Medication info
Donepezil 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

Donepezil 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 202001513 · Approved 2020.03.04 · Insurance code 645906840

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer Donepezil Hydrochloride 5 mg once daily before bedtime. For 4 to 6 weeks, administer a dose of 5 mg and evaluate clinical response during this period before escalating to 10 mg. If escalating to 10 mg per day, watch for gastrointestinal adverse reactions. Underweight females aged 85 and older should not exceed 5 mg per day, as adverse reactions may be pronounced.
Child dose
Pediatric: There is no experience regarding the use in children.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of Alzheimer's dementia symptoms. It helps alleviate major symptoms such as memory loss and cognitive dysfunction, thereby improving quality of life in daily activities.

How to take

Adult dose

Adults: Administer Donepezil Hydrochloride 5 mg once daily before bedtime. For 4 to 6 weeks, administer a dose of 5 mg and evaluate clinical response during this period before escalating to 10 mg. If escalating to 10 mg per day, watch for gastrointestinal adverse reactions. Underweight females aged 85 and older should not exceed 5 mg per day, as adverse reactions may be pronounced.

Child dose

Pediatric: There is no experience regarding the use in children.

Precautions

This medication should not be administered to patients with allergies to certain components. Women who are pregnant, may become pregnant, or are breastfeeding should also refrain from using this medication. Additionally, patients with lactose intolerance or certain genetic metabolic disorders should not be given this medication. Patients with heart diseases or conduction disorders of the heart should use this medication with caution as it may cause bradycardia or arrhythmias. Those with a history of peptic ulcers or taking non-steroidal anti-inflammatory drugs should be cautious as symptoms may worsen. Patients with a history of asthma or obstructive pulmonary disease should also be administered this medication carefully since it may affect bronchial function. Patients with extrapyramidal disorders, such as Parkinson’s disease, should use this medication with caution due to the potential for symptom exacerbation. Serious side effects such as cardiac-related adverse reactions, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, and muscle symptoms may occur, so patients should consult with healthcare providers immediately if symptoms arise. Furthermore, various side effects including hallucinations, anxiety, insomnia, drowsiness, dizziness, diarrhea, nausea, and vomiting have been reported, thus careful observation of symptoms during use is necessary. This medication is used for the treatment of Alzheimer's disease, and regular evaluations of therapeutic effectiveness are recommended. If no efficacy is observed, discontinuation of use is advised. Patients with cardiovascular diseases, especially, need to undergo ECG examinations due to the increased risk of arrhythmias. Additionally, this medication can affect driving or machinery operation abilities, so caution is advised. This medication can interact with multiple drugs; therefore, it is essential to inform healthcare providers if other medications are being taken. Caution is especially warranted when combined with drugs that affect CYP3A4 and CYP2D6 enzymes. When used with certain heart medications, antidepressants, and antibiotics, there may be an increased risk of cardiac rhythm disturbances, necessitating monitoring. Women who are pregnant or breastfeeding are advised against the use of this medication; if absolutely necessary, decisions should be made in consultation with healthcare providers. Safety in pediatric patients has not been established, hence it is not to be used in children. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may appear, and immediate medical attention is required. Atropine can be used as an antidote. This medication should be stored out of reach of children and it is safer not to transfer it to another container.

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 ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremor, involuntary movements, walking difficulties, abnormal posture, speech disorders), neuroleptic malignant syndrome (akinesia, extreme muscle rigidity, swallowing difficulties,

Mild side effects

  • Nausea
  • vomiting
  • decreased appetite
  • diarrhea
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • anxiety
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  • hallucinations
  • agitation
  • aggressive behavior
  • talking excessively
  • mania
  • nightmares
  • nervousness
  • incoherence
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive libido
  • tremor
  • walking disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • eczema
  • itching
  • rash
  • fever
  • decreased body temperature
  • toothache
  • facial flushing
  • malaise

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, and it is recommended to be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

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

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.