البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
Novartis Consumer Health UK Limited
TERBINAFINE HYDROCHLORIDE
1%w/w %w/w
Cream
Authorised
0000-00-00
Pharm aco de XX X READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Lamisil 1% Cream is and what it is used for 2. Before you use Lamisil 1% Cream 3. How to use Lamisil 1% Cream 4. Possible side effects 5. How to store Lamisil 1% Cream 6. Further information. 1. WHAT LAMISIL 1% CREAM IS AND WHAT IT IS USED FOR Lamisil 1% Cream is used to treat Athlete’s foot (Tinea pedis), Dhobie itch (Tinea cruris), a fungal infection of the skin known as Pityriasis versicolour and certain yeast infections of the skin (those caused by the genus Candida). It attacks and kills the fungus or yeast which is causing your infection. 2. BEFORE YOU USE LAMISIL 1% CREAM DO NOT USE LAMISIL 1% CREAM IF YOU: • are allergic (hypersensitive) to any of the ingredients in the product (see Section 6) The cream is NOT recommended for use on children. TAKE SPECIAL CARE WITH LAMISIL 1% CREAM The cream is for external use only. Do not use on the face. Avoid contact with the eyes. In case of accidental contact with the eyes, rinse thoroughly with running water. TAKING OTHER MEDICINES Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. PREGNANCY AND BREAST-FEEDING Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor. Ask your doctor or pharmacist for advice before taking any medicine. DRIVING AND USING MACHIN اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil 1% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Terbinafine hydrochloride 1% w/w. Excipients: Each gram of cream contains 40mg cetyl alcohol and 40mg stearyl alcohol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, smooth to almost smooth, glossy cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin caused by _Trichophyton _(e.g. _T.rubrum, T. mentagrophytes, T. verrucosum, T. violaceum_), _Microsporum canis _and _Epidermophyton floccosum._ Yeast infections of the skin, principally those caused by the genus _Candida _(e.g. _C_._albicans_). Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare _(also known as _Malassezia furfur_). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LAMISIL can be applied once or twice daily depending on the indication. DURATION AND FREQUENCY OF TREATMENT The likely duration of treatment are as follows: Tineapedis: Once a day for 1 week Tineacorporis, cruris: Once a day for 1 week Cutaneous candidiasis: Once or twice a day for 1 to 2 weeks Pityriasisversicolor: Once or twice a day for 2 weeks Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks the diagnosis should be verified. DOSING IN SPECIAL POPULATIONS: Children The experience with topical LAMISIL in children is still limited and its use cannot therefore be recommended. Elderly patients There is no evidence to suggest that elderly patients require different dosages or experience side effects different to those of younger patients. METHOD OF ADMINISTRATION For cutaneous use. IRISH MEDICINES BOARD ______________ اقرأ الوثيقة كاملة