Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMOTRIGINE
KOMEDIC SDN BHD
LAMOTRIGINE
30Tablet Tablets
MEDOCHEMIE (FAR EAST) LTD - ORAL FACILITY
_Consumer Medication Information Leaflet (RiMUP) _ LAMOTRIX TABLET Lamotrigine (25mg, 50mg, 100mg, 200mg) ________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET: 1. What LAMOTRIX is used for 2. How LAMOTRIX works 3. Before you use LAMOTRIX 4. How to use LAMOTRIX 5. While you are using it 6. Side effects 7. Storage and disposal of LAMOTRIX 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LAMOTRIX IS USED FOR LAMOTRIX is used as: - an adjunctive therapy in treatment of partial seizures and generalised tonic- clonic seizures. - a supplementary (add-on) treatment against seizure in connection with Lennox-Gastaut Syndrome in patients MORE THAN 3 years of age. HOW LAMOTRIX WORKS LAMOTRIX treats epilepsy by blocking the signals in the brain that trigger epileptic seizures. LAMOTRIX is an antiepileptic medicine of the phenyltriazine class. Brain cells need to work at a certain rate to function normally. During a seizure, brain cells are forced to work much more rapidly than normal. BEFORE YOU USE LAMOTRIX _When you must not use it _ Do not take LAMOTRIX - if you are allergic to lamotrigine or any of the other ingredients of this medicine (listed in Product description). - If you have liver disease _ _ _Pregnancy _ _and _ _breast-feeding _ _and _ _fertility _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The medicine should not be used in pregnancy unless the benefit is considered to outweigh the potential risk for the foetus. Lamotrigine is found in the milk in small amounts and may affect breast fed infants. Breastfeeding is not recommended during lamotrigine therapy. _Before you start to use it _ Talk to your healthcare providers before taking LAMOTRIX: - If you ever had a rash during previous treatment with lamotrigine or with any other antiepileptic drug - If you have liver or Preberite celoten dokument
LAMOTRIX ® (LAMOTRIGINE) COMPOSITION: LAMOTRIX® tablets contain 25, 50, 100 and 200mg of lamotrigine. PHARMACEUTICAL FORM: LAMOTRIX® 25mg tablets are beige coloured, round, flat, marked MC at one side, with diameter 6mm. LAMOTRIX® 50mg tablets are beige coloured, round, flat and have a break-line, with diameter 8mm. LAMOTRIX® 100mg tablets are beige coloured, round, flat and have a break-line, with diameter 9.5mm. LAMOTRIX® 200mg tablets are beige coloured, round, flat and have a break-line, with diameter 12.7mm. PHARMACOLOGY: _PHARMACOKINETIC PROPERTIES: _Lamotrigine is readily absorbed from the gut with no significant first pass metabolism. Peak plasma concentration occurs in about 2.5 hours. The presence of food would delay the time to reach maximum concentration but the extent of absorption is not affected. The pharmacokinetics are linear up to doses of 450mg. There is considerable inter-individual variation in steady state maximum concentrations but within and individual concentrations vary very little. About 55% of lamotrigine is protein bind. Displacement from plasma protein is highly unlikely to lead to toxicity. The volume of distribution (Vd) is 0.92 to 1.22 l/kg. When given as monotherapy, lamotrigine induces its own metabolism to a modest extend depending on dose. Lamotrigine does not affect the pharmacokinetics of other AEDs or drugs that metabolised by cytochrome P450 enzymes. The mean steady state of clearance in healthy adults is 39 ± 14ml/min and it is independent of the dose. Lamotrigine is metabolised to 2-N-glucuronide conjugate (inactive) which is the major metabolite, representing 70% of total metabolites. Also, to 5-N-glucuronide conjugate (inactive) and to 2-N-methyl metabolite (inactive). The enzymes responsible for metabolism of lamotrigine are the up-glucuronyl transferases. Less than 10% is excreted unchanged in urine and 2% in faeces. The mean elimination half-life is 24 to 35 hours. In adults, the co-administration of lamotrigine and enzyme-inducing drugs such as carbamazepine Preberite celoten dokument