DUOFILM * COLLODIUM 15ML16.7% + 15%

DUOFILM * COLLODIUM 15ML16.7% + 15%

Therapeutic indications

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

Dosage and method of use

For topical use only Adults, including the elderlyDUOFILM must be applied using the special brush only on the affected part, avoiding that the liquid comes into contact with healthy skin. DUOFILM must be applied on the wart, callus or callus once a day, preferably in the evening before going to bed, following the instructions below: 1. Immerse the area to be treated in hot water for about 5 minutes and dry thoroughly with a clean towel. 2. Wipe the affected surface with a nail file, an abrasive stone, a cardboard file or a rough towel, taking care not to cause bleeding. 3. Apply with the special DUOFILM brush on the wart, callus or callus, taking care not to overflow on the surrounding healthy skin. 4. Allow the solution to dry completely: in the case of localized forms of the feet or if the wart, callus or callus involves large areas, the part must be covered with a plaster to facilitate the 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, callus or callus are completely removed and normal skin wrinkles have been restored. For warts, clinically visible improvement should be seen in 1-2 weeks but the maximum effect is expected after 4-8 weeks. Advise the patient to consult the doctor or pharmacist if the wart persists beyond 12 weeks of treatment. Consider alternative treatment if warts cover a large area of the body (more than 5 cm²) (see Special warnings and precautions for use). Advise the patient to consult the doctor or pharmacist if skin irritation develops. Due to the flammable nature of the medicinal product, patients should avoid smoking or approaching open flames during application and immediately after use.Pediatric populationDo not administer under two years of age. In children between 2 and 12 years of age, the product should be administered only in case of real need and under direct medical supervision. Use in children should be under adult supervision. Elderly No dose adjustment is required as significant systemic exposure is not expected. Hepatic impairment No dose adjustment is required as significant systemic exposure is not expected. Renal impairment No dose adjustment is required as significant systemic exposure is not expected. Do not exceed the recommended dose.

Contraindications

The medicinal product is contraindicated in patients with a previous hypersensitivity reaction to the active substances or to any of the excipients listed in section 6.1. Do not use on open wounds, irritated or red skin or any infected area. DUOFILM, should not be applied to the face, the anogenital area and large areas. The product should not be applied to nevi, birthmarks, seborrheic warts, warts, facial or mucous warts, or warts with hair, surrounded by red or unusual colored borders.

Side effects

The following convection is used to classify the frequency of an adverse reaction and is based on the CIOMS guidelines: • very common (> 1/10), • common (> 1/100 to 1 / 1,000 to 1 / 10,000 to

Post marketing data

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. Apply DUOFILM only on warts without overflowing on the surrounding healthy skin. The medicine may cause eye irritation. Avoid contact with eyes and other mucous membranes. If the product accidentally comes into contact with mucous membranes or eyes, rinse immediately and abundantly with water, remove the collodion film that forms and continue rinsing with water for at least a quarter of an hour. Avoid application to healthy skin (see Undesirable Effects). The medicine can cause skin irritation. If unexpected skin irritation develops, treatment should be discontinued. Alternative treatment should be considered if warts cover a large area of the body (more than 5 cm²) due to the potential toxicity of salicylates. The medicine is not recommended in diabetic patients or patients with circulatory problems or peripheral neuropathy, unless under the supervision of a doctor. Taking oral salicylates during or immediately following viral illness has been associated with Reye's syndrome and consequently there is a theoretical risk even with topical salicylates. Therefore, the product should not be used in children or adolescents during or immediately after chickenpox, flu or other viral infections. Salicylates have been reported to be excreted in breast milk (see Fertility, Pregnancy and Lactation). Patients should be advised not to inhale the vapors. Accidental ingestion of keratolytics containing salicylic acid and high concentration lactic acid can have serious, sometimes fatal consequences. The product should not be used to prevent the formation of warts. Do not swallow. Keep out of the sight and reach of children. This medicinal product contains 2228 mg of alcohol (ethanol) in each volume unit which is equivalent to 158 mg / g. It can cause a burning sensation on damaged skin.

Pregnancy and breastfeeding

PregnancyThe safety of the salicylic acid and lactic acid solution in pregnancy is not established. Studies in animals given oral salicylic acid have shown embryo-toxicity at high doses (see Preclinical safety data). The medicine is not recommended during pregnancy.Feeding timeSalicylates are excreted in breast milk. The medicine is not recommended during breastfeeding. If used or administered during breastfeeding, avoid contact with the breast area to prevent accidental ingestion by the infant.

Expiration and retention

Due to its high flammability, it is advisable to store the product at temperatures not exceeding 25 ° C, away from flames and heat sources. Close the bottle tightly after use. A significant increase in the density of the product indicates that the bottle has not been closed properly and that the solvent contained therein is partially evaporated.

Interactions with other drugs

The topical solution of salicylic acid and lactic acid may increase the absorption of other topical medicines. Therefore concomitant use of salicylic acid and lactic acid solution and other topical medications on the treated area should be avoided. Since the systemic absorption of topical solutions of salicylic acid and lactic acid is low, interaction with systemically administered medicinal products is not expected.

Overdose

Signs and symptomsIn case of accidental oral ingestion symptoms of salicylate toxicity may occur. The risk of developing symptoms of salicylate poisoning or salicylism increases if the topical solution of salicylic acid and lactic acid is used in excess or for prolonged periods of time. It is therefore very important to respect the recommended duration and frequency of treatment.TreatmentOverdose should be treated as clinically indicated or as recommended by the poison center, where available. There is no specific treatment for accidental oral ingestion of lactic acid and salicylic acid solutions. In case of accidental ingestion, the patient should be treated according to local guidelines under appropriate observation.

Active principles

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

Excipients

The only excipient of DUOFILM is the elastic collodion BP, consisting of: rosin, castor oil and collodion, in turn consisting of pyroxylin,ethyl alcoholand ether.