Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMOTRIGINE
MEDISPEC (M) SDN.BHD
LAMOTRIGINE
3 x 10 Tablets
UNISON LABORATORIES CO.LTD
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LAMOGA TABLET Lamotrigine (25 mg, 50 mg and 100 mg) 1 WHAT IS IN THIS LEAFLET 1. What LAMOGA is used for 2. How LAMOGA works 3. Before you use LAMOGA 4. How to use LAMOGA 5. While you are using it 6. Side effects 7. Storage and Disposal of LAMOGA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LAMOGA IS USED FOR LAMOGA can be used in two different conditions: Epilepsy and Bipolar disorder (maniac depression). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LAMOTRIGINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. HOW LAMOGA WORKS _Epilepsy _ LAMOGA is used to treat or prevent various types of epilepsy in adults and children. LAMOGA may be used on its own to treat adults and children over 12 years. LAMOGA can also be used in combination with other anti- epileptic medicines in both adults and children aged 2 years and over. Sometimes other anti- epileptic medicines may be stopped after LAMOGA has been started. _Bipolar Disorder _ LAMOGA is also used to help prevent depression in adults over 18 years of age with bipolar disorder. LAMOGA should not be used to treat bipolar disorder in children (under 18 years of age). BEFORE YOU USE LAMOGA _- When you must not use it _ Do not take or use LAMOGA if you are hypersensitive (allergic) to Lamotrigine or any of the other ingredients of LAMOGA Tablets. LAMOGA is not recommended for treatment of epilepsy in children under 2 years of age. _- Before you start to use it _ Talk to your doctor or pharmacist before taking LAMOGA: _ _ • If you have any kidney problems • If you have ever developed a rash after taking Lamotrigine or other medicines for bipolar disorder or epilepsy • If you have ever developed meningitis (swelling of the membranes of the brain and spinal cord) after taking Lamotrigine • If you are already taking medicine that contains Lamotrigine • If you have intolerance to a type o Baca dokumen lengkap
1 of 13 LAMOGA-25 LAMOGA-50 LAMOGA-100 ANTIEPILEPTIC Each film coated tablet contains: LAMOTRIGINE 25 MG LAMOTRIGINE 50 MG LAMOTRIGINE 100 MG PRODUCT DESCRIPTION: _25 MG:_ Pale yellow, arc-square film coated tablet with plain flat face on one side and slope edge, flat face with engraved 25 on the other side _50 MG:_ Pale yellow, arc-square film coated tablet with plain flat face on one side and slope edge, flat face with engraved 50 on the other side _100 MG:_ Pale yellow, arc-square film coated tablet with plain flat face on one side and slope edge flat face with engraved 100 on the other side MECHANISM OF ACTION: _PHARMACOLOGY _ It is suggested that Lamotrigine is a use- and voltage-dependent blocker of voltage gated sodium channels. It inhibits sustained repetitive firing of neurons and inhibits release of glutamate (the neurotransmitter which plays a key role in the generation of epileptic seizures). These effects are likely to contribute to the anticonvulsant properties of Lamotrigine. In contrast, the mechanisms by which Lamotrigine exerts its therapeutic action in bipolar disorder have not been established, although interaction with voltage gated sodium channels is likely to be important. _PHARMACOKINETICS _ Absorption Lamotrigine is rapidly and completely absorbed from the gut with no significant first-pass metabolism. Peak plasma concentrations occur approximately 2.5 hours after oral administration of Lamotrigine. Time to maximum concentration is slightly delayed after food but the extent of absorption is unaffected. There is considerable inter- individual variation in steady state maximum concentrations but within an individual, concentrations rarely vary. Distribution Binding to plasma proteins is about 55%; it is very unlikely that displacement from plasma proteins would result in toxicity. The volume of distribution is 0.92 to 1.22 L/Kg. Biotransformation UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of Lamotrigine. Lamotrigine induces its own met Baca dokumen lengkap