PEVARYL CREMA 30G 1%

PEVARYL

active ingredients

Pevaryl 1% cream 100 g cream contain: active ingredient: nitrate econazole 1.0 g Excipients with known effects: butilate hydroxanesol and pevaryl benzoic acid 1% skin spray, alcohol solution 100 g alcoholic skin solution contain: active ingredient: econazole nitrate 1.0 g Excipients with known effects: ethanol, propylene glycol and Pevaryl perfume 1% skin powder 100 g skin powder contain: active ingredient: econazole nitrate 1.0 g Eccipiente with known effects: Pevaryl 1% Emulsion cutaneous 100 g skin emulsion contain: active ingredient: econazole nitrate 1.0 g Excipients with known effects: hydroxyanisol butilato, benzoic acid and perfume For the complete list of excipients, see paragraph 6.1.

Excellent

Cream Excipients: mixture of stearic acid esters with glycols;mixture of fatty acids with polyethylene glycol;vaseline oil; hydroxyanisol buti; benzoic acid; purified water. Spray cutaneous alcohol solution Excipients: ethanol; ; propylene glycol; ; perfumecontaining linalol, citronellol, 3-metil-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exil cinnamica, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol, benzil); tris(idrossimetil) amino methane. Skin powder Excipients: precipitated silica; perfumecontaining linalol, citronellol, 3-metil-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exl cynnamic, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol; zinc oxide; talc. Skin emulsion Excipients: silica precipitated; stearic acid ester mixture with glycols; mix of fatty acids with polyethylene glycol; vaseline oil; hydroxyanisol butilato; benzoic acid; ; perfumecontaining linalol, citronellol, 3-metil-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exl cynnamic, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol; purified water.

Therapeutic indications

PEVARYL is indicated for the treatment of candid skin, dermatofitosi and pityriasis versicolor, including suspected infections concomitant to Gram-positive bacteria (see paragraph 5.1).

Contraindications

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

Population

PEVARYL must be applied on infected skin areas with a slight massage 2 times a day, morning and evening. The usual duration of treatment ranges from 2 to 4 weeks.If after 4 weeks you do not notice any improvement of symptoms, the treatment should be reassessed. The intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) at the wet stage must be laid with gauze before the application of PEVARYL. In the case of intertrigo can be useful the use of PEVARYL skin powder.

Conservation

Emulsion, spray cutaneous solution alcohol and cream: keep at a temperature below 25°C this medicine does not require any particular condition of conservation.

Warnings

All pharmaceutical forms of PEVARYL are indicated only for external use. PEVARYL is not for ophthalmic or oral use. In case of reaction of sensitization or irritation, stop the use of the product. Econazole nitrate powder contains talc. Avoid inhalation to prevent airway irritation, especially in children and infants. The application of spray forms must be done avoiding inhaling the product and making it an excessive and improper use. Important information about some excipients PEVARYL 1% cream contains hydroxyanionly butilate and benzoic acid. This medicine contains butylated hydroxane only. It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucosa. 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 can increase jaundice (skin and eyes) in infants up to 4 weeks of age. PEVARYL 1% skin spray, alcohol content contains ethanol, propylene glycol and perfume. This medicine contains 49.5% ethanol, equivalent to 0.495 mg/ml. It can cause burning sensation on damaged skin. This medicine contains 983,0 mg of propylene glycol per unit dose, which is equivalent to 491.5 mg/g. Propylene glycol can cause local irritation. This medicine contains a fragrance in turn containing linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geraaniol, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exil cinnamica, d-Linzone, citral, cinnamilic alcohol, liliale. Linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exyl cynnamic, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol benzol. PEVARYL 1% skin powder contains perfume This medicine contains a fragrance in turn containing linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geraaniol, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exil cinnamica, d-Linzone, citral, cinnamilic alcohol, liliale. Linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exyl cynnamic, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol benzol. PEVARYL 1% skin emulsion contains hydroxyanisol butilate, benzoic acid and perfume This medicine contains butylated hydroxane only. It can cause reactions to localized skin (e.g. contact dermatitis) or irritation to the eyes and mucosa. This medicine contains 60 mg of benzoic acid in each 30 g bottle which is equivalent to 2 mg/g of cream. Benzoic acid can cause local irritation. Benzoic acid can increase jaundice (skin and eyes) in infants up to 4 weeks of age. This medicine contains a fragrance in turn containing linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geraaniol, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exil cinnamica, d-Linzone, citral, cinnamilic alcohol, liliale. Linalol, citronellol, 3-methyl-4-(2,6,6-trimethyl-2-cicloesen-1-il)-3-buten-2-one, geranium, hydroxycitronellal, cumarin, benzil salicylate, aldehyde exyl cynnamic, d-Limonene, citral, cinnamilic alcohol, lilial, eugenol benzol.

