Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LAMOTRIGINE
HEALOL PHARMACEUTICALS SDN. BHD.
LAMOTRIGINE
30tablet Tablets; 56tablet Tablets
LABORATORIOS NORMON, S.A.
Consumer Medication Information Leaflet (RiMUP) LAMOTRIGINE NORMON CHEWABLE DISPERSIBLE TABLETS Lamotrigine 50 mg/100 mg 1 WHAT IS IN THIS LEAFLET 1. What Lamotrigine Normon Tablets are used for 2. How Lamotrigine Normon Tablets work 3. What you need to know before you use Lamotrigine Normon Tablets 4. How to take Lamotrigine Normon Tablets 5. While you are using Lamotrigine Normon Tablets 6. Side Effects 7. Storage and disposal of Lamotrigine Normon Tablets 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT LAMOTRIGINE NORMON TABLETS ARE USED FOR Lamotrigine is derived from a group of medicines called antiepileptics. It is used for the treatment of two types of the diseases: epilepsy and bipolar disorder. _Epilepsy: _ Lamotrigine Normon blocks the signals to the brain that may cause epileptic seizures (fit). • In adults and children aged 13 years and over, Lamotrigine can be taken by itself or in combination with other medicines to treat epilepsy, and seizures caused by a disease called Lennox-Gastaut syndrome. • For children aged 2 to 12 years, Lamotrigine can be taken by itself or in combination with other medications to treat the same diseases. It can also be used alone for the treatment of a type of epilepsy called ‘typical absence seizures’. _ _ _Bipolar disorder: _ People with bipolar disorder (formerly known as manic depressive disorder) experience extreme mood swings, with periods of mania (excitation or euphoria) alternating with periods of depression (deep sorrow or desperation). In adults aged 18 years and above, Lamotrigine Normon can be used alone or in combination with other drugs to prevent the depression in bipolar disorder. HOW LAMOTRIGINE NORMON TABLETS WORK Lamotrigine Normon can be used alone or in combination with other drugs to prevent the depression in bipolar disorder. It is not known how Lamotrigine works in the brain to provide the above effects. WHAT YOU NEED TO KNOW BEFORE YOU USE LAMOTRIGINE NORMON TABLETS _When you must not take Прочитајте комплетан документ
LAMOTRIGINE NORMON CHEWABLE/DISPERSIBLE TABLETS PRODUCT DESCRIPTION LAMOTRIGINE NORMON 50 MG CHEWABLE/DISPERSIBLE TABLETS ARE white or almost white, biconvex and round Chewable/Dispersible tablets. The weight of the 50 mg tablet is 130 mg ± 7.5% and the diameter is 7.65 mm ± 25%. LAMOTRIGINE NORMON 100 MG CHEWABLE/DISPERSIBLE TABLETS are white or almost white, biconvex and round Chewable/Dispersible tablets. The weight of the 100 mg tablet is 260 mg and the diameter is 9.65 mm ± 25%. COMPOSITION Each tablet of Lamotrigine NORMON 50 mg Chewable/Dispersible tablets contains Lamotrigine 50 mg and each tablet of Lamotrigine NORMON 100 mg Chewable/Dispersible tablets contains Lamotrigine 100 mg. PHARMACOLOGY MECHANISM OF ACTION The results of pharmacological studies suggest that lamotrigine is a use and voltage dependent blocker of voltage-gated Sodium channels. It produces a use~ and voltage-dependent block of sustained repetitive firing in cultured neurons and inhibits pathological release of glutamate (the amino acid which plays a key role in the generation of epileptic seizures), as well as inhibiting glutamate-evoked bursts of action potentials. PHARMACOKINETICS Absorption Lamotrigine is rapidly and completely absorbed from the gut with no significant first pass metabolism. Peak plasma concentration occurs approximately 2-3 hours after oral administration. High interindividual variability in peak plasma concentration at steady state prevails. 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. Metabolism UDP-glucuronyl transferases have been identified as the enzymes responsible for metabolism of lamotrigine. Lamotrigine induces its o Прочитајте комплетан документ