DUOFILM

DUOFILM Solution

Important notes (mandatory information)

Duofilm 16.7%/15.0% solution. Areas of application: Agent for the treatment of common warts. Warning: Contains 153.18 mg of alcohol (ethanol) per 1 g of solution. Highly flammable liquid!

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Duofilm 16.7%/15.0% solution, for the treatment of common warts in children aged 2 years and older, adolescents and adults
Active ingredients: Salicylic acid, lactic acid

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Duofilm must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 30 days, you must consult a doctor.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

This package leaflet includes

1. WHAT IS DUOFILM AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE USING DUOFILM
3. HOW TO USE DUOFILM
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DUOFILM
6. FURTHER INFORMATION

1. WHAT IS DUOFILM AND WHAT IS IT USED FOR?

DUOFILM contains the active ingredients salicylic acid and lactic acid. DUOFILM is an agent for the treatment of common warts. DUOFILM is used in adults and children aged 2 years and older.

2. WHAT YOU NEED TO KNOW BEFORE USING DUOFILM

DUOFILM must NOT be used:

• if you are allergic to salicylic acid, lactic acid or any of the other ingredients of this medicine listed in section 6
• in infants
• if the wart or surrounding skin is red, irritated, injured or inflamed
• on birthmarks, port-wine stains or hairy warts, warts with reddened edges or of unusual colour
• on warts on your face, in the genital area or on mucous membranes such as the eyes, nose or mouth

Warnings and precautions

Please talk to your doctor or pharmacist before using DUOFILM.

Avoid bringing DUOFILM into contact with the eyes, nose, mouth or vagina (mucous membranes), as this can cause irritation. If you accidentally get DUOFILM in open wounds or in the eyes, nose, mouth or vagina, rinse the affected area immediately with water for 15 minutes.

Please make sure not to bring DUOFILM into contact with the healthy skin around the wart, as this can cause irritation. If severe skin irritation occurs, stop treatment and consult a doctor or pharmacist.

DUOFILM is not recommended for use in diabetics or patients with circulatory disorders or reduced sensation (nerve damage) in the hands or feet. It should only be used under the supervision of a doctor.

Do not inhale the vapours of DUOFILM, as this can cause drowsiness.

Children and adolescents

The use of DUOFILM is not recommended for children or adolescents who show signs of fever (elevated temperature), who are suffering from a viral illness (e.g. flu or chickenpox) or have recently suffered from such an illness. DUOFILM should not be used in children under 2 years of age. Keep DUOFILM out of the sight and reach of children.

Using DUOFILM with other medicines

Tell your doctor or pharmacist if you are using, have recently used or intend to use any other medicines. Do not use any other agents to treat your wart while you are using DUOFILM.

Salicylic acid-lactic acid solutions applied to the skin (such as DUOFILM) can increase the absorption of other medicines applied to the same area. Therefore, the combined use of DUOFILM and other medicines applied to the same area should be avoided.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There are no data on the safety of DUOFILM in pregnant women. DUOFILM is not recommended for use during pregnancy.

The active ingredients of DUOFILM can pass into breast milk. The use of DUOFILM is not recommended during breast-feeding. If you are breast-feeding and using DUOFILM, make sure that it is not applied to the breast area to ensure that your child does not accidentally get DUOFILM in their mouth.

Driving and using machines

No special precautions are required.

DUOFILM contains ethanol (alcohol)

This medicine contains 153.18 mg of alcohol (ethanol) per 1 g of solution. It can cause a burning sensation on damaged skin.

3. HOW TO USE DUOFILM

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 2 years and older

For external use on the skin only! Apply DUOFILM only directly to the wart. Avoid contact with the healthy skin around the wart. DUOFILM should be applied to the wart(s) once a day, preferably before going to bed. Application in children must be supervised by an adult.

Children under 2 years of age

DUOFILM should not be used in children under 2 years of age.

