Medication info

Donepezil 10 mg Tablet (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
코스맥스파마(주)
Appearance
Yellow round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Expired

MFDS item code 202100731 · Approved 2021.01.25

This product's status changed to Expired on 2026.01.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Donepezil Hydrochloride is administered as follows: 5 mg once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. For the first 4-6 weeks, 5 mg should be administered, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, care should be taken with gastrointestinal adverse reactions. Low-weight elderly females should not exceed 5 mg per day.
Child dose
There is no experience in pediatric use.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Alzheimer's dementia symptoms
View approved original text

This medication is used for the treatment of Alzheimer's dementia symptoms. Alzheimer's dementia is a disorder that is accompanied by a decline in memory and cognitive function, and this medication may slow the progression of symptoms or improve them. Therefore, it can help enhance the cognitive function of patients and maintain their daily living.

How to take

Adult dose

Donepezil Hydrochloride is administered as follows: 5 mg once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. For the first 4-6 weeks, 5 mg should be administered, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, care should be taken with gastrointestinal adverse reactions. Low-weight elderly females should not exceed 5 mg per day.

Child dose

There is no experience in pediatric use.

Precautions

This medication should not be used by women who are allergic to certain ingredients or who are pregnant or breastfeeding, as well as patients with genetic issues such as lactose intolerance. Patients with heart disease, peptic ulcer, asthma, obstructive pulmonary disease, or extrapyramidal disorders such as Parkinson's disease should use this medication with special caution. This medication can cause serious side effects such as slowed heart rate, arrhythmia, gastrointestinal bleeding, liver dysfunction, seizures, muscle disorders, etc., so if any abnormal symptoms appear, consultation with a doctor should be sought immediately. In addition, this medication can stimulate gastric acid secretion, worsening symptoms of peptic ulcers, so caution is needed if there is a history of gastrointestinal diseases. It is used for the treatment of dementia, and therapeutic effects should be evaluated regularly; if there is no effect, it is advisable to discontinue use. This medication can increase the risk of serious arrhythmias in patients with cardiac conduction disorders or electrolyte abnormalities, so periodic examination of the heart condition is necessary. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. There may be interactions with other medications, so if you are taking other medicines, be sure to inform your doctor or pharmacist. It is preferable not to use this medication during pregnancy or breastfeeding, and if absolutely necessary, consult with a specialist. Safety in pediatric use has not been established, so it should not be used in children. In the case of overdose, dangerous symptoms such as nausea, vomiting, decreased heart rate, and difficulty breathing may arise, so strict adherence to dosage is necessary, and if any abnormal symptoms occur, immediate emergency treatment should be received. This medication should be kept out of reach of children, and transferring it to another container is not advisable as it is detrimental to maintaining quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • asthma attacks
  • peptic ulcers
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
  • liver dysfunction
Show 14 more
  • jaundice
  • sudden and severe headache
  • seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • altered consciousness
  • visual abnormalities
  • paralysis
  • fainting
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • neuroleptic malignant syndrome

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • anxiety
Show 26 more
  • hallucinations
  • agitation
  • aggressive behavior
  • nightmares
  • irritability
  • delirium
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • increased salivation
  • tremors
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rashes
  • eczema
  • itching
  • hives
  • facial flushing
  • lethargy
  • weakness

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way can help maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 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

No questions yet.

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.