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Draft Community Herbal Monograph On Urtica Dioica L., Urtica Urens L., Their Hybrids Or Their Mixtures, Radix

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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

13 September 2011

EMA/HMPC/461160/2008

Committee on Herbal Medicinal Products (HMPC)

Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix

Draft

Herbal medicinal products; HMPC; Community herbal monographs; traditional use; Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix


Discussion in Working Party on Community monographs and Community list (MLWP)

January 2010 March 2011 July 2011

Adoption by Committee on Herbal Medicinal Products (HMPC) for release for consultation

13 September 2011

End of consultation (deadline for comments). Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

15 February 2012

Rediscussion in Working Party on Community monographs and Community list (MLWP)

Adoption by Committee on Herbal Medicinal Products (HMPC)

Keywords

BG (balgarski): KonpnBa, KopeH

LT (lietuviq kalba):

CS (cestina): koprivovy koren

LV (latviesu valoda): Nätru saknes

DA (dansk): Brændenælderod

MT (malti): Gherq il-Hurrieq

DE (Deutsch): Brennnesselwurzel

NL (nederlands): Brandnetelwortel

EL (elliniká): piÇa Kviôqç

PL (polski): Korzeii pokrzywy

EN (English): Nettle Root

PT (portugués): Urtiga, raiz

ES (espanol): Ortiga, raíz de

RO (romana): rädäcinä de urzica

ET (eesti keel): nögesejuur

SK (slovencina): Prhl'avovy koren

FI (suomi):

SL (slovenscina): korenina koprive

FR (français): Ortie (racine d')

SV (svenska): Brännässelrot

HU (magyar): csalángyokér

IS (íslenska):

IT (italiano): Ortica radice

NO (norsk): Neslerot


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© European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged.

Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix

1.    Name of the medicinal product

To be specified for the individual finished product.

2.    Qualitative and quantitative composition1,2

Well-established use

Traditional use

With regard to the registration application of Article 16d(1) of Directive 2001/83/EC as amended

Urtica dioica L., Urtica urens L., their hybrids or mixtures, radix (nettle root)

Nettle root consists of the whole, cut or powdered dried root and rhizomes of Urtica dioica L. Urtica urens L., their hybrids or mixtures of these.1

i)    Herbal substance Not applicable.

ii)    Herbal preparations

a)    Comminuted herbal substance

b)    Dry extract (DER 7.1-14.3:1), extraction solvent methanol 20% V/V

c)    Dry extract (DER 6.7-8.3:1), extraction solvent ethanol 20% V/V

d)    Dry extract (DER 12-16:1), extraction solvent ethanol 70% V/V

e)    Liquid extract (DER 1:1), extraction solvent ethanol 30% V/V

3. Pharmaceutical form

Well-established use

Traditional use

Comminuted herbal substance as herbal tea for oral use.

Herbal preparations in solid or liquid dosage forms for oral use.

1    The material complies with the German Pharmacopoeia monograph (DAB 10, Nachtrag 1993)

2    The declaration of the active substance(s) for an individual finished product should be in accordance with relevant herbal quality guidance

Well-established use

Traditional 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

Traditional herbal medicinal product for the relief of lower urinary tract symptoms related to benign prostatic hyperplasia after serious conditions have been excluded by a medical doctor.

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

Well-established use

Traditional use

Posology

Adults, elderly Single dose

a)    Herbal tea: 1.5 g of the comminuted herbal substance as a decoction 3-4 times daily

b)    Dry extract (DER 7.1-14.3:1), extraction solvent methanol 20% V/V

160 mg 3 times daily

or

460 mg once a day

c)    Dry extract (DER 6.7-8.3:1), extraction solvent ethanol 20% V/V

240 mg 3 times daily

d)    Dry extract (DER 12-16:1), extraction solvent ethanol 70% V/V

150-190 mg twice a day

e)    Liquid extract (1:1), extraction solvent ethanol

Well-established use

Traditional use

30% V/V

Maximum 5 ml daily divided into 3 or 4 single doses

There is no relevant use in children and adolescents under 18 years of age.

Duration of use

Long-term use is possible (see section 4.4 'Special warnings and precautions for use').

Method of administration

Oral use.

4.3. Contraindications

Well-established use

Traditional use

Hypersensitivity to the active substance.

4.4. Special warnings and precautions for use

Well-established use

Traditional use

If complaints worsen or if symptoms such as fever, spasms or blood in the urine, painful urination, or urinary retention occur during the use of the medicinal product, a doctor should be consulted.

For 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

Well-established use

Traditional use

None reported.

4.6. Fertility, pregnancy and lactation

Well-established use

Traditional use

Not relevant.

4.7. Effects on ability to drive and use machines

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

Well-established use

Traditional use

Gastro-intestinal complaints such as nausea, heartburn, feeling of fullness, flatulence, diarrhoea may occur. The frequency is not known.

Allergic reactions i.e. pruritus, rash, urticaria may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

4.9. Overdose

Well-established use

Traditional use

No case of overdose has been reported.

5. Pharmacological properties

5.1. Pharmacodynamic properties

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

Well-established use

Traditional use

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3. Preclinical safety data

Well-established use

Traditional use

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.

Well-established use

Traditional use

Adequate tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical particulars

Well-established use

Traditional use

Not applicable.

7. Date of compilation/last revision

13 September 2011

Page 6/6

Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their

mixtures, radix

EMA/HMPC/461160/2008

1

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).