NOTICE
ANSM - Updated: 24/08/2017
Name of the drug
MYCONAIL 80 mg / g, medicated nail polish
ciclopirox
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable 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 MYCONAIL 80mg / g, medicated nail polish and when is it used?
2. What information do you need to know before using MYCONAIL 80mg / g, medicated nail polish?
3. How to use MYCONAIL 80mg / g, medicated nail polish?
4. What are the possible side effects?
5. How to store MYCONAIL 80mg / g, medicated nail polish?
6. Contents of the package and other information.
1. WHAT IS MYCONAIL 80mg / g, medicated nail polish AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: Other antifungals for topical use - ATC code: D01AE14
MYCONAIL contains ciclopirox, an active ingredient that belongs to a group of medicines called antifungals. It eliminates a lot of fungi that can cause nail infections.
MYCONAIL is indicated for the treatment of mild to moderate fungus mycosis without matrix involvement (lunula) in adults.
You must talk to a doctor if your symptoms worsen or do not improve after 6 months of treatment for the nails of the hand or 12 months for the nails of the feet.
2. BEFORE YOU USE MYCONAIL 80mg / g, medicated nail polish?
Fungal infection affecting up to 75% of the surface of the nail, involving up to 5 nails without involvement of the nail matrix (lunula).
Never use MYCONAIL 80mg / g, medicated nail polish:
· if you are allergic to ciclopirox or any of the other ingredients of this medicine, listed in section 6.
· in children and adolescents under 18, due to lack of data in this age group.
Warnings and precautions
Talk to your doctor or pharmacist before using MYCONAIL 80mg / g, medicated nail polish:
· If more than 75% of the surface of the nail is involved, or more than 5 nails or nail matrix / lunula.
· In case of sensitization, please stop the treatment and consult a doctor.
· If you have a history of diabetes, immune dysfunction, peripheral vascular involvement, injury, painful or severely damaged nails, skin diseases such as psoriasis or other chronic skin conditions, edema, breathing problems yellow nail).
· If you have diabetes, be careful when cutting your nails.
Avoid contact with eyes and mucous membranes (eg mouth and nostrils).
MYCONAIL is for EXTERNAL USE only
Do not use nail polish or nail polish on treated nails.
The bottle must be capped after use.
The product is flammable. Keep away from heat or flame.
Children and adolescents
MYCONAIL is contraindicated in children and adolescents under 18 years of age (see section 2. "NEVER use MYCONAIL 80mg / g, medicated nail polish").
Other medicines and MYCONAIL 80mg / g, medicated nail polish
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
MYCONAIL 80mg / g, medicated nail polish with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Treatment with MYCONAIL should only be started after consulting a doctor.
There are no data on the passage of ciclopirox in breast milk in women. MYCONAIL nail treatment should be started only if absolutely necessary after consultation with a doctor
Driving and using machines
MYCONAIL has no effect on the ability to drive and use machines.
MYCONAIL 80mg / g, medicated nail polish contains cetostearyl alcohol.
This may cause local skin reactions (eg contact dermatitis).
3. HOW TO USE MYCONAIL 80mg / g, medicated nail polish?
Dosage
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or, pharmacist if in doubt.
Administration mode
Cutaneous use (only for nails and immediately adjacent skin).
MYCONAIL should be used only in adults.
The recommended dose is one application once a day on the infected nails or nails. For this, the nails must be thoroughly washed and dried. The medicated nail polish should be applied over the entire surface of the nail and the adjacent 5 mm of skin. Whenever possible, MYCONAIL should be applied under the free edge of the nail.
Allow MYCONAIL to dry for about 30 seconds.
Frequency of administration
The nail (s) should not be cleaned for at least 6 hours and it is therefore recommended to apply the evening before bedtime. After this period, it is possible to carry out the usual hygiene care.
It is not necessary to eliminate MYCONAIL with a solvent or an abrasive (nail file for example); just clean the nails with water. In case of involuntary washing, MYCONAIL can be applied again. Regular removal of non-adherent parts of the infected nail, such as nail clippers, is recommended.
Duration of treatment
Treatment should be continued until the problem is resolved, until the nail (s) are cleared or virtually free of any lesions and / or healthy nails have grown back. Normally the duration of the treatment of the fingernails is about six months, while that of the toenails is 9 to 12 months.
If you have used more MYCONAIL 80mg / g, medicated nail polish than you should
In case of accidental ingestion of the contents or part of the contents of the vial, immediately go to the nearest hospital or poison control center. Take the bottle with you.
If you forget to use MYCONAIL 80mg / g, medicated nail polish
Do not use a double dose to make up for the one you forgot to apply. Continue the treatment according to point 3 of this leaflet (How to use MYCONAIL 80 mg / g nail polish). If you have failed to apply medicated nail polish for several days, its effectiveness may be diminished.
If you stop using MYCONAIL 80mg / g, medicated nail polish
If you stop taking MYCONAIL before complete or almost complete healing of your nails, it is possible that the fungi have not been eliminated. In this case, it is possible that the condition of your nails deteriorates again.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.Very rare: affects less than 1 user in 10,000
· Redness, peeling, burning and itching at the application site.
Adverse events reported were mild and of short duration.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable 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 the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE MYCONAIL 80mg / g, medicated nail polish?
Keep this medicine out of the sight and reach of children.
Do not use this product after the expiry date which is stated on the carton and on the vial.
Keep the vial in the outer carton in order to protect from light.
Keep the bottle tightly closed to avoid evaporation of its contents.
Do not refrigerate or freeze.
This product is flammable; keep it away from any source of heat or free flame.
After the first opening of the vial: the drug should be kept for a maximum of 6 months.
At temperatures below 15 ° C, medicated nail polish may gel; slight flocculation or formation of a clear precipitate at the bottom of the flask is possible. It is possible to make them disappear by rubbing the bottle between the hands for about 1 minute. After that, the solution is crystal clear again. These anomalies have no impact on the quality or effectiveness of the product.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What MYCONAIL contains 80mg / g, medicated nail polish
· The active substance is: ciclopirox.
One gram of medicated nail polish contains 80 mg of ciclopirox.
· The other components are:
Ethyl acetate, 96% ethanol, cetostearyl alcohol, hydroxypropyl-chitosan and purified water
What MYCONAIL 80mg / g, medicated nail polish and contents of the pack
Medicated nail polish.
MYCONAIL 80 mg / g, medicated nail varnish is a clear, colorless or slightly yellowish solution, presented in clear glass vials with polypropylene screw cap and applicator brush.
Presentations of 3.3 ml and 6.6 ml.
Not all presentations may be marketed.
Marketing Authorization Holder
BAILLEUL-BIORGA LABORATORIES
8, RUE LAUGIER
75017 PARIS
Operator of the marketing authorization
BAILLEUL-BIORGA LABORATORIES
8, RUE LAUGIER
75017 PARIS
Maker
ALFA WASSERMANN SPA
VIA ENRICO FERMI N ° 1
65020 ALANNO (PE)
ITALY
Or
DOPPEL FARMACEUTICI SRL
VIA MARTIRI DELLE FOIBE, 1
29016 CORTEMAGGIORE (PC)
ITALY
Names of the drug in the member states of the European Economic Area
[To be completed later by the holder]
The last date this leaflet was revised is:
Month YYYY
Other
Detailed information on this medicine is available on the ANSM website (France).
