Medication info
Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202003139 · Approved 2020.04.28 · Insurance code 653103590

Summary

Main use
Improvement of Alzheimer-type dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: As donepezil hydrochloride, administer 5 mg once daily before bedtime. Donepezil concentration reaches steady-state 15 days after administration, and the frequency of adverse reactions may be influenced by the rate of increase in dosage, so administer 5 mg for 4-6 weeks. After evaluating the clinical response during this period, the dosage can be increased to 10 mg. When increasing to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions.
Child dose
Pediatrics: There is no experience of use in children.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

Improvement of Alzheimer-type dementia symptoms

  • Symptoms of Alzheimer-type dementia
View approved original text

This medicine is used for the treatment of symptoms of Alzheimer-type dementia.

How to take

Adult dose

Adults: As donepezil hydrochloride, administer 5 mg once daily before bedtime. Donepezil concentration reaches steady-state 15 days after administration, and the frequency of adverse reactions may be influenced by the rate of increase in dosage, so administer 5 mg for 4-6 weeks. After evaluating the clinical response during this period, the dosage can be increased to 10 mg. When increasing to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions.

Child dose

Pediatrics: There is no experience of use in children.

Precautions

This drug contains donepezil hydrochloride as the active ingredient and is mainly used for the treatment of Alzheimer-type dementia. First, this drug should not be used in patients who are allergic to donepezil hydrochloride or piperidine derivatives, or to any component of this drug. Pregnant women, women who may become pregnant, and lactating women should not take this drug. Additionally, it should not be administered to patients with lactose intolerance or certain genetic lactose metabolism disorders. Patients with heart disease or a slow heart rate, and those with heart conduction disorders should use this drug with caution. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should carefully monitor their gastrointestinal condition. Patients with a history of asthma or obstructive pulmonary disease may experience worsening symptoms when taking this drug, so caution is necessary. Patients with extrapyramidal disorders, such as Parkinson's disease, may also experience worsening symptoms when taking this drug, so caution should be exercised. This drug can cause various side effects, and in serious cases, can lead to fainting, arrhythmia, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, etc. Commonly reported symptoms include nausea, vomiting, diarrhea, dizziness, insomnia, and decreased appetite; if these symptoms occur, consult a healthcare professional. This drug can affect the heart, so patients with a history of heart disease or prolonged QT interval may require an electrocardiogram. Furthermore, this drug can interact with other medications, so caution is advised when taken with antibiotics, antiarrhythmics, antidepressants, antipsychotics, and drugs that inhibit or induce enzymes involved in drug metabolism. It is advisable for pregnant or lactating women not to take this drug, and in cases where it is unavoidable, consultation with a specialist is necessary. Safety in children has not yet been confirmed, so it should not be used in children. This drug may affect driving or operating machinery, so caution is particularly necessary during the initial dose or when changing doses. In case of overdose, symptoms such as vomiting, bradycardia, hypotension, respiratory depression, seizures, etc., may occur, and immediate contact with a medical institution for appropriate treatment is necessary. Lastly, this drug 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 sweats, pallor, severe rash along with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal respiration accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe drowsiness, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • anxiety
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  • hallucinations
  • excitement
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • talking excessively
  • mania
  • nightmares
  • nervousness
  • rambling
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • anemia
  • petechiae
  • incontinence
  • frequent urination
  • fecal incontinence
  • toothache
  • facial flushing
  • lethargy
  • weakness

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

Storage

This drug should be stored in a sealed container to prevent exposure to air and kept at room temperature between 1°C and 30°C. Proper storage will maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

White 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

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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.