Pevaryl cutaneous solution sachets 6bust 10g 1% 023603145

PEVARYL * SOL CUT 6BUST 10G 1%

Therapeutic indications

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

Dosage and method of use

PEVARYL must be applied morning and evening, in the infected skin areas, with a light massage, until the mycosis has completely disappeared (1-3 weeks). It is advisable to continue the application of PEVARYL for a few days after the disappearance of the mycosis. Intertriginous spaces (e.g. interdigital spaces of the foot, folds of the buttocks) in the wet stage should be cleansed with gauze prior to applying PEVARYL. An occlusive dressing is recommended in the treatment of onychomycosis. In the treatment of otomycosis (only if there is no lesion of the eardrum) instill 1-2 drops of PEVARYL skin emulsion 1-2 times a day, or insert a strip of gauze soaked with it into the external auditory canal. PEVARYL cutaneous powder should be used as complementary therapy of PEVARYL cream and alcoholic solution cutaneous spray. In the case of intertrigo, the use of PEVARYL cutaneous powder may be sufficient. PEVARYL non-alcoholic cutaneous solution: sprinkle, for three consecutive evenings, the whole wet body by placing the product on a sponge; do not rinse. The drug works during the night and must be washed off the following morning. If after 15 days from the end of the applications the Pityriasis Versicolor is not eradicated, repeat the treatment. To avoid relapses it is recommended to carry out the treatment again after 1 and 3 months. The regular and prescribed use of PEVARYL is of decisive importance for recovery.

Contraindications

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

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 the 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 listed above, and in post-marketing experience are listed below. Frequencies are reported according to the following convention: Very common ( ≥ 1/10); Common ( ≥ 1/100,≥1 / 1,000,≥1 / 10,000, Table 1: Adverse Drug Reactions

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 the treatment and institute a suitable therapy.Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio 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.

Special warnings

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 and improper use of it.Important information about some of the ingredients.PEVARYL1% cream contains butylated hydroxyanisole, benzoic acid and linalool:This medicinal product contains butylated hydroxyanisole. It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. This medicine contains 60mg of benzoic acid in each 30g tube which is equivalent to 2mg / g of cream. Benzoic acid can cause local irritation. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in infants up to 4 weeks of age. This medicine contains a fragrance with linalool. Linalool can cause allergic reactions.PEVARYL 1% cutaneous spray, alcoholic solution contains propylene glycol and linalool: This medicinal product contains 983.0 mg 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 linalool. Linalool can cause allergic reactions.PEVARYL 1% cutaneous powder contains linalool: This medicine contains a fragrance with linalool. Linalool can cause allergic reactionsPEVARYL 1% skin emulsion contains butylated hydroxyanisole, benzoic acid and linalool: This medicinal product contains butylated hydroxyanisole. It can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes. This medicine contains 60mg of benzoic acid in each 30g bottle which is equivalent to 2mg / g of cream. Benzoic acid can cause local irritation. Benzoic acid can increase jaundice (yellowing of the skin and eyes) in infants 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 1mg / g. Benzyl alcohol can cause allergic reactions Benzyl alcohol can cause mild local irritation.

Pregnancy and breastfeeding

Pregnancy: Animal studies have shown reproductive toxicity. The risk in humans is unknown. (see section 5.3) In humans, after topical application to intact skin, the systemic absorption of econazole is poor (Lactation: After oral administration of econazole nitrate to lactating rats, econazole and / or its metabolites were excreted in the Breast milk and detected in infants It is not known whether dermal administration of PEVARYL will result in sufficient systemic absorption of econazole to produce detectable concentrations of the same in human breast milk Caution should be exercised when PEVARYL is administered to lactating women.Fertility: Results from animal reproduction studies showed no effects on fertility (see section 5.3)

Expiration and retention

Emulsion, skin spray, alcoholic solution and cream: store at a temperature not exceeding 25 ° C. Skin powder: this medicinal product does not require any special storage conditions. PEVARYL, like any other medicine, must be kept out of the reach of children.

Interactions with other drugs

Econazole is a known inhibitor of CYP3A4 and CYP2C9 cytochromes. Despite limited systemic availability after skin 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. A dosage adjustment of the oral anticoagulant drug may be necessary during treatment with econazole and after its discontinuation.

Overdose

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

Active principles

Pevaryl 1% cream 100 g of cream 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% 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 medicinal product contains linalool as a fragrance in the perfume. Pevaryl 1% skin emulsion 100 g of skin 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 contain: active ingredient: econazole 1.0 g. Excipients with known effect: This medicinal product contains benzyl alcohol. For the full list of excipients, see section 6.1.

Excipients

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. Alcoholic solution skin spray: Excipients:ethyl alcohol;propylene glycol;perfume n.4074; tris (hydroxymethyl) amino methane. Skin powder: Excipients: precipitated silica;perfume n.4074; 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 n.4074; purified water. Non-alcoholic skin solution: Excipients: polysorbate 20;benzyl alcohol; sorbitan monolaurate; N- acid[2-idrossietil]-N-[2-(laurilamino)-etil]amino acetic sodium salt of 3,6,9-trioxadocosyl sulfate; polyoxyethylene glycol 6000 distearate; purified water.