Donepezil Hydrochloride 10 mg Tablets (Donepezil Hydrochloride Hydrate)

Adult dose

Administer Donepezil Hydrochloride as 5 mg once daily before bedtime. Normal status is reached after 15 days, so administer 5 mg for 4 to 6 weeks. After assessing clinical response, the dose can be increased up to 10 mg. Caution should be taken regarding gastrointestinal adverse reactions when dosing increased to 10 mg per day. Underweight women aged 85 and above should not exceed 5 mg per day, requiring careful monitoring.

Child dose

There is no experience using this medicine in children.

This medicine contains Donepezil Hydrochloride Hydrate as its active ingredient and is used to treat symptoms of Alzheimer's type dementia. This medicine should not be administered to certain patients. For example, patients who are allergic to this medicine or its components, women who are pregnant or may become pregnant, nursing mothers, and those with lactose intolerance or specific genetic metabolic disorders should not take this medicine. Patients with heart disease or a slow heart rate, a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, those with asthma or obstructive lung disease, patients with extrapyramidal disorders such as Parkinson's disease, and those allergic to certain dyes included in this medicine should use it with caution. This medicine can cause serious side effects such as heart-related problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death, so immediate consultation with a doctor should be sought if any symptoms arise. In addition, this medicine can cause various side effects such as fatigue, dizziness, nausea, vomiting, diarrhea, decreased appetite, insomnia, headache, muscle pain, and rash, and particular attention should be paid to cardiovascular abnormalities such as arrhythmias, bradycardia, and heart block. This medicine is only approved for the treatment of Alzheimer's type dementia and is not approved for other types of dementia or memory disorders. Treatment should be conducted under the supervision of an experienced physician, and the treatment effect should be evaluated regularly. Patients with heart disease or a history of QT interval prolongation may require an electrocardiogram while taking this medicine, and caution should be exercised regarding drug interactions. In particular, the efficacy may change when used in conjunction with drugs that affect the CYP3A4 and CYP2D6 enzymes, so consultation with a physician is necessary. Women who are pregnant or breastfeeding are advised not to take this medicine, and if it is absolutely necessary to take it, it is preferable to consult experts and discontinue breastfeeding. Safety in children has not been established, and therefore this medicine should not be used in children. In the event of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate visit to a medical institution, and atropine may be used as an antidote. This medicine should be kept out of reach of children and should not be transferred to other containers, as this can adversely affect quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

• Cold
• decreased appetite
• hallucinations
• agitation
• aggressive behavior
• anxiety
• insomnia
• drowsiness
• increased libido
• talkativeness

This medicine should be stored in a tightly sealed container to prevent air exposure and is best kept at room temperature between 1 and 30 degrees Celsius. This ensures the maintenance of the medicine's efficacy and safety.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle