DUOFILM COLLODIO 15ML16,7%+15%

DUOFILM 16.7% + 15% COLLODIUM

active ingredients

100 g collodion contain: Active ingredients: salicylic acid 16,7 g; lactic acid 15 g. Excipients with known effects: ethiopian alcohol. For the full list of excipients, see paragraph 6.1

Excellent

The only excipient of DUOFILM is the elastic collodium BP, consisting of: cholophony, castor oil and collodium, in turn constituted by pyroxyline, ethyl alcohol and ether.

Therapeutic indications

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

Contraindications

The medicinal product is contraindicated in patients with previous hypersensitivity reaction to active ingredients or any of the excipients listed in the paragraph 6.1. Do not use on open wounds, irritated or reddened skin or any infected area. DUOFILM, should not be applied on the face, on the ano-genital area and on large areas. The product should not be applied on snows, cravings, seborrheic warts, condilomas, facial warts or mucosa, or warts with hairs, surrounded by red or unusual edges.

Population

Only for topical use Adults, including elderly DUOFILM must be applied by means of the appropriate brush only on the affected part, avoiding the liquid to be in contact with healthy skin. DUOFILM must be applied on the wart, on the callo or on the dull once a day, preferably in the evening before going to bed, following the following instructions: 1. Dip in hot water for about 5 minutes the part to be treated and dry thoroughly with a clean towel. 2. Pass on the affected surface a nail file, a abrasive stone, a cardboard file or a rough towel, taking care not to cause bleeding. 3. Apply with the special brush DUOFILM on the wart, on the callo or on the dull, taking care not to debort on the healthy skin surrounding. 4. Allow the solution to dry completely: in the case of forms located at the feet or if the wart, callo or dull involve extended areas, the part must be covered with a plaster to promote the absorption of active ingredients. It is recommended to continue the treatment until one of the following conditions occurs: - calluses and dulls have been treated for 2 weeks - warts have been treated for 12 weeks - or until wart, callo or dull are completely removed and normal skin ripples 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. Recommend the patient to consult the doctor or pharmacist if the wart persists over 12 weeks of treatment. An alternative treatment should be considered if warts cover an extended area of the body (more than 5 cm2) (see Special warnings and precautions of use). Recommend the patient to consult the doctor or pharmacist if skin irritation develops. Due to the flammable nature of the medicine, patients must avoid smoking or approaching flames on during the application and immediately after use. Pediatric population Do not administer under two years of age. In children between 2 and 12 years of age the product must be administered only in case of actual need and under direct medical control. Use in children must be supervised by an adult. Elders No dose adjustment is required since a significant systemic exposure is not expected. Hepatic insufficiency No dose adjustment is required since a significant systemic exposure is not expected. Renal insufficiency No dose adjustment is required since a significant systemic exposure is not expected. Do not exceed the recommended doses.

Conservation

For high flammability it is recommended to keep the product at temperatures not exceeding 25°C, sheltered from flames and heat sources. Close the bottle well after use. A significant increase in product density indicates that the bottle has not been properly closed and that the solvent contained in it has partially evaporated.

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 an appropriate therapy.Apply DUOFILM only on warts without deborting on the healthy skin surrounding. The medicine can cause irritation to the eyes. Avoid contact with eyes and other mucosa. If accidentally the product comes in contact with mucosa or with eyes, rinse immediately and abundantly with water, remove the collodion film that is formed and continue to rinse with water for at least a quarter of an hour. Avoid application on healthy skin (see Undesirable Effects). The medicine can cause skin irritation. If an unexpected irritation of the skin develops, the treatment must be stopped. An alternative treatment is considered if warts cover an extended area of the body (more than 5 cm2) due to the potential toxicity of salicylates. The medicine is not recommended in diabetic patients or with circulatory problems or peripheral neuropathy, if not under the supervision of a doctor. Intake of oral salicylates during or immediately after a viral disease was associated with Reye syndrome and consequently there is a theoretical risk even with salicylates for topical use. Therefore, the product should not be used in children or adolescents during or immediately after chickenpox, influence or other viral infections. It has been reported that salicylates are excreted in breast milk (see Fertility, pregnancy and nursing). Patients must be warned not to inhale vapours. Accidental ingestion of keratolytics containing salicylic acid and high concentration lactic acid may have serious, sometimes fatal consequences. The product should not be used to prevent wart formation. Don't swallow. Keep out of sight and reach of children. This medicine contains 2228 mg of alcohol (ethanol) in each volume unit which is equivalent to 158 mg/g. It can cause burning sensation on damaged skin.

Interactions

The topical solution of salicylic acid and lactic acid can increase the absorption of other medicines for topical use. Therefore the concomitant use of the solution of salicylic acid and lactic acid and other medicines for topical use on the treated area must be avoided. Since systemic absorption of topical solutions of salicylic acid and lactic acid is low, interaction with medicines administered by systemic means is not expected.

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 (from > 1/100 to 1/1.000 to 1/10.000 to Immune system disorders Town Skin rash Pathologies of skin and subcutaneous tissue Very common Reaction to the application site, itching, burning sensation, erythema, desquamation, dryness City: Hypertrophy skin Post marketing data

Immune system disorders
Rare	Reaction of hypersensitivity to the application site including inflammation
Pathologies of skin and subcutaneous tissue
Rare	Pain to the site of application and irritation, alteration of skin color to the site of application/alteration of skin color. Healthy skin exposure can lead to skin exfoliation and bladder formation (see Special warnings and precautions of use). Allergic dermatitis

Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Signs and symptoms In case of accidental oral ingestion, symptoms of toxicity of salicylates may occur. The risk of developing symptoms of poisoning from salicylates 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 duration and frequency of the recommended treatment. Treatment Overdose should be treated as clinically indicated or as recommended by the Antivelene Center, where available. There is no specific treatment for accidental oral ingestion of lactic acid solutions and salicylic acid. In case of accidental ingestion, the patient must be treated in accordance with the local guidelines under appropriate observation.

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.

Food

Salicylates 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.

Source: Farmadati