Each tablet contains 117 mg of phenytoin

For the full list of excipients, see section 6.1

For oral administration only.

Dosage:

Dosage should be individualised as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Diphenin 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 mcg/mL- 20 mcg/mL (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 7 to 10 days may be required to achieve steady state serum levels with Diphenin and changes in dosage should not be carried out at intervals shorter than 7 to 10 days. Maintenance of treatment should be the lowest dose of anticonvulsant consistent with control of seizures.

Posology

Adult Dosage for Seizures:

Initially 3 to 4 mg/kg/day with subsequent dosage adjustment if necessary. For most adults a satisfactory maintenance dose will be 200 mg to 500 mg daily in single or divided doses. Exceptionally, a daily dose outside this range may be indicated. Dosage should normally be adjusted according to serum levels where assay facilities exist.

Dosing in Special Populations

Patients with Renal or Hepatic Disease:

See section 4.4.

Adult Dosage for Trigeminal Neuralgia:

The clinically effective dose has not been established in clinical trials. In adults, 300-500 mg daily given in divided doses has been reported in the literature. Dosing should be adjusted based on clinical response. Determination of serum phenytoin levels is advised. Levels of total phenytoin should not exceed 20 mcg/ml.

Elderly (over 65 years):

Phenytoin clearance may be decreased in elderly patients and lower or less frequent dosing may be required (see section 5.2 Special Populations – Age). As with adults the dosage of Diphenin should be titrated to the patient’s individual requirements using the same guidelines. As older people tend to receive multiple drug therapies, the possibility of drug interactions should be borne in mind.

Paediatric population Dosage for Seizures:

Initially, 5 mg/kg/day in two divided doses, with subsequent dosage individualised to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 mg/kg -8 mg/kg.

Neonates:

The absorption of phenytoin following oral administration in neonates is unpredictable. Furthermore, the metabolism of phenytoin may be depressed. It is therefore especially important to monitor serum levels in the neonate.

Pharmacotherapeutic group: Antiepileptics.

ATC Code: N03AB02.

List of excipients

Microcrystalline cellulose,

Sodium starch glycolate,

Magnesium stearate,

Ethylcellulose,

Sodium bicarbonate,

Talc purified.

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