Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
Generics (UK) Limited
N03AF01
CARBAMAZEPINE
100 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Antiepileptics
Authorised
1989-02-02
PACKAGE LEAFLET: INFORMATION FOR THE USER GERICARB 100 MG TABLETS GERICARB 200 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. 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 Gericarb is and what it is used for 2. What you need to know before you take Gericarb 3. How to take Gericarb 4. Possible side effects 5. How to store Gericarb 6. Contents of the pack and other information 1. WHAT GERICARB IS AND WHAT IT IS USED FOR Gericarb contains the active substance carbamazepine. It belongs to a group of medicines called antiepileptics (medicine for seizures). Gericarb can be used to treat diseases, including: • certain types of seizures (epilepsy). Epilepsy is a condition that causes repeated seizures (fits). Seizures occur when messages from the brain to the muscles are not properly passed on by the nerve pathways in the body. Gericarb helps to control the passing-on of these messages. Gericarb also regulates nerve functions for the other diseases mentioned below. • neurological diseases, such as nerve pain caused by trigeminal neuralgia. It must not be used for common aches or pains. • certain psychiatric conditions, such as episodes of bipolar mood disorders and to help treat mania and prevent depression in those with a manic-depressive illness • Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gericarb 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of Carbamazepine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White flat, bevelled edged tablets, marked “CB” breakline “100” on one side and blank on the reverse. The breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An anticonvulsant in the management of epilepsy (generalised tonic-clonic and partial seizure types). An analgesic in the relief of pain of trigeminal neuralgia, and the lancinating component of deafferentation pain such as in glossopharyngeal neuralgia, peripheral diabetic neuropathy, tabetic lightening pain, superior laryngeal neuralgia, stump pain, phantom limb pain, post hepatic neuralgia. Management of alcohol withdrawal symptoms. Treatment of mania and prophylaxis of manic-depressive illness, especially in patients unresponsive to Lithium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Gericarb is given orally in tablet form, usually in two to four divided doses. _Epilepsy_ Treatment should be initiated with a low daily dose, gradually increasing dosage regimen is used and this should be adjusted to suit the needs of the individual patient to achieve adequate control of seizures. Monitoring of the plasma level of carbamazepine will ensure that the optimum dose is prescribed. 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 section 4.4). If possible a sole anti-epileptic agent should be used but if polytherapy is necessary, the same Soma hati kamili