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.
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.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Wart and anti-corn preparations, ATC Code: D11AF.
5.3 Preclinical safety data
See section 4.6.
6.1 List of excipients
Flexible Collodion BP
(contains pyroxylin, colophony, virgin castor oil, ethanol and ether
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