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Potters Comfrey Ointment

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Comfrey Ointment

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

1 g of ointment contains:

10.0% w/w of extract (as liquid extract) from Comfrey root (Symphytum officinale L.) (2:1)

Extraction solvent: Ethanol 65% v/v

1 g of ointment contains 108 mg of lanolin and 3 mg of benzoic acid.

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Cutaneous ointment.

Light to medium brown ointment.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the symptomatic relief of minor sprains and bruises, based on traditional    use    only.

4.2    Posology and method of administration

For cutaneous use only.

Wash hands before and after use.

Adults and the elderly:: Bathe and dry the affected area in warm water. Apply the ointment sparingly morning and night.

The use in children and adolescents under 18 years is not recommended (see section 4.4 ‘Special warnings and precautions for use’).

Duration of use:

Do not use this product for more than 10 days at a time.

If the symptoms worsen or do not improve after using the product for 10 days, a doctor or a qualified healthcare practitioner should be consulted.

4.3    Contraindications

Hypersensitivity to the active ingredient or any of the excipients.

4.4    Special warnings and precautions for use

Do not exceed the stated dose.

Do not use on broken or irritated skin.

Avoid contact with eyes and mucous membranes.

Discontinue use if redness, irritation or dry skin occurs.

The use in children and adolescents under 18 years is not recommended because data are insufficient and medical advice should be sought.

If the symptoms worsen or do not improve after using the product for 10 days, a doctor or a qualified healthcare practitioner should be consulted.

This product contains lanolin which may cause local skin reactions (e.g. contact dermatitis).

It also contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. Therefore in the absence of sufficient data, the use of this product during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

4.7    Effects on ability to drive and use machines

Not relevant.

4.8    Undesirable effects

None known.

If adverse reactions occur, a doctor or a qualified health care practitioner should be consulted.

4.9    Overdose

No case of overdose has been reported.

5.1    Pharmacodynamic properties

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

5.2    Pharmacokinetic properties

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

5.3    Preclinical safety data

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

Adverse reactions were not observed in clinical studies, but animal studies suggest that excessive amount of pyrrolizidine alkaloids in medicinal products may be hepatotoxic.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Hard Paraffin Anhydrous Lanolin Microcrystalline Wax Yellow Soft Paraffin Benzoic Acid White Soft Paraffin

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

Three years.

6.4    Special precautions for storage

Do not store above 25°C. Keep in the original container.

6.5    Nature and contents of container

Amber glass jar with wadded hard plastic cap: 25g and 55g. Double-wall polyethylene jar with hard plastic screwcap: 25g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7    MARKETING AUTHORISATION HOLDER

Vifor Pharma UK Ltd 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 33656/0050

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

21/12/2012

10 DATE OF REVISION OF THE TEXT

21/12/2012