Medication info

Donepezil Hydrochloride 5 mg, Donepezil Hydrochloride 10 mg

Prescription medication경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg
Manufacturer / importer
(주)코아팜바이오
Appearance
A white or pale yellow powder
Packaging
30 packets/box
Approval status
Active

MFDS item code 202501294 · Approved 2025.05.26 · Insurance code 051700071,051700081

Summary

Main use
Improvement of symptoms associated with Alzheimer's disease
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, take 1 packet (5 mg) once daily before bedtime. After administering 1 packet (5 mg) for 4-6 weeks, evaluate the clinical response and increase the dosage up to 1 packet (10 mg) if necessary. When increasing to 1 packet (10 mg) per day, observe for gastrointestinal adverse reactions. Women over 85 years old who are underweight should not exceed 1 packet (5 mg) daily and need careful monitoring.
Child dose
No experience with use in children.

Ingredients

Manufacturer
(주)코아팜바이오

Efficacy & effects

Improvement of symptoms associated with Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

Used for the treatment of symptoms associated with Alzheimer's disease.

How to take

Adult dose

As donepezil hydrochloride, take 1 packet (5 mg) once daily before bedtime. After administering 1 packet (5 mg) for 4-6 weeks, evaluate the clinical response and increase the dosage up to 1 packet (10 mg) if necessary. When increasing to 1 packet (10 mg) per day, observe for gastrointestinal adverse reactions. Women over 85 years old who are underweight should not exceed 1 packet (5 mg) daily and need careful monitoring.

Child dose

No experience with use in children.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is used to improve the symptoms of Alzheimer's disease. This medication should not be used by patients with an allergy to donepezil hydrochloride, piperidine derivatives, or any components of this medication. Additionally, it is safest for pregnant women, women who may become pregnant, and nursing mothers to avoid taking this medication. Patients with heart-related conditions, such as sick sinus syndrome or cardiac conduction disorders, should use this medication with caution as it may cause bradycardia or arrhythmias. Patients taking nonsteroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful with this medication, as it may increase gastric acid secretion or gastrointestinal motility, worsening ulcer symptoms. Patients with a history of asthma or obstructive lung disease should also exercise caution, as bronchoconstriction and increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious due to potential exacerbation of symptoms from the cholinergic stimulation of this medication. While taking this medication, serious side effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, extrapyramidal disorder symptoms, severe muscle abnormalities, dyspnea, acute pancreatitis, acute renal failure, and sudden death may occur; immediate consultation with healthcare providers is advised if any unusual symptoms appear. Mild side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, anxiety, hallucinations, palpitations, myalgia, and rash may also occur and should be closely monitored. This medication can affect the cardiovascular system, potentially causing bradycardia or arrhythmias, and patients with a history of heart disease or QT interval prolongation may require an electrocardiogram. Caution should be exercised when driving or operating machinery, as dizziness or drowsiness may occur, particularly during the initial stages of treatment or when increasing the dosage. Pregnant and breastfeeding women should avoid taking this medication, and if it is absolutely necessary, discontinuation of breastfeeding is recommended. Safety has not been established for use in children, so it is not used in this population. This medication may interact with other drugs, particularly those affecting CYP3A4 or CYP2D6 enzymes, drugs impacting cardiac conduction, cholinergic drugs, anticholinergic drugs, and NSAIDs, so consultation with a healthcare provider is essential if taken concurrently. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur; immediate emergency treatment is required, and atropine may be used as an antidote. This medication should not be divided into smaller doses, should be stored out of reach of children, and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • paleness
  • severe rash with high fever
  • blisters
  • peeling skin
  • pain in mouth/eye mucosa
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  • wheezing or difficulty breathing
  • asthma attacks
  • abnormal breathing with cough and fever
  • jaundice (yellowing of skin or eyes)
  • extreme lethargy
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • urination problems

Mild side effects

  • Loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talking more
  • mania
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  • nightmares
  • irritability
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive sexual desire
  • dizziness
  • insomnia
  • tremors
  • seizures
  • stupor
  • chest tightness
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorders
  • constipation
  • salivation
  • difficulty swallowing
  • fecal incontinence
  • rash

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. Additionally, it is important to store it at room temperature, between 1°C and 30°C, to maintain its effectiveness.

Appearance and packaging

Appearance

A white or pale yellow powder

Package unit

30 packets/box

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.