Undesirable effects
The most common adverse events are diarrhea, muscle cramps, fatigue, nausea, vomiting and insomnia. The incidence profile for adverse events for severe Alzheimer’s disease is similar to that of mild to moderately severe Alzheimer’s disease. The table below reflects the incidence of
adverse events in patients receivibg treatment with Donepezil hydrochloride (ARICEPT®) for
all stages of Alzheimer’s disease.
Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,100), very rare (<1/10,000) and not known (cannot be estimated from available data).
* In investigating patients for syncope or seizure, the possibility of heart block or long sinusal pauses should be considered (see section 4.4)
** Reports of hallucinations, agitation, aggressive behavior have resolved on dose-reduction or discontinuation of treatment.
*** In cases of unexplained liver dysfunction, withdrawal of Donepezil hydrochloride (ARICEPT®) should be considered.
Reporting of Suspected Adverse Reactions
Please contact:
HI-Eisai Pharmaceutical, Inc.
+63 2 88875837 / +63 2 88875160 / +63 9088672236
Or Report to FDA Philippines: www.fda.gov.ph
Clinical Studies Experience
Donepezil hydrochloride (ARICEPT®) 23 mg tablets has been administered to over 1300 individuals globally in clinical trials. Approximately 1050 of these patients have been treated for at least three months and more than 950 patients have been treated for at least six months.
The range of patient exposure was from 1 to over 500 days.
Adverse Events Leading to Discontinuation
The rate of discontinuation from a controlled clinical trial of Donepezil hydrochloride (ARICEPT®) 23 mg tablets due to adverse events was higher (18.6%) than for the donepezil 10 mg/day treatment group (7.9%).
The most common adverse events leading to discontinuation, defined as those occurring in at least 1% of patients and greater than those occurring with donepezil 10 mg/day doses, are shown in Table 1.
The majority of discontinuations due to adverse events in the Donepezil hydrochloride (ARICEPT®) 23 mg tablets group occurred during the first month of treatment.
Most Frequent Adverse Clinical Events Seen in Association with the Use of Donepezil
hydrochloride (ARICEPT®) 23 mg tablets
The most common adverse events, defined as those occurring at a frequency of at least 5%, include nausea, diarrhea, vomiting, and anorexia. These adverse events were often of mild to moderate intensity.
Adverse Events Reported in Controlled Trials
The events cited reflect experience gained under closely monitored conditions of a controlled clinical trial in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ. Table 2 lists adverse events that were reported in at least 2% of patients who received 23 mg/day of Donepezil hydrochloride (ARICEPT®) and at a higher frequency than those receiving 10 mg/day of Donepezil hydrochloride (ARICEPT®) in a controlled clinical trial that compared the two doses. In this study, there were no important differences in the type of adverse events in patients taking Donepezil hydrochloride (ARICEPT®) with or without memantine.
