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Stiefel
Stockley Park West, , Uxbridge, Middlesex, UB11 1BT , UK Telephone: +44 (0)800 221 441 Fax: +44 (0)208 990 4328 Medical Information e-mail: customercontactuk@gsk.com Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 24/01/2011

SPC

Duofilm

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Duofilm

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Salicylic acid BP 16.7% w/w

Lactic acid BP 16.7% w/w

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3. PHARMACEUTICAL FORM

Solution for topical administration.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Duofilm is indicated for the treatment of warts

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4.2 Posology and method of administration

Adults and the elderly:

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.

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4.3 Contraindications

Duofilm should not be used on the face or anogenital regions. Avoid applying to normal skin.

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4.4 Special warnings and precautions for use

None.

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4.5 Interaction with other medicinal products and other forms of interaction

None known

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4.6 Pregnancy and lactation

There are no restrictions on the use of Duofilm during pregnancy or lactation.

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4.7 Effects on ability to drive and use machines

None.

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4.8 Undesirable effects

None

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4.9 Overdose

Not Applicable.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Lactic acid affects the keratinisation process, reducing the hyperkeratosis which is characteristic of warts. It is caustic, leading to the destruction of the keratotic tissue of the wart and of the causative virus.

Salicylic acid is keratolytic, producing desquamation by solubilising the intercellular cement in the stratum corneum.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

Not applicable.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Flexible Collodion