1 The material complies with the Eur. Ph. monograph (ref. 01/2008:1897)
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
4.1. Therapeutic indications
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Well-established use |
Traditional use a) Traditional herbal medicinal product for relief of minor articular pain. b) Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints. 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 Posology Adolescents over 12 years of age, adults, elderly i) Herbal substance 2-4g whole or cut dried leaves for preparation of tea as single dose up to 3-6 times daily. The daily dosage is equivalent to 8-12 g of herbal substance. Pour one cup of boiling water over 2-4 teaspoonfuls (approximately 2-4 g) nettle leaves. Steep for about 10 minutes and then pass through a tea strainer. ii) Herbal preparations A) 30-40 oral drops of liquid extract (1:5) prepared with 96% ethanol: water: wine 16.5% (V/V) (1.65:1.35:7) as a single dose up to 3-4 times daily B) 750 mg dry extract (4.7-6:1), extraction solvent: water as a single dose up to 2-3 times daily (equivalent with 2-3x 4 g herbal substance) C) 450 mg dry extract (5-10:1), extraction solvent: water as a single dose up to 3 times daily (equivalent with 3x 3.4 g herbal substance) D) 536 mg dry extract (8-10:1), extraction solvent: ethanol 50% (V/V) as a single dose up to 2 times daily (equivalent with 2x 4.8 g herbal substance) |
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The use is not recommended in children under 12 years of age (see section 4.4. Special warnings and precautions for use). | |
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Duration of use | |
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For indication a) 4 weeks For indication b) 2-4 weeks | |
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If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. | |
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Method of administration | |
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Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use Hypersensitivity to the active substance. Condition where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease). |
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4.4. Special warnings and precautions for use | |
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Well-established use |
Traditional use Where articular pain accompanied by swelling of joint, redness or fever are present, a doctor should be consulted. The use is not recommended in children under 12 years of age because of the lack of adequate experience. If minor urinary tract complaints worsen and symptoms such as fever, dysuria, spasm, or blood in the urine occur during the use of medicinal product, a doctor or a qualified health care professional should be consulted. For liquid extracts 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 None reported. |
4.6. Pregnancy and lactation
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Well-established use |
Traditional use 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 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 Mild gastrointestinal complaints (e.g. nausea, vomiting, diarrhoea) and allergic reactions (e.g. itching, exanthema, hives) may occur. The frequency is not known. |
4.9. Overdose
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Well-established use |
Traditional use No case of overdose has been reported. |
5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties
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Well-established use |
Traditional use 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 Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended. |
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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. | |
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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. |
Not applicable. |
7. DATE OF COMPILATION/LAST REVISION
8 May 2008
© EMEA 2008 6/6