Stiefel Ireland

DUOFILM Cutaneous Solution

Salicylic Acid 16.7% w/w

Lactic Acid 16.7% w/w

For a full list of excipients, see section 6.1.

Cutaneous solution.

Yellow to amber coloured, slightly viscous clear liquid having an ether odour.

DUOFILM is indicated in the treatment of warts.

DUOFILM should be applied to warts once daily.

Children under 12 years should only use the product under supervision.

Treatment of infants under the age of 2 years is not recommended.

The patient should be instructed as follows. Soak the warts in warm water for 5 minutes. Rub surface of warts carefully with pumice stone or emery board. Apply, taking care to avoid normal skin. Allow to dry thoroughly. Continue treatment until the wart is completely cleared. If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their doctor.

Hypersensitivity to the active substances or to any of the excipients.

Do not use on open skin wounds, moles, birthmarks, genital warts, warts on the face, or warts with hair growing from them, red edges, or unusual colour.

This medicinal product is for external use only.

Avoid getting the product in the eyes, nose, or mouth, or on the genital and anal areas. If contact with the eyes occurs, flush with water for 15 minutes. Avoid inhaling vapour.

Ensure this product is stored out of the reach of children to avoid accidental ingestion.

Consider alternative treatments if warts cover a large area of the body (more than 5 cm²).

Patients with diabetes and patients suffering from peripheral blood circulation conditions should only use the product under medical supervision.

Care should be taken to apply the product only to the wart and not to the normal skin surrounding the wart. Do not apply to reddened, inflamed or damaged skin.

Although a theoretical risk with topical salicylates, oral salicylates have been associated with Reye's syndrome. Therefore, use is not advised in children or teenagers during or immediately after chickenpox, influenza, or other viral infections.

None known.

Embryo-toxicity effects in humans have not been studied but studies in animals demonstrated embryo-toxicity at high doses.

The systemic absorption from using this topical product is limited.

Caution should be exercised when prescribing to pregnant women.

Prolonged use of Duofilm during pregnancy and lactation should be avoided. The area of treatment should not exceed 5 cm^2.

If used during lactation, it should not be applied to the chest to avoid accidental ingestion by the infant.

None.

A localised irritant reaction will occur if applied to the normal skin surrounding the wart. The irritation will normally be controlled by temporarily discontinuing use and by applying the medication only to the wart site when treatment is resumed. Reported adverse drug reactions from postmarketing experience include burning sensation, pain, erythema, skin discolouration, pruritis, exfoliation, bleeding, inflammation, contact dermatitis and swelling.

Excessive use could cause irritation of the skin. If this occurs, use more sparingly or apply less frequently. In the event of accidental oral ingestion, especially in infants or children, monitor and provide appropriate supportive measures. Symptoms may include headache, nausea, vomiting, diarrhoea and hyperpnoea.

Pharmacotherapeutic group: Wart and anti-corn preparations, ATC Code: D11AF.

Salicylic acid is a widely used and effective keratolytic, it produces desquamation and destruction of the epithelium by solubilising the intercellular cement of the stratum corneum.

Lactic acid affects the keratinisation process, reducing hyperkeratosis and is also caustic, leading to the destruction of hyperkeratotic tissue of the wart and of the causative virus.

Not applicable.

See section 4.6.

Flexible Collodion BP

(contains pyroxylin, colophony, virgin castor oil, ethanol and ether)

Not applicable

3 years

Do not store above 25°C. Keep away from naked flame.

DUOFILM is supplied in amber bottles of 15ml fitted with a brush applicator.

No special requirements.

GlaxoSmithKline (Ireland) Ltd.

Stonemasons Way,

Rathfarnham

Dublin 16,

Ireland

Trading as Stiefel

PA1077/121/001

Date of first authorisation: 21^st January 1977

Date of last renewal: 21^st January 2007

3^rd December 2010