Zebinix

eslicarbazepine acetate

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This is a summary of the European public assessment report (EPAR) for Zebinix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use of Zebinix.

For practical information about using Zebinix, patients should read the package leaflet or contact their doctor or pharmacist.

What is Zebinix and what is it used for?

Zebinix is an epilepsy medicine used to treat adults and children above 6 years of age with partial-onset seizures (epileptic fits) with or without secondary generalisation. This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell, or vision, numbness or a sudden sense of fear. Secondary generalisation occurs when the overactivity later reaches the whole brain. Zebinix must only be used as an ‘add-on’ to other epilepsy medicines.

Zebinix contains the active substance eslicarbazepine acetate.

How is Zebinix used?

Zebinix can only be obtained with a prescription. It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth.

For adults and children weighing 60 kg or more, treatment is started at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks. In children weighing less than 60 kg, the starting dose is 10 mg per kg body weight once a day. The dose is then increased after one or two weeks to 20 mg/kg per day and then to 30 mg/kg per day, based on the patient’s response. For adults and children, the maximum dose is 1,200 mg once a day.

Zebinix should be used with caution in patients with kidney problems and the dose should be adjusted according to how the kidneys are functioning.

How does Zebinix work?

The active substance in Zebinix, eslicarbazepine acetate, is converted into the epilepsy 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 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.

What benefit of Zebinix have been shown in studies?

Three main studies compared the effects of Zebinix with those of placebo (a dummy treatment) in 1,050 adults with partial-onset seizures that were not controlled by other medicines. All of the patients also received other epilepsy medicines. Looking at the results of the three studies taken together, Zebinix 800 mg and 1200 mg were more effective than placebo at reducing the number of seizures, when used as add-on to other epilepsy medicines. At the start of the study, patients had around 13 seizures per month. Over the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix 800 mg and Zebinix 1200 mg respectively, compared with 11.7 per month in those taking placebo.

The effects of Zebinix were also studied in children with partial-onset seizures. In one study involving 123 children aged 6 to 16 years, Zebinix over 12 weeks reduced the number of seizures by half in 51% of patients (42 out of 83). This compared with 25% of patients (10 out of 40) on placebo. A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used.

What are the risks associated with Zebinix?

In clinical trials, almost half of the patients treated with Zebinix experienced side effects compared with around a quarter of patients on placebo. Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment. For adults, the most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). In children, the most common side effects (seen in more than 1 patient in 10) were diplopia (double vision), somnolence and vomiting. For the full list of all side effects reported with Zebinix, see the package leaflet.

Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine). It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).

Why is Zebinix approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zebinix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Zebinix?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zebinix have been included in the summary of product characteristics and the package leaflet.

Other information about Zebinix

The European Commission granted a marketing authorisation valid throughout the European Union for Zebinix on 21 April 2009.

For more information about treatment with Zebinix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zebinix : EPAR - Summary for the public BG = bălgarski 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public ES = español 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public CS = čeština 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public DA = dansk 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public DE = Deutsch 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public ET = eesti keel 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public EL = elliniká 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public EN = English 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public FR = français 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public IT = italiano 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public LV = latviešu valoda 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public LT = lietuvių kalba 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public HU = magyar 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public MT = Malti 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public NL = Nederlands 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public PL = polski 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public PT = português 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public RO = română 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public SK = slovenčina 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public SL = slovenščina 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public FI = suomi 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public SV = svenska 2009-05-20 2016-12-21
Zebinix : EPAR - Summary for the public HR = Hrvatski 2009-05-20 2016-12-21

This EPAR was last updated on 15/02/2017 .

Authorisation details

Product details

Product details for Zebinix
NameZebinix
Agency product numberEMEA/H/C/000988
Active substance

eslicarbazepine acetate

International non-proprietary name (INN) or common name

eslicarbazepine acetate

Therapeutic area Epilepsy
Anatomical therapeutic chemical (ATC) code N03AF04

Publication details

Publication details for Zebinix
Marketing-authorisation holder

BIAL - Portela & Ca, S.A.

Revision19
Date of issue of marketing authorisation valid throughout the European Union21/04/2009

Contact address:

BIAL - Portela & Ca, S.A.
A Avenida da Siderurgia Nacional
PT-4745-457 S. Mamede do Coronado
Portugal

Product information

Product information

04/01/2017  Zebinix -EMEA/H/C/000988 -IB/0059

Name Language First published Last updated
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15
Zebinix : EPAR - Product Information HR = Hrvatski 2009-05-27 2017-02-15

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21
Zebinix : EPAR - All Authorised presentations HR = Hrvatski 2009-05-20 2016-12-21

Pharmacotherapeutic group

Anti-epileptics

Therapeutic indication

Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zebinix : EPAR - Public assessment report HR = Hrvatski 2009-06-03  
Committee for medicinal products for human use summary of positive opinion for Zebinix HR = Hrvatski 2009-02-19  

Authorised

This medicine is approved for use in the European Union