PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Exalief?
Exalief is a medicine that contains the active substance eslicarbazepine acetate. It is found 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, which causes symptoms such as sudden spasmodic movements of a part of the body, alteration of hearing, smell or sight, numbness or sudden sense of fear. Secondary generalization occurs when the overactivity expands subsequently to the entire cortex. Exalief should only be used as an adjunct to other anti-epileptic medicines.
The medicine can only be obtained with a prescription.
How is Exalief used?
Exalief treatment starts at a dose of 400 mg once a day, to be increased to 800 mg once a day after one or two weeks. Depending on the individual response, the dose may be increased up to 1200 mg once a day. Exalief can be taken with or without food.
Exalief should be used with caution in patients over the age of 65, 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, adjusting the dosage based on renal activity. The medicine is not recommended in patients with severe kidney or liver problems. Exalief is also not recommended for children under the age of 18.
How does Exalief work?
The active ingredient 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 the electrical impulses to travel along the nerves, there must be a rapid movement of sodium into the nerve cells. Eslicarbazepine is thought to act by inactivating the "dependent 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 crises.
What studies have been carried out on Exalief?
The effects of Exalief were first tested in experimental models before being studied in humans.
Three main studies were conducted on a total of 1, 050 adults with partial onset seizures refractory to treatment with other medicines. All three studies compared Exalief given at different doses (400 mg, 800 mg or 1200 mg once a day) with a 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, it appears that Exalief 800 mg and 1200 mg were more effective than placebo in reducing the number of seizures, when used in addition to other medicinal products. At the start of the study, patients had about 13 seizures per month. Over 12 weeks of treatment, patients taking Exalief 800 mg and Exalief 1200 mg fell to 9.8 and 9 seizures per month, respectively, compared with 11.7 seizures per month of those given placebo.
What is the risk associated with Exalief?
At least half of the patients treated with Exalief reported side effects. The most common (seen in more than 1 in 10 patients) are dizziness and drowsiness. For the full list of all side effects reported with Exalief, see the Package Leaflet.
Exalief should 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 similar structure to eslicarbazepine acetate, such as carbamazepine, oxcarbazepine). It must not be used in 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 the benefits of Exalief outweigh its risks for the treatment of partial-onset seizures with or without secondary generalization in adults also taking other anti-epileptic medicines. The committee recommended that Exalief be given marketing authorization.
More information on Exalief
On 21 April 2009, the European Commission issued a marketing authorization for Exalief to Bial - Portela & Ca, SA, valid throughout the European Union.
The full EPAR for Exalief can be found here.
Last update of this summary: 02-2009.
