Pevaryl 1% 30 g cutaneous powder

Pevaryl 1% 30 g skin powder is a topical antifungal formulated for the effective treatment of skin mycoses caused by dermatophytes, yeasts and molds . The active ingredient, econazole nitrate , works by inhibiting the growth of microorganisms responsible for skin infections, ensuring a targeted action against skin candidiasis, dermatophytosis and pityriasis versicolor . The skin powder is particularly suitable for application on moist or hard-to-reach areas, such as the spaces between the toes or skin folds, where humidity favors the proliferation of fungi.

The powder formulation of Pevaryl 1% ensures excellent adhesion to the skin, promoting transpiration and keeping the treated area dry, an essential condition for counteracting the growth of microorganisms. In addition to econazole nitrate, the powder contains zinc oxide and talc , which help protect the skin and reduce irritation, while the presence of a delicate fragrance makes the application more pleasant. The product is suitable for both adults and children, and can be used as an adjuvant in the prevention of recurrences of fungal infections, especially in predisposed subjects or in the presence of environmental conditions favorable to the development of mycosis.

Pevaryl skin powder is the ideal solution for those seeking an effective and practical treatment of skin infections of fungal origin, ensuring rapid relief from symptoms such as itching, redness and flaking. Thanks to its broad-spectrum action, it is also indicated in cases of suspected concomitant infections by Gram-positive bacteria . Regular use of the product, according to the doctor or pharmacist's instructions, promotes the complete resolution of mycosis and helps keep the skin healthy and protected.

ACTIVE INGREDIENTS

Active ingredients contained in Pevaryl 1 % 30 g skin powder - What is the active ingredient of Pevaryl 1 % 30 g skin powder?

Pevaryl 1% cream 100 g of cream contain: active ingredient: econazole nitrate 1.0 g Excipients with known effects: butylated hydroxyanisole and benzoic acid Pevaryl 1% cutaneous spray, alcoholic solution 100 g of alcoholic cutaneous solution contain: active ingredient: econazole nitrate 1.0 g Excipients with known effects: ethanol, propylene glycol and perfume Pevaryl 1% cutaneous powder 100 g of cutaneous powder contain: active ingredient: econazole nitrate 1.0 g Excipient with known effects: perfume Pevaryl 1% cutaneous emulsion 100 g of cutaneous emulsion contain: active ingredient: econazole nitrate 1.0 g Excipients with known effects: butylated hydroxyanisole, benzoic acid and perfume For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Pevaryl 1 % 30 g skin powder - What does Pevaryl 1 % 30 g skin powder contain?

Cream Excipients: mixture of stearic acid esters with glycols; mixture of fatty acids with polyethylene glycol; vaseline oil; butylated hydroxyanisole ; benzoic acid ; purified water. Alcoholic solution skin spray Excipients: ethanol ; propylene glycol ; perfume ( containing linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyl, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal ) ; tris(hydroxymethyl) amino methane. Skin powder Excipients: precipitated silica; perfume ( containing linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal); zinc oxide; talc. Skin emulsion Excipients: precipitated silica; mixture of stearic acid esters with glycols; mixture of fatty acids with polyethylene glycol; vaseline oil; butylated hydroxyanisole; benzoic acid ; perfume ( containing linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal); purified water.

DIRECTIONS

Therapeutic indications Pevaryl 1 % 30 g cutaneous powder - Why is Pevaryl 1 % 30 g cutaneous powder used? What is it used for?

PEVARYL is indicated for the treatment of cutaneous candidiasis, dermatophytosis and pityriasis versicolor, including suspected concomitant infections with Gram-positive bacteria (see section 5.1).

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Pevaryl 1 % 30 g skin powder - When should Pevaryl 1 % 30 g skin powder not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Quantity and method of taking Pevaryl 1% 30g skin powder - How to take Pevaryl 1% 30g skin powder?

PEVARYL should be applied to the infected skin areas with a light massage twice a day, morning and evening. The usual duration of treatment is 2 to 4 weeks. If no improvement in symptoms is noted after 4 weeks, the treatment should be re-evaluated. Intertriginous spaces (e.g. interdigital spaces of the foot, buttock folds) in the wet stage should be cleaned with gauze before applying PEVARYL. In the case of intertrigo, the use of PEVARYL skin powder may be useful.

CONSERVATION

Storage Pevaryl 1% 30g skin powder - How to store Pevaryl 1% 30g skin powder?

Emulsion, skin spray, alcoholic solution and cream: store below 25°C. Skin powder: this medicine does not require any special storage conditions.

