Draft Community Herbal Monograph On Polypodium Vulgare L., Rhizoma

Summary

European Medicines Agency Evaluation of Medicines for Human Use

London, 8 May 2008 Doc. Ref. EMEA/HMPC/600668/2007

COMMITTEE ON HERBAL MEDICINAL PRODUCTS

(HMPC)

DRAFT

COMMUNITY HERBAL MONOGRAPH ON POLYPODIUM VULGARE L., RHIZOMA

DISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)	January 2008 March 2008 May 2008
ADOPTION BY HMPC FOR RELEASE FOR CONSULTATION	8 May 2008
END OF CONSULTATION (DEADLINE FOR COMMENTS)	15 September 2008
REDISCUSSION IN WORKING PARTY ON COMMUNITY MONOGRAPHS AND COMMUNITY LIST (MLWP)
ADOPTION BY HMPC

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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; Polypodium vulgare L.; Polypodii rhizoma; polypody rhizome_

COMMUNITY HERBAL MONOGRAPH ON POLYPODIUM VULGARE L., RHIZOMA

1. Name of the medicinal product

To be specified for the individual finished product.

2. Qualitative and quantitative composition¹ ,

Well-established use

Traditional use

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

Polypodium vulgare L., rhizoma (polypody rhizome)

i) Herbal substance Not applicable

ii) Herbal preparations Comminuted herbal substance for tea preparation

3. PHARMACEUTICAL FORM

Well-established use

Traditional use

Herbal preparations in solid dosage forms for oral use.

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

¹ 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

Well-established use

Traditional use

a) Traditional herbal medicinal product used as an expectorant in cough and cold.

b) Traditional herbal medicinal product for short-term use in cases of occasional constipation.

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

Well-established use

Traditional use Posology

Adolescents over 12 years of age, adults, elderly

a) Cough and cold:

Comminuted herbal substance for tea preparation Dried polypody rhizome: 4-5 g 3- 4 times daily

b) Occasional constipation

Comminuted herbal substance for tea preparation Dried polypody rhizome: 14-30 g daily

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

Duration of use

Not to be taken for more than 1 week.

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

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

The use is not recommended in children under 12 years of age due to lack of adequate data.

When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.

4.5. Interactions with other medicinal products and other forms of interaction

Well-established use

Traditional use None reported.

4.6. Pregnancy and lactation

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

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 Indication a)

Mild laxative effect when used in cough and cold. The frequency is not known.

Indication b)

None 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.

5.1. 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.

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

8 May 2008