NOTICE
ANSM - Updated on : 14/06/2022
Product name
ECONAZOLE VIATRIS 1%, emulsion for cutaneous application
Deconazole nitrate
Enclosed
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%, emulsion for cutaneous application and what is it used for?
2. What do I need to know before using ECONAZOLE VIATRIS 1%, emulsion for cutaneous application?
3. How do I use ECONAZOLE VIATRIS 1%, emulsion for cutaneous application?
4. What are the possible side effects?
5. How to store ECONAZOLE VIATRIS 1%, emulsion for cutaneous application?
6. Package contents and other information.
1. WHAT IS ECONAZOLE VIATRIS 1%, emulsion for cutaneous application 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 mycoses of the skin (skin disorders caused by fungi).
Candidiasis
- Mycoses of mucous membranes and semi-mucous membranes: vulvitis, balanitis, anitis, candidiasis of the breech area.
- Mycoses of fragile skin: children, face.
In the case of 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 ECONAZOLE VIATRIS 1%, emulsion for cutaneous application?
Never use ECONAZOLE VIATRIS 1%, 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, pharmacist or nurse before using ECONAZOLE VIATRIS 1%, emulsion for cutaneous application.
FOR EXTERNAL USE ONLY.
Be careful with ECONAZOLE VIATRIS 1%, 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.
- Stop using this product if you develop an allergy (as evidenced by redness or pimples) or irritation.
- Do not apply to the eyes, mouth or nose.
- Candidiasis: do not use soaps with acidic 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%, 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 drug, 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%, emulsion 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 after dermal application, and in the light of clinical experience, the use of ECONAZOLE VIATRIS 1%, emulsion for cutaneous application, is not recommended during pregnancy or breast-feeding, without the advice of your doctor.
Do not apply to breasts while breast-feeding.
If you are pregnant or breast-feeding, 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.
ECONAZOLE VIATRIS 1%, emulsion for cutaneous application contains benzoic acid (E210), butylated hydroxytoluene (E321), butylated hydroxyanisole (E320) and a fragrance containing allergens.
This medicine contains 200 mg benzoic acid per 100 g demulsion. Benzoic acid may cause local irritation and may increase the risk of dicterus (yellowing of the skin and eyes) in newborn infants (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 product contains a fragrance containing linalool, citronellol and butylated hydroxytoluene (E321). Linalool and citronellol may cause allergic reactions. Butylhydroxytoluene (E321) may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
3. HOW DO I USE ECONAZOLE VIATRIS 1%, 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 ECONAZOLE VIATRIS 1% emulsion 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.
1. Clean affected area and surrounding area, then dry skin well before application. Shake bottle before use.
2. Massage gently and evenly until the emulsion for cutaneous application is completely absorbed. Close bottle tightly after each use.
Regular use of this product throughout the treatment period is crucial to its success.
If the condition does not improve, consult a doctor.
If you have accidentally swallowed ECONAZOLE VIATRIS 1%, emulsion 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%, emulsion 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%, emulsion for cutaneous application than you should have :
Consult your doctor or pharmacist immediately.
If you forget to use ECONAZOLE VIATRIS 1%, emulsion for cutaneous application:
Do not take a double dose to make up for the one you forgot to take.
If you stop using ECONAZOLE VIATRIS 1%, emulsion 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%, emulsion for cutaneous application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle or carton after {EXP}. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in the drain or with the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ECONAZOLE VIATRIS 1%, emulsion for cutaneous application, contains
- The active substance is :
econazole nitrate...................................................................................................................... 1 g
per 100 g of emulsion for cutaneous application
- The other components are :
polyoxyethylene glycol 300 and 1500 and ethylene glycol stearates, light liquid kerosene, oleic macrogolglyceridesiques, parfum PCV 1676 [contains butylated hydroxytoluene (E321)], benzoic acid (E210), colloidal anhydrous silica, butylated hydroxyanisole (E320), purified water.
What ECONAZOLE VIATRIS 1%, emulsion for cutaneous application is and what it contains
This medicine comes in the form of an emulsion for cutaneous application. 30 g bottle.
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Marketing authorization holder
VIATRIS SANTE
1 RUE DE TURIN
69007 LYON
Manufacturer
SANDOZ
49 AVENUE GEORGES POMPIDOU
92593 LEVALLOIS-PERRET CEDEX
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.