Country: Մալթա
language: անգլերեն
source: Medicines Authority
TERBINAFINE HYDROCHLORIDE
Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece
D01AE15
TERBINAFINE HYDROCHLORIDE 10 mg
CREAM
TERBINAFINE HYDROCHLORIDE 10 mg
POM
ANTIFUNGALS FOR DERMATOLOGICAL USE
Authorised
2006-04-17
LAMISIL® CREAM PROPERTIES/THERAPEUTIC USE WHAT IS LAMISIL AND WHEN IS IT USED? LAMISIL cream is medicine (antifungal agents) intended for treatment of skin infections caused by fungi (mycoses) such as athlete’s foot or other superficial mycoses of the skin and pityriasis versicolor. LAMISIL cream is also effective against infections caused by yeasts (candidoses of the skin). LAMISIL cream rapidly suppresses symptoms such as itching, desquamation (scaling) and red blotches. ADDITIONAL INFORMATION APART FROM TREATMENT WHAT STEPS CAN BE TAKEN? In order to prevent mycoses, observe the following rules: Change your clothes every day because it is possible that the germs remain attached to parts of the clothes which are in contact with infected regions of the skin. Avoid wearing clothes which fit too tightly or have little permeability to air. Carefully dry the affected parts after washing. Change your flannel and towel every day. If you are suffering from athlete’s foot, do not walk barefoot. In addition, sprinkle or spray the inside of your socks or shoes every day with a powder or spray which is effective against fungal infections. CONTRAINDICATIONS WHEN SHOULD LAMISIL NOT BE USED? Do not use this product if you are allergic to one of its components. As the experience in children under 12 years of age is limited, the use of LAMISIL cream is not recommended in children under 12 years of age. PRECAUTIONS WHAT PRECAUTIONARY MEASURES SHOULD BE OBSERVED WHEN USING LAMISIL? LAMISIL cream should only be used externally. Consult your doctor in the case of large-scale mycoses or when the mycosis involves the nails. Please inform your doctor or pharmacist if you suffer from other illnesses, allergies or use other medicines for internal or external use (even under self-medication!). PREGNANCY/LACTATION Can LAMISIL be used during pregnancy or lactation? Only under medical authorisation. DOSAGE/METHOD OF USE HOW IS LAMISIL USED? For adults and children above 12 years: before applying LAMISIL, carefully wash the affected part read_full_document
1 1. NAME OF THE MEDICINAL PRODUCT Lamisil ® 1%, cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream contains 10 mg terbinafine hydrochloride. For excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Cream White, smooth, glossy cream. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Fungal infections of the skin caused by dermatophytes such as _Trichophyton _ (e.g. _T. _ _rubrum, _ _T. mentagrophytes, _ _T. _ _verrucosum, _ _T. _ _violaceum_ ), _Microsporum _ _canis _ and _Epidermophyton floccosum_ , e.g. tinea pedis (athlete’s foot), tinea cruris (dhobie (jock) itch) and tinea corporis (ringworm). Yeasts infections of the skin, principally those caused by the genus _Candida_ (e.g. _Candida albicans_ ). Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare_ (also known as _Malassezia _ _furfur_ ). 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use Adults and children aged 12 years and over _Duration and frequency of treatment _ • Tinea pedis: 1 week once a day • Tinea cruris and tinea corporis: 1 week once a day • Cutaneous candidiasis: 1 week, once or twice daily • Pityriasis versicolor: 2 weeks, once or twice daily The affected area should be cleaned and dried thoroughly before application of Lamisil Cream. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. 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, patients should see a doctor. _ _ _Children _ Experience with Lamisil Cream in children below 12 years is limited, and its use is therefore not recommended in this age group. _Use in the elderly _ There is no evidence to suggest that elderly patients require different dosages or experience side-effect read_full_document