Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
CARBAMAZEPINE
NOVARTIS ISRAEL LTD
N03AF01
TABLETS SLOW RELEASE
CARBAMAZEPINE 200 MG
PER OS
Required
NOVARTIS FARMA S.P.A., ITALY
CARBAMAZEPINE
CARBAMAZEPINE
Epilepsy, trigeminal neuralgia, diabetes insipidus, mania, prophylactic in manic-depressive illness
2014-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only TEGRETOL ® CR 200 mg Slow Release Tablets Active ingredient: Each tablet contains: Carbamazepine 200 mg TEGRETOL ® CR 400 mg Slow Release Tablets Active ingredient: Each tablet contains: Carbamazepine 400 mg TEGRETOL ® 200 mg Tablets Active ingredient: Each tablet contains: Carbamazepine 200 mg TEGRETOL ® SYRUP 2% Syrup Active ingredient: Each 5 ml contains: Carbamazepine 100 mg Inactive and allergenic ingredients in the preparation: See section 6 ‘Further Information’ and ‘Important information about some of the ingredients of the medicine’ in section 2. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Tegretol has a number of uses: • To treat epilepsy, a condition of recurrent seizures (convulsions). There are many and varied types of seizures, ranging from mild to severe. • To treat sudden recurrent attacks of pain in the face, known as trigeminal neuralgia. • To treat diabetes insipidus, a condition of increased thirst and urination. • To treat mania, a mental condition with episodes of hyperactivity, elation or nervousness. • For the preventative treatment of bipolar affective disorder (manic depression), in which there are periods of mania alternating with periods of depression. Therapeutic group: Antiepileptic, neurotropic, psychotropic. Tegretol belongs to a class of medicines called anticonvulsants. These medicines apparently work by modulating the manner in which signals are conveyed in the brain by nerves so that attacks will not occur. Tegretol also regulates other neural functions in the Læs hele dokumentet
1 TEG API FEB21 V6 REF: New Zealand September20 1. PRODUCT NAME TEGRETOL ® 200 mg Tablets TEGRETOL ® 200 mg CR Tablets TEGRETOL ® 400 mg CR Tablets TEGRETOL ® Syrup 2% 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Tablets • 200 mg: Each tablet contains 200 mg carbamazepine CR tablets • 200 mg: Each slow-release film-coated, divisible tablet contains 200 mg carbamazepine • 400 mg: Each slow-release film-coated, divisible tablet contains 400 mg carbamazepine Syrup • 5 mL: Each 5 mL of syrup contains 100 mg carbamazepine For a full list of excipients, see section 6.1. The syrup contains propylene glycol (refer to section 4.4, subsection _Excipients of known effect_). 3. PHARMACEUTICAL FORM • Tablet containing 200mg carbamazepine. Round, white, flat tablet, 9mm in diameter, with bevelled edges. Imprinted CG on one side, and G/K on the scored side. The tablet can be divided into equal doses. • Controlled Release Tablet containing 200mg carbamazepine. Beige-orange, ovaloid- shaped, film-coated divisible tablet with slightly convex faces. Approximate length is 12.2mm, and approximate width is 5.6mm. Both sides are scored; one side is imprinted C/G, and the other side H/C. The tablet can be divided into equal doses. • Controlled Release Tablet containing 400mg carbamazepine. Brown-orange, ovaloid- shaped, film-coated divisible tablet, with slightly convex faces. Approximately 16.7mm in length, and approximately 6.7mm in width. Imprinted CG/CG on one side, and ENE/ENE on the other side; both sides are scored. The tablet can be divided into equal doses. • Syrup containing 100mg/5mL carbamazepine. A viscous white suspension with a caramel odour and taste. It contains sorbitol (875mg/5mL), which is converted slowly into glucose, making the syrup suitable for diabetics. 2 TEG API JUL23 V7 REF: New Zealand May 2023 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy, Trigeminal neuralgia, Diabetes insipidus, Mania, prophylactic in manic-depressive illness. 4.2 POSOLOGY AND METHOD OF Læs hele dokumentet