Shinshin Donepezil Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, give 5 mg once daily before bedtime. Administer the 5 mg dosage for 4 to 6 weeks, and after assessing clinical response, it can be increased to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal adverse reactions. Underweight elderly females (over 85 years) should not exceed 5 mg and require careful monitoring.

Child dose

No experience in using for children.

This medication contains donepezil hydrochloride monohydrate as the active ingredient and is used to treat symptoms of Alzheimer's type dementia. First, certain patients should not be administered this medication. For example, individuals allergic to this drug or its components, pregnant women or those who may become pregnant, nursing mothers, and those with genetic metabolic disorders such as lactose intolerance should not take it. Additionally, patients with heart disease, a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, patients with asthma or obstructive pulmonary disease history, and patients with extrapyramidal disorders such as Parkinson's disease should be cautious when administering this drug. This is because it can slow down heart rate or exacerbate gastrointestinal symptoms. Various adverse reactions may occur during treatment with this medication. Cardiac issues such as bradycardia, heart block, and myocardial infarction have been reported, and gastrointestinal issues such as gastric ulcers and gastrointestinal bleeding may occur. Also reported are abnormal liver function, cerebrovascular disorders, extrapyramidal symptoms, severe muscle damage, acute pancreatitis, acute renal failure, shortness of breath, and even sudden death. Psychiatric and neurological disorders may manifest as hallucinations, anxiety, insomnia, confusion, and depression, while cardiovascular effects include hypertension, hypotension, and palpitations. Common gastrointestinal symptoms may include nausea, vomiting, diarrhea, and abdominal pain. This medication is not approved for the treatment of other types of memory disorders besides dementia and treatment should be initiated and continuously managed by an experienced physician. The therapeutic effect should be regularly evaluated, and if deemed ineffective, discontinuation should be considered. Moreover, since this medication may affect cardiac conduction, patients with a history of heart disease or prolonged QT interval require special caution and, if necessary, electrocardiograms should be performed. It can affect the ability to drive or operate machinery, as dizziness or fatigue may occur at the beginning of treatment, thus caution is advised. This drug may interact with several other medications. Especially when taken with drugs metabolized by the liver, the efficacy may increase or decrease, so it's essential to consult healthcare personnel. In addition, there may be changes in efficacy when taken with other cholinergic or anticholinergic drugs. Pregnant women or nursing mothers are advised not to use this medication, and if absolutely necessary, they should consult a specialist before using it. Safety in children has not been established; therefore, its use is not recommended. In case of overdose, serious symptoms such as severe nausea, vomiting, hypotension, respiratory depression, muscle weakness may occur, and immediate medical attention is required, with atropine as an antidote. Finally, this medication should be kept out of reach of children, and transferring it to other containers may adversely affect product quality.

Serious side effects

• Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
• Severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes → severe skin adverse reactions
• Shortness of breath or difficulty breathing, asthma attack, accompanied by cough+fever → respiratory issues
• Yellowing of skin or eyes (jaundice), extreme lethargy → liver issues (jaundice)
• Sudden and

Mild side effects

• Headache
• dizziness
• nausea
• vomiting
• diarrhea
• insomnia
• loss of appetite
• fatigue
• muscle pain
• rash

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness for a long time.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle