prucalopride
Resolor · ATC code A06AX05
Also known as: Prucaloprid · Brand names: Resolor, Prucaloprid Al, Prucaloprid Aristo, Prucaloprid Axunio, Prucaloprid Dexcel, Prucaloprid Zentiva, Prucalopride Holsten
- Key facts
- Active substance
- prucalopride
- ATC code
- A06AX05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Resolor 1 mg film-coated tablets. · Resolor 2 mg film-coated tablets
- Marketing authorisation holder
- Takeda Pharmaceuticals International AG Ireland
- Information as of
- 2026-10-27
Key facts
Prucalopride is a serotonin 5-HT4 receptor agonist that stimulates propulsive gut motility (Resolor film-coated tablets). It is used in adults with chronic constipation when laxatives fail to provide adequate relief.
What it is used for
- Symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief
Dosing
- Adults: 2 mg once daily, with or without food, at any time of day; higher doses are not expected to increase efficacy
- Older people (>65 years): start 1 mg once daily, increase to 2 mg if needed
- Severe renal impairment (GFR <30 ml/min/1.73 m2): 1 mg once daily
- Severe hepatic impairment (Child-Pugh C): start 1 mg, may increase to 2 mg
- If not effective after 4 weeks, reconsider the benefit; not for patients under 18 years
Contraindications
- Hypersensitivity to the active substance or any excipient
- Renal impairment requiring dialysis
- Intestinal perforation or obstruction, obstructive ileus, severe inflammatory bowel conditions (Crohn's disease, ulcerative colitis) and toxic megacolon/megarectum
Important warnings
- Caution in severe hepatic impairment (limited data)
- Caution in severe, clinically unstable concomitant disease, especially with a history of arrhythmias or ischaemic cardiovascular disease
- Severe diarrhoea may reduce oral contraceptive efficacy; an additional method is recommended
- Contains lactose
Side effects
- Most frequent: headache (17.8%), abdominal pain (13.7%), nausea (13.7%), diarrhoea (12.0%), mainly at the start of therapy
- Common: decreased appetite, dizziness, vomiting, dyspepsia, flatulence, fatigue
- Uncommon: tremors, palpitations, rectal haemorrhage, pollakiuria
Interactions
- Low pharmacokinetic interaction potential
- Erythromycin plasma concentrations increased by 30% during co-administration
- Ketoconazole increased prucalopride exposure by approximately 40% (not clinically relevant)
Pregnancy and breastfeeding
- Pregnancy: not recommended; women of childbearing potential must use effective contraception
- Breast-feeding: excreted in breast milk; decide whether to stop breast-feeding or therapy
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)
- ResolorTakeda Pharmaceuticals International AG Ireland · EMEA/H/C/001012
Source: European Medicines Agency (EMA), product information
Germany
- Prucaloprid AlAliud Pharma Gmbh · 1 register entry
- Prucaloprid AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Prucaloprid AxunioAxunio Pharma Gmbh · 1 register entry
- Prucaloprid DexcelDexcel Pharma Gmbh · 1 register entry
- Prucaloprid ZentivaZentiva Pharma Gmbh · 1 register entry
- Prucalopride HolstenHolsten Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 20 more European countries
- Belgium
- Prucalopride Fagron, Prucalopride Koanaa Healthcare, Prucalopride Orifarm
- Bulgaria
- Енилис, Стеркор
- Croatia
- Abemot, Colopridix
- Cyprus
- Absken, Stercore
- Denmark
- Prucalopride "holsten", Prucalopride Amarox, Prucalopride Axunio, Prucalopride Orifarm, Prucalopride Stada, Prucalopride Zentiva
- Finland
- Prucalopride Stada
- France
- Prucalopride Amarox
- Greece
- Absken
- Hungary
- Prucalopride Supremex, Tsatsago
- Iceland
- Prucalopride Stada, Pucalopride Stada, Resolor
- Ireland
- Prucalopride
- Liechtenstein
- Resolor
- Malta
- Absken, Colopridix, Prucalopride, Stercore
- Netherlands
- Prucalopride Amarox, Prucalopride Fagron, Prucalopride Prolepha
- Norway
- Prucalopride Orifarm, Prucalopride Zentiva, Resolor
- Romania
- Colselax, Stercore
- Slovakia
- Stercore
- Slovenia
- Colopridix
- Spain
- Prucalopride Tarbis
- Sweden
- Prucalopride Amarox, Prucalopride Axunio, Prucalopride Holsten, Prucalopride Orifarm, Prucalopride Stada, Prukaloprid Evolan
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. Resolor – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/resolor-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
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.