Pevaryl 1% is an effective skin solution for fungal infections, including dermatophytes, yeasts and Malassezzia furfur. Suitable for skin of all ages, twice-daily application soothes and eliminates fungal infections with a rapid, targeted effect.
Pevaryl 1% skin solution is an antifungal product based on econazole nitrate, designed to effectively treat and relieve skin mycoses. This product is ideal for skin prone to fungal infections such as dermatophytes (Trichophyton, Epidermophyton, Microsporum), Candida and yeasts. Its powerful action lies in its proven efficacy against fungi and Gram+ bacterial agents. This latest-generation treatment also relieves skin disorders caused by Malassezzia furfur, the agent of Pityriasis versicolor and Pityriasis capitis.
The active ingredient, econazole nitrate, exerts a powerful, targeted antifungal effect at several cellular levels. It modifies cell membrane permeability, inhibits oxidative processes in mitochondria and blocks RNA synthesis in the nuclei of infected cells. This combination of actions ensures rapid, effective eradication of fungal infections, while preserving skin health.
Pevaryl 1% also has a valuable antibacterial action, particularly for mixed infections with Corynebacterium minutissimum (erythrasma) and certain actinomycetes. This dual antifungal and antibacterial action makes Pevaryl 1% a complete solution for mycoses complicated by bacterial infections.
Finally, Pevaryl 1% is designed for safe use even in sensitive populations. Adolescents, adults, babies and children can all benefit from this treatment, subject to medical advice, particularly for pregnant and breast-feeding women.
Pevaryl 1% is also distinguished by its ease of use, offering a practical solution for treating fungal infections on a daily basis. Thanks to its spray bottle, it guarantees precise, even application to hard-to-reach areas. This format is particularly well-suited to limiting wastage while ensuring even distribution of the product. Its light texture penetrates quickly without leaving a greasy residue, for an immediate sensation of comfort. What's more, its discreet fragrance contributes to a pleasant application experience, while respecting sensitive skin prone to irritation or allergies.
Looking for a complementary treatment? Consider using Pevaryl 1% Powder 30 g powder bottle to enhance the effectiveness and duration of the product's benefits.
For optimum effect in the treatment of fungal infections, apply Pevaryl 1% solution twice a day, until lesions have completely disappeared. Take a few drops of the solution in the palm of your hand or apply directly to infected areas. Massage gently until fully absorbed, allowing the active ingredients to penetrate deeply.
Duration of treatment: For Pityriasis versicolor, a treatment duration of two weeks is recommended for optimal results.
Give your opinion on the advice for use and dosage of Pevaryl 1% with our partner Avis Vérifiés after your purchase.
Precautions for use
Econazole Nitrate, 1.0 g
Ethanol, Propylene Glycol, Trometamol, Parfum, 3-Methyl-4-(2,6,6-Trimethyl-2-Cyclohexen-1-Yl)-3-Buten-2-One, Benzylic Alcohol, Benzyl Benzoate, Benzyl Salicylate, Cinnamal, Cinnamic Alcohol, Citral, Citronellol, Coumarin, D-Limonene, Eugenol, Farnesol, Géraniol, Hexyl Aldéhyde Cinnamique, Hydroxycitronellal, Isoeugénol, Lilial, Linalool
Packaging
30 g spray bottle (aluminum) with metering pump.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 21/06/2021
Product name
PEVARYL 1 PER CENT, solution for topical application in spray bottle
Deconazole nitrate
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is PEVARYL 1 PER CENT, solution for topical application in a spray bottle and what is it used for?
2. What do I need to know before using PEVARYL 1 PER CENT, solution for topical application in a spray bottle?
3. How do I use PEVARYL 1 PER CENT, solution for topical application in a spray bottle?
4. What are the possible side effects?
5. How do I keep PEVARYL 1 PER CENT, solution for topical application in a spray bottle?
6. Package contents and other information.
1. WHAT IS PEVARYL 1 PER CENT, solution for topical application in a spray bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: IMIDAZOLE DERIVATIVES, LOCAL ANTIFUNGAL, ATC code: D01AC03.
This medicine contains an antifungal agent (active against fungi) of the imidazole family.
