Active Substance: prucalopride succinate
Common Name: prucalopride
ATC Code: A06AX05
Marketing Authorisation Holder: Shire Pharmaceuticals Ireland Limited
Active Substance: prucalopride succinate
Authorisation Date: 2009-10-15
Therapeutic Area: Constipation
Pharmacotherapeutic Group: Other drugs for constipation
Resolor is indicated for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.
What is Resolor?
Resolor is a medicine that contains the active substance prucalopride. It is available as tablets (1 and 2Â mg).
What is Resolor used for?
Resolor is used to treat symptoms of chronic (long-term) constipation in women for whom laxatives (medicines that trigger bowel movements) do not work well enough.
The medicine can only be obtained with a prescription.
How is Resolor used?
The recommended dose of Resolor is 2 mg taken once a day. Women 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.
How does Resolor work?
The active substance in Resolor, prucalopride, is a â€˜5-HT4 receptor agonistâ€™. This means that it works like a substance in the body called 5-hydroxytryptamine (5HT, also known as serotonin) and attaches to the same receptors in the gut called â€˜5-HT4 receptorsâ€™. When it binds to these receptors, 5HT 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.
How has Resolor been studied?
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. The main measure of effectiveness 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.
What benefit has Resolor shown during the studies?
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 2Â 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 4Â mg was similar to those who took the 2Â mg dose.
What is the risk associated with Resolor?
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 Crohnâ€™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.
Why has Resolor been approved?
The CHMP decided that Resolorâ€™s benefits are greater than its risks and recommended that it be given marketing authorisation. The CHMP noted that almost all the patients in the main study were women and that new data are required to understand how the medicine works in men. Therefore, based on the available data, the Committee concluded that Resolor should only be indicated for women.
What measures are being taken to ensure the safe and effective use of Resolor?
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.
Other information about Resolor
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.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.