País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carbamazepine
Novartis Pharmaceuticals UK Ltd
N03AF01
Carbamazepine
100mg
Oral tablet
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04080100; GTIN: 5010678545609
Artwork creator: Rizwana Shaik Creation date: 22-Jul-2022 Proof No.: 2 Artwork Order No.: 300029568 AW identifier No. New: 934030-GB AW identifier No. Old: 933725 Artwork Order description: LEAFLET_TEGRETOL_TAB_GB Packaging site: CM, IT, MILANO, MIPHARM (IM) Dimension: 160 X 710 MM Tech. Drawing No.: LFT_160x710_pp30 Live text: Yes No Both Condensed font: Yes No Font type: News Gothic MT Pro Minimum font size body text: 9pt Variable data prefixes font size: N/A Braille: N/A Print enhancements: N/A Technical colours: Cutting Printing colours: Black Pantone 2144 C ! P L E A S E T U R N O V E R P R I N T I N G O N ! 1 of 2 934030-GB PACKAGE LEAFLET: INFORMATION FOR THE USER TEGRETOL ® 100, 200 AND 400 MG TABLETS (CARBAMAZEPINE) WHAT YOU NEED TO KNOW ABOUT TEGRETOL TABLETS Your doctor has decided that you need this medicine to help treat your condition. PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE. IT CONTAINS IMPORTANT INFORMATION. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist. This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Tegretol Tablets are and what they are used for 2. What you need to know before you take Tegretol Tablets 3. How to take Tegretol Tablets 4. Possible side effects 5. How to store Tegretol Tablets 6. Contents of the pack and other information 1. WHAT TEGRETOL TABLETS ARE AND WHAT THEY ARE USED FOR Carbamazepine, the active ingredient in Tegretol Tablets, can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders. Tegretol is used • To Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tegretol® 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is 5H-dibenzo[b,f]azepine-5-carboxamide. Each tablet contains 100 mg carbamazepine Ph.Eur. 3 PHARMACEUTICAL FORM The tablets are white, round, flat, uncoated tablets with bevelled edges, having one side impressed “GEIGY”, the other “B/W” and a score. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy - generalised tonic-clonic and partial seizures. Note: Tegretol is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tegretol is given orally, usually in two or three divided doses. Tegretol may be taken during, after or between meals, with a little liquid e.g. a glass of water. Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome (See information on genetic testings and cutaneous reactions in section 4.4). _ _ _Epilepsy_: The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions). _ Adults:_ It is advised that with all formulations of Tegretol, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Tegretol should be taken in a number of divided doses although Leia o documento completo