Medication info
Donepezil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201502455 · Approved 2015.04.27 · Insurance code 645208760

Summary

Main use
Improvement of symptoms associated with 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, 5 mg is to be administered, after which the dosage may be increased to 10 mg based on clinical response. When increasing to 10 mg, monitor for gastrointestinal adverse reactions. In underweight female patients over 85 years old, the daily dose should not exceed 5 mg, requiring careful monitoring.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of symptoms associated with Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's disease.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, 5 mg is to be administered, after which the dosage may be increased to 10 mg based on clinical response. When increasing to 10 mg, monitor for gastrointestinal adverse reactions. In underweight female patients over 85 years old, the daily dose should not exceed 5 mg, requiring careful monitoring.

Child dose

There is no experience of use in children.

Precautions

This medication should not be taken by individuals who are allergic to specific components. Women who are pregnant, or may become pregnant, and women who are breastfeeding should also avoid this medication. Patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. Patients with heart disease or conduction disorders should use this medication with caution, as there may be a slowing of the heart rate or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should carefully monitor their gastrointestinal condition while taking this medication. Patients with a history of asthma or obstructive pulmonary disease should use this medication cautiously, as it may affect bronchial function. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious, as their symptoms may worsen with this medication. This medication contains specific dyes, so individuals allergic to these components must consult a healthcare professional before use. This medication can affect the heart, leading to serious side effects such as fainting, heart block, or myocardial infarction; symptoms should be reported to a doctor immediately. Various side effects have been reported, including gastrointestinal problems such as peptic ulcers, gastrointestinal bleeding, liver function abnormalities, cerebrovascular disorders, and motor dysfunction; it is important to notify healthcare professionals if these symptoms occur during use. This medication may impact driving or machinery operation; caution is advised if experiencing fatigue, dizziness, etc. after taking. There may be interactions with other medications; it is especially important to inform healthcare professionals if taking medications metabolized by the liver or heart-related medications. It is advisable for pregnant or breastfeeding women to avoid this medication unless necessary, in which case consultation with a professional is recommended. Safety in children has not been established; therefore, this medication is not used in children. In case of overdose, serious symptoms such as vomiting, sweating, bradycardia, hypotension, and respiratory depression may occur, requiring immediate emergency treatment. This medication should be stored out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

  • Fainting
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforating duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver function abnormalities
  • jaundice
  • cerebral seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function disorders
  • ataxia
  • movement disorders
  • muscle rigidity
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disorders
  • neuroleptic malignant syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute kidney failure.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • anxiety
Show 29 more
  • hallucinations
  • agitation
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • apathy
  • hyperkinesia
  • tremor
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • blood pressure increases
  • skin rash
  • itching
  • rash
  • eczema
  • myalgia
  • urinary incontinence
  • frequent urination
  • urination disorders
  • fecal incontinence
  • increased salivation
  • facial flushing
  • lethargy
  • weakness
  • sweating
  • and heat.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness and safety for use.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.