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Pevaryl 1% Skin Emulsion is your ally in the fight against skin fungal infections. Designed to provide powerful antifungal action, it quickly and effectively relieves skin infections. Its fluid formula ensures comfortable and precise application.
Pevaryl 1% fluid emulsion is an effective antifungal medication in the imidazole class, designed to treat fungal skin infections, such as ringworm. Applied topically, this formula works to eliminate pathogenic fungi that grow on the skin, causing itching, redness, and discomfort. With its concentration of econazole nitrate, a well-established active ingredient, it provides targeted treatment that quickly penetrates the superficial layers of the skin for fast and effective action.
This product is particularly suitable for people suffering from candidiasis, whether it involves infections of the skin, mucous membranes, or skin folds. It is suitable for fungal infections in sensitive areas such as the groin, where recurrences can occur without proper care. By treating fungal skin infections, Pevaryl helps restore the skin’s integrity and reduce the risk of reinfection.
In addition to its antifungal properties, Pevaryl also relieves the discomfort associated with dermatophytosis and other deep skin fungal infections, such as folliculitis and kerions. This product’s fluid formula allows for gentle and even application, ideal for covering affected areas without irritating the skin.
Thanks to its carefully selected ingredients, Pevaryl 1% fluid emulsion helps restore healthy skin, minimizing itching and irritation. By choosing this product, you’re opting for an effective treatment to combat skin fungi and restore soft, comfortable skin.
Pevaryl 1% fluid emulsion for topical application stands out for its light, non-greasy texture, which makes it easy to apply to large or hard-to-reach areas. Its formula is designed for rapid absorption, allowing the product to blend seamlessly into your daily skincare routine without leaving a sticky residue. This product is suitable for the whole family and can be used specifically to provide comfort and care for sensitive areas of the skin. Convenient to carry thanks to its 30-ml size, it fits easily into a first-aid kit for discreet use, whether at home or on the go.
Pevaryl is also recommended for more stubborn infections. For best results, it can be used in conjunction with other antifungal treatments or proper hygiene practices to prevent recurrences. With this in mind, applying Pevaryl 1% Powder (30 g powder bottle ) as a supplement helps maximize the treatment’s effectiveness, ensuring that all affected areas are thoroughly cleansed.
For optimal effectiveness, apply Pevaryl 1% fluid emulsiontwo to three times a day, taking care not to exceed three applications per day. The product should be applied to clean, dry skin, completely covering the affected area. Gently massage until fully absorbed, ensuring the product penetrates the skin thoroughly. This treatment should be continued for two to four weeks for lasting results.
Share your feedback on the usage instructions and dosage for Pevaryl 1% with our partner Verified Reviews after your purchase.
Precautions for use:
Econazole Nitrate, Ethylene Glycol Stearates, Macrogol 300, Macrogol 1500, Liquid Paraffin, Unsaturated Polyglycolized Glycerides, Anhydrous Colloidal Silica, Benzoic Acid, Fragrance, Benzyl Alcohol, Benzyl Benzoate, Benzyl Salicylate, Cinnamal, Cinnamic Alcohol, Citral, Citronellol, Coumarin, D-Limonene, Eugenol, Farnesol, Geraniol, Hexyl Cinnamaldehyde, Hydroxycitronellal, Isoeugenol, Lilial, Linalool.
Product Description
Pevaryl 1% fluid emulsion for topical application is an antifungal solution packaged in a 30-ml bottle, ideal for prolonged treatment of affected skin areas. This product is intended for external use only, and its fluid formula allows for even and comfortable application to the skin, making it easy to incorporate into your daily routine for treating fungal infections.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 20/10/2023
Product name
PEVARYL 1%, fluid emulsion for cutaneous application
Deconazole nitrate
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided 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%, fluid emulsion for cutaneous application and what is it used for?
2. What do I need to know before using PEVARYL 1%, emulsion fluide pour application cutanée?
3. How do I use PEVARYL 1%, emulsion fluide pour application cutanée?
4. What are the possible side effects?
5. How should I store PEVARYL 1%, emulsion for cutaneous application?
6. Package contents and other information.
1. WHAT IS PEVARYL 1%, fluid emulsion for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: LOCAL ANTIFUNGAL IMIDAZOLE DERIVATIVES, ATC code: D01AC03.
This medicine contains an antifungal agent (active against fungi) of the imidazole family.
