DUOFILM ŠĶĪD.KĀRPU ĀRSTĒŠANAI 15ML

ATC code: D11AF 

Active substances: Acidum Salicylicum, Acidum Lacticum

Vendor, principal: Stiefel Laboratories. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

DUOFILM 167MG/+150MG/1ML 15ML

Package leaflet: Information for the user

Duofilm, 167 mg/150 mg/g cutaneous solution

Salicylic acid, lactic acid

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 12 weeks.

What is in this leaflet:

1.   What Duofilm is and what it is used for
2.   What you need to know before you use Duofilm
3.   How to use Duofilm
4.   Possible side effects
5.   How to store Duofilm
6.   Contents of the pack and other information

1.   What Duofilm is and what it is used for

Duofilm 167 mg/150 mg/g cutaneous solution contains two active substances - salicylic acid and lactic acid. The solution softens the skin on skin warts and causes the skin warts to peel off.
Duofilm is indicated for topical treatment of skin warts.
-   A skin wart is a virus-induced infectious disease of upper skin layers.
-   Skin warts may spread if the virus gets in contact with damaged skin.
-   Spreading of the disease is more probable in warm and moist places. Hence the most common place to get the infection is public pools.
-   Skin wart may develop in several weeks to several months.

2.   What you need to know before you use Duofilm Do not use Duofilm solution:

-   if you are allergic to salicylic acid or lactic acid, or any of the other ingredients of this medicine (listed in section 6);
-   if the skin wart or the skin around it is red, irritated, damaged or inflamed;
-   on birthmarks or warts covered with hair, warts with red edges or strange colour;
-   warts on the face, anal region, genitalia or mucous membranes, e.g. eyes or mouth.
Do not use Duofilm if aforementioned applies to you. Check with your doctor or pharmacist before taking Duofilm if you are not sure.

Warnings and precautions

Ask your doctor or pharmacist for advice before taking Duofilm.
Apply Duofilm only on skin warts, avoid getting the solution on healthy skin around the wart, because this medication may irritate the skin. If you suffer from severe skin irritation, discontinue the treatment and consult your doctor or pharmacist.
It is not advisable to use Duofilm on a skin area larger than 5 cm² (about the size of a postage stamp).
Avoid getting the Duofilm solution in the eyes, nose, mouth, genitalia and anal region as it may cause irritation. If you accidentally get the solution on open wounds, in the eye, nose, mouth or vagina, you must wash the region with clean water in 15 minutes.
Do not inhale the vapours of Duofilm, it may cause dizziness.
Do not use Duofilm on children and adolescents suffering from chickenpox, flu, or other viral diseases, or who have just recovered from the aforementioned diseases.
You must take special caution when using Duofilm:
-   if you have diabetes,
-   if your doctor has told you that you have peripheral circulation disorder or disturbed sensitivity in hands or legs.
In these cases the treatment should take place under medical supervision.

Other medicines and Duofilm

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Doufilm skin solution should not be used concomitantly with other topically administered medications.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
No data are available about the safety of Duofilm in pregnant women. Is not advisable to use the Duofilm solution during pregnancy.
The ingredients of Duofilm may be excreted into breast milk. Treatment with Duofilm is not recommended during lactation period.
Be careful while breast-feeding to prevent getting the solution on your breasts and from there into your baby's mouth.

Driving and using machines

Duofilm solution does not affect the ability to drive and operate machinery.

3. How to use Duofilm

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Usage instructions for Duofilm solution

The medicine is meant only for external use.
Use in adults and children over two years of age
-   Apply Duofilm solution once daily, using the brush provided in the package. It may take 6 to 12 weeks before the entire wart will detach.
-   Use Duofilm solution until the complete disappearance of the wart. When the wart has disappeared you can see your skin lines again.
How to use Duofilm
1. If the skin wart is covered with a patch, remove the patch.
2.   Soak your wart in warm water for 5 minutes.
3.   Dry the region with your personal towel.
4.   Rub the top of the wart carefully with a pumice stone or any other appropriate tool.
5.   After that apply sufficient amount of Duofilm on the wart. Avoid getting the solution on the healthy skin around the wart.
6.   Let the Duofilm solution dry.
7.   Use patch to cover the wart if it is big or if it is on your foot.
Do not use the solution for longer than 12 weeks. If the warts have not disappeared after 12 weeks of treatment, consult your doctor or pharmacist.
Duofilm solution is very flammable. Do not smoke or stand next to a heater, fire or open flame when you apply the solution to the wart or have just done so.

How to restrain the spreading of the warts

Do not forget that the warts may spread.
-   Use only your personal towel.
-   If you got warts on your feet, do not walk barefoot.

Children

It is not advisable to use Duofilm in children under 2 years of age. In children under 12 years of age the medication should only be used under careful adult medical observation.

If you use more Duofilm than you should

If you accidentally swallow Duofilm, overuse it, use it for too long or on a too large skin area, your organism may absorb too much salicylic acid. This may cause salicylic acid poisoning (salicylism). Some of the common symptoms of salicylism are thirst, ringing in the ears (tinnitus) or deafness, malaise, fatigue, increased respiratory rate, dizziness, warm hands and feet or unusual moods and thoughts.
If you develop these or any other symptoms, discontinue using Duofilm and contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Around the skin region treated with Duofilm, you may develop:
•   allergic reactions
•   inflammation
•   pain
•   skin irritation
•   burning sensation on the skin
•   redness
•   itching (pruritus)
•   skin discoloration
•   rash
•   swelling (oedema)
•   flaking
•   dry skin
If you get Duofilm on healthy skin, you may develop:
•   blisters
•   flaking of the skin, incrustation

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Duofilm

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 carton after {date DD.MM.YYYY}. The expiry date refers to the last day of that month.
Store below 25°C.
The medication is inflammable, keep it away from open flame.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Duofilm contains

-   Active substances are salicylic acid and lactic acid. 1 g of cutaneous solution contains 167 mg of salicylic acid and 150 mg of lactic acid.
-   The excipients are: elastic collodion (contains campol, virgin castor oil, collodion, pyroxylin, ether, ethanol).

What Duofilm looks like and contents of the pack

The solution of salicylic acid and lactic acid is a clear viscous liquid, yellowish to amber-coloured. Package: 15 ml of solution in amber-coloured screw cap glass bottle, equipped with a brush.

Marketing Authorisation Holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited 980 Great West Road, Brentford Middlesex, TW8 9GS United Kingdom

Manufacturer

Stiefel Laboratories (Ireland) Ltd.
Finisklin Business Park, Sligo Ireland
Famar Nederland B.V.
Industrieweg 1 5531 AD BLADEL Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Eesti OÜ Löötsa 8a 11415 Tallinn Estonia
Phone: 6676 900
This leaflet was last revised in August 2016.