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

Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution is a topical antifungal formulated for the effective treatment of skin mycoses caused by dermatophytes, yeasts and molds , as well as for skin infections caused by Gram-positive bacteria such as streptococci and staphylococci. Thanks to its active ingredient, econazole nitrate , this solution acts directly on the affected skin, counteracting the proliferation of microorganisms responsible for infections.

The non-alcoholic formulation of Pevaryl 1% is particularly suitable for those seeking a delicate and well-tolerated treatment , reducing the risk of skin irritation. The 10 g single-dose sachets guarantee practicality and hygiene in application, making the product ideal for home use and for the treatment of large or difficult-to-reach areas. Pevaryl 1% non-alcoholic cutaneous solution is also indicated for pityriasis versicolor and onychomycosis , offering a targeted and prolonged action against fungal skin infections.

This topical solution is intended for external use and is a reliable choice for those who need an effective dermatological treatment against fungal and bacterial skin infections . The absence of alcohol makes it suitable even for the most sensitive skin, ensuring a deep antifungal action without burning or dryness. Choose Pevaryl 1% non-alcoholic skin solution for a safe, practical and targeted treatment of skin mycoses .

ACTIVE INGREDIENTS

Active ingredients contained in Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - What is the active ingredient of Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution?

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.

EXCIPIENTS

Composition of Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - What does Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution contain?

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)aminomethane. 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-[2-hydroxyethyl]-N-[2-(laurylamino)-ethyl]aminoacetic acid sodium salt of 3,6,9-trioxadocosyl sulfate; polyoxyethylene glycol 6000 distearate; purified water.

DIRECTIONS

Therapeutic indications Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - Why is Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - When should Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution not be used?

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

DOSAGE

Quantity and method of taking Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - How is Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution taken?

PEVARYL should be applied morning and evening, on the infected skin areas, with a light massage, until the mycosis has completely disappeared (1-3 weeks). It is recommended to continue the application of PEVARYL for a few days after the mycosis has disappeared. The 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 treatment of onychomycosis, an occlusive dressing is recommended. 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 skin powder must be used as a complementary therapy to PEVARYL cream and alcohol-based skin spray. In the case of intertrigo, the use of PEVARYL skin powder may be sufficient. PEVARYL non-alcoholic cutaneous solution: spread, for three consecutive evenings, all over the damp body by placing the product on a sponge; do not rinse. The medicine works during the night and must be removed by washing the following morning. If after 15 days from the end of the applications the Pityriasis Versicolor has not been eradicated, repeat the treatment. To avoid relapses it is recommended to carry out the treatment again after 1 and 3 months. Regular use of PEVARYL according to the prescriptions is of decisive importance for healing.

CONSERVATION

Storage Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - How is Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution stored?

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

WARNINGS

Warnings Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - About Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution 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 . PEVARYL1% cream contains butylated hydroxyanisole, benzoic acid and linalool: 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. This medicine contains a fragrance with linalool. Linalool may cause allergic reactions. PEVARYL 1% cutaneous spray, alcoholic solution contains propylene glycol and linalool : This medicine 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 may cause allergic reactions. PEVARYL 1% cutaneous powder contains linalool : This medicine contains a fragrance with linalool. Linalool may cause allergic reactions PEVARYL 1% cutaneous emulsion 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 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 may 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 may cause allergic reactions. Benzyl alcohol may cause mild local irritation.

INTERACTIONS

Interactions Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - Which medicines or foods can modify the effect of Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution?

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% 6 sachets 10 g non-alcoholic cutaneous solution can cause side effects - What are the side effects of Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution?

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 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. 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). In the table below, where adverse reactions of Pevaryl dermatological formulations are reported, all ADRs with a known incidence (common or uncommon) are from clinical trial data and all adverse reactions with an unknown incidence are from post-marketing 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 www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution - What are the risks of Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution 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% 6 sachets 10 g non-alcoholic cutaneous solution.

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% 6 sachets 10 g non-alcoholic cutaneous solution before driving or using machines - Does Pevaryl 1% 6 sachets 10 g non-alcoholic cutaneous solution affect driving or using machines?

Not known.