Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbinafine hydrochloride
Dowelhurst Ltd
D01AE15
Terbinafine hydrochloride
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100200
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil AT 1% Cream Boots Athlete’s Foot 1%w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Terbinafine hydrochloride 1% w/w 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of tinea pedis (athlete’s foot) and tinea cruris (dhobie itch/jock itch) caused by _Trichophyton_ (e.g. _T. rubrum, T. mentagrophytes, T. _ _verrucosum, T. violaceum) and Epidermophyton floccosum. _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 16 years of age Lamisil AT 1% Cream is applied once daily. DURATION AND FREQUENCY OF TREATMENT Duration of treatment is one week for tinea pedis and tinea cruris. 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 by a physician. DOSING IN SPECIAL POPULATIONS: Paediatric population The experience with topical Lamisil AT 1% Cream in children is still limited and its use in children under 16 years 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. The affected area should be cleaned and dried thoroughly before application of Lamisil AT 1% 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 (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night. 4.3 CONTRAINDICATIONS Hypersensitivity to terbinafine or to any of the excipients contained in the cream, listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Lamisil AT 1% cream is for external use only. Should be used with caution in patients with lesions where alcohol could be irrita Læs hele dokumentet