Apezil FD Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Adult dose

As donepezil hydrochloride, administer 5 mg once daily at bedtime. During the initial 4-6 weeks, administer the 5 mg dose. After evaluating the clinical response during this period, the dose may be increased to 10 mg. If increasing to 10 mg, administer cautiously while paying attention to gastrointestinal adverse reactions. This medication is an oral disintegrating tablet that can be placed on the tongue to dissolve and taken with or without water.

Child dose

There is no experience of use in pediatric patients.

This drug is used to treat symptoms of Alzheimer's disease, with donepezil hydrochloride monohydrate as its main ingredient. This medication should not be administered to patients with hypersensitivity to donepezil hydrochloride or the components of this drug, pregnant women or those who may become pregnant, and nursing mothers. Patients with heart-related diseases or heart conduction disorders, a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or obstructive pulmonary diseases, and patients with extrapyramidal disorders such as Parkinson's disease should be administered this drug with caution. This drug may stimulate the vagus nerve and cause cardiac side effects such as bradycardia or heart block, so patients with heart diseases need to be particularly cautious. Since it can stimulate gastric acid secretion and increase gastrointestinal motility, there may be a risk of peptic ulcers or gastrointestinal bleeding, requiring monitoring per a doctor's instructions in patients with gastrointestinal disease histories. Patients with asthma or lung diseases should be cautious as symptoms may worsen due to bronchoconstriction or increased mucus secretion. This drug may exacerbate extrapyramidal symptoms or provoke seizures, so patients with these conditions should consult their healthcare provider. During treatment, adverse reactions such as nausea, vomiting, diarrhea, dizziness, insomnia, arrhythmias, liver function abnormalities, muscle pain, and respiratory difficulties may occur; if symptoms are severe, immediate consultation with medical personnel is essential. This medication can affect liver and kidney functions, so regular testing may be necessary. It is safest for pregnant or nursing women not to use this drug, and if necessary, treatment should be determined after consultation with a specialist. Safety for children has not been established, and it should not be used in pediatric patients. This drug may interact with other medications, particularly those related to CYP3A4 or CYP2D6, cardiac medications, anticholinergic drugs, NSAIDs, etc., requiring particular caution when administered in combination. During treatment, caution is needed when driving or operating machinery, and dizziness or muscle cramps may occur with dosage changes, requiring attention. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, necessitating immediate emergency treatment, with atropine available as an antidote. If this medication is in a tablet form, it should be dissolved in the mouth. It must be kept out of the reach of children and stored in unopened packaging as it may discolor due to light exposure.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/ocular mucosa, difficulty breathing or shortness of breath, asthmatic attacks, respiratory issues with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual abnormalities, paralysis, urination.

Mild side effects

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should ideally be maintained between 1 degree and 30 degrees Celsius.

Appearance

White or pale yellow round oral disintegrating tablet

Package unit

30 tablets/PTP (10 tablets/PTP x 3)