Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201708602 · Approved 2017.12.28 · Insurance code 644502500

Summary

Main use
Improvement of symptoms in Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
For Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer a dose of 5 mg for 4 to 6 weeks. After evaluating the clinical response, it can be increased to 10 mg. When increasing the daily dosage to 10 mg, it should be administered with caution regarding gastrointestinal side effects. Underweight elderly women should not exceed 5 mg daily.
Child dose
There is no experience regarding the use in pediatric patients.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Improvement of symptoms in Alzheimer's-type dementia

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

This medication is used to treat symptoms of Alzheimer's-type dementia, helping to improve memory decline and cognitive function. It supports brain function by reducing confusion and disorientation in daily life and is used to enhance the overall cognitive abilities of patients. By taking it consistently, it contributes to delaying the worsening of symptoms and improving quality of life. Therefore, it is used to treat symptoms of Alzheimer's-type dementia.

How to take

Adult dose

For Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer a dose of 5 mg for 4 to 6 weeks. After evaluating the clinical response, it can be increased to 10 mg. When increasing the daily dosage to 10 mg, it should be administered with caution regarding gastrointestinal side effects. Underweight elderly women should not exceed 5 mg daily.

Child dose

There is no experience regarding the use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride as its active ingredient and is used for the treatment of Alzheimer's-type dementia symptoms. Firstly, this medication should not be used by patients allergic to Donepezil Hydrochloride or any of its components, by women who are pregnant or may become pregnant, and by breastfeeding women. Patients with heart diseases or conduction disorders should be cautious when using this medication and require medical supervision, as it may cause problems such as bradycardia or arrhythmia. Additionally, patients with a history of peptic ulcer or those taking non-steroidal anti-inflammatory drugs should be cautious due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or chronic obstructive pulmonary disease should also be careful, as use of this medication may worsen symptoms due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication with caution, as it may worsen symptoms. This drug has been reported to cause serious adverse reactions such as fainting, heart block, myocardial infarction, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death; if any symptoms occur, medical attention should be sought immediately. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue. This medication may cause cardiac arrhythmia or prolong the QT interval; therefore, patients with heart disease or those taking QT-prolonging medications require regular electrocardiograms. Pregnant or breastfeeding women are advised not to use this medication unless absolutely necessary, and they should consult a healthcare professional before use. Safety in children has not been established, so it should not be used in pediatric patients. This medication can interact with other drugs, especially those affecting CYP3A4 or CYP2D6 enzymes, muscle relaxants, cholinergic drugs, anticholinergic drugs, antiarrhythmics, certain antibiotics, and antidepressants; patients should definitely inform their healthcare provider. Care should be taken as this medication may affect the ability to drive or operate machinery, and fatigue, dizziness, or muscle cramps may occur during the initial stages of treatment or when changing doses. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, necessitating immediate emergency treatment, and atropine may be used as an antidote. Finally, this medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, prolonged QT interval, myocardial infarction, heart failure, asthma attack, respiratory distress, gastrointestinal bleeding, peptic ulcer, hepatitis, liver dysfunction, jaundice, seizures, convulsions, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (including movement disorders, ataxia, tremors), neuroleptic malignant syndrome (stupor, extreme rigidity, difficulty swallowing, tachycardia, blood pressure fluctuations, sweating, fever accompanying), rhabdomyolysis (muscle pain,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • tremors
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  • anxiety
  • hallucinations
  • aggressive behavior
  • delusions
  • confusion
  • involuntary movements
  • walking difficulties
  • palpitations
  • elevated blood pressure
  • edema
  • fever
  • abdominal pain
  • muscle pain
  • urinary incontinence
  • urinary disturbances
  • dehydration
  • thrombocytopenia
  • anemia
  • hematologic abnormalities
  • skin rash
  • itching
  • mild urticaria
  • sweating
  • facial flushing
  • lethargy
  • weakness
  • toothache
  • periodontal disease
  • bowel movements

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 ingress. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Doing so will help safely preserve the medication's effectiveness.

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.