País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARBAMAZEPINE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
CARBAMAZEPINE
50Tablet Tablets
NOVARTIS FARMA S.P.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TEGRETOL TABLETS/CR TABLETS/ SYRUP ® carbamazepine (200mg, 400mg, 100mg/5mL) 1 WHAT IS IN THIS LEAFLET 1. What Tegretol is used for 2. How Tegretol works 3. Before you use Tegretol 4. How to use Tegretol 5. While you are using Tegretol 6. Side effects 7. Storage and Disposal of Tegretol 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT TEGRETOL IS USED FOR Tegretol belongs to a group of medicines called antiepileptics (medicine for seizures). Due to its mode of action it can be used for other diseases too. Tegretol is used to treat certain types of seizures (epilepsy). It is also used to treat some neurological diseases (such as a painful condition of the face called ‘trigeminal neuralgia’), certain psychiatric conditions (such as a disorder known as mania, episodes of bipolar mood disorders and a certain type of depression) as well as alcohol-withdrawal syndrome. It must not be used for common aches or pains. HOW TEGRETOL WORKS Epilepsy is a disorder characterized by two or more seizures (fits). Seizures occur when messages from the brain to the muscles are not properly passed on by the nerve pathways in the body. Tegretol helps to control the passing- on of these messages. Tegretol also regulates nerve functions for the other diseases mentioned above. BEFORE YOU USE TEGRETOL You may only take Tegretol after a full medical examination. The risk of serious skin reactions in patients of Han Chinese or Thai origin associated with carbamazepine or chemically related compounds may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking Tegretol. _ _ _- When you must not use it _ If you are allergic (hypersensitive) to carbamazepine or to any of the other ingredients of Tegretol listed at the end of this leaflet. If you have severe heart disease. If you have had a serious blood illness in the past. If y Llegiu el document complet
Novartis Business Use Only Page 2 of 24 Malaysian Package Leaflet 13-Jan-2023 Tegretol TEGRETOL ® Antiepileptic, neurotropic, and psychotropic agent DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS TABLETS : 200 mg carbamazepine. CR TABLETS (modified-release film-coated tablets, divisible): 200 mg and 400 mg carbamazepine. ORAL SUSPENSION : 5 mL (= 1 measure) contain 100 mg carbamazepine. ACTIVE SUBSTANCE Carbamazepine. Certain dosage strengths and dosage forms may not be available in all countries. DESCRIPTION TEGRETOL 200 MG TABLETS White, round, flat, with bevelled edges. One side bears the imprint “CG”, the other “GK” and a score. TEGRETOL CR 200 MG TABLETS Beige-orange, oval, slightly biconvex coated tablets with a score on each side. One side bears the imprint “H/C”, the other “C/G”. TEGRETOL CR 400 MG TABLETS Brownish-orange, oval, slightly biconvex coated tablets with a score on each side. One side bears the imprint “ENE/ENE”, the other “CG/CG”. TEGRETOL SYRUP Viscous suspension, white, caramel flavored. INDICATIONS Epilepsy – Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. – Generalized tonic-clonic seizures. Mixed forms of seizures. Tegretol is suitable for both monotherapy and combination therapy. Tegretol is usually not effective in absences (petit mal) and myoclonic seizures (see section WARNINGS AND PRECAUTIONS). Acute mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence. Alcohol-withdrawal syndrome. Idiopathic trigeminal neuralgia and trigeminal neuralgia due to multiple sclerosis (either typical or atypical). Idiopathic glossopharyngeal neuralgia. Novartis Business Use Only Page 3 of 24 Malaysian Package Leaflet 13-Jan-2023 Tegretol DOSAGE REGIMEN AND ADMINISTRATION EPILEPSY When possible, Tegretol should be prescribed as monotherapy. Treatment should be initiated with a low daily dosage, to be slowly increased until an optimal effect is obt Llegiu el document complet