PEVARYL Topical cream Ref.[8009] Active ingredients: Econazole

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.

Animal studies have shown reproductive toxicity (see section 5.3).

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

Breast-feeding

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.

Fertility

Results of econazole animal reproduction studies showed no effects on fertility.

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 reactions were (with % incidence): pruritus (1.3%), skin burning sensation (1.3%), and pain (1.1%).

Including the above-mentioned adverse reactions, the following table displays adverse reactions 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 adverse reaction table below, all adverse reactions with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence are from post-marketing data.

Table 1: Adverse Reactions

Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Not Known

Immune System Disorder

Not Known: Hypersensitivity

Skin and Subcutaneous Tissue Disorders

Common: Pruritus, Skin burning sensation

Uncommon: Erythema

Not Known: Angioedema, Contact dermatitis, Rash, Urticaria, Blister, Skin exfoliation

General Disorders and Administration Site Conditions

Common: Pain

Uncommon: Discomfort, Swelling

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

None stated.