PEVARYL

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. The usual treatment duration is 2 to 4 weeks. If no improvement in symptoms is experienced after 4 weeks, the treatment should be reassessed.

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. 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 Adverse Reactions Frequency Category System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Not Known Immune System Disorder Hypersensitivity Skin and Subcutaneous Tissue Disorders Pruritus Skin burning sensation Erythema Angioedema Contact dermatitis Rash Urticaria Blister Skin exfoliation General Disorders and Administration Site Conditions Pain 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. Excipients This medicine contains 30 mg benzoic acid in each tube of 15 g which is equivalent to 2 mg/g cream.

This medicine contains 60 mg benzoic acid in each tube of 30 g which is equivalent to 2 mg/g cream. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).

g. contact dermatitis) or irritation to the eyes and mucous membranes.

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