Medication info

Donepezil Hydrochloride Orally Disintegrating Tablet 10 mg

Prescription medicationOrally disintegrating Tablet경구Approval withdrawn
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
Yellow round orally disintegrating tablet
Packaging
30 tablets (10 tablets/PTP) X 3
Approval status
Approval withdrawn

MFDS item code 201901684 · Approved 2019.03.20

This product's status changed to Approval withdrawn on 2023.10.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of Alzheimer's dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer a dose of 5 mg. After evaluating clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg daily, administer with caution regarding gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue and taken with or without water.
Child dose
There is no experience with the use in children.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Improvement of symptoms of Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's dementia. Alzheimer's dementia is characterized by a decline in memory and cognitive function, and this medication helps alleviate these symptoms and improve the patient's daily functioning. Therefore, it is used to treat dementia symptoms and enhance quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer a dose of 5 mg. After evaluating clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg daily, administer with caution regarding gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue and taken with or without water.

Child dose

There is no experience with the use in children.

Precautions

This medication should not be used in patients who are hypersensitive to specific ingredients or in women who are pregnant or breastfeeding. Patients with heart disease or heart rhythm issues should use this medication with caution and be alert for cardiac symptoms. Patients with a history of peptic ulcers or who are taking non-steroidal anti-inflammatory drugs should closely monitor their gastrointestinal condition. Patients with asthma or obstructive lung disease should be cautious as this medication might exacerbate respiratory symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should administer this medication carefully due to the possibility of worsening symptoms. This medication can slow down heart rate or cause arrhythmias; therefore, regular monitoring of cardiovascular status is necessary. Severe side effects such as gastrointestinal bleeding, liver dysfunction, seizures, and muscle disorders may occur, so immediate consultation with healthcare providers is required if any unusual symptoms appear. Caution is needed when driving or operating machinery as dizziness or drowsiness may occur. There is a high potential for interactions with other medications, so it is essential to inform the healthcare provider or pharmacist of any other medications being taken. It is safest for pregnant or breastfeeding women not to use this medication; if absolutely necessary, it should be discussed with a healthcare professional. Safety in children has not been established, thus it should not be used in pediatric patients. In cases of overdose, symptoms such as nausea, vomiting, muscle weakness, and difficulty breathing may arise, requiring immediate emergency care. This medication is an orally disintegrating tablet; it is important to let it dissolve completely in the mouth before swallowing.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforating duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death, severe allergic reactions (urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat).

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • fever
  • insomnia
  • dizziness
  • tremors
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  • myalgia
  • edema
  • thrombocytopenia
  • anemia
  • incontinence
  • urinary disorders
  • anxiety
  • hallucinations
  • aggressive behavior
  • drowsiness
  • confusion
  • elevated blood pressure
  • frequent urination
  • involuntary movements
  • gait disturbances
  • decreased concentration
  • mental dullness
  • lethargy
  • weight loss
  • dehydration
  • hyperlipidemia
  • hypertension
  • hypotension
  • palpitations
  • dental pain
  • flushing
  • malaise
  • rash.

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

Storage

Store this medication in a tightly closed container to prevent air or moisture from entering. It is also advisable to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets (10 tablets/PTP) 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.