Draft Community Herbal Monograph On Leonurus Cardiaca L., Herba
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EUROPEAN MEDICINES AGENCY
SCIENCE MEDICINES HEALTH
6 May 2010
EMA/HMPC/127428/2010
Committee on Herbal Medicinal Products (HMPC)
Community herbal monograph on Leonurus cardiaca L., herba
Draft
Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Leonurus cardiaca L., herba; Leonuri cardiacae herba, motherwort
BG (balgarski): fl^BO^CKa ycTa
CS (cestina): srdecníková naf
DA (dansk): Almindelig Hjertespand
DE (Deutsch): Herzgespannkraut
EL (elliniká): AeovTÔvoupoç o KapôiaKÔç
EN (English): Motherwort
ES (espanol): Agripalma
ET (eesti keel): Laane-sûdamerohi
FI (suomi): Nukula
FR (français): Agripaume
HU (magyar): szúrós gyöngyajak (szu'ro's
gyo'ngyajak)
IT (italiano): Cardiaca comune
LT (lietuviq kalba): Sukatzol LV (latviesu valoda): Mätere MT (malti):
NL (nederlands): Hartgespan PL (polski): Serdecznik pospolity PT (portugués):
RO (romana): Talpa gåstei SK (slovencina): Srdcovník obycajny SL (slovenscina): Deljenolistna srcnica SV (svenska): Hjärtstilla IS (íslenska):
NO (norsk): Lovehale
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Discussion in Working Party on Community monographs and Community list (MLWP) |
May 2010 |
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Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation |
6 May 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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© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.
Community herbal monograph on Leonurus cardiaca L., herba
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 Leonurus cardiaca L., herba (Motherwort) i) Herbal substance Not applicable. ii) Herbal preparations a) Comminuted herbal substance, b) Powdered herbal substance, c) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 70% V/V, d) Tincture (ratio of herbal substance to extraction solvent 1:5), extraction solvent ethanol 45% V/V, e) Liquid extract (DER 1:1), extraction solvent ethanol 25% V/V. |
3. Pharmaceutical form
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Well-established use |
Traditional use |
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Tinctures and liquid extract in liquid dosage forms for oral use. Powdered herbal substance for oral use. Comminuted herbal substance as herbal tea for oral use. The pharmaceutical form should be described |
1 The material complies with the Ph. Eur. monograph (ref.: 01/2008:1833)
2 The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance.
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Well-established use |
Traditional use |
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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 used to relieve symptoms of nervous tension. 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
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Well-established use |
Traditional use |
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Posology Adults and elderly a) Comminuted herbal substance for tea preparation: single dose 1.5 to 4.5 g, daily dose 3 to 10 g. b) Powdered herbal substance: single dose 150 mg, 1-3 times per day. c) Tincture 1:5, ethanol 70% V/V: single dose 0.5- 1.0 g, 3-4 times per day. d) Tincture 1:5, ethanol 45% V/V: single dose 2-6 ml, 3 times per day. e) Liquid extract : single dose 2-4 ml, 3 times per day. 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 4 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Method of administration |
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Well-established use |
Traditional use |
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Oral use. |
4.3. Contraindications
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Well-established use |
Traditional use |
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Hypersensitivity to the active substance. Not to be used in pregnancy. |
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. If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. Tinctures, liquid extract: 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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None reported. |
4.6. Pregnancy and lactation
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Well-established use |
Traditional use |
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Contraindicated during pregnancy. The safety during lactation has not been established. |
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. |
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Well-established use |
Traditional use |
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May impair ability to drive and use machines. Affected patients should not drive or operate machinery. |
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. Adequate tests on reproductive toxicity have not been performed. Tests on 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
6 May 2010
Page 6/6
Community herbal monograph on Leonurus cardiaca L., herba
EMA/HMPC/127428/2010