Duofilm 16.7% + 15% collodion 15ml

Duofilm 16.7% + 15% collodion 15ml is a dermatological solution specifically formulated for the topical treatment of warts, corns and calluses . This product combines the effectiveness of 16.7% salicylic acid and 15% lactic acid , two active ingredients known for their keratolytic properties, which help remove dead skin cells and reduce the thickness of skin lesions. The elastic collodion formulation ensures targeted application and effective penetration, facilitating the healing process. Duofilm is ideal for those looking for a reliable and targeted treatment for common skin imperfections, ensuring visible results thanks to its combined action.

ACTIVE INGREDIENTS

Active ingredients contained in Duofilm 16.7% + 15% collodion 15ml - What is the active ingredient in Duofilm 16.7% + 15% collodion 15ml?

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

EXCIPIENTS

Composition of Duofilm 16.7% + 15% collodion 15ml - What does Duofilm 16.7% + 15% collodion 15ml contain?

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

DIRECTIONS

Therapeutic indications Duofilm 16.7% + 15% collodion 15ml - Why is Duofilm 16.7% + 15% collodion 15ml used? What is it used for?

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

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Duofilm 16.7% + 15% collodion 15ml - When should Duofilm 16.7% + 15% collodion 15ml not be used?

The medicinal product is contraindicated in patients with previous hypersensitivity reaction to the active substances or to any of the excipients listed in paragraph 6.1. Do not use on open wounds, irritated or red skin or any infected area. DUOFILM should not be applied to the face, anogenital area and large areas. The product should not be applied to moles, birthmarks, seborrheic warts, condylomas, warts on the face or mucous membranes, or warts with hair, surrounded by red edges or of an unusual color.

DOSAGE

Quantity and method of taking Duofilm 16.7% + 15% collodion 15ml - How to take Duofilm 16.7% + 15% collodion 15ml?

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

Storage Duofilm 16.7% + 15% collodion 15ml - How to store Duofilm 16.7% + 15% collodion 15ml?

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.

WARNINGS

Warnings Duofilm 16.7% + 15% collodion 15ml - About Duofilm 16.7% + 15% collodion 15ml it is important to know that:

The use, especially if prolonged, of products for topical use may give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute an appropriate therapy. Apply DUOFILM only on the warts without spilling onto the surrounding healthy skin. The medicine may cause eye irritation. Avoid contact with the eyes and other mucous membranes. If the product accidentally comes into contact with mucous membranes or eyes, rinse immediately and thoroughly with water, remove the collodion film that forms and continue rinsing with water for at least a quarter of an hour. Avoid application on healthy skin (see Undesirable effects). The medicine may cause skin irritation. If unexpected skin irritation develops, treatment must be stopped. An alternative treatment should be considered if the 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. The use of oral salicylates during or immediately after a viral illness has been associated with Reye's syndrome and consequently there is a theoretical risk also with topical salicylates. Therefore, the product should not be used in children or adolescents during or immediately after chickenpox, influenza 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 vapours. Accidental ingestion of keratolytics containing salicylic acid and lactic acid at high concentrations 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 unit of volume which is equivalent to 158 mg/g. May cause a burning sensation on damaged skin.

INTERACTIONS

Interactions Duofilm 16.7% + 15% collodion 15ml - Which medicines or foods can modify the effect of Duofilm 16.7% + 15% collodion 15ml?

Salicylic acid and lactic acid solution for topical use may increase the absorption of other topical medicinal products. Therefore, concomitant use of salicylic acid and lactic acid solution and other topical medicinal products on the treated area should be avoided. Since the systemic absorption of salicylic acid and lactic acid solution for topical use is low, interactions with systemically administered medicinal products are not expected.

SIDE EFFECTS

Like all medicines, Duofilm 16.7% + 15% collodion 15ml can cause side effects - What are the side effects of Duofilm 16.7% + 15% collodion 15ml?

The following convention is used to classify the frequency of an adverse reaction and is based on CIOMS guidelines: • very common (> 1/10), • common (> 1/100 to < 1/10), • uncommon (> 1/1,000 to < 1/100), • rare (> 1/10,000 to < 1/1,000) and • very rare (< 1/10,000), • not known (frequency cannot be estimated from the available data). Data from clinical studies:

Post marketing data

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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.

OVERDOSE

Overdose Duofilm 16.7% + 15% collodion 15ml - What are the risks of Duofilm 16.7% + 15% collodion 15ml in case of overdose?

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

PREGNANCY AND BREASTFEEDING

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 Duofilm 16.7% + 15% collodion 15ml.

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.

DRIVING AND USE OF MACHINERY

Taking Duofilm 16.7% + 15% collodion 15ml before driving or using machines - Does Duofilm 16.7% + 15% collodion 15ml affect driving or using machines?

No effects are expected based on the safety profile of the product.