NOTICE
ANSM - Updated on : 27/10/2022
Product name
FAZOL 2 PER CENT, fluid emulsion for topical application
Disoconazole 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 or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- 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.
Keep out of the reach of children.
What does this leaflet contain?
1. What is FAZOL 2 PER CENT, fluid emulsion for topical application and what is it used for?
2. What do I need to know before using FAZOL 2 PER CENT, fluid emulsion for topical application?
3. How do I use FAZOL 2 PER CENT, fluid emulsion for topical application?
4. What are the possible side effects?
5. How do I keep FAZOL 2 PER CENT, emulsion fluid for topical application?
6. Package contents and other information.
1. WHAT IS FAZOL 2 PER CENT, fluid emulsion for topical application AND WHAT IS IT USED FOR?
LOCAL ANTIFUNGAL - ATC code: D01AC05
This drug is recommended for the treatment or complementary treatment of certain skin or mucous membrane disorders caused by fungi (mycoses).
2. WHAT DO I HAVE TO KNOW BEFORE USING FAZOL 2 PER CENT, emulsion fluid for topical application?
Never use FAZOL 2 POUR CENT, emulsion fluide pour application locale:
- if you are allergic (hypersensitive) to imidazole derivatives or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using FAZOL 2 PER CENT, fluid emulsion for topical application.
Precautions for use
- Avoid application near the eyes.
- Do not use acidic soaps (acidity favors the multiplication of certain fungi).
- Discontinue use in case of allergy or intolerance.
Children
In the event of application to children, over a large surface area or on damaged skin, it is essential to follow the recommendations and dosage indicated by your doctor, as the product penetrates more deeply in these circumstances.
Other drugs and FAZOL 2 PER CENT, fluid emulsion for local application
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
FAZOL 2 PER CENT, fluid emulsion for topical application with food and drink
Not applicable.
Pregnancy and 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 using this product.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
FAZOL 2 PER CENT, fluid emulsion for topical application contains butylated hydroxyanisole (E320).
Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
FAZOL 2 PER CENT, fluid emulsion for topical application contains benzoic acid (E210).
Benzoic acid may cause local irritation, and may increase the risk of dicterus (yellowing of the skin and eyes) in neonates (up to 4 weeks of age).
3. HOW DO I USE FAZOL 2 PER CENT, fluid emulsion for topical application?
Apply to affected areas and surrounding areas twice a day, after cleansing and drying the skin.Follow with gentle, regular massage until completely absorbed.
For use on the skin.
Shake bottle before use.
Treatment lasts from 2 to 4 weeks, depending on the mycosis, and may be longer for certain localizations. Regular use of the product throughout the treatment period is crucial to its success.
If you have used more FAZOL 2 PER CENT, fluid emulsion for topical application than you should have :
Not applicable.
If you forget to use FAZOL 2 PER CENT, emulsion fluid for topical application :
Not applicable.
If you stop using FAZOL 2 PER CENT, emulsion fluid for topical application :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this product may cause undesirable effects, but these do not always occur in everyone.
Cases of itching, irritation, burning sensations, exceptional general allergic manifestations (angioedema, urticaria) and contact eczema (notably linked to the presence of butylhydroxyanisole and benzoic acid) have been reported.
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 Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW DO I USE FAZOL 2 PER CENT, fluid emulsion for topical application?
Keep out of sight and reach of children.
Do not use after the expiration date indicated on the bottle.
Store away from frost.
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. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What FAZOL 2 PER CENT, fluid emulsion for topical application, contains
- The active substance is :
Micronized disoconazole nitrate...................................................................................... 2,000 g
- The other components are :
Glycol stearate and polyethylene glycol (mixture of monoesters and diesters of ethylene glycol and polyethylene glycol of pamitic and stearic acids), polyoxyethylenated oleic glycerides, liquid kerosene, butylated hydroxyanisole, benzoic acid, purified water.
What FAZOL 2 PER CENT, fluid emulsion for local application is and what it contains
This medicine is in the form of an emulsion for cutaneous application. 30 g bottle.
Marketing authorization holder
ALLIANCE PHARMA (IRELAND) LTD
UNITED DRUG HOUSE
MAGNA DRIVE
DUBLIN
D24 X0CT
IRELAND
Marketing authorization holder
ALLIANCE PHARMA France SAS
13 RUE PAUL VALERY
75116 PARIS
Manufacturer
FARMACLAIR
440 AVENUE DU GENERAL CHARLES DE GAULLE
14200 HEROUVILLE SAINT-CLAIR
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]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.