Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Carbamazepine
Novartis Ireland Limited
N03AF; N03AF01
Carbamazepine
200 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Carboxamide derivatives; carbamazepine
Marketed
1993-05-31
1 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 are and 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 ARE AND WHAT THEY ARE 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 fits). It can also modify some types of pain and can control mood disorders. Tegretol SR Prolonged Release Tablets are used in adults to treat the following: • some forms of epilepsy • a painful condition of the face called “trigeminal neuralgia” and some other nerve pains • serious mood disorders when other medicines have not worked • alcohol withdrawal problems. Tegretol SR Prolonged Release Tablets are also used in children to treat some forms of epilepsy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TEGRETOL SR PROLONGED RELEASE TABLETS DO NOT TAKE TEGRETOL SR PROLONGED RELEASE TABLETS IF: • you are allergic to Prečítajte si celý dokument
Health Products Regulatory Authority 25 July 2023 CRN00DQT7 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tegretol SR 200mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tegretol SR 200 mg prolonged release tablets contains 200 mg carbamazepine Excipient(s) with known effect: polyethoxylated castor oil 0.22 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablet. Film coated tablets, beige-orange in colour, oval shaped, slightly biconvex with a score on each side and imprinted with ‘H/C’ on one side and ‘C/G’ on the other side. 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. Tegretol SR Prolonged Release tablets should not be chewed but should be taken with a little liquid, e.g. Prečítajte si celý dokument