Resolor Film-coated Tablet 2 mg

DCH AURIGA SINGAPORE

DCH AURIGA SINGAPORE

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** **Dosage** _**Adults**_ 2 mg once daily _**Elderly (> 65 years)**_ Start with 1 mg once daily (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_); if needed the dose can be increased to 2 mg once daily. _**Children and adolescents**_ RESOLOR® is not recommended in children and adolescents younger than 18 years (see _Pediatric Population_ and _Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**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 _Contraindications_ and _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose adjustment is required for patients with mild to moderate renal impairment. _**Patients with hepatic impairment**_ The dose for patients with severe hepatic impairment (Child-Pugh class C) is 1 mg once daily (see _Warnings and Precautions_ and _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No dose adjustment is required for patients with mild to moderate hepatic impairment. Due to the specific mode of action of prucalopride (stimulation of propulsive motility) exceeding the daily dose of 2mg is not expected to increase in efficacy. It has also been shown in clinical trials, a doubling of the daily dose to 4mg did not lead to an increase in 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. If treatment is continued longer than 3 months, the benefit should be reassessed at regular intervals. **Administration** RESOLOR® film-coated tablets are for oral use and can be taken with or without food.