It is recommended for the treatment or adjunctive treatment of certain skin mycoses (skin disorders caused by fungi).
Pytiriasis versicolor.
2. WHAT DO I HAVE TO KNOW BEFORE USING PEVARYL 1 PER CENT, solution for topical application in a spray bottle?
Never use PEVARYL 1 PER CENT, solution for topical application in a spray bottle:
- if you are allergic to deconazole nitrate or any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using PEVARYL 1 PER CENT, solution for topical application in spray bottle.
Take special care with PEVARYL 1 PER CENT, solution for topical application in a spray bottle:
- in children,
- on large areas of skin,
- on damaged skin,
- in situations where local occlusion may recur (e.g. elderly subjects, bedsores, submammary lesions).
In such cases, it is essential to follow the recommendations and dosage indicated in the package leaflet, as the product penetrates the skin more easily.
- You should stop using this product if you develop an allergy (recognizable by redness, pimples) or irritation.
- Do not apply to the eyes, mouth or nose.
- Candidiasis: do not use soaps with acidic pH (pH favors Candida multiplication).
- This product contains 49.15 g of propylene glycol per 100 g of solution and may cause skin irritation; do not use on open wounds or large areas of injured or damaged skin (burns) without informing your doctor or pharmacist.
- This medicine contains a fragrance containing the following substances: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamic alcohol, citral, citronellol, coumarin, d-limonène, eugenol, farnesol, geraniol, cinnamic hexyl aldehyde, hydroxycitronellal, isoeugenol, lilial and linalool. These substances may cause allergic reactions.
If in doubt, ask your doctor or pharmacist.
Children and teenagers
Not applicable.
Other medicinal products and PEVARYL 1 PER CENT, solution for topical application in spray bottle
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Tell your doctor if you are taking a blood-thinning medication, the antivitamins K (such as acenocoumarol, fluindione, warfarin), as PEVARYL may modify the action of antivitamins K in some people. You should therefore monitor your INR (blood tests) frequently. Depending on your situation, your doctor may also decide to modify the dose of your antivitamin K during or after treatment with PEVARYL.
PEVARYL 1 PER CENT, solution for topical application in spray bottle with food and drink
Not applicable.
Pregnancy and breast-feeding
In view of the limited but possible systemic passage of PEVARYL after topical application, and in the light of clinical experience, PEVARYL 1 PER CENT, solution for topical application in spray bottle, is not recommended for use during pregnancy or while breast-feeding, without the advice of your doctor.
Do not apply to breasts while breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and use of machinery
Not applicable.
PEVARYL 1 PER CENT, solution for topical application in spray bottle contains propylene glycol and ethanol.
3. HOW DO I USE PEVARYL 1 PER CENT, solution for topical application in a spray bottle?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For EXTERNAL USE ONLY: it is applied directly to the skin.
Be sure to follow the steps below when applying:
1. Cleanse the affected area and its surroundings, then dry the skin well before application.
2. Apply PEVARYL to and around the affected area twice a day.
3. Massage gently and evenly until the topical spray is completely absorbed.
|
TREATMENT DURATION |
|
|
Pityriasis versicolor |
2 weeks |
Regular use of the product throughout the treatment period is crucial to its success.
If there is no improvement, consult a doctor.
If you accidentally swallow PEVARYL 1 PER CENT, solution for topical application in a spray bottle :
Consult a physician for treatment of any side effects that may result from swallowing PEVARYL.
If you accidentally squirt PEVARYL 1 PER CENT, solution for topical application in a spray bottle in the eyes:
Wash with clean water or saline solution.
If this does not help, consult a doctor.
If you have used more PEVARYL 1 PER CENT, solution for topical application in a spray bottle, than you should have
Not applicable.
If you forget to use PEVARYL 1 PER CENT, solution for topical application in a spray bottle
Not applicable.
If you stop using PEVARYL 1 PER CENT, solution for topical application in spray bottle
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Common side effects (1 to 10 out of 100 users) are :
- itching,
- burning sensation,
- pain at the application site.
Uncommon adverse reactions (1 to 10 out of 1,000 users) are :
- redness,
- discomfort
- swelling at the application site.
