Donepezil Sublingual Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, a 5 mg dosage should be given. After evaluating clinical response during this period, the dosage may be increased to 10 mg. Caution should be taken for gastrointestinal adverse reactions when increasing the dosage to 10 mg daily. This medication is a sublingual tablet and can be placed on the tongue to dissolve and be taken with or without water.

Child dose

There is no experience using this drug in children.

This medication should not be administered to patients with a genetic disease known as phenylketonuria, as the artificial sweetener aspartame contained in this medication breaks down to phenylalanine in the body. This medication should not be used in patients with allergies to donepezil hydrochloride or other components of this medication, in women who are pregnant or may become pregnant, and in women who are breastfeeding. Patients with heart disease, especially those with sick sinus syndrome or cardiac conduction disorders, should be cautious when using this medication as bradycardia or arrhythmias may occur. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication carefully, as it may stimulate gastric acid secretion and worsen symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be cautious as bronchoconstriction or increased mucus production may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be administered this medication with caution as it may exacerbate symptoms. Adverse reactions related to the heart may include syncope, bradycardia, heart block, and myocardial infarction, while gastrointestinal bleeding, hepatic dysfunction, cerebrovascular disorders, and neurological symptoms have also been reported. Psychologically, symptoms such as hallucinations, anxiety, insomnia, depression, and confusion may appear, so changes in symptoms should be monitored carefully. This medication may affect driving or machinery operation abilities, so caution is especially needed during the initial treatment or when dosage changes are made. Women who are pregnant or breastfeeding are advised not to use this medication, and if absolutely necessary, should consult with a healthcare professional to make an informed decision. This medication may interact with other drugs, so caution is required particularly when used in combination with cardiac medications, antibiotics, antidepressants, and antipsychotics. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may occur, necessitating immediate medical assistance. It is recommended to allow the tablet to dissolve on the tongue and swallow with saliva or water, and to store it out of reach of children. Regular medical check-ups and monitoring of adverse reactions are necessary during treatment with this medication, and if treatment appears ineffective or side effects are severe, consideration should be given to discontinuation.

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, decreased urine output.

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 is well ventilated, at a temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and prevent degradation.

Appearance

White, round sublingual tablet

Package unit

30 tablets (10 tablets/ PTP packaging × 3)