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In a pooled analysis of placebo-controlled studies in patients with Alzheimer’s dementia treated with galantamine an increased incidence of certain cardiovascular adverse events were observedsee section 4.8
Data from clinical trials in patients indicate that the plasma concentrations of galantamine in patients with Alzheimer’s disease are 30to 40higher than in healthy young subjects primarily due to the advanced age and reduced kidney functionBased upon the population pharmacokinetic analysisclearance in female subjects is 20lower as compared to malesThe galantamine clearance in poor metabolisers of CYP2D6 is about 25lower than in extensive metabolisersbut no bimodality in the population is observedThereforethe metabolic status of the patient is not considered to be of clinical relevance in the overall population.
Galantamine plasma consentrations may be increased in patients with moderate to severe hepatic impairmentsee section 5.2
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