Apezil FD Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Adult dose

As donepezil hydrochloride, it is administered at a dosage of 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing of this medication may be considered. The concentration of donepezil reaches a steady state 15 days after administration, and the frequency of adverse reactions is influenced by the rate of dose increase, thus it is recommended to administer 5 mg for 4-6 weeks. The clinical response during this period should be assessed.

Child dose

There is no experience of use in children.

This drug contains donepezil hydrochloride as its active ingredient and is used in the treatment of symptoms of Alzheimer's dementia. First, this drug should not be used by individuals allergic to donepezil hydrochloride or any of the components of the drug, pregnant or potentially pregnant women, or nursing mothers. Patients with heart disease or conduction abnormalities should use this drug with caution, as it can stimulate the vagus nerve and cause bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers must use caution, as increased gastric acid secretion and gastrointestinal motility may worsen ulcer symptoms. Patients with asthma or obstructive pulmonary disease should also be careful, as bronchoconstriction and increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious, as cholinergic nerve stimulation from this drug may worsen symptoms. While taking this drug, symptoms such as syncope, bradycardia, heart block, and other cardiac-related adverse reactions, as well as peptic ulcers, hepatic dysfunction, seizures, and muscle symptoms may occur, so immediate consultation with medical professionals is required if such symptoms occur. Additionally, this drug can cause drowsiness, dizziness, insomnia, hallucinations, and depression, requiring caution when operating vehicles or machinery. This drug is metabolized in the liver, so interactions with specific antibiotics, antidepressants, antiarrhythmics, etc., may alter its effects, and patients must inform healthcare providers of all medications taken. Pregnant or nursing mothers should avoid using this drug, and if necessary, it should be decided with caution after consulting a specialist. Safety in children has not been established, and thus it should not be used. In cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency care, and atropine may be used as an antidote. Finally, this drug is taken in the form of orally disintegrating tablets, which should be placed on the tongue to dissolve and can be taken with or without water. It should be stored out of the reach of children and kept in the original packaging to prevent discoloration from light exposure.

Serious side effects

• Syncope
• bradycardia
• heart block
• QT interval prolongation
• myocardial infarction
• heart failure
• peptic ulcers
• perforated duodenal ulcer
• gastrointestinal bleeding
• hepatitis

Mild side effects

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

Store this drug in a sealed container to protect it from air and moisture, and keep it at room temperature between 1 and 30 degrees Celsius. By doing so, the drug's effectiveness can be well maintained.

Appearance

White or light yellow round orally disintegrating tablet

Package unit

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