Samsung Donepezil Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Adult dose

This medication is taken once daily immediately before bedtime, regardless of food intake. The initial recommended dose of donepezil hydrochloride is 5 mg taken once daily. Normal status is reached after 15 days, and 5 mg should be administered for 4 to 6 weeks. After evaluating clinical response, it may be increased to 10 mg, and care should be taken for gastrointestinal adverse reactions when increasing to 10 mg per day. At least 10 mg should be maintained for a minimum of 3 months.

This medication contains donepezil hydrochloride as the active ingredient and is used for the treatment of Alzheimer-type dementia symptoms. This medication should not be administered to patients with allergies to donepezil hydrochloride or any components of this drug, pregnant women or women who may become pregnant, and nursing mothers. Additionally, since it contains lactose, patients with genetic problems such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Patients with heart disease or heart conduction disorders should be cautious, as this medication could stimulate the vagus nerve leading to bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious, as increased gastric acid secretion and gastrointestinal motility might worsen their condition. Patients with a history of asthma or obstructive pulmonary disease should also use this medication carefully, as it could exacerbate symptoms due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should also be cautious, as symptoms may worsen. This drug can cause various adverse reactions, with cardiac side effects including syncope, bradycardia, heart block, and myocardial infarction. Gastrointestinal adverse reactions such as peptic ulcers, gastrointestinal bleeding, nausea, vomiting, and diarrhea are common, and liver dysfunction or jaundice has also been reported. Additionally, neurological abnormal reactions like seizures, convulsions, movement disorders, dyskinesia, and tremors can occur. During the course of this medication, mental-neurological symptoms such as hallucinations, insomnia, anxiety, depression, drowsiness, and dizziness may appear, along with skin reactions like rashes or itching, muscle pain, and fatigue. Particularly, the higher the dose of this medication, the more frequently gastrointestinal side effects like nausea, vomiting, and diarrhea occur, so if symptoms are severe, dosage adjustment should be discussed with a physician. This medication has not established safety during pregnancy and should not be used unless necessary, and nursing mothers should discontinue breastfeeding while taking this medication. Safety in children has not been confirmed, so this medication should not be given to children. This medication may interact with other medications, so caution is necessary when taken with drugs that affect CYP3A4 or CYP2D6 enzymes, drugs that impact heart conduction, non-steroidal anti-inflammatory drugs, or anticholinergic medications. In case of overdose, severe nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and atropine or similar antidotes can be used for treatment, making it essential to notify medical personnel immediately. When storing this medication, keep it out of reach of children, and do not transfer it to other containers. Finally, while this drug may help improve cognitive function in dementia patients, treatment effects should be regularly evaluated, and any adverse reactions should be addressed with a physician immediately.

Serious side effects

• Hives
• severe swelling (edema)
• chest tightness
• difficulty breathing
• cold sweat
• paleness
• syncope
• bradycardia
• heart block
• QT interval prolongation

Mild side effects

• Nausea
• vomiting
• diarrhea
• loss of appetite
• dizziness
• headache
• fatigue
• lethargy
• drowsiness
• insomnia

This medication should be stored in a tightly sealed container to prevent air from entering, and it is best stored at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's effectiveness.

Appearance

Red, double-convex, round film-coated tablet

Package unit

30 tablets/bottle