NOTICE
ANSM - Updated on: 03/15/2019
Name of the drug
VERRUFILM, solution for local application in a vial
Lactic acid / salicylic acid
Framed
Read all of this leaflet carefully before using this medicine because it contains important information for you.
You should always use this medicine by carefully following the information given in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are 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 booklet contain ?
1. What is VERRUFILM, solution for local application in a vial and in which cases is it used?
2. What information should I know before using VERRUFILM, solution for local application in a vial?
3. How to use VERRUFILM, solution for local application in a vial?
4. What are the possible side effects?
5. How to store VERRUFILM, solution for local application in a vial?
6. Contents of the pack and other information.
1. WHAT IS VERRUFILM, solution for local application in a vial AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: VERRUCIDES and CORICIDES - ATC code: D11AF.
Treatment of plantar warts, common warts of the hand and mosaic warts.
2. WHAT YOU NEED TO KNOW BEFORE USING VERRUFILM, solution for local application in a vial?
Never use VERRUFILM, solution for local application in a vial:
· if you are allergic to the active substance or to any of the other ingredients of this medicine mentioned in section 6.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Special warnings
Do not apply over a large area.
Precautions for use
When applying the product, avoid spilling onto healthy skin.
Talk to your doctor or pharmacist before using VERRUFILM, solution for local application in a vial .
Children and adolescents
Not applicable.
Other medicines and VERRUFILM, solution for local application in a vial
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
VERRUFILM, solution for local application in a vial with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
This drug should be used with caution during pregnancy and lactation.
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.
Driving and using machines
Not applicable.
VERRUFILM, solution for local application in a vial contains castor oil and may cause skin reactions (for example: eczema).
3. HOW TO USE VERRUFILM, solution for local application in a vial?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Dosage
Thoroughly clean and dry the area to be treated.
Using the spatula, apply the liquid to the wart without overflowing on healthy skin. It is possible to protect healthy skin beforehand by applying a neutral varnish.
The application is to be renewed every day, preferably in the evening, for about 8 weeks.
Every 2 to 3 days, gently rub the treated area before application with a cardboard file or pumice stone, avoiding bleeding and so as to remove the rough surface part of the wart.
If bleeding occurs, stop treatment for 2 to 3 days.
Administration mode
LOCAL TRACK
Frequency of administration
Once a day, preferably at bedtime.
Duration of treatment
About 8 weeks
If you have used more VERRUFILM, solution for local application in a vial than you should
Not applicable.
If you forget to use VERRUFILM, solution for local application in a vial
Not applicable.
If you stop using VERRUFILM, solution for local application in a vial
Not applicable.
If you have any further questions on 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, including skin irritation with a burning sensation.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Products Safety (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 VERRUFILM, solution for local application in a vial?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiration date refers to the last day of that month.
Flammable product, close the bottle well after use.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What VERRUFILM contains, solution for local application in a vial
· The active substances are:
Lactic acid................................................ .................................................. ................ 16.7 g
Salicylic acid................................................ .................................................. ............ 16.7 g
Per 100 g.
· The other ingredients are: castor oil, collodion.
What is VERRUFILM, solution for local application in a vial and contents of the outer packaging
This medication is in the form of a solution for local application. 14 ml bottle.
Marketing authorization holder
BAILLEUL SA LABORATORIES
10-12, AVENUE PASTEUR
L-2310 LUXEMBOURG
LUXEMBOURG
Marketing authorization operator
BAILLEUL LABORATORIES
264 RUE DU FAUBOURG SAINT-HONORE
75008 PARIS
Maker
CHEMINEAU LABORATORIES
93 COIN ROUTE
37210 VOUVRAY
Names of the drug in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is
[to be completed later by the holder]
Other
Detailed information on this medication is available on the ANSM website (France).