WARNINGS

Warnings Pevaryl 1 % 30 g skin powder - About Pevaryl 1 % 30 g skin powder it is important to know that:

All pharmaceutical forms of PEVARYL are 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 spray forms must be done avoiding inhalation of the product and excessive and improper use. Important information about some of the excipients PEVARYL 1% cream contains butylated hydroxyanisole and benzoic acid. This medicine contains butylated hydroxyanisole. It can 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 can cause local irritation. Benzoic acid may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age. PEVARYL 1% cutaneous spray, alcoholic solution contains ethanol, propylene glycol and perfume. This medicinal product contains 49.5% ethanol, equivalent to 0.495 mg/ml. It may cause a burning sensation on damaged skin. This medicinal product contains 983.0 mg propylene glycol per unit dose, which is equivalent to 491.5 mg/g. Propylene glycol may cause local irritation. This medicine contains a fragrance which contains linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal. Linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal may cause allergic reactions. PEVARYL 1% cutaneous powder contains perfume This medicine contains a fragrance which in turn contains linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal. Linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal may cause allergic reactions. PEVARYL 1% skin emulsion contains butylated hydroxyanisole, benzoic acid and perfume This medicine contains butylated hydroxyanisole. It may cause localised skin reactions (e.g. contact dermatitis) or irritation to 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 containing linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal. Linalool, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, geraniol, hydroxycitronellal, coumarin, benzyl salicylate, hexyl cinnamic aldehyde, d-Limonene, citral, cinnamyl alcohol, lilyal, eugenol, benzyl beanzoate, isoeugenol, farnesol, benzyl alcohol and cinnamal may cause allergic reactions.

INTERACTIONS

Interactions Pevaryl 1 % 30 g skin powder - Which medicines or foods can modify the effect of Pevaryl 1 % 30 g skin powder?

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

SIDE EFFECTS

Like all medicines, Pevaryl 1 % 30 g skin powder can cause side effects - What are the side effects of Pevaryl 1 % 30 g skin powder?

Adverse Drug Reactions (ADRs) reported with the use of the different dermatological formulations of PEVARYL both in clinical studies and in post-marketing experience are listed below. Data from clinical studies The safety of econazole nitrate cream (1%) and econazole nitrate emulsion (1%) has been evaluated in 12 clinical studies in 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 ADRs (incidence ≥ 1%) were (with incidence%): pruritus (1.3%), burning sensation of the skin (1.3%) and pain (1.1%). In the table below, where the adverse reactions of the dermatological formulations of Pevaryl are reported, all ADRs with a known incidence (common or uncommon) come from clinical study data and all adverse reactions with an unknown incidence come from post-marketing data. The frequencies are reported according to the following convention: Very common ( ≥ 1/10); Common ( ≥ 1/100, <1/10); Uncommon ( ≥ 1/1,000, <1/100); Rare ( ≥ 1/10,000, <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from the available data). Table 1: Adverse Drug Reactions

Classification by systems and organs	Adverse drug reactions
	Frequency
	Common (≥ 1/100, < 1/10)	Uncommon (≥ 1/1,000, < 1/100)	Not Known
Immune system disorders			Hypersensitivity
Skin and subcutaneous tissue disorders	Itching, burning sensation of the skin	Erythema	Angioedema, contact dermatitis, rash, urticaria, vesiculation, skin exfoliation
Systemic disorders and conditions related to the administration site	Pain	Discomfort Swelling

The use of topical products, especially if prolonged, may give rise to sensitization phenomena. In case of hypersensitivity reactions, it is necessary to interrupt the treatment and institute appropriate therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Pevaryl 1% 30g skin powder - What are the risks of Pevaryl 1% 30g skin powder in case of overdose?

The available pharmaceutical forms are intended for topical application only. In case of accidental ingestion, nausea, vomiting and diarrhea may occur and should be treated with symptomatic therapy. If the product accidentally comes into contact with the eyes, wash with clean water or saline and seek medical advice if symptoms persist. Pevaryl 1% cutaneous powder The powder formulation contains talc: massive accidental aspiration of the powder may cause airway blockage, particularly in infants and children. Respiratory arrest should be treated with supportive therapy and oxygen. If breathing is compromised, the following measures should be considered: endotracheal intubation, removal of the material and assisted ventilation.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Pevaryl 1% 30 g cutaneous powder.

Pregnancy Studies in animals have shown reproductive toxicity. The risk in humans is unknown. (see section 5.3). In humans, after topical application to intact skin, systemic absorption of econazole is low (< 10%). There are no adequate and controlled studies, nor epidemiological data, on the adverse effects resulting from the use of PEVARYL during pregnancy. Due to systemic absorption, PEVARYL should not be used during the first trimester of pregnancy unless the doctor considers it necessary for the health of the patient. PEVARYL can be used during the second and third trimester of pregnancy if the potential benefit for the mother outweighs the possible risks for the fetus. Breastfeeding After oral administration of econazole nitrate in rats during lactation, econazole and/or its metabolites were excreted in breast milk and detected in pups. It is not known whether dermal administration of PEVARYL can result in sufficient systemic absorption of econazole to produce detectable concentrations of econazole in human breast milk. Caution should be exercised when PEVARYL is administered to women who are breast-feeding. Fertility Results from reproduction studies in animals have shown no effects on fertility (see section 5.3).

DRIVING AND USE OF MACHINERY

Taking Pevaryl 1% 30g skin powder before driving or using machines - Does Pevaryl 1% 30g skin powder affect driving or using machines?

Not known.