Medication info
Union Donepezil Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Union Donepezil Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Yellow, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901858 · Approved 2019.03.28 · Insurance code 665507170

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 5 mg once daily before bedtime. For 4-6 weeks, 5 mg is administered, and after clinical response evaluation, it can be increased to 10 mg. When increasing to 10 mg daily, gastrointestinal adverse reactions should be monitored. Underweight female patients over 85 years should not exceed 5 mg per day and require careful monitoring.
Child dose
No experience with pediatric use.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

Used for the treatment of Alzheimer's dementia symptoms.

How to take

Adult dose

As Donepezil Hydrochloride, take 5 mg once daily before bedtime. For 4-6 weeks, 5 mg is administered, and after clinical response evaluation, it can be increased to 10 mg. When increasing to 10 mg daily, gastrointestinal adverse reactions should be monitored. Underweight female patients over 85 years should not exceed 5 mg per day and require careful monitoring.

Child dose

No experience with pediatric use.

Precautions

This medication contains Donepezil Hydrochloride as its main ingredient and is used for the treatment of Alzheimer's dementia symptoms. First, this medication should not be administered to certain patients. Those allergic to Donepezil Hydrochloride or any of the components of this medication, pregnant women or those who may become pregnant, and nursing mothers should not take this medication. Additionally, since it contains lactose, those with lactose intolerance or certain genetic metabolic disorders should avoid its use. Patients with heart disease, specifically those with bradycardia or conduction disturbances, should use this medication with caution as it may slow the heart rate or cause arrhythmias. Also, individuals with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious of the risk of gastrointestinal bleeding. Caution should also be taken for those with a history of asthma or obstructive lung disease as bronchoconstriction and increased mucus secretion may occur. This medication contains a dye called Yellow No. 5, which requires cautious use in individuals who have an allergy to it. Various adverse reactions may occur while taking this medication. Cardiovascular symptoms reported include syncope, bradycardia, heart block, myocardial infarction, etc., while gastrointestinal bleeding, peptic ulcers, liver dysfunction, cerebrovascular issues, extrapyramidal symptoms, and muscular abnormalities may also present. Particular attention should be paid to serious muscle damage symptoms such as myalgia, weakness, and rhabdomyolysis. Additionally, this medication may provoke psychiatric symptoms such as hallucinations, agitation, aggressive behavior, anxiety, insomnia, and confusion, and if such symptoms appear, one should consult healthcare professionals. Cardiovascular side effects may include bradycardia, palpitations, hypertension, hypotension, atrial fibrillation, and it is crucial to periodically check heart health status. This medication may affect the ability to drive or operate machinery; thus, caution is needed during the early days of usage or when adjusting the dose. Furthermore, this medication may interact with various drugs. Especially when taken with medications that inhibit or induce the CYP3A4 and CYP2D6 enzymes, the effectiveness may change, requiring caution. There may also be interaction risks with medications affecting heart conduction, cholinergic drugs, and anticholinergic drugs, so it is important to inform healthcare professionals of any ongoing medications. Pregnant or nursing women are advised against using this medication unless necessary and should carefully decide after consulting with a specialist. Safety in children has not yet been established; therefore, it should not be used in pediatric populations. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions may occur, and immediate visit to a medical institution for appropriate treatment is necessary. Atropine can be used as an antidote in the case of overdose. Finally, this medication should be stored out of reach of children, and transferring it to another container should be avoided as it may compromise the quality.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
Show 18 more
  • liver dysfunction
  • jaundice
  • cerebral seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal disorders
  • neuroleptic malignant syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cardiac arrest
  • vascular hemorrhage
  • cardiac arrhythmia
  • cerebrovascular anomalies
  • respiratory distress
  • urticaria.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • muscle pain
Show 20 more
  • rash
  • itching
  • blood pressure fluctuations
  • muscle cramps
  • urinary incontinence
  • constipation
  • abdominal pain
  • dehydration
  • weight loss
  • thrombocytopenia
  • anemia
  • anxiety
  • hallucinations
  • drowsiness
  • aggressive behavior
  • insomnia
  • hematological disorders
  • fever
  • malaise
  • etc.

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 exposure to air or moisture. It is recommended to keep it at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Yellow, 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

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.