Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PHENYTOIN SODIUM
LTT Pharma Limited
100 Milligram
Capsules Hard
2010-11-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epanutin 100 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Phenytoin Sodium 100mg Each capsule also contains lactose monohydrate For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, hard _Product imported from Greece_ A white powder in a No. 3 hard gelatin capsule with a white opaque body and orange cap, radially imprinted ‘EPANUTIN 100’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. Epanutin has also been employed in the treatment of trigeminal neuralgia but it should only be used as second line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. _Dosage:_ Dosage should be individualized as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Epanutin should be introduced in small dosages with gradual increments until control is achieved or until toxic effects appear. In some cases serum level determinations may be necessary for optimal dosage adjustments – the clinically effective level is usually 10–20mg/l (40–80 micromoles/l) although some cases of tonic-clonic seizures may be controlled with lower serum levels of phenytoin. With recommended dosage a period of seven to ten days may be required to achieve steady state serum levels with Epanutin and changes in dosage should not be carried out at intervals shorter than seven to ten days. Maintenance Read the complete document