Method of application

1. The wart should be soaked in warm water for 5 minutes and then dried thoroughly with a clean towel.
2. The surface of the wart should be carefully abraded - to avoid bleeding - with a nail file, pumice stone, callus file or rough washcloth.
3. A thin layer of DUOFILM is applied directly to the wart. DUOFILM should not get on the healthy skin around the wart.
4. The solution must dry thoroughly. The wart should be covered with a plaster if it is very large or if it is on the foot, to improve the penetration of the active ingredients.

Continue treatment until one of the following two points applies, whichever comes first:

• The wart has been treated for a period of 12 weeks.
• The wart has completely regressed and the skin looks normal again.

An improvement is noticeable within 1 - 2 weeks, the maximum effect is usually seen within 4 - 8 weeks. Do not use DUOFILM for longer than 12 weeks.

If the wart has not disappeared after a treatment period of 12 weeks, consult your doctor or pharmacist. You should also consult your doctor or pharmacist if skin irritation occurs.

The use of DUOFILM is not recommended for warts that cover an area of more than 5 cm2 (about the size of a postage stamp).

DUOFILM is flammable and can catch fire. Keep away from heat, fire or flames and do not smoke while applying DUOFILM or shortly after applying DUOFILM.

Warts are contagious!

To prevent the spread of infection, never share your towel with others. Do not walk barefoot if you have foot warts!

Please talk to your doctor or pharmacist if you have the impression that the effect of DUOFILM is too strong or too weak.

If you have used more DUOFILM than you should

If you accidentally swallow DUOFILM, use it too often, over a long period of time or over a large area, your body may absorb too much salicylic acid. This could lead to salicylate poisoning (salicylism). Some of the common symptoms that can occur in connection with salicylism include thirst, ringing in the ears or deafness, nausea or vomiting, fatigue, increased respiratory rate, dizziness, warm hands and feet or unusual moods/thoughts.

Stop using DUOFILM and see your doctor if this occurs or if you experience these or other symptoms.

If you forget to use DUOFILM

Do not use double the amount to make up for the missed application.

If you stop using DUOFILM

In this case, no special measures are necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may notice the following at and near the skin area treated with DUOFILM

Very common side effects (may affect more than 1 in 10 people)

Reactions at the treated site, itching, burning sensation, redness, swelling, skin peeling, dryness.

Common side effects (may affect up to 1 in 10 people)

Skin rash, thickening of the skin.

Uncommon side effects (may affect up to 1 in 1,000 people)

allergic reactions including inflammation, pain, skin irritation, skin discolouration

If you accidentally apply DUOFILM to healthy skin areas, the following may also occur:
Blistering, skin peeling

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE DUOFILM

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and carton after "use by" or "exp.". The expiry date refers to the last day of the month indicated. Do not store above 25ºC.

Highly flammable liquid. Keep away from naked flames. The bottle should always be tightly closed after use.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see: www.bfarm.de/arzneimittelentsorgung.

6. FURTHER INFORMATION.

What DUOFILM contains

The active ingredients are: Salicylic acid and lactic acid. 10 g of solution contain 1.67 g of salicylic acid and 1.5 g of lactic acid.

The other ingredients are

Colophony, refined castor oil, collodion (consisting of pyroxylin, ethanol, ether, water).

What DUOFILM looks like and contents of the pack:
DUOFILM is a clear, viscous yellowish to amber liquid and is available in 15 ml bottles.

Pharmaceutical entrepreneur

STADA Consumer Health Deutschland GmbH Stadastraße 2-18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Delpharm Bladel B.V.
Industrieweg 1
5531 AD Bladel
Netherlands

This package leaflet was last revised in September 2021.

Source: Information from the package leaflet
Status: 01/2025
Areas of application: Agent for the treatment of common warts. Warning: Contains 153.18 mg of alcohol (ethanol) per 1 g of solution. Highly flammable liquid!