Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
FLUOROURACIL
MEGAPHARM LTD
L01BC
CREAM
FLUOROURACIL 50 MG / 1 G
DERMAL
Required
ICN POLFA RZESZOW S.A., POLAND
PYRIMIDINE ANALOGUES
Antineoplastic agent to treat actinic keratosis multiple and superfacial basel cell carcinoma.
2016-11-30
Page 1 of 5 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 THIS MEDICINE IS DISPENSED WITH A PHYSICIAN’S PRESCRIPTION ONLY EFUDIX CREAM 5% COMPOSITION: ACTIVE INGREDIENT: EACH GRAM OF CREAM CONTAINS 50 MG OF FLUOROURACIL FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS IN THE MEDICINE, SEE SECTION 2 - "BEFORE USING THE MEDICINE" AND SECTION 6- “ADDITIONAL INFORMATION”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult your physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? EFUDIX CREAM 5% is used for the treatment of skin problems, such as keratosis and basal cell carcinoma (BCC). The active ingredient Fluorouracil. THERAPEUTIC GROUP: Belongs to a group of anti-cancer medicines. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient FLUOROURACIL or to any of the additional ingredients that the medicine contains (please see section 6, “Additional information”). • You are pregnant, you think you may be pregnant or you are breastfeeding. • You are using any medicines known as antiviral nucleosides (e.g., brivudine, sorivudine). These medicines are usually used to treat chickenpox or shingles. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE: BEFORE TREATMENT WITH EFUDIX CREAM 5%, TELL YOUR PHYSICIAN IF: • You suffer from inactivity or deficiency of the enzyme DPD (dihydropyrimidine dehydrogenase) (complete or partial deficiency of the enzyme). PARTICULAR CAUTION USING EFUDIX CREAM 5% IS REQUIRED IN THE FOLLOWING INSTANCES: • When using the medicine, do not smoke or go near open flames – there is a risk of severe burns. Fabric (e.g., clothing, bedding, dressings, etc.) that comes in contact with th Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS Go to top of the page 1. NAME OF THE MEDICINAL PRODUCT EFUDIX CREAM 5% Go to top of the page 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Efudix Cream 5% contains 50 MG/ 1G fluorouracil. For the full list of excipients, see section 6.1. Go to top of the page 3. PHARMACEUTICAL FORM White, opaque cream. Go to top of the page 4. CLINICAL PARTICULARS top of the page 4.1 THERAPEUTIC INDICATIONS Antineoplastic agent to treat actinic keratosis multiple and superfacial basal cell carcinoma. Go to top of the page 4.2 POSOLOGY AND METHOD OF ADMINISTRATION EFUDIX CREAM 5% is for topical application. _Pre-malignant conditions_ The cream should be applied thinly to the affected area once or twice daily; an occlusive dressing is not essential. _Malignant conditions_ The cream should be applied once or twice daily under an occlusive dressing where this is practicable. The cream should not harm healthy skin. Treatment should be continued until there is marked inflammatory response from the treated area, preferably with some erosion in the case of pre-malignant conditions. Severe discomfort may be alleviated by the use of topical steroid cream. The usual duration of treatment for an initial course of therapy is three to four weeks, but this may be prolonged. 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. _Elderly_ Many of the conditions for which EFUDIX CREAM 5% is indicated are common in the elderly. No special precautions are necessary. _ _ _Children_ In view of the lack of clinical data available, EFUDIX CREAM 5% is not recommended for use in children. the page 4.3 CONTRAINDICATIONS EFUDIX CREAM 5% is contraindicated in patients with known hypersensitivity to fluorouracil or any of the excipients listed in section 6.1. Coadministration of EFUDIX CREAM 5% with antiviral nucleoside drugs (e.g. brivudine and analogues) Lesen Sie das vollständige Dokument