Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
LACTIC ACID, SALICYLIC ACID
Beecham Group PLC 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
D11AF
LACTIC ACID 15 % (W/W) SALICYLIC ACID 16.7 % (W/W)
CUTANEOUS SOLUTION
LACTIC ACID 15 % (W/W) SALICYLIC ACID 16.7 % (W/W)
OTC
OTHER DERMATOLOGICAL PREPARATIONS
Withdrawn
2006-05-30
PHARMA CODE REF. NO. 625 PHARMA CODE REF. NO. 625 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 your 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). • you have warts on your face, around your back passage or genitals, moles, birthmarks, warts with hair growing from them or other sensitive areas. • the area of skin is irritated, reddened or infected. Do not use on open wounds. • the child being treated is under 2 years of age. 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 • Do not inhale the vapour. • Do not use with other medicine Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duofilm 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Salicylic acid BP 16.7% w/w Lactic acid BP 15% w/w Also contains colophony For the full list of excipients, see section 6.1 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, the elderly and children aged 2 years and over. 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. Duofilm should be applied to the wart 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: • Warts have been treated for 12 weeks • The wart is completely cleared and the normal ridgelines of the skin have been restored. For warts, clinically visible improvement should occur in 1-2 weeks, but the maximum effect may be expected after 4-8 weeks. If warts persist beyond 12 weeks of treatment, the patient should be advised to consult their pharmacist or doctor. Consider alternative treatments if warts cover a large area of the body (more than 5 cm 2 ) (see _Warnings and Precautions_). Patients should be advised to consult a pharmacist or doctor if skin irritation develops. Due to the flammable natur Aqra d-dokument sħiħ