NOTICE
ANSM - Updated on : 21/06/2021
Product name
PEVARYL 1%, powder for cutaneous application in powder flask
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%, powder for cutaneous application in a powder vial and what is it used for?
2. What do I need to know before using PEVARYL 1%, powder for cutaneous application in a powder vial?
3. How do I use PEVARYL 1%, powder for cutaneous application in a powder vial?
4. What are the possible side effects?
5. How should PEVARYL 1% powder for cutaneous application be stored?
6. Package contents and other information.
1. WHAT IS PEVARYL 1%, powder for cutaneous application in a powder vial AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: TOPICAL ANTIFUNGAL, DERIVATIVES OF IMIDAZOLES AND TRIAZOLES ATC code: D01AC03.
This medicine contains an antifungal agent (active against fungi) of the imidazole family.
It is indicated for the treatment of certain skin mycoses (skin disorders caused by fungi).
Candidiasis :
- Treatment of macerated fold mycoses: genital, submammary and interdigital intertrigo.
In the case of wool fold infections, oral antifungal treatment is required to treat a possible digestive and/or vaginal focus, and thus avoid any recurrence.
Dermatophytes :
- Treatment :
o Genital and crural macerated intertrigo.
o Toe intertrigo
2. WHAT DO I HAVE TO KNOW BEFORE USING PEVARYL 1%, powder for cutaneous application in a powder vial?
Never use PEVARYL 1%, powder for cutaneous application in a powder vial:
- 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%, powder for cutaneous application in a powder vial.
Be careful with PEVARYL 1%, powder for cutaneous application in a powder vial:
- 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 or pimples) or irritation.
- Do not apply to the eyes, nose or mucous membranes in general.
- Candidiasis: do not use soaps with an acid pH (pH favors Candida multiplication).
- This product 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.
Talk to your doctor or pharmacist before using PEVARYL 1%, powder for cutaneous application in a powder bottle.
Children and adolescents
Not applicable.
Other medicinal products and PEVARYL 1%, powder for cutaneous application in a powder vial
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%, powder for cutaneous application in powder vial 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%, powder for cutaneous application in a powder vial, 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 using this product.
Driving and use of machinery
Not applicable.
3. HOW TO USE PEVARYL 1%, powder for cutaneous application in a powder 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.
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: apply directly to the skin.
Cleanse the affected area and its surroundings, then dry the skin well before application.
Regular use of this product throughout the treatment period is crucial to its success.
If there is no improvement, consult your doctor.
If you accidentally inhale PEVARYL 1%, powder for cutaneous application in a powder vial :
Seek prompt medical advice as the talcum powder may block your breathing (especially in infants and children).
If you accidentally swallow PEVARYL 1%, powder for cutaneous application in a powder vial:
Consult your physician for treatment appropriate to the side effects that may occur as a result of this ingestion.
If you accidentally squirt PEVARYL 1%, powder for cutaneous application in powder form, into your eyes:
Wash with clean water or saline solution.
If this does not help, consult a doctor.
If you have used more PEVARYL 1%, powder for cutaneous application in a powder vial, than you should have
Not applicable.
If you forget to use PEVARYL 1%, powder for cutaneous application in a powder vial
Not applicable.
If you stop using PEVARYL 1%, powder for cutaneous application in a powder vial
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,
- blistering,
- peeling skin (exfoliation).
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%, powder for cutaneous application in a powder vial?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. 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%, powder for cutaneous application in a powder vial, contains
- The active substance is :
Deconazole nitrate............................................................................................................ 1.0 g
Per 100 g of powder for cutaneous application.
- Other components are :
Colloidal anhydrous silica, perfume, zinc oxide, talc.
What is PEVARYL 1%, powder for cutaneous application in a powder vial and what does it contain?
This medicine comes in the form of a powder for topical application.
30 g powder 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
Product 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.