Interactions

Econazole is a well-known cytochrome inhibitor CYP3A4 and CYP2C9. Despite the limited systemic availability after skin application, clinically relevant interactions with other medicines may occur, and some have been reported in patients with oral anticoagulants such as warfarin and acenocumarol. In patients with oral anticoagulants, caution is needed and the INR must be monitored more frequently. An adjustment of the dosage of the oral anticoagulant drug may be necessary during treatment with econazole and after its interruption.

Effects

Adverse Drug Reactions (ADRs) reported with the use of different dermatological formulations PEVARYL both in clinical studies and in post-marketing experience, are listed below. Data from clinical trials The safety of econazole nitrate cream (1%) and emulsion nitrate econazole (1%) has been evaluated in 12 clinical studies of 470 subjects, which received the administration of at least one of the formulations. Based on the security data collected by these clinical trials, the most commonly reported ADRs (impact ≥ 1%), were (with % incidence): itching (1.3%), burning sensation of the skin (1.3%) and pain (1.1%). In the table below, in which adverse reactions of Pevaryl dermatological formulations are reported, all ADRs with a known incidence (common or uncommon) come from clinical studies data and all adverse reactions with an unknown incidence come from post-marketing data. The frequencies are given in accordance with the following convention: Very common ( ≥ 1/10); City ( ≥ 1/100, ≥ 1/1.000, ≥ 1/10.000, Table 1: Adverse reactions to Farmaco

Classification for systems and organs	Drug adverse reactions
	Frequency
	Town (≥ 1/100,	Not common (≥ 1/1.000,	Note
Immune system disorders			Hypersensitivity
Pathologies of skin and subcutaneous tissue	Prurito, burning sensation of the skin	Eritema	Angioedema, contact dermatitis, rash, hives, bladder, skin exfoliation
Systemic pathologies and conditions for administration	Pain	Malessere Gonfiore

The use of topical products, especially if protracted, can give rise to awareness phenomena. In case of hypersensitivity reactions it is necessary to stop treatment and to establish suitable therapy. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The available pharmaceutical forms are intended exclusively for the topical application. In case of accidental ingestion, nausea, vomiting and diarrhea may occur to be treated with symptomatic therapy. If the product accidentally enters into contact with the eyes, wash with clean water or physiological solution and turn to the doctor if the symptoms persist. Pevaryl 1% skin powder The powder formulation contains talc: a massive accidental suction of dust can cause blocking of airways, especially in infants and children. Respiratory arrest should be treated with support and oxygen therapy. If breathing is compromised, the following measures should be considered: intratracheal intubation, material removal and assisted ventilation.

Pregnancy Animal studies have shown reproductive toxicity. The risk in man is not known. (see paragraph 5.3). In man, after topical application on intact skin, systemic absorption of econazole is poor (Adjustment After oral administration of nitrate econazole in rats during breastfeeding, econazole and/or its metabolites were excreted in breast milk and detected in small ones. It is not known if the skin administration of PEVARYL can cause a systemic absorption of econazole sufficient to produce detectable concentrations of the same in human breast milk. It must be used caution when PEVARYL is given to women during breastfeeding. Fertility The results of animal reproduction studies showed no effect on fertility (see paragraph 5.3).

Source: Farmadati