RESOTRANS Film-coated tablet Ref.[50730] Active ingredients: Prucalopride

Dosage

RESOTRANS film-coated tablets are for oral use and can be taken with or without food.

Adults

2 mg once daily.

Elderly (>65 years)

Start with one 1 mg tablet once daily (see section 5.2); if needed the dose can be increased to 2 mg once daily.

Children and adolescents

RESOTRANS is not recommended in children and adolescents younger than 18 years.

Patients with renal impairment

The dose for patients with severe renal impairment (GFR <30 mL/min/1.73m²) 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

The dose for patients with severe hepatic impairment (ChildPugh class C) is 1 mg once daily (see sections 4.4 and 5.2). No dose adjustment is required for patients with mild to moderate hepatic impairment. Due to the specific mode of action of RESOTRANS (stimulation of propulsive motility), exceeding the daily dose of 2 mg is not expected to increase efficacy.

Treatment Duration

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

The efficacy of RESOTRANS has been established in double-blind placebo controlled studies for up to 3 months. In case of prolonged treatment, the benefit should be reassessed at regular intervals.

In a study in healthy subjects, treatment with RESOTRANS was well tolerated when given in an up-titrating scheme up to 20mg once daily (10 times the recommended therapeutic dose). An overdose may result in symptoms resulting from an exaggeration of the medicinal product’s known pharmacodynamic effects and include headache, nausea and diarrhoea. Specific treatment is not available for RESOTRANS 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.

For advice on the management of overdosage, please contact the National Poisons Centre on 0800 POISON (0800 764766).

36 months.

RESOTRANS tablets should be kept out of reach of children. Store below 30°C. Protect from moisture.

Both strengths of RESOTRANS film-coated tablets are available in aluminium/aluminium perforated unit dose blisters containing 7 tablets. Each pack contains 28 film-coated tablets.

No special requirements.