Zebinix

eslicarbazepine acetate

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This is a summary of the European public assessment report (EPAR) for Zebinix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zebinix.

What is Zebinix?

Zebinix is a medicine that contains the active substance eslicarbazepine acetate. It is available as white tablets (200 mg, 400 mg, 600 mg and 800 mg).

What is Zebinix used for?

Zebinix is used to treat adults 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 anti-epileptic medicines.

The medicine can only be obtained with a prescription.

How is Zebinix used?

Zebinix treatment starts 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. The dose may be increased to 1,200 mg once a day depending on how the patient responds to treatment.

Zebinix should be used with caution in patients with kidney problems and the dose should be adjusted according to how the kidneys are functioning. The medicine is not recommended in patients with severely reduced kidney or liver function.

How does Zebinix work?

The active substance in Zebinix, 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 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.

How has Zebinix been studied?

Three main studies were performed, involving a total of 1,050 adults with partial-onset seizures that were not controlled by other medicines. All three studies compared Zebinix given at different doses (400 mg, 800 mg or 1200 mg once a day) with placebo (a dummy treatment). All of the patients also received other anti-epileptic medicines. The main measure of effectiveness for the three studies was the reduction in the number of seizures over 12 weeks.

What benefit has Zebinix shown during the studies?

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-ons to other anti-epileptic 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 seizures per month in patients taking Zebinix 800 mg and Zebinix 1200 mg respectively, compared with 11.7 per month in those taking placebo.

What is the risk associated with Zebinix?

Almost a half of the patients treated with Zebinix experience side effects. Side effects were usually mild to moderate in intensity and occurred mostly in the first week of treatment. The most common side effects with Zebinix (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness). For the full list of all side effects reported with Zebinix, see the package leaflet.

Zebinix should not be used in people who may be 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 has Zebinix been approved?

The CHMP decided that Zebinix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public ES = español 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public CS = čeština 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public DA = dansk 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public DE = Deutsch 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public ET = eesti keel 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public EL = elliniká 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public EN = English 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public FR = français 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public IT = italiano 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public LV = latviešu valoda 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public LT = lietuvių kalba 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public HU = magyar 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public MT = Malti 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public NL = Nederlands 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public PL = polski 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public PT = português 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public RO = română 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public SK = slovenčina 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public SL = slovenščina 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public FI = suomi 20/05/2009 14/09/2012
Zebinix : EPAR - Summary for the public SV = svenska 20/05/2009 14/09/2012

This EPAR was last updated on 21/06/2016 .

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.

Revision17
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

07/04/2016  Zebinix -EMEA/H/C/000988 -N/0052

Name Language First published Last updated
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016
Zebinix : EPAR - Product Information SV = svenska 27/05/2009 19/05/2016

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 SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012
Zebinix : EPAR - All Authorised presentations SV = svenska 20/05/2009 14/09/2012

Pharmacotherapeutic group

Anti-epileptics

Therapeutic indication

Zebinix is indicated as adjunctive therapy in adults 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 SV = svenska 03/06/2009  
Committee for medicinal products for human use summary of positive opinion for Zebinix SV = svenska 19/02/2009  

Authorised

This medicine is approved for use in the European Union