Duofilm Cutaneous Solution

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Section 4.8 - Addition of HPRA reporting statement

Sections 1 and 2 Lactic acid content amended from 16.7% to 15%

Section 5.1 - Information on flexible collodion added
Section 5.2 all information new (previously N/A)

Section 4.2 reformatted to include more comprehensive directions for use.  Advice to cover with a dressing, and warning about flammability added
Section 4.4 reformatted and warning to store out of reach and sight of children added
Section 4.5 Section previously stated none known
Section 4.6 Now not recommended during pregnancy and lactation
Section 4.8 reformatted to include frequency
Section 4.9 treatment section added

Section 7 has been changed from GlaxoSmithKline (Ireland) Ltd. to GlaxoSmithKline Consumer Healthcare Limited

Section 8 has been changed from PA 1077/121/1 to PA 678/114/1

Section 10 has been updated to February 2013

This approval was for the official addition of ‘Trading as Stiefel’ to the end of the MAH address in section 7.

 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).

1.         NAME OF THE MEDICINAL PRODUCT

 

DUOFILM Cutaneous Solution

Salicylic Acid 16.7% w/w

Lactic Acid 16.7% w/w

4.2       Posology and method of administration

 

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.

 

4.3       Contraindications

 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.      

        

   Avoid applying to normal skin.

DUOFILM should not be used on the face or anogenital regions.

Special warnings and precautions for use

 

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.

1.         Care should be taken to ensure that the product is not applied to surrounding skin, as this may result in burning of the normal skin.

 

            2.         The product should be kept away from the eyes and mucous membranes.  Thorough flushing with water should be carried out to remove any material accidentally in contact with these tissues.

 

4.5       Interaction with other medicinal  products and other forms of interactions

 

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 cm².

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

There are no restrictions on the use of DUOFILM in pregnancy and lactation.

 

4.8       Undesirable effects

 Application of DUOFILM to normal skin may result in burning.

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.

4.9       Overdose

 

 

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.
Not applicable.

5.1       Pharmacodynamic properties

 

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

 

5.3       Preclinical safety data

 

See section 4.6.           Not appplicable

6.1       List of excipients                                                                               

 

Flexible Collodion  BP

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

6.5       Nature and contents of container

 

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

 

6.6       Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Instructions for use/handling

10.       DATE OF REVISION OF THE TEXT

 

July 2009 March 2010

 

 

        

 

 

           

   

 

 

 

 

 

 

In section 7, the address of the Marketing Authorisation Holder has been changed.

In section10, the date of approval has been updated.