Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Medicines Authority
CARBAMAZEPINE
Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland
N03AF01
CARBAMAZEPINE 400 mg
MODIFIED-RELEASE TABLET
CARBAMAZEPINE 400 mg
POM
ANTIEPILEPTICS
Authorised
2006-07-31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEGRETOL ® 200MG TABLETS TEGRETOL ® CR 200 TABLETS TEGRETOL ® CR 400 TABLETS TEGRETOL ® 100MG/5ML ORAL SUSPENSION 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. - 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 you doctor, pharmacist or healthcare provider. This includes any possible side effects not listed in this leaflet. See section 4. - If you have any further questions, ask your doctor, pharmacist or healthcare provider. WHAT IS IN THIS LEAFLET 1 What Tegretol is and what it is used for 2 What you need to know before you take Tegretol 3 How to take Tegretol 4 Possible side effects 5 How to store Tegretol 6 Contents of the pack and other information 1 WHAT TEGRETOL IS AND WHAT IT IS USED FOR WHAT TEGRETOL ® IS The name of your medicine is Tegretol. It contains the active ingredient carbamazepine. Tegretol belongs to a group of medicines called antiepileptics (medicine for seizures). Due to its mode of action it can be used for other diseases too. WHAT TEGRETOL ® IS USED FOR Tegretol is used to treat certain types of seizures (epilepsy). It is also used to treat some neurological diseases (such as a painful condition of the face called ‘trigeminal neuralgia’) as well as certain psychiatric conditions (such as a disorder known as mania episodes of bipolar mood disorders and a certain type of depression). It must not be used for common aches or pains. Epilepsy is a disorder characterised by two or more seizures (fits). Seizures occur when messages from the brain to the muscles are not properly passed on by the nerve pathways in the body. Tegretol helps to control the passing-on of these messages. Tegretol also regulates nerve functions for the other diseases mentioned above. 2 WHAT Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TEGRETOL 200mg tablets TEGRETOL CR 200mg modified-release film-coated tablets TEGRETOL CR 400mg modified-release film-coated tablets TEGRETOL 100mg/5ml oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: 5H-dibenzo[b,f]azepine-5-carboxamide (carbamazepine) TABLETS: 200 mg carbamazepine. CR TABLETS (modified-release film-coated tablets, divisible) : 200 mg and 400 mg carbamazepine. ORAL SUSPENSION: 5 mL (= 1 measure) contain 100 mg carbamazepine. EXCIPIENT(S) WITH KNOWN EFFECT: CR 200 MG AND 400 MG: macrogolglycerol hydroxystearate/castor oil polyoxyl 40 hydrogenated 0.22 mg and 0.44 mg per tablet. ORAL SUSPENSION: Sorbitol (E 420) 875 mg per 5 ml, methyl parahydroxybenzoate (E 218) 6.00 mg per 5 ml propylparahydroxybenzoate (E 216) 1.50 mg per 5 ml and propylene glycol (E 1520) 125 mg per 5 ml. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablets White, round flat tablets with bevelled edges. One side bears the imprint “CG”, the other “G/K” and a score. Modified-release film-coated tablets (CR tablets) • CR 200mg: Beige-orange, oval, slightly biconvex. One side debossed with “H/C”, the other with “C/G”, both sides are scored. • CR 400mg: Brownish-orange, oval, slightly biconvex. One side debossed with “ENE/ENE”, the other with “CG/CG”, both sides are scored Oral suspension (white, viscous suspension) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Epilepsy - Complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization. - Generalized tonic-clonic seizures. Mixed forms of seizures. Tegretol ® is suitable for both monotherapy and combination therapy. Tegretol is usually not effective in absences (petit mal) and myoclonic seizures (see section 4.4 Special warnings and precautions for use). • Acute mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrenc Διαβάστε το πλήρες έγγραφο