Pevaryl 1% Topical Cream.

Econazole nitrate . 1.0% w/w.

Each gram of cream contains 10 mg econazole nitrate

Excipients: each gram of cream contains 2 mg benzoic acid and

52 micrograms butylated hydroxyanisole

For a full list of excipients, see section 6.1

Cream.

For the treatment of fungal infections of the skin.

For cutaneous administration.

Dosage

The dosage regimen is the same for all patients.

Apply twice daily to the affected part and rub into the skin gently with the finger. Continue the application until all skin lesions are healed.

In the treatment of fungal infections of the nail, the cream should be applied once a day and covered with an occlusive dressing.

Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

Hypersensitivity has rarely been recorded, if it should occur, administration of the product should be discontinued.

Econazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored.

Only small amounts of the drug are absorbed through the skin and no teratogenic effects have been observed in animals. Hence the product may be used with caution during pregnancy.

None known.

Rarely, transient local irritation may occur after immediate application. If this persists please contact your doctor for advice.

This product is for topical application only.

If large amounts have been taken by mouth or swallowed, gastric emptying may be considered desirable.

Econazole nitrate is a broad spectrum antimycotic with activity against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.

Econazole nitrate is only slightly absorbed from the skin. No active drug has been detected in the serum. Radio labelling shows that less than 0.1% of an oral dose is absorbed. Peak serum levels are achieved after 2 hours and 90% binds to plasma proteins. Metabolism is limited but occurs primarily in the liver with excretion of metabolites in the urine.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Pegoxyl-7-stearate

Peglicol-5-oleate

Liquid paraffin

Butylated hydroxyanisole (E320)

Benzoic acid (E210)

Flower Perfume 4074

Purified water

None stated.

24 months.

Do not store above 25°C.

Resin lined, aluminium tubes containing 15 g or 30 g of cream.

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 00242/0259

Date of first authorisation: 01/07/95

Renewal of authorisation 18^th March 2009

11^th September 2009