Donepezil containing medicinal products: Addition to the product safety information regarding cardiac conductions disorders including QT prolongation and Torsade de Pointes.

Summary 

• There have been post-marketing reports of QTc interval prolongation and Torsade de Pointes in association with donepezil therapy
• Caution is advised in patients with pre-existing or family history of QTc prolongation
• Caution is advised in patients with concomitant treatment with medicinal products that affect the QTc interval or induce bradycardia
• Caution is advised in patients with relevant heart disease or electrolyte disturbances. At risk patients should be considered for monitoring with electrocardiograms (ECG).
• Addition of undesirable effects: Polymorphic ventricular tachycardia including Torsade de Pointes, Electrocardiogram QT interval prolonged
• Update of Drug interactions