Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
NOVARTIS SOUTH AFRICA (PTY) LTD
Tablet
Each tablet contains TERBINAFINE HYDROCHLORIDE equivalent to 125 mg TERBINAFINE
1992-11-05
Page 1 of 4 PATIENT INFORMATION LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING LAMISIL TABLETS Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: LAMISIL ® 125 mg TABLETS LAMISIL ® 250 mg TABLETS 1. COMPOSITION OF THE MEDICINE (I.E., WHAT THIS MEDICINE CONTAINS): 125 MG TABLETS The ACTIVE SUBSTANCE of LAMISIL ® is terbinafine hydrochloride. The OTHER INGREDIENTS are magnesium stearate; hydroxypropylmethyl cellulose; microcrystalline cellulose; lactose; sodium carboxymethyl starch. 250 MG TABLETS The ACTIVE SUBSTANCE of LAMISIL ® is terbinafine hydrochloride. The OTHER INGREDIENTS are magnesium stearate; silica colloidal anhydrous; hydroxypropylmethyl cellulose; microcrystalline cellulose; sodium carboxymethyl starch. 2. APPROVED INDICATION AND USE (I.E., WHAT THIS MEDICINE IS USED FOR): LAMISIL ® tablets are used to treat fungal infections of the fingernails and toenails. LAMISIL ® tablets are also used to treat tinea (ringworm) infections of the scalp and hair, groin and other body areas and the feet (athlete’s foot), as well as yeast infections of the skin. Terbinafine belongs to the group of medicines called antifungal agents and is used to treat fungal infections of the skin, hair and nails. When taken by mouth, it reaches the site of infection in concentrations strong enough to kill the fungus or stop it growing. 3. BEFORE TAKING THE MEDICINE: It is important to tell your doctor if you have other medical problems or if you are taking other medicines DO NOT TAKE LAMISIL ® If you are allergic (hypersensitive) to terbinafine or any of the other ingredients of LAMISIL ® listed at the beginning of this leaflet. If you have or had any liver problems. If you Read the complete document
Page 1 of 12 SCHEDULING STATUS: PROPRIETARY NAME (AND DOSAGE FORM): LAMISIL ® 125 mg tablet LAMISIL ® 250 mg tablet COMPOSITION: _Active ingredient: _ _ _ Each 125 mg tablet contains 125 mg terbinafine as terbinafine hydrochloride. Each 250 mg tablet contains 250 mg terbinafine as terbinafine hydrochloride _List of excipients _ _LAMISIL_ _® _ _125 mg: _ Magnesium stearate; silica colloidal anhydrous; hydroxypropylmethyl cellulose; microcrystalline cellulose; lactose; sodium carboxymethyl starch. _LAMISIL_ _® _ _250 mg: _ _ _ Magnesium stearate; silica colloidal anhydrous; hydroxypropylmethyl cellulose; microcrystalline cellulose; sodium carboxymethyl starch. PHARMACOLOGICAL CLASSIFICATION: A 20.2.2. Antimicrobial (Chemotherapeutic) agents. Fungicides. PHARMACOLOGICAL ACTION: Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. Its activity against yeasts is fungicidal or fungistatic, depending on the species. Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in cell S4 Page 2 of 12 death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. _PHARMACOKINETICS: _ _ _ A single oral dose of 250 mg terbinafine results in peak plasma concentrations of 1.3 microgram/mL within 1.5 hours of administration. At steady-state, in comparison to a single dose, peak concentration of terbinafine was on average 25% higher and plasma AUC increased by a factor of 2.3. From the increase in plasma AUC an effective half-life of ~30 hours can be calculated. The bioavailability of terbinafine is affected by food but dose adjustments are not required. Terbinafine binds strongly to plasma proteins (99%). It rapidly diffuses through the dermis and concentrates in the Read the complete document