Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
PCO Manufacturing
250 Milligram
Tablets
2003-04-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil 250mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg terbinafine (as hydrochloride). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Greece_ Circular, biconvex, white tablets with ‘ST’ and a breakline on one side and plain on the other side. _Product imported from Spain and the Czech Republic_ Circular, biconvex white tablets with ‘Lamisil 250’ on one side and a breakline on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Fungal infections of the skin and nails caused by Trichophyton (e.g. T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. o Treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) where oral therapy is considered appropriate due to the site, severity or extent of the infection. o Treatment of onychomycosis (nail infections) caused by dermatophyte fungi. o Complete resolution of the symptoms may not occur until several weeks after mycological cure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults_ 250mg once daily. The bioavailability of terbinafine is not affected by food. The duration of treatment varies according to the indication and the severity of the infection. _Skin infections_ Likely durations of treatment are as follows: Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks Tinea corporis: 4 weeks Tinea cruris: 2 to 4 weeks _Onychomycosis_ The duration of treatment for most patients is between 6 weeks and 3 months. Treatment periods of less than 3 months can be anticipated in patients with fingernail infection, toenail infection other than of the big toe, or patients of young Read the complete document