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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: 1800 441 442
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 09/07/2014
SPC Duofilm Cutaneous Solution

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 09/07/2014 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   05-Jun-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 5.1 - Information on flexible collodion added
Section 5.2 all information new (previously N/A)
Updated on 03/04/2014 and displayed until 09/07/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   31-Mar-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

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
Updated on 27/02/2013 and displayed until 03/04/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-Feb-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

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
Updated on 07/06/2012 and displayed until 27/02/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   16-Jan-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

This approval was for the official addition of ‘Trading as Stiefel’ to the end of the MAH address in section 7.
Updated on 18/08/2011 and displayed until 07/06/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   03-Dec-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

 Transfer of Marketing Authorisation from Stiefel Laboratories (UK) Ltd to GSK (Ireland) Ltd (Trading as Stiefel).
Updated on 19/07/2010 and displayed until 18/08/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Mar-2010
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



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

 

 

        

 

 

           

   

 

 

 

 

 

 

Updated on 15/08/2009 and displayed until 19/07/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Jul-2009
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

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

In section10, the date of approval has been updated.
Updated on 31/08/2007 and displayed until 15/08/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2
Addition of 'For full list of excipients, see section 6.1'
 
Section 3
Addition of 'Yellow to amber coloured, slightly viscous clear liquid having an ether odour'
 
Section 6.1
Addition of '(contains colophony, virgin castor oil and colloidon)'
 
Section 6.3
Change from '36 months' to '3 years'
 
Section 6.6
Change from 'None' to 'No special requirements'
 
Section 9
Change from '21st January 1977/21st January 2002' to 'Date of first authorisation: 21st January 1977  Date of last renewal: 21st January 2007'
 
Section 10
Change from '12th August 2003' to 'August 2007'
Updated on 17/03/2007 and displayed until 31/08/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/08/2006 and displayed until 17/03/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08/2003
Legal Category:   retail sale through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.3    Shelf life has increased from 30 months to 36 months
 
Section 10    Date of revision of text is 12th August 2003 as shown on licence   
Updated on 16/08/2005 and displayed until 17/08/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Salicylic Acid
   Lactic Acid