Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Carbamazepine 400mg;
Novartis New Zealand Ltd
Carbamazepine 400 mg
400 mg
Modified release tablet
Active: Carbamazepine 400mg Excipient: Carmellose sodium Colloidal silicon dioxide Ethylcellulose Hypromellose Yellow, Red, White Suspension Iron oxide red Iron oxide yellow Magnesium stearate Methacrylic acid copolymer Microcrystalline cellulose Polyethylene glycol hydrogenated castor oil Purified talc Purified water Titanium dioxide
Blister pack, 100 tablets
Prescription
Prescription
Zhejiang Raybow Pharmaceutical Co Ltd
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
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al, Super Triplex - 100 tablets - 24 months from date of manufacture stored at or below 30°C protect from moisture
1988-10-28
_____________________________________________________________________________________________________ Tegretol 1 TEGRETOL _200mg and 400mg tablets _ _200mg and 400mg CR tablets _ _100mg/5mL syrup _ _Carbamazepine_ _____________________________________________________________________________________ CONSUMER MEDICINE INFORMATION ____________________ WHAT IS IN THIS LEAFLET __________________________________ This leaflet answers some common questions about Tegretol. It does not contain all the available information . It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking this medicine against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. ________________________ WHAT TEGRETOL IS USED FOR ______________________ Tegretol has several uses: • to control epilepsy, a condition in which there are repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. • to control sudden, repeated attacks of facial pain, known as trigeminal neuralgia. • to control mania, a mental condition with episodes of overactivity, elation or irritability. • to control bipolar mood disorder where periods of mania alternate with periods of depression. • to control the pain associated with painful diabetic neuropathy. • to control diabetes insipidus, a condition where there is excessive thirst Read the complete document
NEW ZEALAND DATA SHEET 1 1. PRODUCT NAME TEGRETOL ® 200 mg Tablets TEGRETOL ® 400 mg Tablets TEGRETOL ® 200 mg CR Tablets TEGRETOL ® 400 mg CR Tablets TEGRETOL ® 100 mg / 5 mL Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Tablets • 200 mg: Each tablet contains 200 mg carbamazepine • 400 mg: Each tablet contains 400 mg carbamazepine CR tablets • 200 mg: Each modified-release film-coated, divisible tablet contains 200 mg carbamazepine • 400 mg: Each modified-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. • Tablet containing 400mg carbamazepine. White, flat, rod-shaped tablet with bevelled edges. 17mm in length and 5.5mm in width. Imprinted CG/CG on one side and LR/LR on the second side; both sides of the tablet are scored. 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. • 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 6.6mm in width. Imprinted CG/CG on one side, and ENE/ENE on the other side; both sides are scored. • 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 Read the complete document