Donepezil 10 mg Tablet (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as abnormal dreams, nightmares, or insomnia occur, morning administration of this drug may be considered. Since donepezil concentrations reach steady state 15 days after administration and the incidence of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg once daily, administer with caution for gastrointestinal adverse reactions. If treatment with this drug is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

○ Pediatric patients: There is no experience with use in children.

This drug should not be used by individuals allergic to certain components, or by pregnant or nursing women. Particular caution should be taken when using this drug if there is a history of heart disease or peptic ulcers. Patients with asthma or obstructive pulmonary disease should also be careful as symptoms may worsen during the course of treatment with this drug. Patients with extrapyramidal disorders such as Parkinson's disease should use this drug cautiously as it may exacerbate symptoms. This drug can cause serious side effects such as bradycardia, arrhythmia, worsening of peptic ulcer, abnormal liver function, seizures, movement disorders, etc., thus, patients should consult a doctor immediately if any symptoms arise. Some patients may experience side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, and anxiety, so caution is advised. This drug is approved only for Alzheimer's dementia and should not be used for other types of dementia or memory disorders. Patients with heart disease or electrolyte imbalances have a higher risk of heart-related side effects, thus regular ECG monitoring may be required. This drug may affect driving or operating machinery, hence caution is needed. Interactions with other drugs may occur, so especially when taking it with heart medications, antibiotics, antidepressants, antipsychotic drugs, patients should inform their doctor and be careful. Pregnant or nursing women should not use this drug or should do so only under a doctor's guidance, and if nursing, it is advisable to discontinue breastfeeding. Safety in children has not been established, thus it should not be used. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, respiratory depression may occur, and immediate hospital treatment is required. This drug should be stored out of reach of children and it is safe not to transfer it to another container.

• Syncope
• bradycardia
• heart block
• prolonged QT interval
• myocardial infarction
• heart failure
• peptic ulcer
• perforated duodenal ulcer
• gastrointestinal bleeding
• hepatitis

This drug should be stored in a tightly sealed container that allows air circulation, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle