Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

The product is indicated in the therapy of: - skin mycosis caused by dermatophytes, yeasts and moulds; - skin infections caused by Gram-positive bacteria: streptococci and staphylococci; - mycotic otitis externa, ear canal mycosis (limited to the skin emulsion form); - onychomycosis; - Pityriasis Versicolor.

CONTRAINDICATIONS

PEVARYL is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, listed in paragraph 6.1.

WARNINGS AND PRECAUTIONS FOR USE

All pharmaceutical forms of PEVARYL are indicated for external use only. PEVARYL is not for ophthalmic or oral use. In case of sensitization or irritation reaction, discontinue use of the product. Econazole nitrate powder contains talc. Avoid inhalation to prevent irritation of the airways, especially in children and infants. The application of the spray forms must be done avoiding inhaling the product and making excessive or improper use of it. Important information about some excipients. PEVARYL1% cream contains butylated hydroxyanisole, benzoic acid and linalool: This medicine contains butylated hydroxyanisole. May cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. This medicine contains 60 mg of benzoic acid in each 30 g tube which is equivalent to 2 mg/g of cream. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age. This medicine contains a fragrance with linalool. Linalool can cause allergic reactions. PEVARYL 1% skin spray, alcoholic solution contains propylene glycol and linalool: This medicinal product contains 983.0 mg of propylene glycol per unit dose, which is equivalent to 491.5 mg/g. Propylene glycol may cause local irritation. This medicine contains a fragrance with linalool. Linalool can cause allergic reactions. PEVARYL 1% skin powder contains linalool: This medicine contains a fragrance with linalool. Linalool can cause allergic reactions PEVARYL 1% skin emulsion contains butylated hydroxyanisole, benzoic acid and linalool: This medicinal product contains butylated hydroxyanisole. May cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. This medicine contains 60 mg of benzoic acid in each 30 g bottle which is equivalent to 2 mg/g of cream. Benzoic acid may cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age. This medicine contains a fragrance with linalool. Linalool can cause allergic reactions. PEVARYL 1% non-alcoholic cutaneous solution contains benzyl alcohol: This medicine contains 10 mg of benzyl alcohol in each sachet (10 mg), which is equivalent to 1 mg/g. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause mild local irritation.

INTERACTIONS

Econazole is a known inhibitor of cytochromes CYP3A4 and CYP2C9. Despite the limited systemic availability after cutaneous application, clinically relevant interactions with other medicinal products may occur and some have been reported in patients treated with oral anticoagulants, such as warfarin and acenocoumarol. In patients receiving oral anticoagulants, caution should be used and the INR should be monitored more frequently. A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

SIDE EFFECTS

Data from clinical studies: The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) was evaluated in 12 clinical studies involving 470 subjects, who received administration of at least one of the formulations. Based on the safety data collected from these clinical studies, the most commonly reported adverse drug reactions (ADRs) (incidence ≥ 1%) were (with incidence%): pruritus (1.3%), burning sensation of the skin (1.3%) and pain (1.1%). The ADRs reported with the use of PEVARYL dermatological formulations both in clinical studies, including the adverse reactions reported above, and in post-marketing experience are reported below. Frequencies are reported according to the following convention: Very common ( ≥ 1/10); Municipality ( ≥ 1/100, <1/10); Uncommon ( ≥ 1/1,000, <1/100); Rare ( ≥ 1/10,000, <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data). In the table below, which shows the adverse reactions of the dermatological formulations of Pevaryl, all ADRs with a known incidence (common or uncommon) come from clinical trial data and all adverse reactions with an unknown incidence come from post-marketing data. Table 1: Adverse Drug Reactions

Classification by systems and organs | Adverse drug reactions

Adverse drug reactions: Frequency

Adverse drug reactions: Municipality (≥ 1/100, < 1/10) | Adverse drug reactions: Uncommon (≥ 1/1.000, < 1/100) | Adverse drug reactions: Not Known

Immune system disorders | Adverse drug reactions: Hypersensitivity

Pathologies of the skin and subcutaneous tissue | Adverse drug reactions: Itching, burning sensation of the skin | Adverse drug reactions: Erythema | Adverse drug reactions: Angioedema, contact dermatitis, rash, urticaria, vesiculation, skin exfoliation

Systemic pathologies and conditions relating to the administration site | Adverse drug reactions: Pain | Adverse drug reactions: Malaise Swelling

The use of products for topical use, especially if prolonged, can give rise to sensitization phenomena. In case of hypersensitivity reactions it is necessary to interrupt treatment and institute appropriate therapy. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.