DISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)

January 2007 July 2007 September 2007

ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION

7 September 2007

END OF CONSULTATION (DEADLINE FOR COMMENTS)

15 December 2007

REDISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)

ADOPTION BY HMPC

Well-established use

Traditional use

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

Urtica dioica L., Urtica urens L., their hybrids or mixtures, herba (nettle herb)

i) Herbal substance

Dried cut or fragmented aerial parts of the plant collected or harvested during the flowering period

ii) Herbal preparations

Comminuted herbal substance Expressed juice from the fresh herb^{1 2}, Urticae herbae succus (1:1)³ Liquid extract with 25% ethanol 1:1 Tincture with 45% ethanol 1:5

Well-established use

Traditional use

Herbal substance or herbal preparation in solid or liquid dosage forms or as an herbal tea for oral

use.

The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Well-established use

Traditional use

a)    Traditional herbal medicinal product to increase the amount of urine to achieve flushing of the urinary tract as an adjuvant in minor urinary complaints.

b)    Traditional herbal medicinal product for relief of minor articular pain.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Well-established use

Traditional use Posology

Adolescents over 12 years of age, adults, elderly Single dose

Dried cut or fragmented herbal substance: 2-4 g as single dose up to 3 times daily as infusion.

Expressed juice²: 5-10 ml as a single dose up to 3 times daily.

Urticae herbae succus (1:1)³: 2.5-5 ml as a single dose, up to 3 times daily.

Liquid extract: 3-4 ml as single dose up to 3 times daily.

Tincture: 2-6 ml as single dose up to 3 times daily.

The use is not recommended in children under 12 years of age (see also 4.4. Special warnings and precautions for use).

Duration of use

Indication a)

If symptoms persist or do not improve within one week, a doctor or a qualified health care practitioner should be consulted.

Indication b)

If symptoms persist or do not improve within one month, a doctor or a qualified health care practitioner should be consulted.

Method of administration

Oral use.

Indication a)

For extracts, ensure appropriate fluid intake.

Well-established use

Traditional use

Hypersensitivity to nettle herb.

Condition where a reduced fluid intake is recommended (e.g. severe cardiac or renal disease).

Well-established use

Traditional use

Patients suffering from diabetes or hypertension should consult their doctor before using nettle herb preparations.

The product is not intended to be used in case of acute arthritis as this condition requires medical advice.

The use is not recommended in children under 12 years of age because of the lack of available experience.

If complaints or 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 tinctures and 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.

Well-established use

Traditional use

Concomitant treatment with synthetic diuretics is not recommended.

For preparations other than herbal teas:

Patients under anticoagulant therapy should consult their doctor because of the vitamin K content of nettle herb.

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.

Well-established use

Traditional use

No studies on the effect on the ability to drive and use machines have been performed.

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.

Well-established use

Traditional use

No case of overdose has been reported.

Well-established use

Traditional use

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

Well-established use

Traditional use

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

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.

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

Well-established use

Traditional use

Not applicable.