Medication info
Apezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Apezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
에이치케이이노엔(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200802064 · Notified 2008.02.22 · Insurance code 640004320

Summary

Main use
Improvement of symptoms of Alzheimer's disease
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and after evaluating the clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised regarding gastrointestinal side effects during administration. Women over 85 years who are underweight should not exceed 5 mg per day.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
에이치케이이노엔(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This drug is used to treat symptoms of Alzheimer's disease. It helps improve symptoms such as memory decline and cognitive dysfunction, and aids in enhancing the patient's ability to live independently. It is effective for alleviating dementia symptoms, so regular intake will help manage the symptoms.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and after evaluating the clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised regarding gastrointestinal side effects during administration. Women over 85 years who are underweight should not exceed 5 mg per day.

Child dose

There is no experience of use in children.

Precautions

This drug contains Donepezil Hydrochloride Hydrate, which is used to alleviate symptoms of Alzheimer's disease. This drug should not be used by individuals allergic to Donepezil Hydrochloride or piperidine derivatives, or any components of this medication. Women who are pregnant, potentially pregnant, or breastfeeding should avoid taking this drug, and should consult a specialist if necessary. Patients with heart disease or conduction disorders should take this drug cautiously, as it may affect heart rate, and it is advisable to undergo an electrocardiogram if needed. Patients with a history of gastrointestinal diseases or peptic ulcers should closely monitor their condition, as this drug may stimulate gastric acid secretion or increase gastrointestinal motility, potentially worsening symptoms. Patients with asthma or chronic obstructive pulmonary disease should use this drug cautiously, as it may cause bronchial constriction or increase mucus secretion, worsening respiratory symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, should be cautious as this drug may exacerbate symptoms. While taking this drug, you may experience adverse reactions such as nausea, vomiting, diarrhea, dizziness, insomnia, irregular heartbeats, or liver function abnormalities, so consult your doctor immediately if symptoms are severe or persistent. Especially serious side effects, such as severe bradycardia, heart block, hepatitis, cerebrovascular disorders, rhabdomyolysis, and acute renal failure may occur; if such symptoms arise, stop taking the medication immediately and seek medical attention. This drug can affect the cardiovascular system, so patients with a history of heart disease or QT interval prolongation should consult their doctor before taking it. Additionally, as this drug is metabolized in the liver, caution is needed when using it in conjunction with medications that affect CYP3A4 or CYP2D6 enzymes, as this may alter its effectiveness. Caution is advised when driving or operating machinery, as symptoms such as dizziness or drowsiness may occur, particularly in the early stages of treatment or when dosage is adjusted. Pregnant or nursing mothers should avoid this drug, and if necessary, may need to discuss discontinuing breastfeeding with a specialist. The safety of this drug in children has not been established, so it is generally not recommended for pediatric use. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, and immediate medical attention should be sought for appropriate treatment. This drug should be kept out of the reach of children, and transferring it to another container may result in quality deterioration or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, breathing difficulties with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

Anorexia, hallucinations, agitation, aggressive behavior, anxiety, insomnia, drowsiness, increased libido, talking more than usual, mania, nightmares, nervousness, nonsensical speech, delusions, depression, confusion, apathy, hyperactivity, excessive libido, dizziness, insomnia, tremors, stupor, palpitations, hypertension, hypotension, atrial fibrillation, diarrhea, nausea, vomiting, abdominal discomfort (including abdominal pain), constipation, salivation, swallowing difficulty, fecal incontinence, rashes, itching, muscle cramps, muscle

Not everyone experiences these, and they can vary from person to person.

Storage

This drug must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.