Pracalog 1/Pracalog 2 Special Precautions

Use with caution in patients with a history of arrhythmia, ischemic cardiovascular disease, pre-excitation syndromes (e.g. Wolff- Parkinson-White syndrome) or AV nodal rhythm disorders.
Use with caution in severe hepatic impairment (Child-Pugh class C) initial dose reduction is recommended.
Use with caution in renal impairment dose reduction is recommended in severe impairment and contraindicated in patients requiring dialysis.
Use with caution in patients with severe and unstable concomitant disease (e.g. Cancer, AIDs, psychiatric, hepatic, pulmonary, insulin dependent diabetes mellitus) has not been studied.
Patients with severe or persistent diarrhea should discontinue therapy and consult health care provider.
Discontinue therapy if severe and/or worsening abdominal symptoms, bloody diarrhea, or rectal bleeding and advise patient to discontinue treatment and consult health care provider.
May cause CNS depression (particularly during the first day of treatment), which may impair physical or mental abilities, patients must be cautioned about performing tasks that require mental alertness (e.g. operating machine or driving).
Pracalog 1 and Pracalog 2 contain lactose, do not use in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndromes
Effects on ability to drive and use machines: No studies on the effects of prucalopride on the ability to drive and use machines have been performed. Prucalopride has been associated with dizziness and fatigue particularly during the first day of treatment which may have an effect on driving and using machines.