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entacapone

Comtan, Comtess, Entacapone Orion · ATC code N04BX02

Also known as: Entacapon, Entakapon

Key facts
Active substance
entacapone
Drug class
Dopaminergic
ATC code
N04BX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Comtan 200 mg film-coated tablets · Comtess 200 mg film-coated tablets · Entacapone Orion 200 mg film-coated tablets
Marketing authorisation holder
Orion Corporation
Information as of
2026-10-28

Key facts

Entacapone (Comtan, Comtess, Entacapone Orion) is a COMT inhibitor that prolongs the effect of levodopa and is used as an add-on in Parkinson's disease with end-of-dose fluctuations.

What it is used for

  • Adjunct to standard levodopa/benserazide or levodopa/carbidopa in adults with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Dosing

  • One 200 mg tablet with each levodopa/dopa decarboxylase inhibitor dose; maximum 200 mg ten times daily, i.e. 2,000 mg of entacapone.
  • Because entacapone enhances levodopa, the daily levodopa dose often needs to be reduced by about 10–30% within the first days to weeks; patients on levodopa/benserazide may need a larger reduction.
  • Renal impairment: no adjustment; a longer dosing interval may be considered in dialysis. Elderly: no adjustment.
  • When stopping, adjust other antiparkinsonian treatment, especially levodopa; withdraw slowly.

Contraindications

  • Hypersensitivity to the active substance or any excipient (for Comtess and Entacapone Orion also to peanut or soya).
  • Hepatic impairment; phaeochromocytoma.
  • Concomitant non-selective MAO inhibitors (e.g. phenelzine, tranylcypromine) or a selective MAO-A plus a selective MAO-B inhibitor.
  • History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.

Important warnings

  • Neuroleptic malignant syndrome, especially after abrupt reduction or discontinuation – withdraw dopaminergic therapy slowly.
  • Caution in ischaemic heart disease and with medicines metabolised by COMT.
  • Somnolence and sudden sleep onset with levodopa; caution when driving.
  • Prolonged or persistent diarrhoea may indicate colitis; monitor weight.
  • Monitor regularly for impulse control disorders (e.g. pathological gambling, hypersexuality, compulsive buying, binge eating).

Side effects

  • More often than with placebo: dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%).
  • Dopaminergic reactions occur mostly at the start of treatment and decrease with levodopa reduction.
  • Reddish-brown urine discolouration (harmless).

Interactions

  • Caution with COMT substrates (e.g. adrenaline, noradrenaline, dopamine, dobutamine, isoprenaline, alpha-methyldopa, apomorphine) and with tricyclic antidepressants and noradrenaline reuptake inhibitors.
  • May be used with selegiline, but the selegiline daily dose should not exceed 10 mg.
  • Entacapone may form chelates with iron in the gastrointestinal tract; for spacing of doses see the full text.

Pregnancy and breastfeeding

  • Should not be used during pregnancy; women should not breast-feed during treatment.

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 →

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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)

Source: European Medicines Agency (EMA), product information

Germany

  • Entacapon HecHec Pharm Gmbh · 1 register entry

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

Brand names in 14 more European countries
Croatia
Entakapon Hec
Cyprus
Encapia
Denmark
Entacapone Viatris
Finland
Entacapone Orion Pharma
France
Entacapone Arrow, Entacapone Viatris
Iceland
Comtan, Comtess, Entacapone Orion, Entacapone Teva
Liechtenstein
Comtan, Comtess, Entacapone Orion, Entacapone Teva
Lithuania
Medapia
Malta
Medapia
Netherlands
Encapia, Entacapone Unichem, Entacapone Viatris
Norway
Comtan, Comtess, Entacapone Orion, Entacapone Teva
Portugal
Entacapona Aurobindo, Medapia
Spain
Entacapona Viatris, Medapia
Sweden
Entacapone Viatris

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. Comtan – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/comtan-epar-product-information_en.pdf
  2. European Medicines Agency. Comtess – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/comtess-epar-product-information_en.pdf
  3. European Medicines Agency. Entacapone Orion – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/entacapone-orion-epar-product-information_en.pdf
  4. 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
  5. Wikidata (CC0): ATC N04BX.

Editorial: Medelix editorial team · last updated 2026-10-28 · 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.