pramipexole
Mirapexin, Sifrol · ATC code N04BC05
Also known as: Pramipexol · Brand names: Mirapexin, Sifrol, Pramipexol Actavis, Pramipexol Stada, Pramipexol Al, Pramipexol Hexal, Pramipexol Tad, Pacto, Parkipex, Parkyn, Parson, Pexa, Pexola, Pidrex, Pradose …
- Key facts
- Active substance
- pramipexole
- Drug class
- Dopamine agonist
- ATC code
- N04BC05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- MIRAPEXIN 0.088 mg tablets / MIRAPEXIN 0.18 mg tablets / MIRAPEXIN 0.35 mg tablets · MIRAPEXIN 0.26 mg prolonged-release tablets / MIRAPEXIN 0.52 mg prolonged-release tablets / MIRAPEXIN 1.05 mg prolonged-release tablets · SIFROL 0.088 mg tablets / SIFROL 0.18 mg tablets / SIFROL 0.35 mg tablets · SIFROL 0.26 mg prolonged-release tablets / SIFROL 0.52 mg prolonged-release tablets / SIFROL 1.05 mg prolonged-release tablets
- Marketing authorisation holder
- Boehringer Ingelheim International GmbH
- Information as of
- 2026-10-27
Key facts
Pramipexole is a dopamine agonist (Sifrol, Mirapexin). It is used in adults for Parkinson's disease and, as immediate-release tablets, for moderate to severe restless legs syndrome.
What it is used for
- Idiopathic Parkinson's disease in adults, alone or with levodopa, through to late stages with fluctuations
- Immediate-release tablets: moderate to severe idiopathic restless legs syndrome at doses up to 0.54 mg base (0.75 mg salt)
Dosing
- Tablets in Parkinson's: daily dose in 3 divided doses; start at 0.264 mg base (0.375 mg salt) per day, increased every 5-7 days
- Prolonged-release tablets in Parkinson's: once daily; start at 0.26 mg base (0.375 mg salt) per day, increased every 5-7 days
- Titrate to maximal therapeutic effect without intolerable effects; schedules and maximum doses are in the full text
- Reduced dose in renal impairment
- With levodopa: reduce the levodopa dose while increasing pramipexole
Contraindications
- Hypersensitivity to the active substance or any of the excipients
Important warnings
- Sudden onset of sleep and somnolence: caution when driving; affected patients must not drive
- Impulse control disorders (gambling, hypersexuality, compulsive buying, binge eating): monitor regularly
- Hallucinations, mania and delirium
- Dyskinesia with levodopa; axial dystonia
- Avoid co-administration of antipsychotics; care in severe cardiovascular disease
Side effects
- Parkinson's, most common (≥ 5%): nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache, fatigue
- Hypotension especially with too rapid titration
- Impulse control disorders, sudden onset of sleep
- Restless legs syndrome: augmentation may occur
Interactions
- Inhibitors of renal elimination (e.g., cimetidine, amantadine, mexiletine, zidovudine, cisplatin, quinine, procainamide): consider dose reduction
- Additive effects with sedating medicines or alcohol
- No pharmacokinetic interaction with selegiline and levodopa
Pregnancy and breastfeeding
- Should not be used during pregnancy unless clearly necessary
- Inhibition of lactation is expected (prolactin suppression)
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- MirapexinBoehringer Ingelheim International GmbH · EMEA/H/C/000134
- Oprymea · genericKrka, d.d., Novo mesto · EMEA/H/C/000941
- Pramipexole Teva · genericTeva Pharma B.V. · EMEA/H/C/000940
- SifrolBoehringer Ingelheim International GmbH · EMEA/H/C/000133
Source: European Medicines Agency (EMA), product information
Austria
- Pramipexol ActavisActavis Group Ptc Ehf. · 1 register entry
- Pramipexol StadaStada Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Pramipexol AlAliud Pharma Gmbh · 1 register entry
- Pramipexol HexalHexal Ag · 1 register entry
- Pramipexol StadaStadapharm Gmbh · 1 register entry
- Pramipexol TadTad Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- PactoNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 4 register entries
- ParkipexGENVEON İLAÇ SAN. VE TİC. A.Ş. · 11 register entries
- ParkynABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
- ParsonULKAR İLAÇ PAZARLAMA LTD. ŞTİ. · 1 register entry
- PexaALİ RAİF İLAÇ SAN. A.Ş. · 10 register entries
- PexolaBOEHRİNGER INGELHEİM İLAÇ TİC. A.Ş. · 7 register entries
- PidrexSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 16 register entries
- PradoseSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 6 register entries
- PramituONKO İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- PranowVİTALİS İLAÇ SAN. TİC. A.Ş. · 6 register entries
- RamipexDEVA HOLDİNG A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 16 more European countries
- Belgium
- Pramipexol, Pramipexole Eg
- Denmark
- Pramipexol Stada, Pramipexole Stada
- Finland
- Pramipexol
- France
- Pramipexole Eg
- Greece
- X-Tremble
- Hungary
- Pramipexol Stada
- Iceland
- Oprymea, Pramipexol Stada, Pramipexole Stada
- Ireland
- Miramel
- Italy
- Pramiperal, Pramipexolo Eg, Pramipexolo Pensa
- Latvia
- Pramipexole Elvim
- Luxembourg
- Pramipexol Eg, Pramipexole Eg
- Norway
- Oprymea
- Romania
- Pramipexol Arena, Pramipexol Stada
- Slovakia
- Pramipexol Stada
- Spain
- Pramipexol Pensa, Pramipexol Sandoz Farmacéutica, Pramipexol Stada
- Sweden
- Pramipexol Stada
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Mirapexin – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/mirapexin-epar-product-information_en.pdf
- European Medicines Agency. Sifrol – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sifrol-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N04BC.
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.