Tokatz Special Precautions

Renal excretion is the main route of elimination of prucalopride (see Pharmacology: Pharmacokinetics under Actions). A dose of 1 mg is recommended in subjects with severe renal impairment (see Dosage & Administration).
There is limited information on the safety and efficacy of prucalopride for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders). Caution should be exercised when prescribing prucalopride to patients with these conditions especially when used in patients with a history of arrhythmias or ischaemic cardiovascular disease.
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 (see the prescribing information of the oral contraceptive).
Ischemic colitis is a potential and rare adverse event. No cases of ischemic colitis have been reported with prucalopride tablets during the clinical studies. Nonetheless, patients should be advised to discontinue prucalopride therapy and consult their physician if they develop severe, persistent, and/or worsening abdominal symptoms, bloody diarrhea or rectal bleeding.
The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Prucalopride may have a minor influence on the ability to drive and use machines, since dizziness and fatigue have been observed in clinical studies, particularly during the first day of treatment (see Adverse Reactions).