ZEBINIX Tablet Ref.[8699] Active ingredients: Eslicarbazepine

Posology

Adults

Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200 mg once daily. Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).

Special populations

Elderly (over 65 years of age)

No dose adjustment is needed in the elderly population provided that the renal function is not disturbed. Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population.

Renal impairment

Caution should be exercised in the treatment of patients, adult and children above 6 years of age, with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows:

• CL_CR >60 ml/min: no dose adjustment required.
• CL_CR 30-60 ml/min: initial dose of 200 mg (or 5 mg/kg in children above 6 years) once daily or 400 mg (or 10 mg/kg in children above 6 years) every other day for 2 weeks followed by a once daily dose of 400 mg (or 10 mg/kg in children above 6 years). However, based on individual response, the dose may be increased.
• CL_CR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data.

Hepatic impairment

No dose adjustment is needed in patients with mild to moderate hepatic impairment. The pharmacokinetics of eslicarbazepine acetate has not been evaluated in patients with severe hepatic impairment (see sections 4.4 and 5.2) and use in these patients is, therefore, not recommended.

Paediatric population

Children above 6 years of age: The recommended starting dose is 10 mg/kg/day once daily. Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day, based on individual response. The maximum dose is 1,200 mg once daily (see section 5.1).

Children with a body weight of ≥60 kg: Children with a body weight of 60 kg or more should be given the same dose as for adults.

The safety and efficacy of eslicarbazepine acetate in children aged 6 years and below has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

Method of administration

Oral use.

Zebinix may be taken with or without food.

For patients who are unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally.

Switching preparations

Based on comparative bioavailability data for the tablet and the suspension formulations, switching patients from one formulation to the other can be done.

Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac arrhythmia). There is no known specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).

4 years.

This medicinal product does not require any special storage conditions.

PVC/Aluminium blisters placed into cardboard boxes containing 20 or 60 tablets.

HDPE bottles with polypropylene child resistant closure, inside a cardboard box, containing 60 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.