RESOLOR FILM-COATED TABLET 2 MG [SIN14104P]

Product Info

RESOLOR FILM-COATED TABLET 2 MG

[SIN14104P]

Indications
RESOLOR® is indicated for symptomatic treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief.

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.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Renal impairment requiring dialysis.

• Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon/megarectum.