Donepezil Hydrochloride Orally Disintegrating Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. Maintain the dose at 5 mg for 4 to 6 weeks. After assessing clinical responses during this period, the dose may be increased up to 10 mg. When increasing to 10 mg daily, administer with caution regarding gastrointestinal adverse reactions. This medication is an orally disintegrating tablet and can be taken by placing it on the tongue to dissolve, with or without water.

Child dose

No experience in using for children.

This medication should not be administered to patients with phenylketonuria, a genetic disorder. The artificial sweetener aspartame included in this medication breaks down into phenylalanine in the body. It should not be used by patients with hypersensitivity to this drug, pregnant women, women of childbearing potential, and nursing mothers. Patients with heart disease should exercise caution as this medication may stimulate the vagus nerve and cause bradycardia or arrhythmia. Patients who are taking non-steroidal anti-inflammatory drugs or have a history of peptic ulcer should be cautious as it can increase gastric acid secretion and exacerbate symptoms. Patients with a history of asthma or chronic obstructive pulmonary disease should be careful as this medication may constrict bronchial smooth muscles or increase mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as this medication may exacerbate symptoms. During the use of this medication, serious abnormal symptoms such as syncope, cardiac abnormalities, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, and respiratory difficulties may occur, so if any abnormal symptoms arise, consult a doctor immediately. Various side effects including loss of appetite, nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, and heart rhythm abnormalities may occur in some patients, so symptoms should be monitored closely during use. This medication is only for the treatment of Alzheimer's dementia and should not be used for other types of dementia or memory disorders. The therapeutic effects should be regularly evaluated, and if no effect is observed, discontinuation should be considered. Patients with heart disease or electrolyte abnormalities may require an electrocardiogram due to the risk of cardiac arrhythmias. Caution is advised while driving or operating machinery as dizziness or fatigue may occur. This medication can interact with various drugs, so consult a doctor or pharmacist before taking it with other medications. It is safer for pregnant or nursing women not to use this medication; if necessary, consult a specialist. Safety has not been established for children, so this medication should not be used in pediatric patients. In cases of overdose, severe nausea, vomiting, bradycardia, respiratory depression, convulsions, etc., may occur, so immediate medical attention is necessary. This medication dissolves in the mouth but is not absorbed through the oral mucosa, so follow the dosage instructions carefully. Store out of reach of children, and keep in an unopened state as exposure to light may cause discoloration.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin detachment, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthmatic attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary abnormalities.

Mild side effects

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

This medication should be stored in a tightly sealed container that allows for good air circulation, at room temperature between 1°C and 30°C. Proper storage will help maintain the drug’s effectiveness and prevent deterioration.

Appearance

White round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)