Duofilm (Solution) Instructions for Use

Marketing Authorization Holder

Stiefel Laboratories (Ireland) Limited (Ireland)

ATC Code

D11AF (Drugs for the treatment of calluses and warts)

Active Substances

Salicylic acid (USP)

Lactic acid (Ph.Eur.)

Dosage Form

Duofilm

Solution for external use 167 mg+167 mg/1 g: bottle 15 ml with applicator included

Dosage Form, Packaging, and Composition

15 ml – dark glass bottles (1) with applicator included – cardboard packs.

Clinical-Pharmacological Group

Drug for topical treatment of benign skin lesions with cauterizing and mummifying action

Pharmacotherapeutic Group

Keratolytic agent

Pharmacological Action

A combined topical drug. The preparation contains salicylic acid and lactic acid, which in these concentrations cause protein coagulation and have a cauterizing effect.

It is effective for common and plantar warts.

When the drug is applied topically, systemic absorption of the active components is not observed.

Indications

• For the topical treatment of common warts (verruca vulgaris) and plantar warts.
• Apply only to the specific wart lesion, avoiding contact with the surrounding healthy skin, mucous membranes, and eyes.
• Use is restricted to external application on the skin; do not apply on the face, anogenital area, or on moles, birthmarks, or unusual warts with hair growth.

ICD codes

Dosage Regimen

Apply once or twice daily. Soak the affected area in warm water for 5 minutes and dry thoroughly before application.

Use the applicator to apply one thin layer of solution directly to the wart, allowing it to dry. The maximum daily dose for adults is 10 ml; for children, it is 1 ml.

Protect the surrounding healthy skin with petroleum jelly or a similar barrier. Continuous treatment is typically required for several weeks until the wart is removed.

Adverse Reactions

Local reactions at the application site are common and include skin irritation, manifested as hyperemia, a burning sensation, pain, pruritus, and dermatitis.

Allergic contact dermatitis and skin hypersensitivity reactions may also occur. Systemic absorption is minimal with topical use, but excessive application or use on large areas can lead to systemic salicylism.

Drug Interactions

Concomitant use with other topical medications on the same area is not recommended due to the risk of increased skin irritation or altered effects.

Avoid using with other topical salicylic acid preparations, peeling agents, or abrasive cleansers, as this may enhance the keratolytic and irritant effects.

Exercise caution in patients taking oral anticoagulants or antidiabetic agents, as theoretical risk of interaction exists with significant systemic absorption.

Contraindications

• Hypersensitivity to salicylic acid, lactic acid, or any other component of the formulation.
• Do not use on moles, pigmented nevi, hairy warts, or warts with signs of malignant change.
• Avoid application on the face, mucous membranes, anogenital region, and on irritated or broken skin.
• Contraindicated in patients with severe renal impairment and in children under 12 years of age.

Overdose

Overdosage typically results from excessive topical application, leading to increased local skin reactions such as severe irritation, inflammation, blistering, and ulceration.

Systemic absorption is generally low, but application over very large body surface areas, especially in children or patients with renal impairment, may cause salicylate toxicity (salicylism).

Symptoms of salicylism include tinnitus, vertigo, hyperventilation, nausea, vomiting, and electrolyte imbalances. In case of suspected systemic overdose, discontinue use immediately and seek medical attention; treatment is supportive and symptomatic.

Use in Pregnancy and Lactation

During pregnancy, the treated skin area should not exceed 5 cm².

During lactation, accidental ingestion of the drug by the infant through contact with treated surfaces should be avoided.

Use in Renal Impairment

With caution in renal insufficiency.

Pediatric Use

Contraindication: children under 12 years of age.

The drug should be prescribed with caution to children aged 12 years and older. When treating children, several areas should not be treated simultaneously.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

When treating children, several areas should not be treated simultaneously.

The solution must be applied carefully, avoiding contact with healthy skin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.