DUOFILM 16.7% + 15% COLLODIUM

Name
DUOFILM 16.7% + 15% COLLODIUM

Active ingredients
100 g of collodion contain: Active ingredients: salicylic acid 16.7 g; lactic acid 15 g. Excipients with known effect : ethyl alcohol. For the full list of excipients, see section 6.1

Therapeutic indications
DUOFILM is indicated for the topical treatment of warts, calluses and corns.

Dosage
For topical use only Adults, including the elderly DUOFILM must be applied using the special brush only on the affected area, avoiding contact of the liquid with healthy skin. DUOFILM must be applied to the wart, callus or corn once a day, preferably in the evening before going to bed, following the following instructions for use: 1. Immerse the area to be treated in hot water for approximately 5 minutes and dry thoroughly with a clean towel. 2. Pass a nail file, an abrasive stone, a cardboard file or a rough towel over the affected area, taking care not to cause bleeding. 3. Apply DUOFILM to the wart, callus or corn using the special brush, taking care not to spill over onto the surrounding healthy skin. 4. Allow the solution to dry completely: in the case of localised forms on the feet or if the wart, corn or callus involves large areas, the area should be covered with a plaster to promote absorption of the active ingredients. It is recommended to continue treatment until one of the following conditions occurs: - corns and calluses have been treated for 2 weeks - warts have been treated for 12 weeks - or until the wart, corn or callus is completely removed and the normal skin creases have been restored. For warts, a clinically visible improvement should be observed in 1-2 weeks but the maximum effect is expected after 4-8 weeks. Advise the patient to consult a doctor or pharmacist if the wart persists beyond 12 weeks of treatment. Consider an alternative treatment if the warts cover a large area of ​​the body (more than 5 cm²) (see Special warnings and precautions for use). Advise the patient to consult a doctor or pharmacist if skin irritation develops. Due to the flammable nature of the medicinal product, patients should avoid smoking or proximity to open flames during application and immediately after use. Paediatric population Do not administer to children under two years of age. In children between 2 and 12 years of age the product should be administered only if clearly needed and under direct medical supervision. Use in children should be under the supervision of an adult. Elderly No dose adjustment is required since significant systemic exposure is not expected. Hepatic impairment No dose adjustment is required since significant systemic exposure is not expected. Renal impairment No dose adjustment is required since significant systemic exposure is not expected. Do not exceed the recommended doses.

Conservation
Due to its high flammability, it is recommended to store the product at temperatures no higher than 25°C, away from flames and heat sources. Close the bottle tightly after use. A significant increase in density of the product indicates that the bottle has not been closed properly and that the solvent contained within has partially evaporated.

Pregnancy and breastfeeding
Pregnancy The safety of use of salicylic acid and lactic acid solution during pregnancy has not been established. Studies in animals administered salicylic acid orally have shown embryotoxicity at high doses (see Preclinical safety data). The medicinal product is not recommended during pregnancy. Breastfeeding Salicylates are excreted in breast milk. The medicinal product is not recommended during breastfeeding. If used or administered during breastfeeding, avoid contact with the breast area to prevent accidental ingestion by the infant.