Medication info

Donepezil Orally Disintegrating Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationOrally disintegrating Tablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow round orally disintegrating tablet
Packaging
30 tablets (10 tablets/PTP packaging x 3)
Approval status
Expired

MFDS item code 201902814 · Approved 2019.04.30

This product's status changed to Expired on 2024.04.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of Alzheimer-type dementia symptoms
Who takes it
Adults
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For the first 4 to 6 weeks, continue with the 5 mg dosage. After evaluating clinical response during this period, the dosage may be increased to 10 mg. When increasing to 10 mg per day, careful monitoring for gastrointestinal adverse reactions is required. This medicine is an orally disintegrating tablet that can be taken by placing it on the tongue to dissolve and swallow with water, or without water.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of Alzheimer-type dementia symptoms

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

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

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For the first 4 to 6 weeks, continue with the 5 mg dosage. After evaluating clinical response during this period, the dosage may be increased to 10 mg. When increasing to 10 mg per day, careful monitoring for gastrointestinal adverse reactions is required. This medicine is an orally disintegrating tablet that can be taken by placing it on the tongue to dissolve and swallow with water, or without water.

Precautions

This drug contains the artificial sweetener aspartame and should not be taken by patients with the genetic disorder phenylketonuria. This medicine should be avoided by individuals allergic to any of its ingredients or similar drugs, women who are pregnant or may become pregnant, and women who are breastfeeding. Patients with heart disease or heart conduction disorders should use this medicine with caution, as it may slow heart rate or cause arrhythmias. Patients with peptic ulcers or those taking non-steroidal anti-inflammatory drugs should monitor their symptoms carefully due to the potential gastrointestinal burden. Patients with a history of asthma or chronic obstructive pulmonary disease should be cautious, as this medicine may worsen symptoms due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders, such as Parkinson's disease, should take this medicine with caution as it may exacerbate symptoms. This medicine contains the dye Yellow No. 4 (Tartrazine), so patients with allergies to this ingredient should be careful. During treatment with this medicine, if symptoms related to the heart, gastrointestinal bleeding, liver function abnormalities, neurological symptoms, movement disorders, severe muscle pain, respiratory distress, acute pancreatitis, or kidney failure occur, consult a doctor immediately. Additionally, this medicine may affect the ability to drive or operate machinery, requiring caution, especially during the initial treatment period or after dosage increases. Pregnant or breastfeeding women are advised to avoid this medicine, and if it must be taken, discontinuing breastfeeding is recommended for safety. It is preferable not to use this medicine in children as safety has not been established. This medicine may interact with other drugs, so if currently taking other medications, it is essential to inform a doctor or pharmacist. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical attention. When taking this medicine, it is recommended to dissolve it in the mouth and swallow it with saliva or water, and keep it out of children's reach.

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
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal disorders
  • neuroleptic malignant syndrome
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • rhabdomyolysis
  • myalgia
  • weakness
  • kidney dysfunction
  • respiratory distress
  • acute pancreatitis
  • acute

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • dizziness
  • insomnia
  • drowsiness
  • headache
  • muscle pain
  • pain
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  • fatigue
  • fever
  • elevated blood pressure
  • edema
  • rash
  • itching
  • anxiety
  • hallucinations
  • excitability
  • aggressive behavior
  • drowsiness
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • gibberish
  • confusion
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • ventricular tachycardia
  • abnormal electrocardiogram
  • constipation
  • abdominal

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

Storage

Store this medicine in a tightly sealed container to prevent exposure to air or moisture, preferably at room temperature between 1 to 30 degrees Celsius. Storing it this way ensures that the effectiveness of the medicine is safely maintained.

Appearance and packaging

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP packaging x 3)

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.