Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

○ Adults : Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning administration of this medicine 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 daily, administer with attention to gastrointestinal adverse reactions. Upon discontinuation, the effect of this medicine gradually decreases, and no rebound effect occurs with abrupt discontinuation. ○ Female patients aged 85 years and older who are underweight : Careful monitoring is required because adverse reactions occur more frequently. Elderly women who are underweight should not exceed 5 mg daily.

Child dose

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

This medication is made from the ingredient donepezil hydrochloride and is primarily used in the treatment of symptoms of Alzheimer's dementia. This medication should not be administered to certain patients. For example, individuals who are allergic to this medication's components or similar drugs, women who are pregnant or may become pregnant, and patients with genetic issues that prevent them from digesting lactose should not take this drug. Patients with heart disease, a history of asthma, peptic ulcers, or those with extrapyramidal disorders such as Parkinson's disease should exercise special caution when using this medication. Those who are allergic to specific colors included in this drug should also take it carefully. Taking this medication may lead to severe side effects such as a decrease in heart rate, arrhythmias, exacerbation of peptic ulcers, liver dysfunction, cerebral hemorrhage, motor impairment, severe muscle pain, breathing difficulties, acute pancreatitis, acute renal failure, among others, so if any of these symptoms occur, you should consult a physician immediately. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, headache, and fatigue may occur and should be monitored closely during use. This medication can affect the heart, so individuals with heart conditions should regularly check their heart status through ECG tests, and patients with a history of peptic ulcers or gastrointestinal bleeding should monitor for symptom exacerbation closely. Caution is needed when driving or operating machinery, as dizziness or fatigue may occur. This drug may interact with other medications, so especially when taken alongside drugs metabolized in the liver, those affecting the heart, or anticholinergic drugs, consultation with a physician or pharmacist is essential. It is recommended that women who are pregnant or nursing avoid using this medication; if it must be taken, it should be under the guidance of a specialist. Safety in children has not been established, so it should not be used in pediatric patients. In case of overdose, severe vomiting, bradycardia, and respiratory depression may occur; immediate medical treatment is required, and atropine may be used as an antidote. This medication should be kept out of reach of children and not transferred to other containers for safety.

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

This drug should be stored in a sealed container to prevent air ingress and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy for a longer period.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle