NOTICE
ANSM - Updated on : 22/03/2022
Product name
ECONAZOLE VIATRIS 1%, powder for cutaneous application
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 it is described in this leaflet or by your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. 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 ECONAZOLE VIATRIS 1%, powder for cutaneous application and what is it used for?
2. What do I need to know before using ECONAZOLE VIATRIS 1%, powder for dermal application?
3. How do I use ECONAZOLE VIATRIS 1%, powder for application?
4. What are the possible side effects?
5. How to store ECONAZOLE VIATRIS 1%, powder for application?
6. Package contents and other information.
1. WHAT IS ECONAZOLE VIATRIS 1%, powder for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: TOPICAL ANTIFUNGAL, IMIDAZOLES AND TRIAZOLES 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 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 ECONAZOLE VIATRIS 1%, powder for cutaneous application?
Never use ECONAZOLE VIATRIS 1%, powder for cutaneous application:
- if you are allergic to deconazole nitrate or any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ECONAZOLE VIATRIS 1%, powder for cutaneous application.
FOR EXTERNAL USE ONLY.
Be careful with ECONAZOLE VIATRIS 1%, powder 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 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).
If in doubt, ask your doctor or pharmacist.
Children and teenagers
Not applicable.
Other medicinal products and ECONAZOLE VIATRIS 1%, powder 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 ECONAZOLE VIATRIS 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 ECONAZOLE VIATRIS.
ECONAZOLE VIATRIS 1%, powder for cutaneous application with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
In view of the limited but possible systemic passage of ECONAZOLE VIATRIS 1%, powder for cutaneous application, and in the light of clinical experience, the use of ECONAZOLE VIATRIS 1%, powder 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 using this product.
Driving and use of machinery
Not applicable.
ECONAZOLE VIATRIS 1%, powder for cutaneous application contains
Not applicable.
3. HOW DO I USE ECONAZOLE VIATRIS 1%, powder 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 ECONAZOLE VIATRIS 1%, powder for cutaneous application to the skin 2 to 3 times a day, not exceeding 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 a doctor.
If you have accidentally inhaled ECONAZOLE VIATRIS 1%, powder for cutaneous application :
Seek prompt medical advice as the talc contained in the powder may block your breathing (particularly in infants and children).
If you have accidentally swallowed ECONAZOLE VIATRIS 1%, powder for cutaneous application :
Consult your doctor for treatment appropriate to the side effects which may occur as a result of swallowing ECONAZOLE VIATRIS.
If you accidentally squirt ECONAZOLE VIATRIS 1%, powder for cutaneous application into your eyes:
Wash with clean water or saline solution.
If this does not help, consult a doctor.
If you have used more ECONAZOLE VIATRIS 1%, powder for cutaneous application than you should have:
Consult your doctor or pharmacist immediately.
If you forget to take ECONAZOLE VIATRIS 1%, powder for cutaneous application :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ECONAZOLE VIATRIS 1%, powder 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).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. 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 Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE ECONAZOLE VIATRIS 1%, powder for cutaneous application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at a temperature not exceeding +25°C, away from moisture.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ECONAZOLE VIATRIS 1%, powder for cutaneous application, contains
- The active substance is :
deconazole nitrate..................................................................................................................... 1 g
per 100 g of powder for cutaneous application.
- Other ingredients are :
talc, colloidal anhydrous silica (AEROSIL 300), light zinc oxide.
What ECONAZOLE VIATRIS 1%, powder for cutaneous application is and what it contains
This medicine comes in the form of a powder for cutaneous application. 30 g powder in a powder bottle.
Marketing authorization holder
VIATRIS SANTE
1 rue de turin
69007 lyon
Marketing authorization holder
VIATRIS SANTE
1 rue de turin
69007 lyon
Manufacturer
VIATRIS SANTE
1 rue de turin
69007 lyon
or
LABORATOIRES CHEMINEAU
93 ROUTE DE MONNAIE
37210 VOUVRAY
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.