Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terbinafine hydrochloride
DE Pharmaceuticals
D01BA02
Terbinafine hydrochloride
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020500
PACKAGE LEAFLET: INFORMATION FOR THE USER LAMISIL ® 250MG TABLETS (terbinafine hydrochloride) WHAT YOU NEED TO KNOW ABOUT LAMISIL TABLETS Your doctor has decided that you need this medicine to help treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IT CONTAINS IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is Lamisil 250mg Tablets, but will be referred to as Lamisil Tablets throughout out the remainder of the leaflet. IN THIS LEAFLET: 1. What Lamisil Tablets are, and what they are used for 2. Things to consider before you start to take Lamisil Tablets 3. How to take Lamisil Tablets 4. Possible side effects 5. How to store Lamisil Tablets 6. Further information 1. WHAT LAMISIL TABLETS ARE AND WHAT THEY ARE USED FOR Terbinafine, the active ingredient in Lamisil Tablets, is an antifungal medicine. Lamisil Tablets are used to treat a number of fungal infections of the skin and nails. 2. THINGS TO CONSIDER BEFORE YOU START TO TAKE LAMISIL TABLETS SOME PEOPLE MUST NOT TAKE LAMISIL TABLETS. TALK TO YOUR DOCTOR IF: • you think you may be allergic to terbinafine or to any of the other ingredients of Lamisil Tablets. (These are listed in Section 6.) • you have or have had any liver problems • you are breast-feeding YOU SHOULD ALSO ASK YOURSELF THESE QUESTIONS BEFORE TAKING LAMISIL TABLETS. If the answer to any of these questions is YES, tell your doctor or pharmacist because Lamisil Tablets might not be the right medicine for you. • Are you pregnant or trying to become pregnant? Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lamisil® Tablets 250mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 281.25mg terbinafine hydrochloride, equivalent to 250mg terbinafine 3. PHARMACEUTICAL FORM Tablets for oral administration. LAMISIL Tablets 250mg: Whitish to yellow tinged white, circular, biconvex tablets, scored on one side and coded LAMISIL 250 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin and nails caused by _Trichophyton _(eg. _T. rubrum_, _T.mentagrophytes, T. verrucosum, T. violaceum_), _ Microsporum canis _ and _Epidermophyton floccosum _ 1. Oral LAMISIL is indicated in the 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. 2. Oral LAMISIL is indicated in the treatment of onychomycosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults 250mg once daily. 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 younger age. In the treatment of toenail infections, 3 months is usually sufficient although a few patients may require treatment of 6 months or longer. Poor nail outgrowth during the first weeks of treatment may enable identification of those patients in whom longer therapy is required. Complete resolution of the signs and symptoms of infection may not occur until several weeks after mycological cure. Additional information on special population _Liver impairment _ Lamisil tablets are contraindicated for patients with chro Διαβάστε το πλήρες έγγραφο