Nazione: Indonesia
Lingua: indonesiano
Fonte: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
LAMOTRIGINE
GLAXO WELLCOME INDONESIA - Indonesia
LAMOTRIGINE
100.00 MG
TABLET
DUS, 2 BLISTER @ 15 TABLET
GLAXOSMITHKLINE PHARMACEUTICALS S.A. - Poland
2021-05-16
ERS_leaLAM_Update PI GDS50IPI27_circ1_17May2021 _Page 1 of 22_ LAMICTAL LAMOTRIGINE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION TABLETS: _LAMICTAL _50 mg and 100 mg DISPERSIBLE/CHEWABLE TABLETS: _LAMICTAL _5 mg and 25 mg 2. CLINICAL INFORMATION 2.1 INDICATIONS EPILEPSY • ADULTS AND ADOLESCENTS (OVER 12 YEARS OF AGE) _LAMICTAL _is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome. • CHILDREN (2 TO 12 YEARS OF AGE) _LAMICTAL _is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox- Gastaut Syndrome. Initial monotherapy treatment in newly diagnosed paediatric patient is not recommended. After epileptic control has been achieved during adjunctive therapy, concomitant anti-epileptic drugs (AEDs) may be withdrawn and patients continued on _LAMICTAL_ monotherapy. If _LAMICTAL_ 2 mg dispersible/chewable tablet is not available and the calculated dose in children is less than 2.5 mg daily, then _LAMICTAL_ cannot be used. DO NOT attempt to administer partial quantities of the dispersible/chewable tablets. BIPOLAR DISORDER • ADULTS (18 YEARS OF AGE AND OVER) _LAMICTAL_ is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes. 2.2 DOSAGE AND ADMINISTRATION Pharmaceutical form: Tablets and Dispersible/Chewable tablets. _LAMICTAL_ tablets should be swallowed whole, and should not be chewed or crushed. _LAMICTAL_ dispersible/chewable tablets may be chewed, dispersed in a small volume of water (at least enough to cover the whole tablet) or swallowed whole with a little water. DO NOT attempt to administer partial quantities of the dispersible/chewable tablets. If a calculated dose of _LAMICTAL,_ e.g. for use in children (epilepsy only) or patients with hepatic impai Leggi il documento completo