DUOFILM

Adults, the elderly and children aged 2 years and over. Apply daily to the affected areas only.

Children:

Children under the age of 12 years should be treated under supervision. Treatment of infants under the age of 2 years is not recommended. Duofilm should be applied to the wart once daily preferably at bedtime. Procedure for application: 1.

The wart should be soaked in warm water for 5 minutes and dried thoroughly with a clean towel. 2. The surface of the wart should be rubbed with a nail file, pumice stone, emery board or coarse washcloth, with care taken not to cause bleeding.

3. A thin layer of Duofilm should be applied directly to the wart. Care should be taken to avoid the healthy surrounding skin. 4. The solution should be allowed to dry thoroughly. The wart should be covered with a plaster (dressing) if it is large or if it is on the foot to help penetration of ingredients.

It is recommended that treatment continues until whichever of the following occurs first: • Warts have been treated for 12 weeks • The wart is completely cleared and the normal ridgelines of the skin have been restored. For warts, clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected after 4-8 weeks.

If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their pharmacist or doctor. Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) (see Warnings and Precautions).

Patients should be advised to consult a pharmacist or doctor if skin irritation develops. Due to the flammable nature of Duofilm, patients should avoid smoking or being near an open flame during application and immediately after use.

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.

Clinical Trial Data Immune system disorders Common:

Rash Skin and subcutaneous tissue disorders Very common: Application site reaction, pruritus, burning sensation, erythema, scaling, dryness Common: Skin hypertrophy Post Marketing Data Immune system disorders Rare: Application site hypersensitivity including inflammation Skin and subcutaneous tissue disorders Rare: Application site pain and irritation Application site discoloration/skin discoloration Exposure to healthy skin can lead to application site blistering and skin exfoliation (see Warnings and Precautions).

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

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Duofilm contains colophony which may cause allergic contact dermatitis. This medicine contains 10%v/v ethanol in each application. It may cause burning sensation on damaged skin. Duofilm may cause eye irritation. Avoid contact with eyes and other mucous membranes.

In case of accidental contact with the eyes or other mucous membranes, flush with water for 15 minutes. Avoid exposure to healthy skin (see Adverse Reactions). Duofilm may cause skin irritation. If undue skin irritation develops treatment should be discontinued.

Consider alternative treatments if warts cover a large area of the body (more than 5 cm2) due to the potential risk of salicylate toxicity. Duofilm is not recommended in patients with diabetes, circulatory problems or peripheral neuropathy except under the supervision of a doctor.

Oral salicylates taken during or immediately after a viral illness have been associated with Reye’s syndrome and hence there is a theoretical risk with topical salicylates. Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza, or other viral infections.

It has been reported that salicylates are excreted via breast milk (see Pregnancy and Lactation). Patients should be advised not to inhale the vapour. Keep out of the sight and reach of children.

1. Do not use on open wounds, irritated or reddened skin, or any area that is infected. Duofilm should not be used on the face, anogenital regions, moles, birthmarks, mucous membranes, warts with hair growing from them, red edges or an unusual colour.

Avoid applying to normal skin.