Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
Novartis Pharmaceuticals UK Ltd
N03AF01
CARBAMAZEPINE
400 Milligram
Tablet Prolonged Release
Product subject to prescription which may be renewed (B)
Antiepileptics
Authorised
1993-05-31
1 of 2 Live Text: Yes / No / Both Production Site: Torre WO: 1516620 CTM: Flagiello, Angela Comp. Description: LEAFLET_TEGRETOL SR_FCT_ALL DOSAGES_IE Printing Colours: Black Comp. No. New: 1516620_IE Comp. No. Old: N/A Format/Dimension: 148 x 630 mm Tech. Drawing No.: 5666/O Technical Colours: Cutting Min. Font Size Text: 9 pt Font Type: News Gothic Version No.: 1 Date: 22 Jun 2016 J.N.: 284016 Braille: N/A ! PLEASE TURN OVERPRINTING ON ! Telephone +353 (0)1 440 3222 novartis@perigordgroup.com www.perigordpremedia.com 1516620_IE PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEGRETOL SR 200MG AND 400MG PROLONGED RELEASE TABLETS Carbamazepine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE – BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tegretol SR Prolonged Release Tablets areand what they are used for 2. What you need to know before you take Tegretol SR Prolonged Release Tablets 3. How to take Tegretol SR Prolonged Release Tablets 4. Possible side effects 5. How to store Tegretol SR Prolonged Release Tablets 6. Contents of the pack and other information 1. WHAT TEGRETOL SR PROLONGED RELEASE TABLETS IS AND WHAT IT IS USED FOR Tegretol SR Prolonged Release Tablets contains a medicine called carbamazepine. Carbamazepine can affect the body in several different ways. Tegretol SR Prolonged Release Tablets helps to control messages passed from the brain to muscles along the nerve pathways in the body. It is an anti-epileptic medicine (prevents fit Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tegretol SR 400mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tegretol SR 400mg prolonged release tablet contains 400 mg carbamazepine Excipients: Polyethoxylated castor oil 0.44 mg per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. Brownish-orange, oval, slightly biconvex , film-coated, prolonged release tablets with a score on each side, imprinted with ‘ENE/ENE’ on one side and ‘CG/CG’ on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. As an anticonvulsant in the management of epilepsy (generalised tonic – clonic and partial seizure types). 2. The paroxysmal pain of trigeminal neuralgia. Tegretol may also be used to relieve the lancinating component of other forms of deafferentation pain, for example glossopharyngeal neuralgia, peripheral diabetic neuropathy, tabetic lightning pain, superior laryngeal neuralgia, stump pain, phantom limb pain and post herpetic neuralgia. 3. Management of alcohol withdrawal symptoms. 4. Treatment of mania and prophylaxis of manic-depressive illness, especially in patients unresponsive to lithium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tegretol SR Prolonged Release tablets are given orally, usually in two to four divided doses. Tegretol SR Prolonged Release tablets are generally given in the same total does as conventional Tegretol dosage forms but in a few patients when changing from other oral dosage forms of Tegretol to Tegretol SR Prolonged Release tablets, the total daily dose may need to be increased. The final dose adjustment should always depend on the clinical response in the individual patient. Tegretol may be taken during, after or between meals. The SR Prolonged Release tablets should not be chewed but should be taken with a little liquid, e.g. a glass of water. As a result of slow, controlled release of the active substance from the SR Prolonge Lesen Sie das vollständige Dokument