PEVARYL CUT 6BUST 10G 1%

PEVARYL 1%

active ingredients

Pevaryl 1% cream 100 g of cream contain: active ingredient: econazole nitrate 1.0 g.Excipients with known effect: This medicine contains butylated hydroxyanisole, benzoic acid and linalool as a fragrance in the perfume.Pevaryl 1% cutaneous spray, alcoholic solution 100 g of alcoholic cutaneous solution contain: active ingredient: econazole nitrate 1.0 g.Excipients with known effect: This medicine contains propylene glycol and linalool as a fragrance in the perfume.Pevaryl 1% cutaneous powder 100 g of cutaneous powder contain: active ingredient: econazole nitrate 1.0 g.Excipients with known effect: This medicine contains linalool as a fragrance in the perfume.Pevaryl 1% cutaneous emulsion 100 g of cutaneous emulsion contain: active ingredient: econazole nitrate 1.0 g.Excipients with known effect: This medicinal product contains butylated hydroxyanisole, benzoic acid and linalool as a fragrance in the perfume.Pevaryl 1% non-alcoholic cutaneous solution 100 g of non-alcoholic cutaneous solution contains: active substance: econazole 1.0 g.Excipients with known effect: This medicinal product contains benzyl alcohol.For the full list of excipients, see section 6.1.

Excellent

Cream: Excipients: mixture of stearic acid esters with glycols;mixture of fatty acids with polyethylene glycol;vaseline oil; butylated hydroxyanisole; ; perfume n.4074; ; benzoic acid; purified water. Alcohol solution skin spray: Excipients: ethyl alcohol; ; propylene glycol; ; perfume n.4074; tris(idrossimetil) amino methane. Skin powder: Excipients: precipitated silica; perfume n.4074; 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; ; perfume n.4074; purified water. Non-alcoholic skin solution: Excipients: polysorbed 20; alcohol benzig; single-laurated sorbitan; acid N-[2-idrossietil]-NO-[2-(laurilamino)-etil] amino acetic salt sodium of 3,6,9-triossadocosil sulphate; polyoxethyleneglycol 6000 distearate; purified water.

Therapeutic indications

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

Contraindications

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

Population

PEVARYL must be applied morning and evening, in the infected skin areas, with a slight massage, until total disappearance of the mycosis (1-3 weeks). It is recommended to continue the application of PEVARYL for a few days after the disappearance of the mycosis. The intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) at the wet stage should be laid with gauze before the application of PEVARYL. An occlusive bandage is recommended in the treatment of onicomycosis. In the treatment of otomycosis (only if there is no lesion of thympane) instill 1-2 times a day 1-2 drops of PEVARYL cutaneous emulsion, or insert a gauze strip soaked with the same in the external ear canal. PEVARYL skin dust should be used as complementary treatment PEVARYL cream and spray cutaneous alcohol solution. In the case of intertrigo the use of PEVARYL skin powder. PEVARYL non-alcoholic skin solution: sprinkle, for three consecutive nights, the whole wet body placing the product on a sponge; don't rinse. The drug carries out its action during the night and should be removed with washing the following morning. If after 15 days from the end of the application the Pityriasis Versicolor did not prove unfair, repeat the treatment. To avoid relapses it is recommended to perform the treatment again after 1 and 3 months. Regular use and according to the requirements of PEVARYL is of decisive importance for healing.

Conservation

Emulsion, spray cutaneous solution alcohol and cream: keep at a temperature not exceeding 25°C this medicine does not require any particular condition of conservation. PEVARYL, like any medicine, must be kept out of the reach of children.

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. . PEVARYL1% cream contains hydroxyanisol butilate, benzoic acid and linalol: 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. This medicine contains a fragrance with linalol. Linalol can cause allergic reactions. PEVARYL 1% skin spray, alcohol content contains propylene glycol and linalol: 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 with linalol. Linalol can cause allergic reactions. PEVARYL 1% skin powder contains linalol: This medicine contains a fragrance with linalol. Linalol can cause allergic reactions PEVARYL 1% skin emulsion contains hydroxyanisol butilate, benzoic acid and linalol: 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 every 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 with linalol. Linalol can cause allergic reactions. PEVARYL 1% non-alcoholic skin solution contains benzyl alcohol: This medicine contains 10 mg of benzilic alcohol in each sachet (from 10 mg), which is equivalent to 1mg/g. Benzyl alcohol can cause allergic reactions. Benzyl alcohol can cause mild local irritation.

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

Data from clinical trials: The safety of nitrate econazole 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 safety data collected by these clinical trials, the most commonly reported adverse drug reactions (Adverse Drug Reactions, ADRs) were (with % incidence): itching (1.3%), burning sensation of the skin (1.3%) and pain (1.1%). LeADRs reported using PEVARYL dermatological formulations both in clinical studies, including adverse reactions mentioned above, and in post-marketing experience are listed below. 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 from 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	Erythema	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 www.agenziafarmaco.gov.it/it/responsabili.

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 (Acting: After oral administration of nitrate econazole in rats during lactation, 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 breeding studies showed no effects on fertility (see paragraph 5.3)

Source: Farmadati