Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Salicylic acid; Lactic acid
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D11AF
Salicylic acid; Lactic acid
16.7 %w/w + 15.0 percent weight/weight
Cutaneous solution
Product not subject to medical prescription
Wart and anti-corn preparations
Marketed
1977-01-21
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Duofilm carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist or doctor if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Duofilm is and what it is used for 2. Before you use Duofilm 3. How to use Duofilm 4. Possible side effects 5. How to store Duofilm 6. Further information 1. WHAT DUOFILM IS AND WHAT IT IS USED FOR The name of your medicine is Duofilm. It contains two medicines called salicylic acid and lactic acid. It works by softening the skin of a wart, causing it to peel off. Duofilm is used to treat warts. • A wart is an infection in the top layers of the skin. It is caused by a virus. • Warts can be spread when the virus touches damaged skin. • It is more likely to spread in places which are warm and moist. This is why one of the most common places to catch warts is swimming pools. • It can take from a few weeks to several months for the wart to appear. 2. BEFORE YOU USE DUOFILM DO NOT USE DUOFILM: • if you are allergic to the salicylic acid, lactic acid or any of the other ingredients of Duofilm (listed in Section 6). • on open skin wounds, moles, birthmarks, warts on your face, genital warts, warts with hair growing from them, warts with red edges or with an unusual colour. Do not use Duofilm if the above applies to you. If you are not sure, talk to your doctor or pharmacist before you start using Duofilm. TAKE SPECIAL CARE WITH DUOFILM: • Duofilm is for external use only. • Don’t get Duofilm in your eyes, nose, or mouth, or on the genital and anal areas. If you do get Duofilm in your eyes, flush with water for 15 minutes. • Do not inhale the vapour. • Ensure you k Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DUOFILM Cutaneous Solution Salicylic Acid 16.7% w/w Lactic Acid 15.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Salicylic Acid 16.7 % w/w Lactic Acid 15.0 % w/w For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution. Yellow to amber coloured, slightly viscous clear liquid having an ether odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DUOFILM is indicated in the treatment of warts. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Adults, the elderly and children aged 2 years and over: Children under 12 years should only use the product under supervision. Duofilm should be applied to the affected areas only. Duofilm should be applied to warts once daily, preferably at bedtime. Procedure for application: 1. The wart should be soaked in warm water for 5 minutes and dried thoroughly with a clean towel. 2. The surface of the wart should be rubbed with a nail file, pumice stone, emery board or coarse washcloth, with care taken not to cause bleeding. 3. A thin layer of Duofilm should be applied directly to the wart. Care should be taken to avoid the healthy surrounding skin. 4. The solution should be allowed to dry thoroughly. The wart should be covered with a plaster (dressing) if it is large or if it is on the foot to help penetration of ingredients. It is recommended that treatment continues until whichever of the following occurs first: • The wart is completely cleared and the normal ridgelines of the skin have been restored. • The wart has been treated for 12 weeks. Clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected after 4-8 weeks. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lees het volledige document