RESOLOR Film-coated tablet Ref.[8877] Active ingredients: Prucalopride

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.

In a study in healthy volunteers, treatment with prucalopride was well tolerated when given in an up-titrating scheme up to 20 mg once daily (10 times the recommended therapeutic dose). An overdose may result in symptoms resulting from an exaggeration of prucalopride’s known pharmacodynamic effects and include headache, nausea and diarrhoea. Specific treatment is not available for Resolor overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

4 years.

Store in the original blister in order to protect from moisture.

Aluminium/aluminium perforated unit dose blisters (calendar marked) containing 7 tablets. Each pack contains 7 × 1, 14 × 1, 28 × 1 or 84 × 1 film-coated tablet.

Not all pack sizes may be marketed.

No special requirements.