Eslicarbazepine acetate is indicated as an add-on therapy for partial seizure with or without secondary generalization.

Eslicarbazepine acetate is converted into the anti-epileptic medicine Eslicarbazepine in the body. Epilepsy is caused by excessive electrical activity in the brain. For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells. Eslicarbazepine acetate is thought to work by blocking ‘voltage-gated sodium channels’, which stops sodium entering the nerve cells. This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.

Adult: Eslicarbazepine acetate must be 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 1200 mg once daily

Elderly (over 65 years of age): Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Eslicarbazepine acetate in these patients.

Paediatric: The safety and efficacy of Eslicarbazepine acetate below 18 years has not yet been established. No data are available

Carbamazepine: Based on individual response, the dose of Eslicarbazepine acetate may need to be increased if used concomitantly with carbamazepine.

Phenytoin: The dose of Eslicarbazepine acetate may need to be increased and the dose of phenytoin may need to be decreased.

Oral contraceptives: Administration of Eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinyloestradiol, respectively. Therefore, women of childbearing potential must use adequate contraception during treatment with Eslicarbazepine acetate.

Simvastatin: The dose of Simvastatin shall be increased if used with Eslicarbazepine.

Hypersensitivity to the active substance, to other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or to any of the excipients.

The use of Eslicarbazepine acetate is associated with increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. AV block, syncope, bradycardia) may occur.

There are no data from the use of Eslicarbazepine acetate in pregnant women. Studies in animals have shown reproductive toxicity. If women receiving Eslicarbazepine acetate become pregnant or plan to become pregnant, the use of Exalief should be carefully re-evaluated.

It is unknown whether Eslicarbazepine acetate is excreted in human breast milk.

Eslicarbazepine acetate has been associated with some central nervous system adverse reactions, such as dizziness and somnolence, which could increase the occurrence of accidental injury.

Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. Additional non-hormonal forms of contraception are recommended when using Eslicarbazepine acetate.

As with other anti-epileptic medicinal products, if Eslicarbazepine acetate is to be discontinued it is recommended to withdraw it gradually to minimize the potential of increased seizure frequency.

Concomitant use of Eslicarbazepine acetate with oxcarbazepine is not recommended because this may cause overexposure to the active metabolites.

Rash developed as an adverse reaction in 1.1% of total population treated with Eslicarbazepine acetate in placebo-controlled add-on studies in epileptic patients. If signs or symptoms of hypersensitivity develop, Eslicarbazepine acetate must be discontinued. Hyponatraemia has been reported as an adverse reaction in less than 1% of patients treated with Eslicarbazepine acetate.

Patients with renal impairment: Caution should be exercised in the treatment of patients with renal impairment and the dose should be adjusted according to creatinine clearance (CLCR) as follows:

• CLCR >60 ml/min: no dose adjustment required
• CLCR 30-60 ml/min: initial dose of 400 mg every other day for 2 weeks followed by a once daily dose of 400 mg.
• CLCR <30 ml/min: use is not recommended in patients with severe renal impairment due to insufficient data

Patients with 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 and use in these patients is therefore not recommended.

Adjunct anti-epileptic drugs

Store in a cool and dry place, protected from light and moisture. Keep the medicine out of the reach of children.