It is indicated for the treatment of certain mycoses of the skin (skin disorders caused by fungi).
Candidiasis :
- Mycoses of mucous membranes and semi-mucous membranes: vulvitis, balanitis, anitis, candidiasis of the seat.
- Mycoses of fragile skin: children, face.
For wool fold infections, oral antifungal treatment is necessary to treat any digestive and/or vaginal outbreaks, and thus avoid any recurrence.
Dermatophytes :
- Treatment of hair mycoses: folliculitis, kerion, sycosis.
2. WHAT DO I HAVE TO KNOW BEFORE USING PEVARYL 1%, emulsion fluid for cutaneous application?
Never use PEVARYL 1%, fluid emulsion for cutaneous application:
- 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%, emulsion fluide pour application cutanée.
Be careful with PEVARYL 1%, fluid emulsion for cutaneous application:
- in children,
- on large areas of skin,
- on damaged skin,
- in situations where the local docclusion phenomenon 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 drug 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 benzoic acid and may cause local irritation. Benzoic acid may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
- This medicine contains butylated hydroxyanisole (E320) and may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
- 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.
Children and teenagers
Not applicable.
Other medicinal products and PEVARYL 1%, fluid emulsion for cutaneous application
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%, fluid emulsion for cutaneous application with food and drink
Not applicable.
Pregnancy and breast-feeding
In view of the limited but possible systemic passage of PEVARYL after dermal application, and based on clinical experience, the use of PEVARYL 1% emulsion for cutaneous application is not recommended during pregnancy or breast-feeding, without the advice of your doctor.
Do not apply to the 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%, fluid emulsion for cutaneous application contains benzoic acid and butylated hydroxyanisole (E320).
3. HOW DO I USE PEVARYL 1%, fluid emulsion for cutaneous application?
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.
Dosage
Apply PEVARYL to the skin 2 to 3 times a day, up to a maximum of 3 applications per day. Treatment should be continued for 2 to 4 weeks.
Method of administration
For EXTERNAL USE ONLY: applied directly to the skin.
1. Clean affected area and surrounding area, then dry skin thoroughly before application.
2. Massage gently and evenly until the fluid emulsion for cutaneous application is completely absorbed.
Regular use of this product throughout the treatment period is crucial to its success.
If there is no improvement, consult your doctor.
If you have accidentally swallowed PEVARYL 1%, fluid emulsion for cutaneous application :
Consult a physician for treatment appropriate to the side effects that may occur as a result of swallowing.
If you accidentally squirt PEVARYL 1%, emulsion fluide pour application cutanée into your eyes:
Wash with clean water or saline solution.
If this does not help, consult a doctor.
Instructions for opening the bottle:
The bottle comes with a child-resistant cap and should be opened as follows:
Press the cap while turning counter-clockwise.
If you have used more PEVARYL 1%, emulsion fluid for cutaneous application than you should have
Not applicable.
If you forget to use PEVARYL 1%, emulsion fluid for cutaneous application
Not applicable.
If you stop using PEVARYL 1%, emulsion fluid for cutaneous application
Not applicable.
If you have any further questions about the use of this medicine, please 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%, emulsion fluid for cutaneous application?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the box. The expiration date refers to the last day of that month.
No special storage precautions 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%, fluid emulsion for cutaneous application, contains
- The active substance is :
Deconazole nitrate............................................................................................................ 1.0 g
per 100 g demulsion.
- Other ingredients are :
Ethylene glycol stearates and macrogols 300 and 1500 (Téfose 63), liquid kerosene, unsaturated polyglycolysed glycerides (Labrafil M 1944 CS), anhydrous colloidal silica (Aérosil 200), benzoic acid, fragrance (essential oils of rose, jasmine, iris, sandalwood, ylang-ylang, coriander, vetyver, linalool, cinnamic alcohol, cinnamic aldehyde), butylated hydroxyanisole (E320), purified water.
What PEVARYL 1%, emulsion fluide pour application cutanée is and what it contains
This medicine comes in the form of a fluid emulsion for cutaneous application. 30 ml 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
JANSSEN PHARMACEUTICA N.V
TURNHOUTSEWEG 30
B-2340 BEERSE
BELGIUM
or
Temmler Italia S.R.L.
Via Delle Industrie, 2 20061
Carugate (MI)
ItaliE
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 ?
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