Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CARBAMAZEPINE
McDermott Laboratories Ltd t/a Gerard Laboratories
400mg Milligram
Tablets
2000-04-28
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gericarb SR 400 mg, prolonged-release tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged release tablet contains 400 mg carbamazepine _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Prolonged release tablets White to yellowish, round, flat, cloverleaf shaped tablets with bevelled edge, double-sided cross break-mark, 4 notches on the band. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy ○ generalised tonic-clonic ○ partial seizures ○ For the paroxysmal pain of trigeminal neuralgia. ○ For the prophylaxis of manic or hypomanic phases of manic-depressive psychosis in patients unresponsive or with contraindications to lithium therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment is started with a low dose set individually according to the type and severity of symptoms. The dose is then slowly increased to the optimal maintenance dose to suit the patient. Doses should be based on seizure control and the development of clinical intolerance. Plasma levels are indicative whether a patient is within or outside the therapeutic range in order to explain a lack of seizure control or development of intolerance. This may be particularly useful, if combination therapy is used. Therapeutic plasma levels of carbamazepine are typically between 4 - 12 µg/l corresponding to a dosage of 400 - 1200 mg per day. A maximum daily dose of 1600-2000 mg may be required in adults. When patients are transferred from an immediate-release carbamazepine product, the same total daily dose will generally be suitable. In a few patients, it may be necessary to increase the total daily dose, particularly when it is used with other antiepileptics. The tablet Read the complete document