Undesirable effects for which the frequency is not determined are :
- allergy (hypersensitivity),
- swelling of the throat or face (angioedema),
- skin rash,
- urticaria,
- blisters,
- peeling skin (exfoliation).
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE PEVARYL 1 PER CENT, solution for topical application in spray bottle?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the carton. The expiration date refers to the last day of that month.
No special storage conditions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What PEVARYL 1 PER CENT, solution for topical application in spray bottle, contains
- The active substance is :
Deconazole nitrate............................................................................................................ 1.0 g
per 100 g of solution.
- Other components are :
Ethanol, propylene glycol, trometamol, fragrance*;
*Fragrance composition: essential oils of rose, jasmine, diris, sandalwood, dylang, coriander, vetyver, linalool, cinnamic alcohol, cinnamic aldehyde.
What PEVARYL 1 PER CENT, solution for topical application in a spray bottle is and what it contains
This medicine is a solution for topical application. 30 g spray bottle.
Marketing authorization holder
KARO PHARMA AKTIEBOLAG
BOX 16184
103 24 STOCKHOLM
SWEDEN
Marketing authorization holder
ALLOGA FRANCE
ZAC DE CHAPOTIN SUD
69970 CHAPONNAY
Manufacturer
LUSOMEDICAMENTA SOCIEDADE TECNICA FARMACEUTICA, S.A.
ESTRADA CONSIGLIERI PEDROSO
N°69 - B, QUELUZ DE BAIXO
2730-055 BARCARENA
PORTUGAL
or
JANSSEN PHARMACEUTICA N.V
TURNHOUTSEWEG 30
B-2340 BEERSE
BELGIUM
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Ce médicament d'action locale contient un antifongique de la famille des imidazolés.
Il est utilisé dans le traitement de certaines maladies de la peau, des ongles et des muqueuses, dues à des champignons microscopiques (mycoses) : candidose, dermatophyties...
La solution pour application locale est réservée au traitement du pityriasis versicolor.
Les prix mentionnés ne tiennent pas compte des « honoraires de dispensation » du pharmacien.
| p 100 g (crème) | p 100 g (émulsion) | |
| Éconazole nitrate | 1 g | 1 g |
| Acide benzoïque | + | + |
| Butylhydroxyanisole | + | + |
| Butylhydroxytoluène | + | + |
| p 100 g (poudre) | p 100 g (solution) | |
| Éconazole nitrate | 1 g | 1 g |
| Propylèneglycol | + |
Ce médicament ne doit pas être utilisé en cas d'allergie aux antifongiques de la famille des imidazolés.
Évitez d'utiliser ce médicament de manière prolongée et sur des surfaces étendues ou profondément lésées, notamment chez l'enfant, sans l'avis de votre pharmacien ou de votre médecin.
Rincez abondamment en cas de contact accidentel avec les yeux.
Un traitement prolongé par éconazole peut interagir avec certains anticoagulants oraux (antivitamine K) et nécessiter un contrôle plus fréquent de l'INR.
Les médicaments contenant de l’éconazole peuvent être utilisés pendant la grossesse après avis de votre médecin ou de votre pharmacien.
La possibilité d'un effet du médicament chez le nourrisson est très improbable. Il peut être utilisé chez la femme qui allaite.
Le médicament doit être appliqué après lavage et séchage soigneux de la zone à traiter. La forme utilisée (crème, émulsion, solution, poudre) et la durée du traitement varient selon les cas. Suivre la prescription de votre médecin ou les conseils de votre pharmacien.
Crème, solution, émulsion : appliquer avec le bout des doigts, une petite quantité de produit ayant été déposé dans le creux de la main ou directement sur les lésions, puis masser pour faire pénétrer. Dans les plis de la peau, la crème doit être appliquée en petite quantité pour limiter le risque de macération.
Poudre : appliquer directement sur la zone à traiter ; elle peut être également utilisée dans les chaussures, source fréquente de recontamination en cas de mycose des pieds.
2 ou 3 applications par jour, pendant 2 à 4 semaines.
Dans le traitement du pityriasis versicolor : 2 applications par jour, pendant 2 semaines.
En cas de candidose, évitez d'utiliser des savons acides : ils favorisent la multiplication des champignons.
