Aricept 23 mg

Aricept 23 mg Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea, vomiting and insomnia.
Adverse reactions reported as more than an isolated case are listed as follows, by system organ class and by frequency. Frequencies are defined as: Common (>1/100, <1/10), uncommon (>1/1,000, <1/100) and rare (>1/10,000, <1/1,000). (See Table 3.)

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Adverse Events Leading to Discontinuation: The rate of discontinuation from a controlled clinical trial of ARICEPT Film-coated Tablets 23 mg due to adverse events was higher (18.6%) than for the donepezil hydrochloride 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 hydrochloride 10 mg/day doses, are shown in Table 4: (See Table 4.)

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The majority of discontinuations due to adverse events in the ARICEPT Film-coated Tablets 23 mg group occurred during the first month of treatment.
Most Frequent Adverse Clinical Events Seen in Association with the Use of ARICEPT Film-Coated Tablets 23 mg: 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 lands of patients treated may differ. Table 5 lists adverse events that were reported in at least 2% of patients who received 23 mg/day of ARICEPT and at a higher frequency than those receiving 10 mg/day of 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 ARICEPT with or without memantine. (See Table 5.)

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