Exalief - eslicarbazepine acetate

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

What is Exalief?

Exalief is a medicine that contains the active substance eslicarbazepine acetate. It comes in the form of white tablets (round: 400 mg; oblong: 600 mg and 800 mg).

What is Exalief used for?

Exalief is used to treat adults with partial onset seizures (seizures) with or without secondary generalization. It is a type of epilepsy in which there is "excessive electrical activity in one part of the brain, causing symptoms such as sudden spasmodic movements of a part of the body, changes in hearing, smell or vision, numbness or a sudden sense of fear." Secondary generalization occurs when overactivity subsequently spreads to the entire cortex Exalief should only be used in addition to other antiepileptic medicinal products.
The medicine can only be obtained with a prescription.

How is Exalief used?

Treatment with Exalief starts at a dose of 400 mg once a day, which should be increased to 800 mg once a day after one or two weeks. Based on individual response the dose may be increased up to 1200 mg once daily. Exalief can be taken with or without food.
Exalief should be used with caution in patients over 65 years of age as there is insufficient information on the safety of the medicine in these patients. Exalief should also be used with caution in patients with kidney problems by adjusting the dosage based on kidney activity. The medicine is not recommended in patients with severe kidney or liver problems. Exalief is also not recommended in children under 18 years of age. .

How does Exalief work?

The active substance in Exalief, eslicarbazepine acetate, is converted into the antiepileptic medicine eslicarbazepine in the body. Epilepsy is caused by excessive electrical activity in the brain. For electrical impulses to travel along the nerves, there must be a rapid movement of sodium In nerve cells Eslicarbazepine is thought to work by inactivating "voltage-gated sodium channels," thus preventing sodium from entering nerve cells. This reduces the activity of nerve cells in the brain, resulting in a decrease in the intensity and frequency of seizures.

How has Exalief been studied?

The effects of Exalief were first tested in experimental models before being studied in humans.
Three main studies were conducted involving a total of 1,050 adults with partial-onset seizures refractory to treatment with other medicinal products. All three studies compared Exalief given at different doses (400 mg, 800 mg or 1200 mg once daily) with placebo (a dummy treatment). All patients were also given other antiepileptic medicines. The main measure of effectiveness for the three studies was the reduction in the number of seizures over 12 weeks.

What benefit has Exalief shown during the studies?

From the three studies taken together, Exalief 800 mg and 1200 mg were shown to be more effective than placebo in reducing the number of seizures when used in addition to other entiepileptic medicines. At the start of the study, patients had approximately 13 seizures per month. Over 12 weeks of treatment, patients taking Exalief 800 mg and Exalief 1200 mg decreased to 9.8 and 9 seizures per month, respectively, compared with 11, respectively. 7 seizures per month of those treated with placebo.

What is the risk associated with Exalief?

At least half of the patients treated with Exalief have reported side effects. The most common (seen in more than 1 in 10 patients) are dizziness and sleepiness. For the full list of side effects reported with Exalief, see the package leaflet.
Exalief must not be used in people who may be hypersensitive (allergic) to eslicarbazepine acetate, to any of the other ingredients or to other carboxamide derivatives (medicines with a structure similar to eslicarbazepine acetate, such as carbamazepine, oxcarbazepine). It must not be given to people with second or third degree atrioventricular block (electrical transmission problem in the heart).

Why has Exalief been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Exalief's benefits are greater than its risks for the treatment of partial onset seizures with or without secondary generalization in adults who are also taking other antiepileptic medicines. The committee recommended the granting of a marketing authorization for Exalief.

Learn more about Exalief

On April 21, 2009, the European Commission granted Bial - Portela & Ca, SA a "Marketing Authorization" for Exalief, valid throughout the European Union.
For the full version of Exalief's EPAR click here.

Last update of this summary: 02-2009.

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