Medication info
Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 200605447 · Notified 2006.05.30 · Insurance code 643500330

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. The 5 mg dose is to be used for 4 to 6 weeks, and after evaluating clinical response, the dose may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. For underweight female patients aged over 85, 5 mg should not be exceeded.
Child dose
No experience of use in pediatric patients.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

  • Symptoms of Alzheimer's type dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. The 5 mg dose is to be used for 4 to 6 weeks, and after evaluating clinical response, the dose may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. For underweight female patients aged over 85, 5 mg should not be exceeded.

Child dose

No experience of use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is used for the improvement of symptoms in patients with Alzheimer's type dementia. This medication should not be administered to patients with hypersensitivity to specific ingredients, pregnant women or nursing mothers, or patients with lactose intolerance or genetic lactose metabolism disorders. Patients with heart disease should use this medication with caution, as it may slow down heart rate or induce arrhythmias, and patients with a history of gastric ulcers or who are taking non-steroidal anti-inflammatory drugs should also be cautious. Patients with a history of asthma or obstructive pulmonary diseases should use this medication carefully, as it may induce bronchoconstriction or worsen symptoms. Caution should be exercised in patients with extrapyramidal disorders such as Parkinson's disease, as this medication may worsen symptoms. During the use of this medication, serious side effects such as syncope, bradycardia, heart block, peptic ulcer, liver dysfunction, seizures, muscular symptoms, etc., may occur, so immediate consultation with healthcare professionals is required if such symptoms appear. Common side effects may include nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, headache, and fatigue, most of which are temporary and mild. This medication requires special caution in patients with cardiac conduction disorders or prolonged QT intervals, as the risk of side effects may increase when used in combination with heart-related medications. Additionally, as this medication is metabolized by certain liver enzymes (CYP3A4, CYP2D6), drug effects may change when used in conjunction with other medications that inhibit or induce these enzymes, so patients should inform their healthcare provider of any concomitant medications. Pregnant or nursing women are advised not to use this medication unless absolutely necessary and under the supervision of a healthcare professional. Safety in pediatric patients has not been established, so this medication is not to be used in children. Patients should be cautious about dizziness or fatigue while driving or operating machinery during the use of this medication. In case of overdose, severe symptoms such as nausea, vomiting, significant muscle weakness, and difficulty breathing may occur, which requires immediate medical attention; atropine may be used as an antidote. This medication should be stored out of reach of children, and it is safe not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, mouth/eye mucosal pain, difficulty breathing or wheezing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • decreased appetite
  • headache
  • fatigue
  • drowsiness
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  • itching
  • rash
  • muscle pain
  • urinary incontinence
  • frequent urination
  • swelling
  • fever
  • thrombocytopenia
  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • drowsiness
  • tremors
  • gait disturbances
  • involuntary movements
  • mental dullness
  • decreased concentration
  • lethargy
  • fluctuations in blood pressure
  • petechiae
  • abnormal dreams
  • eczema
  • dehydration
  • hyperlipidemia
  • weight loss
  • weight gain
  • toothache
  • facial.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/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.