Posology : מינונים

4.2    Posology and method of administration

Posology
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.

If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered.

The efficacy of prucalopride has been established in double-blind, placebo-controlled studies for up to 3 months. Efficacy beyond three months has not been demonstrated in placebo-controlled studies (see Section 5.1). In case of prolonged treatment, the benefit should be reassessed at regular intervals.
Special populations
Older people (>65 years): Start with 1 mg once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.

Patients with renal impairment: The dose for patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) is 1 mg once daily (see sections 4.3 and 5.2). No dose adjustment is required for patients with mild to moderate renal impairment.

Patients with 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 (see sections 4.4 and 5.2). No dose adjustment is required for patients with mild to moderate hepatic impairment.

Paediatric population: Resolor should not be used in children and adolescents younger than 18 years (see section 5.1).

Method of administration
Oral use