Sweden - Reports of central nervous system disorders, including confusion, hallucinations, psychosis, agitation, seizures, and impaired coordination, have been made to the Swedish adverse drug reactions data base at the Medicines Products Agency.

Many of the affected patients had renal insufficiency and most were aged over 60 years of age. Approximately half the patients with renal insufficiency who experienced CNS effects received higher than recommended dosages of the drugs; the product information states that the dosage should be adjusted to a patient’s degree of renal insufficiency. Concomitant psychoactive medications could also be a risk factor. Such adverse reactions can be treated with haemodialysis, which results in symptomatic improvement.

Reference: Medicines Products Agency, 12: 30, February 2001.