En cas de lésion importante des ongles des orteils, un meulage préalable par un pédicure facilite l'action du médicament.
Une transpiration excessive contribue au développement des lésions dues à des champignons. Le port de chaussettes en fibre naturelle (coton, laine) est recommandé. La même paire de chaussures ne doit pas être portée deux jours de suite.
Fréquents (1 à 10 % des personnes) : démangeaisons, sensation de brûlure, douleur au site d'application.
Peu fréquents (moins de 1 personne sur 100) : rougeur, gêne, gonflement au site d'application.
Fréquence indéterminée : réaction allergique (éruption cutanée, urticaire, œdème de Quincke...).
Réaction cutanée (démangeaisons, boutons, gonflement) ou malaise général apparaissant après un contact avec une substance particulière, l'utilisation d'un médicament ou l'ingestion d'un aliment. Les principales formes d'allergie sont l'eczéma, l'urticaire, l'asthme, l'œdème de Quincke et le choc allergique (choc anaphylactique). L'allergie alimentaire peut également se traduire par des troubles digestifs.
Médicament qui détruit les champignons et levures microscopiques. Ceux-ci peuvent être présents sur la peau ou les muqueuses (tube digestif ou organes génitaux). La levure la plus courante est le Candida albicans.
Multiplication anormale d'une levure microscopique, Candida albicans le plus souvent. Il s'agit d'une complication fréquente et bénigne des traitements antibiotiques. Les principaux symptômes sont des troubles digestifs, une coloration marron ou noire de la langue, des taches blanches sur le palais ou la langue (muguet), des démangeaisons ou des brûlures de la vulve ou du gland.
Infection de la peau ou des ongles par un champignon microscopique (dermatophyte).
Apparition de boutons ou de plaques sur la peau. Ces lésions peuvent être dues à un aliment, à un médicament, et traduire une allergie ou un effet toxique. De nombreux virus peuvent également provoquer des éruptions de boutons : celles de la rubéole, de la roséole et de la rougeole sont les plus connues.
La fréquence d'un effet indésirable est décrite dans les documents officiels de la manière suivante :
Famille de médicaments qui regroupe des antifongiques, des antibiotiques et des antiparasitaires.
Mode de préparation de certaines tisanes ; ce procédé permet d'extraire les substances contenues dans les plantes en les faisant tremper de façon prolongée dans de l'eau froide. Cette technique diffère de l'infusion ou de la décoction.
Tissu (membrane) qui tapisse les cavités et les conduits du corps communiquant avec l'extérieur (tube digestif, appareil respiratoire, voies urinaires, etc.).
Affection due à des champignons microscopiques, favorisée par la prise d'antibiotiques.
Consultez l'article : Mycose de la peau, Mycose vaginale.
Enfant de un à 30 mois. Un enfant de moins de un mois est un nouveau-né.
Infection de la peau due à un champignon microscopique. Elle se manifeste par des taches qui paraissent brunes sur une peau blanche et blanches sur une peau bronzée. Après traitement, seule une exposition au soleil permet de faire disparaître les taches.
Réaction allergique touchant généralement le visage. L'œdème de Quincke se traduit par un gonflement parfois spectaculaire. Les paupières sont souvent les premières touchées. Dans les rares cas où l'œdème touche la gorge, des troubles respiratoires peuvent survenir et un traitement urgent est nécessaire.
Réaction due à l'hypersensibilité de l'organisme à un médicament. Les réactions allergiques peuvent prendre des aspects très variés : urticaire, œdème de Quincke, eczéma, éruption de boutons rappelant la rougeole, etc. Le choc anaphylactique est une réaction allergique généralisée qui provoque un malaise par chute brutale de la tension artérielle.
Consultez l'article : Peut-on être allergique aux médicaments ?
Éruption de boutons sur la peau, dont l'origine est le plus souvent allergique. Les boutons ressemblent à des piqûres d'orties et leur couleur varie du rose pâle au rouge. L'urticaire peut apparaître ou disparaître en quelques minutes, et provoque d'intenses démangeaisons ; elle peut être localisée ou généralisée à la totalité de la surface cutanée.
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