Adults: 2 mg once daily with or without food, at any time of the day. Due to the specific mode of action of prucalopride (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.

Older people: Start with 1 mg once daily; if needed the dose can be increased to 2 mg once daily.

Children: Prucalopride should not be used in children and adolescents younger than 18 years

In-vitro data indicate that, Prucalopride has a low interaction potential and therapeutic concentrations of Prucalopride are not expected to affect the CYP-mediated metabolism of co medicated medicinal products. Although Prucalopride may be a weak substrate for P-glycoprotein (P-gp), it is not an inhibitor of P-gp at clinically relevant concentrations.

Ketoconazole (200 mg b.i.d.), a potent inhibitor of CYP3A4 and of P-gp, increased the systemic exposure to prucalopride by approximately 40%. This effect is too small to be clinically relevant. Interactions of similar magnitude may be expected with other potent inhibitors of P-gp such as verapamil, cyclosporine A and quinidine.

Studies in healthy subjects showed that, there were no clinically relevant effects of Prucalopride on the pharmacokinetics of warfarin, digoxin, alcohol, paroxetine or oral contraceptives.

• Renal excretion is the main route of elimination of prucalopride. A dose of 1 mg is recommended in subjects with severe renal impairment.
• Caution should be exercised when prescribing Prucalopride to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment.
• In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.
• The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Renal Impairment: The dose for patients with severe renal impairment (GFR <30 ml/min/1.73 m²) is 1 mg once daily. No dose adjustment is required for patients with mild to moderate renal impairment.

Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class C) start with 1 mg once daily which may be increased to 2 mg if required to improve efficacy and if the 1 mg dose is well tolerated. No dose adjustment is required for patients with mild to moderate hepatic impairment.