PRUTAS

What it is

PRUTAS contains prucalopride (as succinate), available as 1 mg or 2 mg film-coated tablets.

Approved indications

— Treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

Dosing overview

The recommended dose for adults is 2 mg once daily. In elderly patients over 65 years, treatment should start with 1 mg once daily, with the option to increase to 2 mg once daily if needed. Patients with severe hepatic impairment (Child-Pugh class C) should receive 1 mg once daily. Patients with severe renal impairment (GFR < 30 mL/min/1.73m²) should receive 1 mg once daily. PRUTAS tablets are for oral use and can be taken with or without food.

Key safety warnings

Suicides, suicide attempts and suicidal ideation have been reported in clinical trials and post-market experience, although a causal association between treatment with PRUTAS and suicidal ideation and behaviour has not been established. Patients should be monitored for persistent worsening of depression or the emergence of suicidal thoughts and behaviours. PRUTAS should be used with caution in patients with a history of arrhythmias or ischaemic cardiovascular disease. PRUTAS should be used with caution in patients receiving concomitant drugs known to cause QTc prolongation. The most frequently reported adverse reactions are headache and gastrointestinal symptoms (abdominal pain, nausea or diarrhoea) occurring in approximately 20% of patients each, predominantly at the start of therapy and usually disappearing within a few days with continued treatment. In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception.

Contraindications

PRUTAS is contraindicated in patients with 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 and active severe inflammatory conditions of the intestinal tract such as Crohn's disease and ulcerative colitis and toxic megacolon/megarectum, and recent bowel surgery.

PBS listing

No PBS listing information is available in the provided sources.

Regulatory history

PRUTAS prucalopride 1 mg and 2 mg film-coated tablets were first listed on the ARTG on 12 September 2022.