Duofilm

1. Name Of The Medicinal Product

Duofilm

2. Qualitative And Quantitative Composition

Salicylic acid BP 16.7% w/w

Lactic acid BP 16.7% w/w

3. Pharmaceutical Form

Solution for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Duofilm is indicated for the treatment of warts

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

None

4.9 Overdose

Not Applicable.

5. Pharmacological Properties

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.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Flexible Collodion

6.2 Incompatibilities

None

6.3 Shelf Life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

Amber screw capped applicator bottle containing 15ml.

6.6 Special Precautions For Disposal And Other Handling

There are no special instructions for use or handling of Duofilm.

7. Marketing Authorisation Holder

Stiefel Laboratories (UK) Ltd

Eurasia Headquarters

Concorde Road

Maidenhead

SL6 4BY

UK

8. Marketing Authorisation Number(S)

PL 0174/0025R

9. Date Of First Authorisation/Renewal Of The Authorisation

14^th February 1990

10. Date Of Revision Of The Text

August 2009