SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Varicose Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g of ointment contains:

7.4 % w/w Hamamelis Water (Hamamelis virginiana L.)

3.6 % w/w Zinc Oxide

2.3% w/w Cade Oil (Juniperus oxycerus L.)

1 g of ointment contains 16 mg of wool fat (lanolin) and 0.5 mg butylated hydroxyanisole (See Section 4.4. ‘Special warnings and precautions for use’)

For full list of excipients see Section 6.1

3 PHARMACEUTICAL FORM

Cutaneous ointment.

Pink/brown ointment.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of minor skin inflammation and irritation due to varicose veins in the lower legs, 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: Apply to the affected area once in the morning and once in the evening..

Not recommended for children and adolescents under 18 years of age. (See section 4.4 ‘Special warnings and precautions for use’).

If the symptoms worsen or persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Do not apply to broken or ulcerated skin.

Avoid contact with eyes and mucous membranes.

Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

If the symptoms worsen or persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

If the varicose vein starts to bleed and does not stop, if severe pain is experienced, if ulcers develop or if any unusual changes in the skin occur, a doctor or qualified healthcare practitioner should be consulted immediately.

This product contains lanolin which may cause local skin reactions (e.g. contact dermatitis) and butylated hydroxyanisole (E320) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the 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

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

4.8 Undesirable effects

Allergic contact dermatitis may occur in sensitive patients with hamamelis use. The frequency is not known.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

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.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Emulsifying Wax

Acetylated Wool Alcohols (Acetylated Lanolin Alcohols) Hard Paraffin

Butylated Hydroxyanisole (E320)

Ariabel Russett 300405 (synthetic iron oxide colour) Ariabel Mocha 3000408 (synthetic iron oxide colour) Yellow Soft Paraffin Maltodextrin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

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

6.5 Nature and contents of container

Double-wall opaque polyethylene pot with hard plastic screwcap: 28g. Glass jar with hard plastic screwcap: 28g.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7 MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/0017

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/04/2013

10 DATE OF REVISION OF THE TEXT

28/09/2015