Resolor - prucalopride

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 whose laxatives (medicines that stimulate bowel movements) 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; the treatment can be increased to 2 mg once a day if necessary.

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 intestine called "5-HT4 receptors". When it binds to these receptors, 5HT normally stimulates movements in the intestine. Similarly, when prucalopride binds and stimulates these receptors, it increases this movement and allows the intestine to empty itself more quickly.

What studies have been carried out on Resolor?

The effects of Resolor were first analyzed 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 a day) was compared with placebo (a dummy treatment). The patients had not responded well enough to previous treatments with laxatives. The main measure of effectiveness was the number of patients who emptied their bowels altogether at least three times in a 12-week period without the help of laxatives.

What benefit has Resolor shown during the studies?

Resolor was more effective than placebo in the treatment of 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% of patients (73 out of 645) who took the placebo. The result obtained by patients who took Resolor at the highest 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 with Resolor (seen in more than 1 patient in 10) are headache, nausea, diarrhea and abdominal pain. For the full list of all 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 should not be used in patients with kidney problems on dialysis (a blood clearance technique). Nor should it 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 that causes ulceration and bleeding), as well as megacolon and toxic megarectum (very serious complication of colitis).

Why has Resolor been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that almost all of the patients in the main study were women and that new information is needed to understand how the medicine works in humans. Based on the available data, the CHMP decided that Resolor's benefits are greater than its risks for treating symptoms of chronic constipation in women who are not adequately relieved by laxatives. The committee recommended that Resolor be given marketing authorization.