NOTICE
ANSM - Updated on: 18/01/2019
Name of the drug
FENTICONAZOLE BAILLEUL 2%, cream
Fenticonazole nitrate
Box
Read all of this leaflet carefully before using this medicine as it contains important information for you.
You should always use this medicine by carefully following the information provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is FENTICONAZOLE BAILLEUL 2%, cream and in which cases it is used?
2. What information should you know before using FENTICONAZOLE BAILLEUL 2%, cream?
3. How to use FENTICONAZOLE BAILLEUL 2%, cream?
4. What are the possible side effects?
5. How to store FENTICONAZOLE BAILLEUL 2%, cream?
6. Contents of the pack and other information.
1. WHAT FENTICONAZOLE BAILLEUL 2%, cream IS AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: antifungals for topical use: imidazole and triazole derivatives - ATC code: D01AC12
Fenticonazole Bailleul 2%, cream contains an active substance called fenticonazole nitrate and is used in and adult Adolescents aged 12 years and older in the treatment of fungal diseases of the skin or mucous membranes.
Fenticonazole Bailleul 2%, cream is used in case:
· d Fungal infections of the skin or mucous membranes, especially in case of candidiasis, dermatophytosis and pityriasis versicolor.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENTICONAZOLE BAILLEUL 2%, cream?
Never use FENTICONAZOLE BAILLEUL 2%, cream:
· if you are allergic to the active substance or to any of the other ingredients of this medicine, listed in section 6. In case of an allergic reaction, treatment with Fenticonazole Bailleul 2%, cream should be stopped.
· in infants and children under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using FENTICONAZOLE BAILLEUL 2%, cream .
Do not use soap with an acidic pH.
Avoid all contact with eyes.
Children
Infants and children younger than 12 years of age should not use this medication because data on the Use of this drug in these groups of Age are insufficient.
Other medicines and FENTICONAZOLE BAILLEUL 2%, cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
The effects of some medicines can be influenced by Concomitant use Other medicines.
No interaction with d Other drugs n Is known.
FENTICONAZOLE BAILLEUL 2%, cream with food and drink
Not applicable.
Pregnancy and breast feeding
Fenticonazole Bailleul 2%, cream should not be used during pregnancy and Breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine .
Driving and using machines
Fenticonazole Bailleul 2%, cream n Has no influence or negligible influence on your ability to drive and use machines.
FENTICONAZOLE BAILLEUL 2%, cream contains l Cetyl alcohol and lanolin
He is likely to '' cause local skin reactions (e.g. eczema).
FENTICONAZOLE BAILLEUL 2%, cream contains propylene glycol
He is likely to '' cause skin irritation.
3. HOW TO USE FENTICONAZOLE BAILLEUL 2%, cream?
Always use this medication exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Before To use this cream, you must thoroughly clean and dry the affected area of skin or mucosa. Unless otherwise instructed by your doctor, fenticonazole Bailleul 2%, cream should be applied to the affected area of skin or mucosa in a thin layer and lightly massaged, once or twice a day.
Unless your hands need to be treated, wash them thoroughly after Application of the drug in order to '' avoid transmission of fungal disease to d Other parts of your body, or even to ' other people. Please do not use any possible rest of this drug in self-medication in case of recurrence of this skin disease or in case of Other skin problems.
Additional Precautions
Change the towels and clothing that have come into contact with infected skin daily. This will prevent reinfection. Always dry yourself thoroughly after washing or taking a bath, especially in hard-to-reach areas of the body, such as spaces between the toes.
Duration of treatment
The duration of treatment depends among other things on the type of Infectious agent, location (skin or mucosa), of Extent and severity of Infection as well as individual factors. In most cases, regular treatment for 2 to 4 weeks (longer in rare cases) may be sufficient. It is very important to n Forget any application and always apply the treatment on a regular basis until '' fully healed. Treatment should be continued even if the symptoms have disappeared after a few days. Talk to your pharmacist or doctor to find out the duration of your treatment.
If you use more FENTICONAZOLE BAILLEUL 2%, cream than you should
There n 'No known symptoms of overdose.
If you forget to use FENTICONAZOLE BAILLEUL 2%, cream
Not applicable.
If you stop using FENTICONAZOLE BAILLEUL 2%, cream
Not applicable.
If you have Other questions about Use of this product, ask for Information your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the Applying the cream on the skin, a slight burning sensation of the skin and transient stinging may occur.
Very rare (may affect up to '' to 1 in 10,000 people): temporary redness of the skin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FENTICONAZOLE BAILLEUL 2%, cream?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the tube after the mention EXP. The expiration date refers to the last day of this month.
Do not store above 25 ° C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What FENTICONAZOLE BAILLEUL 2% contains, cream
· The active substance is:
Fenticonazole nitrate ............................................... .................................................. 2,000 g
Quantity corresponding to fenticonazole base ............................................. ..................... 1,757 g
Per 100 g of cream.
· The other components are:
Propylene glycol, hydrogenated lanolin, olive oil Almond virgin, polyglycolic ester of Fatty acids, cetyl alcohol, glycerol monostearate, disodium edetate, purified water.
What is FENTICONAZOLE BAILLEUL 2%, cream and contents of the pack?
Fenticonazole Bailleul 2%, cream is white to off-white in color. It is packaged in a 15 g or 30 g aluminum tube fitted with '' a plastic cap.
Not all presentations may be marketed.
Marketing authorization holder
BAILLEUL SA LABORATORY
10-12 AVENUE PASTEUR
L-2310 LUXEMBOURG
LUXEMBOURG
Marketing authorization operator
BAILLEUL LABORATORY
264 RUE DE FAUBOURG SAINT HONORE
75008 PARIS
FRANCE
Maker
CHEMINEAU LABORATORIES
93 COIN ROUTE
37210 VOUVRAY
FRANCE
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with the regulations in force.
[To be completed later by the holder]
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).