País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXCARBAZEPINE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
OXCARBAZEPINE
100Tablet Tablets; 50Tablet Tablets
NOVARTIS FARMA S.P.A.
_Consumer Medication Information Leaflet (RiMUP) _ TRILEPTAL ® TABLET _ _ Oxcarbazepine (300mg, 600mg) 1 WHAT IS IN THIS LEAFLET 1. WHAT TRILEPTAL IS USED FOR 2. HOW TRILEPTAL WORKS 3. BEFORE YOU USE TRILEPTAL 4. HOW TO USE TRILEPTAL 5. WHILE USING TRILEPTAL 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF TRILEPTAL 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER WHAT TRILEPTAL IS USED FOR Trileptal belongs to group of medicines called anticonvulsants or antiepileptics (medicines to treat epilepsy). Trileptal is used to treat partial seizure (involves a limited area of the brain) and generalised tonic- clonic seizures (involves a wide area of the brain, cause loss of consciousness and can affect the whole body), in adults and children. Trileptal can be used alone (i.e. monotherapy) or in combination with other antiepileptic medicines. It can replace other antiepileptic medicines when current therapy provides insufficient seizure control. HOW TRILEPTAL WORKS Trileptal works by keeping the brain’s “overexcitable” nerve cells under control, thereby suppressing or reducing the frequency of such seizures. BEFORE YOU USE TRILEPTAL Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with oxcarbazepine, carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients. _ _ _MONITORING DURING YOUR TREATMENT _ _WITH TRILEPTAL _ Before and during your treatment with Trileptal, your doctor may perform blood tests to determine the dose for you. Your doctor will tell you when to have the tests. _When you must not use Trileptal _ If you are allergic (hypersensitive) to oxcarbazepine (the active substance of Trileptal) or eslicarbazepine (another active substance related to oxcarbazepine) or any of the other ingredients of Trileptal listed at the end of this leaflet. Leia o documento completo
Novartis Page 2 of 19 Malaysian Package Leaflet 23-June-2023 Trileptal FCT TRILEPTAL ® Antiepileptics. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM(S) 300 MG : yellow, ovaloid slightly biconvex tablets, scored on both sides. Debossed with “TE”, score, inverted “TE” on one side and “CG”, score, inverted “CG” on the other side. The score line on Trileptal 300 mg film-coated tablets is to divide the tablet into equal doses. _ _ 600 MG : light pink, ovaloid slightly biconvex tablets scored on both sides. Debossed with “TF”, score, inverted “TF” on one side and “CG”, score, inverted “CG” on the other side. The score line on two sides of 600 mg film-coated tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Certain dosage strengths and dosage forms may not be available in all countries. ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg or 600 mg oxcarbazepine. Appearance of tablets may differ between countries. Certain dosage strengths may not be available in all countries. EXCIPIENTS Tablet core: silica, colloidal anhydrous; cellulose, microcrystalline; hypromellose; crospovidone; magnesium stearate; Tablet coating: hypromellose; talc; titanium dioxide (E 171); _300 mg tablet coating only:_ macrogol 8000; iron oxide, yellow (E 172). _600 mg tablet coating only: _ macrogol 4000; iron oxide, red; iron oxide, black (E 172). Pharmaceutical formulations may vary between countries. INDICATIONS Trileptal is indicated for the treatment of partial seizures (which include the seizure subtypes of simple, complex and partial seizures evolving to secondarily generalized seizures) and generalized tonic-clonic seizures, in adults and in children. Trileptal is indicated as a first-line antiepileptic medicinal product for use as monotherapy or adjunctive therapy. Trileptal can replace other antiepileptic medicinal products when current therapy provides insufficient seizure control (see section CLINICAL STUDIES). DOSAGE REGIMEN AND ADMINISTRATION Leia o documento completo