Exelon®
Active ingredient: Rivastigmine
Marketing authorisation holder: Novartis Europharm Ltd
Availability: Private Sector
Variations: The SmPC of the oral solution was updated to state that patients suffering from hepatic or renal
impairment may experience more adverse effects. Since no studies have been carried out in patients suffering
from severe hepatic impairment, these patients shall be closely monitored. Section 4.2 of the SmPC of oral
formulations was amended to include that dosage adjustment is not required in patients suffering from mild to
moderate renal or hepatic impairment. Due to the fact that patients with clinically significant hepatic or renal
impairment may encounter more adverse effects, dosage regimen may be titrated according to individual
tolerability. This is due to increased exposure in these populations.
The following adverse effects were included in the undesirable effects list in the SmPC: dehydration, hepatitis,
aggression, restlessness and sick sinus syndrome. Their frequency was set as unknown. The adverse effect
“anxiety” which was already listed for the transdermal patch formulation is now applicable for the oral
formulations.
The warning of gastrointestinal disturbances that may be experienced on initiation of treatment and step-up
dosage strength in treatment was added in the SmPC. These effects are dose-related and affects mostly the
female gender. Dehydration should be prevented as it can lead to serious consequences. In such circumstances,
the patient should be managed on IV fluids and dose reduction or discontinuation.
Patients suffering from Alzheimer’s disease experience weight loss which may be further aggravated with
cholinesterease inhibitors. Therefore these patients should have their weight monitored during treatment.
Reference: European Medicines Agency. Exelon. [online]. 2011 Aug 4 [cited 2011 Aug 23]; Available from: URL:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000169/human_med_000777.jsp&murl=menus/medicine
s/medicines.jsp&mid=WC0b01ac058001d124