What is Resolor?
Resolor is a medicine that contains the active substance prucalopride. It is available as round tablets (white: 1 mg and pink: 2 mg).
What is Resolor used for?
Resolor is used to treat the symptoms of chronic (long-term) constipation in women for whom laxatives (medicines that stimulate bowel movement) fail to provide adequate relief.
The medicine can only be obtained with a prescription.
How is Resolor used?
The recommended dose of Resolor is 2 mg once a day. Women over the age of 65 should start by taking a 1 mg dose once a day; treatment can be increased to 2 mg once daily if needed.
Resolor can be taken at any time of the day, regardless of food intake.
How does Resolor work?
The active substance in Resolor, prucalopride, is a '5-HT4 receptor agonist'. This means that it acts as a substance in the body called 5-hydroxytryptamine (5HT, also called serotonin) and binds to the same receptors in the "gut called" 5-HT4 receptors. "When it binds to these receptors, 5HT normally stimulates movement in the" gut. " intestine. Likewise, when prucalopride binds to and stimulates these receptors, it increases this movement and allows the bowel to empty more quickly.
How has Resolor been studied?
The effects of Resolor were first tested in experimental models before being studied in humans.
In three main studies involving 1,999 patients with chronic constipation, of which 88% were women, Resolor (2 or 4 mg once daily) was compared with placebo (a dummy treatment). they had responded fairly well to previous laxative treatments. The main measure of effectiveness was the number of patients who overall emptied their bowels at least three times over a 12-week period without the aid of laxatives.
What benefit has Resolor shown during the studies?
Resolor was more effective than placebo in treating chronic constipation. Over a 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 took placebo The result obtained by patients who took Resolor at the higher dose of 4 mg was similar to that of those who took the 2 mg dose.
What is the risk associated with Resolor?
The most common side effects seen with Resolor (seen in more than 1 in 10 patients) are headache, nausea, diarrhea and abdominal pain. For the full list of side effects reported with Resolor, see the package leaflet.
Resolor should not be used in people who may be hypersensitive (allergic) to prucalopride or any other ingredient. It must not be used in patients with kidney problems who are undergoing dialysis (a blood clearance technique). It should also not be used in patients with intestinal perforation or obstruction, severe inflammatory bowel conditions such as Crohn's disease, ulcerative colitis (inflammation of the large intestine which causes ulceration and bleeding), as well as toxic megacolon and megarectum (a very serious complication of colitis).
Why has Resolor been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that almost all the patients in the main study were women and that new information is needed to understand how the medicine works in men. Based on the available data, the CHMP decided that the Resolor's benefits outweigh its risks in treating symptoms of chronic constipation in women for whom laxatives do not provide adequate relief. The Committee recommended that Resolor be given a marketing authorization.
Other information about Resolor:
On 15 October 2009, the European Commission granted Movetis NV a "marketing authorization" for Resolor, valid throughout the European Union.
For the full version of Resolor's EPAR, click here.
Last update of this summary: 09-2009.
The information on Resolor - prucalopride published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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