NOTICE
ANSM - Last updated: 27/04/2017
Name of the medicinal product
DUOFILM, solution for local application
Salicylic Acid / Lactic Acid
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS DUOFILM, a solution for local application AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE DUOFILM, a solution for local application?
3. HOW TO USE DUOFILM, solution for local application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DUOFILM, solution for local application?
6. ADDITIONAL INFORMATION
1. WHAT IS DUOFILM, a solution for local application AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
KERATOLYTIC (D: Dermatology)
Therapeutic indications
Treatment of plantar warts, vulgar warts of the hand and "mosaic" warts.
2. BEFORE YOU USE DUOFILM, a solution for local application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use DUOFILM, solution for local application in the following cases:
Intolerance or allergy to salicylic acid
Precautions for use; special warnings
Take special care with DUOFILM, solution for local application:
Precaution of use
Do not use for warts of the face and genitals.
Interaction with other medicines
Taking or using other medicines
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE DUOFILM, solution for local application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
External use.
· Soap and rinse the area to be treated thoroughly. To dry.
· Using the brush, apply the liquid to the wart without spilling over the healthy skin.
· The application is to be renewed every day, preferably in the evening, for about 6 to 12 weeks. Early interruption of treatment may lead to relapse. If applied in the morning, protect with a small adhesive dressing.
· Every 2 or 3 days, gently rub the surface of the warts before application with a cardboard file or a pumice stone avoiding bleeding and to remove the rough surface of the wart. If bleeding occurs, stop treatment for 3 days.
Administration mode
DERMAL
Frequency of Administration
1 time a day, preferably in the evening at bedtime.
Symptoms and Instructions for Overdose
If you have taken more DUOFILM, solution for local application than you should:
Risk of burns in case of overdose.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, DUOFILM, solution for local application is likely to have undesirable effects, although not everyone is subject to it.
Use of this product may cause irritation, sometimes accompanied by burning and crusting. In this case, promptly stop the applications and consult your doctor.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE DUOFILM, solution for local application?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use DUOFILM, solution for local application after the expiry date stated on the outer packaging.
Storage conditions
Flammable product: Close the bottle after use.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does DUOFILM contain for local application?
The active substances are:
Salicylic acid ................................................ .................................................. .............................. 16.7 g
Lactic acid ................................................ .................................................. .................................. 16.7 g
For 100 g of solution for local application.
The other components are:
Soft Collodion: Fulmicoton, 90% v / v alcohol, ether.
Pharmaceutical form and content
What is DUOFILM, solution for local application and contents of the outer packaging?
This medication is in the form of a solution for local application.
Bottle of 15 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 road to Versailles
CS - 80001
78164 MARLY LE ROI Cedex
exploiting
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100 ROUTE OF VERSAILLES
CS 80001
78164 MARLY LE ROI CEDEX
Maker
STIEFEL LABORATORIES (IRELAND) LTD
Finisklin Business Park
SLIGO
IRELAND
or
FAMAR NEDERLAND BV
INDUSTRIEWEG 1
5531 AD BLADEL
NETHERLANDS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
USAGE TIPS
EVERYDAY : Soap and rinse thoroughly the place to be treated. To dry. In the case of a rebellious wart, advised to soak the wart in warm water to facilitate the treatment. Using the brush, apply each day the DUOFILM solution on the wart, ensuring that it is covered of product. The brush allows a application of DUOFILM on The wart avoids overflowing healthy skin. If you are afraid to overflow, it is possible to apply nail polish colorless around the wart. Allow to dry until appearance of a white film. If the wart is located on a part of the body exposed to friction, it is preferable to protect with a small adhesive plaster. EVERY 2 OR 3 DAYS: Prior to the application of DUOFILM, gently rub the surface of the wart with a file in cardboard or stone pumice to remove the surface portion rough from the wart. Avoid bleeding. In case of bleeding, stop treatment for 3 days. RECOMMENDATIONS: - Close the bottle after use to avoid evaporation of the DUOFILM solution. - Treatment should be done every day and continued as directed by your doctor or pharmacist. Early interruption of treatment may lead to relapse. - Warts can be contagious: make sure no one uses your towel. - Do not use for warts of the face or genitals. |