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Eslicarbazepine acetate

Zebinix · ATC code N03AF04

Also known as: Eslicarbazepinacetat, Eslikarbazepin asetat · Brand names: Zebinix, Eslibon, Eslicarbazepin Al, Eslicarbazepin Amarox, Eslicarbazepin Aristo, Eslicarbazepin Ascend, Eslicarbazepin Beta, Eslicarbazepin Heumann, Eslicarbazepin Neuraxpharm, Eslicarbazepin Puren

Key facts
Active substance
Eslicarbazepine acetate
Drug class
Anticonvulsant agent
ATC code
N03AF04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Zebinix 200 mg tablets · Zebinix 400 mg tablets · Zebinix 600 mg tablets · Zebinix 800 mg tablets · Zebinix 50 mg/ml oral suspension
Marketing authorisation holder
BIAL - Portela & Ca, S.A.
Information as of
2026-10-29

Key facts

Eslicarbazepine acetate (Zebinix) is a carboxamide antiepileptic used to treat partial-onset seizures in adults and children above 6 years of age.

What it is used for

  • Monotherapy of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.
  • Adjunctive therapy in adults, adolescents and children above 6 years with partial-onset seizures with or without secondary generalisation.

Dosing

  • Adults (tablets or suspension): start with 400 mg once daily, increased to 800 mg once daily after one or two weeks; up to 1,200 mg once daily depending on response, and some patients on monotherapy may benefit from 1,600 mg once daily.
  • Children above 6 years: start with 10 mg/kg/day once daily, increase in weekly or bi-weekly steps of 10 mg/kg/day up to 30 mg/kg/day; maximum 1,200 mg once daily. From 60 kg body weight, adult dosing.
  • Renal impairment: CLCR 30-60 ml/min start with 200 mg once daily or 400 mg every other day for 2 weeks, then 400 mg once daily; CLCR <30 ml/min not recommended.
  • Elderly: 1,600 mg monotherapy not recommended; severe hepatic impairment: not recommended.
  • With or without food; withdraw gradually.

Contraindications

  • Hypersensitivity to the active substance, other carboxamide derivatives (e.g. carbamazepine, oxcarbazepine) or any excipient.
  • Second or third degree atrioventricular (AV) block.

Important warnings

  • Suicidal ideation and behaviour may occur; monitor patients.
  • Dizziness and somnolence may increase the risk of accidental injury.
  • Severe cutaneous reactions (SJS/TEN, DRESS); screen for HLA-B*1502 in Han Chinese and Thai patients whenever possible.
  • Hyponatraemia (1.5% of patients), dose-related; discontinue if clinically relevant.
  • PR interval prolongation; caution in relevant conditions.

Side effects

  • Most common: dizziness, somnolence, headache and nausea, usually mild to moderate and mainly in the first weeks of treatment.
  • 51% of patients in clinical studies experienced adverse reactions.
  • Post-marketing: severe cutaneous reactions including SJS/TEN and DRESS.

Interactions

  • Do not combine with oxcarbazepine.
  • Reduces exposure to combined oral contraceptives (levonorgestrel, ethinylestradiol).
  • Induces CYP3A4 (e.g. simvastatin may need a higher dose); phenytoin lowers eslicarbazepine levels and eslicarbazepine increases phenytoin exposure; carbamazepine: more adverse reactions possible.

Pregnancy and breastfeeding

  • Women of childbearing potential must use adequate contraception during treatment and until the end of the current menstrual cycle after stopping.
  • General risks of epilepsy and antiepileptics in pregnancy apply – see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ZebinixBIAL - Portela & Ca, S.A. · EMEA/H/C/000988

Source: European Medicines Agency (EMA), product information

Austria

  • EslibonG.L. Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • EslibonG.L. Pharma Gmbh · 1 register entry
  • Eslicarbazepin AlAliud Pharma Gmbh · 1 register entry
  • Eslicarbazepin AmaroxAmarox Pharma Gmbh · 1 register entry
  • Eslicarbazepin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Eslicarbazepin AscendAscend Gmbh · 1 register entry
  • Eslicarbazepin BetaBetapharm Arzneimittel Gmbh · 2 register entries
  • Eslicarbazepin HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Eslicarbazepin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
  • Eslicarbazepin PurenPuren Pharma Gmbh & Co. Kg · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 18 more European countries
Bulgaria
Еслибон
Cyprus
Esran
Czechia
Eslibon, Eslikarbazepin Neuraxpharm
Denmark
Arupsan, Eslicarbazepinacetat "stada"
France
Eslicarbazepine
Greece
Esran
Hungary
Eslicarbazepine
Iceland
Eslicarbazepin, Eslicarbazepine Acetate Stada, Zebinix
Italy
Arupsan, Eslicarbazepina Acetato Aurobindo, Eslicarbazepina Doc
Liechtenstein
Zebinix
Malta
Esran
Netherlands
Eslibon
Norway
Zebinix
Poland
Eslibon
Portugal
Acetato De Eslicarbazepina Alter, Acetato De Eslicarbazepina Aristo, Acetato De Eslicarbazepina Generis, Acetato De Eslicarbazepina Jubilant, Acetato De Eslicarbazepina Mylan Pharma, Acetato De Eslicarbazepina Pentafarma, Acetato De Eslicarbazepina Pharmakern, Arupsan, Bixcar, Escarpilo, Esran
Slovakia
Eslibon
Spain
Arupsan, Bixcar, Escarpilo, Eslicarbazepina Acetato Aurovitas, Eslicarbazepina Alter, Eslicarbazepina Cinfa, Eslicarbazepina Normon, Eslicarbazepina Stada, Eslicarbazepina Tarbis, Eslicarbazepina Tecnigen, Eslicarbazepina Teva, Eslicarbazepina Zentiva, Eslicarbazepine, Eslipimad, Esran, Feoxan, Zekilep
Sweden
Arupsan

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Zebinix – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/zebinix-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. Wikidata (CC0): ATC N03AF.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.