Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Carbamazepine
Azure Pharmaceuticals Ltd
N03AF01
Carbamazepine
200 milligram(s)
Tablet
carbamazepine
Not marketed
2020-10-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARBAMAZEPINE 100 MG TABLETS CARBAMAZEPINE 200 MG TABLETS CARBAMAZEPINE 400 MG 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 Carbamazepine Tablets are and what they are used for 2. What you need to know before you take Carbamazepine Tablets 3. How to take Carbamazepine Tablets 4. Possible side effects 5. How to store Carbamazepine Tablets 6. Contents of the pack and other information 1. WHAT CARBAMAZEPINE TABLETS ARE AND WHAT THEY ARE USED FOR Carbamazepine Tablets contain a medicine called carbamazepine. Carbamazepine can affect the body in several different ways. Carbamazepine Tablets help 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. Carbamazepine is 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. Carbamazepine Tablets are also used in children to treat some forms of epilepsy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARBAMAZEPINE TABLETS DO NOT TAKE CARBAMAZEPINE TABLETS IF: • you are allergic to carbamazepine or similar medicines such as oxcarbazepine (Trileptal), or to any of a related group of medicines called tricyclic antidepressants (such Přečtěte si celý dokument
Health Products Regulatory Authority 19 September 2022 CRN00CXVD Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carbamazepine 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated tablet contains 200 mg of Carbamazepine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet: White to off white, round, flat, uncoated tablets with bevelled edges, having one side score line debossed with '200' and plain on other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 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. Carbamazepine 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 Carbamazepine is given orally, usually in two or four divided doses. The final dose adjustment should always depend on the clinical response in the individual patient. 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 SJS (See information on genetic testings and cutaneous reactions in section 4.4). 1. EPILEPSY Treatment should be initiated with a low daily dosage, to be slowly increased until an optimal effect is obtained. 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 Přečtěte si celý dokument