SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Carnation Athlete’s Foot Powder 1% w/w tolnaftate topical powder Superdrug Athlete’s Foot Powder 1% w/w tolnaftate topical powder Tesco Medicated Athlete’s Foot Powder 1% w/w tolnaftate topical powder

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

T olnaftate    1.0 % w/w.

For excipients see 6.1.

3    PHARMACEUTICAL FORM

Powder topical

A white to off white powder, free from grittiness.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the treatment and prevention of athlete’s foot.

4.2    Posology and method of administration

Wash the feet and dry carefully between the toes.

For adults, children and the elderly: Turn top of pack to open. Apply twice daily, morning and night, by dusting the feet liberally, especially between the toes. Treatment should be continued for up to two weeks after the symptoms disappear. Repeat courses may be required. The powder may also be used to dust the insides of footwear and hosiery.

Do not use on broken or sensitive skin.

4.3    Contraindications

Allergy to tolnaftate or any of the ingredients.

4.4    Special warnings and precautions for use

For external use only.

Keep out of eyes.

Keep out of reach of children.

If symptoms persist consult your doctor.

Diabetics should seek professional advice before using any foot care product. Not recommended for nail or scalp infections.

4.5    Interaction with other medicinal products and other forms of interaction

Not applicable

4.6    Pregnancy and lactation

Based on available published data there is no requirement to contraindicate the use of the product during pregnancy and lactation.

4.7    Effects on ability to drive and use machines

None stated.

4.8    Undesirable effects

Rarely may cause minor skin irritation

4.9    Overdose

Not applicable.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Tolnaftate is an antifungal which inhibits the fungi responsible for cutaneous athlete’s foot infections.

5.2    Pharmacokinetic properties

Not applicable for a topical dosage form of this type.

5.3    Preclinical safety data

There are no preclinical data of relevance to the prescriber other than that which is already included in other sections of the SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Talc (Talc purified),

Starch maize sterilisable.