MedeliX
Start asking

opicapone

Ongentys · ATC code N04

Also known as: Opicapon, Opikapon

Key facts
Active substance
opicapone
ATC code
N04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ongentys 25 mg hard capsules / Ongentys 50 mg hard capsules
Marketing authorisation holder
Bial - Portela Cª, S.A.
Information as of
2026-10-29

Key facts

Opicapone (Ongentys) is a COMT inhibitor that prolongs the effect of levodopa and is used in Parkinson's disease with motor fluctuations.

What it is used for

  • Adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in adults with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

Dosing

  • 50 mg once daily at bedtime, at least one hour before or after levodopa combinations; capsules swallowed whole with water.
  • Levodopa often needs adjusting within the first days to weeks (longer dosing intervals and/or smaller doses).
  • A missed dose should not be made up.
  • No dose adjustment in the elderly (caution at ≥ 85 years), renal impairment or mild hepatic impairment; caution in moderate hepatic impairment, not recommended in severe.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Phaeochromocytoma, paraganglioma or other catecholamine-secreting neoplasms.
  • History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.
  • Concomitant MAO inhibitors (e.g. phenelzine, tranylcypromine, moclobemide) other than those for Parkinson's disease.

Important warnings

  • Enhances levodopa effects: dopaminergic reactions such as dyskinesia, hallucinations, nausea and orthostatic hypotension may occur; levodopa may need reducing, and readjusting if opicapone is stopped.
  • Impulse control disorders (e.g. pathological gambling, hypersexuality, compulsive buying, binge eating) can occur; regular monitoring.
  • With progressive anorexia, asthenia and weight decrease, liver function should be evaluated.
  • Contains lactose.

Side effects

  • Most common are nervous system disorders; dyskinesia was the most frequent adverse reaction (17.7%).
  • Common: dizziness, headache, somnolence, abnormal dreams, hallucination, insomnia, orthostatic hypotension, constipation, dry mouth, nausea, vomiting, muscle spasms.

Interactions

  • Non-Parkinson MAO inhibitors are contraindicated; rasagiline (up to 1 mg/day) and selegiline (up to 10 mg/day orally) are permissible.
  • May interfere with metabolism of catechol-containing medicines (e.g. adrenaline, noradrenaline, dopamine, dobutamine), potentiating their effects.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women not using contraception.
  • Breast-feeding should be discontinued 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 →

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)

  • OngentysBial - Portela Cª, S.A. · EMEA/H/C/002790

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Ongentys
Liechtenstein
Ongentys
Norway
Ongentys

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.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Ongentys – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_en.pdf

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.