Država: Malta
Jezik: angleščina
Source: Medicines Authority
FLUOROURACIL
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
L01BC02
FLUOROURACIL 5 % (W/W)
CREAM
FLUOROURACIL 5 % (W/W)
POM
ANTINEOPLASTIC AGENTS
Authorised
2006-11-08
PACKAGE LEAFLET: INFORMATION FOR THE USER EFUDIX 5% W/W CREAM Fluorouracil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Efudix Cream is and what it is used for 2. What you need to know before you use Efudix Cream 3. How to use Efudix Cream 4. Possible side effects 5. How to store Efudix Cream 6. Contents of the pack and other information 1. WHAT EFUDIX CREAM IS AND WHAT IT IS USED FOR Efudix Cream belongs to a group of anti-cancer medicines. Efudix Cream is used to treat certain skin conditions caused by abnormal cell growth including different types of keratosis (a horny growth of the skin), keratocanthoma (a firm nodule on the skin), Bowen’s disease, and some simple skin cancers. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EFUDIX CREAM Do not use Efudix Cream: - If you are pregnant, think you may be pregnant, or are breast feeding. - If you are allergic to fluorouracil or any of the other ingredients of this medicine (listed in section 6). - If you are taking antiviral nucleoside drugs (e.g. brivudine) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Efudix Cream. - The cream should be kept away from your eyes and mucosal surfaces (such as mouth, nose, genital or anus). (see section 3, ‘How to use Efudix Cream’) - If you have broken, inflamed or ulcerated skin as this can lead to too much cream being absorbed into the blood, which very rarely can cause side effects. - if you know that you have reduced or no activity of the enzyme dihydropyrimidine dehydrogenase (DP Preberite celoten dokument
Page 1 of 7 1. NAME OF THE MEDICINAL PRODUCT Efudix 5% w/w Cream. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efudix cream contains: Active substance: 5% w/w Fluorouracil Excipients: 15% stearyl alcohol 11.5% propylene glycol (E1520) 0.025% methyl parahydroxybenzoate (E218) 0.015% propyl parahydroxybenzoate (E216) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. Smooth, white, opaque cream. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Efudix is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenic forms; keratoacanthoma, Bowen's disease, superficial basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Adults, including elderly_ : Efudix cream is for topical application. _Pre-malignant conditions _ The cream should be applied thinly once or twice daily to the lesion; an occlusive dressing is not essential Page 2 of 7 _Malignant conditions _ The cream should be applied once or twice daily under an occlusive dressing where this is applicable.. Treatment should be continued until there is marked inflammatory response from the treated area, preferably some erosion in the case of pre-malignant conditions. Severe discomfort may be alleviated by the use of topical steroid cream. The usual treatment for an initial course is 3 to 4 weeks, but this may be prolonged if required. Lesions on the face usually respond more quickly than those on the trunk or lower limbs whilst lesions on the hands and forearms respond more slowly. Healing may not be complete until one or two months after therapy is stopped. _Children_ : In view of the lack of clinical data available, Efudix is not recommended for use in children. Special population _Elderly _ Many of the conditions for wh Preberite celoten dokument