Resolor
Authorised
This medicine is authorised for use in the European Union
prucalopride
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Resolor. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Resolor.
Resolor is a medicine that contains the active substance prucalopride. It is available as tablets (1 and 2 mg).
Resolor is used to treat symptoms of chronic (long-term) constipation in adults for whom laxatives (medicines that trigger bowel movements) do not work well enough.
The medicine can only be obtained with a prescription.
The recommended dose of Resolor is 2 mg taken once a day. Patients aged over 65 years should start with a 1 mg dose once a day, and this can be increased to 2 mg once a day if needed.
The active substance in Resolor, prucalopride, is a ‘5-HT4 receptor agonist’. This means that it works like a substance in the body called 5-hydroxytryptamine (5-HT, also known as serotonin) and attaches to receptors for 5-HT in the gut called ‘5-HT4 receptors’.
When 5-HT binds to these receptors, it normally stimulates movement in the gut. In the same way, when prucalopride attaches to and stimulates these receptors, it increases this movement and allows the bowels to empty faster.
Resolor (2 or 4 mg once a day) was compared with placebo (a dummy treatment) in three main studies involving 1,999 patients with chronic constipation, 88% of whom were women. The patients had not responded well enough to previous treatment with laxatives.
Resolor 2 mg once a day was also compared with placebo in another main study involving 374 men with chronic constipation.
The main measure of effectiveness in the studies was the number of patients who completely emptied their bowels at least three times a week over a 12 week period without the help of laxatives.
Resolor was more effective than placebo at treating chronic constipation. Over the 12-week period, 24% (151 out of 640) of patients who received Resolor 2 mg completely emptied their bowels at least three times a week, compared with 11% (73 out of 645) of patients who received placebo. The result from patients who received Resolor at the higher dose of 4 mg was similar to those who took the 2 mg dose.
In the study of men with chronic constipation, 38% of patients treated with Resolor 2 mg (67 out of 177) completely emptied their bowels at least three times a week, compared with 18% of those given placebo (32 out of 181).
The most common side effects with Resolor (seen in more than 1 patient in 10) are headache, nausea (feeling sick), diarrhoea and abdominal (tummy) pain. For the full list of all side effects reported with Resolor, see the package leaflet.
Resolor must not be used in patients with kidney problems requiring dialysis (a blood clearance technique). It must also not be used in patients with intestinal perforation or obstruction, severe inflammatory conditions of the intestines such as Crohn’s disease, ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding) and toxic megacolon and megarectum (very serious complications of colitis). For the full list of restrictions, see the package leaflet.
The CHMP decided that Resolor’s benefits are greater than its risks and recommended that it be given marketing authorisation.
A risk-management plan has been developed to ensure that Resolor is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Resolor, including the appropriate precautions to be followed by healthcare professionals and patients.
The European Commission granted a marketing authorisation valid throughout the European Union for Resolor on 15 October 2009.
For more information about treatment with Resolor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IAIN/0057
14/12/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Resolor
- Active substance
- Prucalopride succinate
- International non-proprietary name (INN) or common name
- prucalopride
- Therapeutic area (MeSH)
- Constipation
- Anatomical therapeutic chemical (ATC) code
- A06AX05
Pharmacotherapeutic group
Other drugs for constipationTherapeutic indication
Resolor is indicated for symptomatic treatment of chronic constipation in adults in whom laxatives fail to provide adequate relief.
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