Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
Niche Generics Limited
1 %w/w
Cream
2005-11-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lanafine AFR 1% (w/w) Cream Terbinafine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream. Excipients: Also contains cetyl alcohol (0.04g in 1g cream) and cetostearyl alcohol (0.04g in 1g cream). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White or almost white cream, with slight almond odour. 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 Method of administration Topical administration. Lanafine AFR Cream is applied once or twice daily. The affected area should be cleaned and dried thoroughly before application of Lanafine AFR 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. Duration of treatment is one week for tinea pedis and one to two weeks for 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. Children The experience with topical Lanafine AFR Cream in children is still limited and its use in children under 16 years cannot therefore be recommended. Use in the elderly There is no evidence to suggest that eld Read the complete document