Patient Information Leaflet

DUOFILM 16.7% + 15% collodion

salicylic acid + lactic acid
Please read this leaflet carefully before using this medicine because it contains important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen.

Contents of this leaflet:

What DUOFILM is and what it is used for
What you need to know before using DUOFILM
How to use DUOFILM
Possible side effects
How to store DUOFILM
Contents of the pack and other information

1. What DUOFILM is and what it is used for

DUOFILM contains the active substances salicylic acid and lactic acid.
Salicylic acid, when applied locally, acts on the superficial layer of the skin, causing the shedding of the upper skin layer (desquamation). Lactic acid reduces the process of skin thickening.
DUOFILM is a medicine used for the local treatment of corns, calluses, and warts.
Consult your doctor if you do not feel better or feel worse after 2 weeks of treatment in the case of corns and calluses, or after 3 months in the case of warts.

2. What you need to know before using DUOFILM

Do not use DUOFILM

if you are allergic to salicylic acid, lactic acid, or any of the other ingredients of this medicine (listed in section 6);
if the wart, callus, corn, or surrounding skin is red, irritated, cracked/wounded, or infected;
on moles, birthmarks, or warts with hairs, surrounded by red borders or of unusual color;
on warts located on the face, genitals, or mucous membranes such as those of the eyes, nose, and mouth.

Warnings and precautions

DUOFILM is intended for external use only;
avoid accidental contact with eyes, nose, mouth, or vagina (mucous membranes), as this may cause irritation. In case of contact with mucous membranes or open wounds, rinse immediately and thoroughly with water, remove the medicinal film that forms, and continue rinsing with water for at least 15 minutes;
do not apply the medicine on healthy skin surrounding the wart, callus, or corn, as this may cause irritation. If excessive skin irritation occurs, discontinue treatment and consult your doctor or pharmacist;
do not use DUOFILM on warts covering an area larger than 5 cm (approximately the size of a postage stamp);
if you have diabetes, circulatory problems (poor circulation), or reduced sensitivity (nerve damage) in your hands or feet, consult your doctor or pharmacist before using DUOFILM;
do not use DUOFILM to prevent the formation of warts;
do not inhale DUOFILM vapors, as they may cause dizziness;
the use, especially prolonged use, of topical products such as DUOFILM may lead to sensitization (allergic reactions). If this occurs, stop treatment and consult your doctor.

Children and adolescents
Do not use DUOFILM in children or adolescents who have a fever, a viral infection (such as influenza or chickenpox), or who have recently recovered from these conditions.
DUOFILM may be used in children aged 2 to 12 years only if prescribed by a doctor (see section 3 "How to use DUOFILM").

Other medicines and DUOFILM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use other treatments for warts, calluses, or corns simultaneously with DUOFILM.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There is no information available on the safety of DUOFILM during pregnancy.
The use of DUOFILM is not recommended during pregnancy.

Breastfeeding
The active ingredients of DUOFILM may pass into breast milk.
The use of DUOFILM is not recommended during breastfeeding.
If DUOFILM is used during breastfeeding, do not apply it to the breast area to avoid accidental ingestion of the product by the infant.

Driving and using machines
No effects on the ability to drive or operate machinery are expected.

DUOFILM contains ethanol (alcohol)
This medicine contains 2228 mg of alcohol (ethanol) per unit volume, equivalent to 158 mg/g. It may cause a burning sensation on damaged skin.

3. How to use DUOFILM

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
Warning: Do not exceed the recommended doses.
Adults, including elderly patients
DUOFILM should be applied once daily.
Children up to 12 years
Do not use in children under 2 years of age.
Consult your doctor before using this medicine in children aged between 2 and 12 years:
DUOFILM should only be used if clearly necessary and under direct medical supervision.
Application in children must be supervised by an adult.
How to apply
Apply DUOFILM to the wart, callus or corn using the provided brush. Apply it only to the affected area, taking care to avoid contact with healthy skin.
Do not use DUOFILM on warts covering an area larger than 5 cm (approximately the size of a postage stamp).
Keep away from sources of heat, flames or fire, and do not smoke during or immediately after using DUOFILM, as the medicine is flammable.
Instructions for application

Soak the area to be treated in warm water for about 5 minutes. Dry thoroughly with a clean towel and gently file the surface with a nail file, pumice stone, cardboard file or rough cloth, taking care not to cause bleeding.
Using the provided brush, apply DUOFILM directly to the wart, callus or corn, taking care to avoid applying the medicine to surrounding healthy skin.
Allow the solution to dry completely. In case of foot lesions or if the wart, callus or corn covers a large area, cover the treated area with a plaster to enhance absorption of the active ingredients.

When and for how long
Apply DUOFILM once daily, preferably in the evening.
Calluses and corns: Do not exceed 2 weeks of treatment. If the callus or corn has not disappeared after 2 weeks of treatment, consult your doctor or pharmacist.
Warts: Do not exceed 12 weeks of treatment. If the wart has not disappeared after 12 weeks of treatment, consult your doctor or pharmacist.
Additionally, consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes in its appearance.
If you use more DUOFILM than you should
If DUOFILM is accidentally ingested, used too frequently, for prolonged periods or over very large areas, excessive amounts of salicylic acid may be absorbed by the body. This may lead to salicylate poisoning (salicylism). Common symptoms associated with salicylism may include: feeling thirsty, ringing in the ears or hearing loss, nausea, fatigue, increased breathing rate, dizziness, hot hands and feet, unusual mood or thoughts.
Do not ingest DUOFILM. If you accidentally swallow the medicine or experience any of the symptoms listed above, stop treatment immediately and consult your doctor or go to the nearest hospital.
If you forget to use DUOFILM
Continue treatment as described in section 3 "How to use DUOFILM".
Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following effects may occur on or around the treated area:

allergic reaction
inflammation
pain
skin irritation
burning sensation
redness
itching
change in skin colour
skin rash
swelling
loss of the upper layer of skin (desquamation)
dryness.

If DUOFILM is accidentally applied to healthy skin, peeling of the skin surface and blistering may occur.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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 store above 25°C. DUOFILM is highly flammable: keep away from flames and sources of heat.
Do not use this medicine after the expiry date stated on the bottle and outer carton after "Exp.". The expiry date refers to the last day of that month. The expiry date applies to the product in its original unopened packaging, correctly stored.
Close the bottle tightly after use. A significant increase in product density indicates that the bottle has not been properly closed and that the solvent contained within has partially evaporated.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.

6. Package contents and other information

What DUOFILM contains

The active substances are salicylic acid and lactic acid. 100 g of product contain 16.7 g of salicylic acid and 15 g of lactic acid.
The other components are BP flexible collodion (composed of: rosin, castor oil and collodion, the latter being composed of: pyroxylin, ethyl alcohol and ether).

Description of the appearance of DUOFILM and contents of the pack
DUOFILM is a clear, viscous liquid, contained in a 15 ml amber glass bottle closed with a plastic cap and a brush applicator.
Marketing Authorization Holder
EG S.p.A.
Via Pavia 6
20136 Milan, Italy
Manufacturer*
Stiefel Laboratories (Ireland) Ltd.,
Finisklin Business Park,
Sligo (Ireland)
Or
Delpharm Bladel B.V.,
Industrieweg 1,
Bladel, 5531 AD,
Netherlands