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.

For external use only. Care should be taken not to get Pevaryl Topical Cream in the eyes or mouth. If the product is accidently applied to the eyes the patient should wash with clean water or saline and seek medical attention if symptoms persist.

If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Care should be taken in the presence of eczematous dermatitis.

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, and acenocoumarol caution should be exercised and anticoagulant effect should be monitored more frequently.

Adjustment of the oral anticoagulant dosage may be necessary during the treatment with econazole and after its termination

.

Pregnancy

Systemic absorption of econazole is low (< 10%) after topical application to the intact skin in humans. There are no adequate and well-controlled studies on adverse effects from the use of Pevaryl Topical cream in pregnant women, and no other relevant epidemiological data are available. No adverse effects of Pevaryl Topical cream on pregnancy or on the health of the foetus/newborn child have been identified from a limited number of post-marketing reports.

In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents. The significance of this in humans is unknown. (See section 5.3)

Because there is systemic absorption, use of Pevaryl Topical Cream is not recommended during pregnancy.

Lactation

It is not known whether cutaneous administration of Pevaryl Topical cream results in sufficient systemic absorption of econazole nitrate to produce detectable quantities in breast milk in humans. (see section 5.3)

A risk to the breast-fed child cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Pevaryl Topical Cream therapy taking into account the benefit of breast feeding for the child and benefit of therapy for the woman.

If Pevaryl Topical Cream is used while breast feeding care should be taken to ensure the cream is not applied to the nipple or surrounding area.

None known.

.

The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 470 subjects who participated in 12 clinical trials and received at least one administration of either formulation. Based on pooled safety data from these clinical trials, the most commonly reported (1% incidence) adverse drug reactions (ADRs) were (with % incidence): pruritus (1.3%), skin burning sensation (1.3%), and pain (1.1%).

Including the above-mentioned ADRs, the following table displays ADRs that have been reported with the use of PEVARYL Dermatological Formulations from either clinical trial or post-marketing experiences. The displayed frequency categories use the following convention:

Very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).

In the PEVARYL Dermatological Formulations ADR table below, all ADRs with a known incidence (common or uncommon) are from clinical trial data and all ADRs with an unknown incidence are from post-marketing data.

Table 1: Adverse Drug Reactions

.

Pevaryl Topical Cream is for cutaneous application only. In the event of accidental ingestion, treat symptomatically

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

03^rd February 2011