Scholl Athlete's Foot Powder

Scholl Athlete's Foot Powder

Tolnaftate 1.00 o/ow/w

For a full list of excipients, see section 6.1.

Cutaneous powder.

A white fine, free flowing powder.

As a fungistat in the topical treatment of infections due to dermatophytes sensitive to this agent including micorspora, epidermophyta and trichophyte.

Posology:

Adults: Recommended dose: apply liberally on affected area twice daily or as directed by a doctor. Continue treatment for two weeks after symptoms disappear.

Paediatric population: As above for adults.

Method of administration:

Cutaneous Use. Topical application only. Wash and dry the affected area before applying. Wear clean socks or hosiery.

Contraindicated in nail or scalp infections.

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1.

For external use only.

Keep out of eyes.

If symptoms do not improve within 10 days, discontinue use and consult your doctor.

Keep out of reach of children.

If irritation or rash occurs, use of the product should be discontinued and medical advice should be sought.

Not relevant to topical use.

Pregnancy

No effects during pregnancy are anticipated since systemic exposure to Tolnaftate is negligible. Tolnaftate can be used during pregnancy.

Breast-feeding

It is unknown whether Tolnaftate and Tolnaftate metabolites are excreted in human milk.

Fertility

No data on human fertility is available.

This medication has no known effects on the ability to drive and use machines.

Adverse events which have been associated with Tolnaftate are given below, tabulated by system organ class and frequency.

Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.

System Organ Class	Frequency	Adverse Events
Skin and Subcutaneous Tissue Disorders	Not known	Skin reaction, skin irritation, pruritus, dermatitis contact

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorization 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 HPRA Pharmacovigilance, Earlsfort Terrace, Dublin 2.

Tel: +53 1 6764971. Fax: +353 1 6762517. Website: www.hpra.ie. E-mail: medsafety@hpra.ie

Symptoms: There have been no reports of over dosage with the use of this product.

Management: In the case of over dosage, treatment should be symptomatic and supportive.

Pharmacotherapeutic group: Dermatologicals, Antifungals for Dermatological use, Antifungals for Topical use, other Antifungals for Topical use.

Mechanism of action:

Tolnaftate is an antifungal agent for topical use. It is a thiocarbamate derivative that inhibits sterol synthesis at the level of squalene epoxidase in the growing of cells. Pharmacodynamic and pharmacokinetics are not relevant for a topical dosage form.

Not applicable.

There are no preclinical safety data of relevant to the consumer.

Talc

Corn starch

Not applicable

2 years

Do not store above 25°C.

High density polyethylene container with sifter cap, containing 70, 75 or 80g powder.

Combined pack: 25g Athlete's Foot Cream and 75g Athlete's Foot Powder.

Not all pack sizes may be marketed.

No special requirements.

Scholl Consumer Products Ltd

103-105 Bath Road

Slough

SL1 3UH

United Kingdom

PA 455/1/2

Date of first authorisation: 19 November 1986

Date of last renewal: 19 November 2006

August 2016