Medication info

Donepezil Hydrochloride Orally Disintegrating Tablets 5 mg

Prescription medicationOrally disintegrating Tablet경구Approval withdrawn
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.21mg / 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Approval withdrawn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 201901685 · Approved 2019.03.20

This product's status changed to Approval withdrawn on 2023.10.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of Alzheimer's disease
Who takes it
Adults
Adult dose
Administer 5 mg once daily before bedtime as donepezil hydrochloride. Dose at 5 mg for 4-6 weeks, and it can be increased to 10 mg based on clinical response. When increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions is advised. The orally disintegrating tablet can be placed on the tongue to dissolve and taken with or without water.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Improvement of symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used in the treatment of symptoms of Alzheimer's disease. It helps alleviate symptoms such as memory decline, cognitive function impairment, and decreased ability to perform daily activities, thus improving the quality of life for patients. Early treatment can slow the progression of symptoms and assist in making daily life more manageable. Regular intake is recommended, and it is important to use it according to healthcare professional's instructions.

How to take

Adult dose

Administer 5 mg once daily before bedtime as donepezil hydrochloride. Dose at 5 mg for 4-6 weeks, and it can be increased to 10 mg based on clinical response. When increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions is advised. The orally disintegrating tablet can be placed on the tongue to dissolve and taken with or without water.

Precautions

This medication contains donepezil hydrochloride as its active ingredient and is used in the treatment of symptoms of Alzheimer's disease. Firstly, this medication should not be used in patients who have an allergy to donepezil hydrochloride or any other ingredient in this medication, in women who are pregnant or may become pregnant, and in breastfeeding women. Patients with heart disease should use this medication cautiously, as it may slow down heart rate or cause arrhythmias. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be administered with caution due to the risk of gastrointestinal bleeding or worsening of ulcers. Patients with asthma or chronic obstructive pulmonary disease should be careful as symptoms may worsen or bronchoconstriction may occur. Patients with Parkinson's disease or extrapyramidal disorders should exercise caution as this medication may exacerbate symptoms. Serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, and breathing difficulties may occur during the use of this medication, and if such symptoms appear, it is essential to consult a doctor immediately. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue, which are mostly mild and temporary. This medication carries a risk of arrhythmia in patients with heart disease or electrolyte abnormalities, so it is necessary to regularly monitor heart conditions. Additionally, this medication may affect the central nervous system; therefore, caution is necessary when driving or operating machinery. This medication may interact with other drugs, and it is crucial to follow the doctor's instructions when used in conjunction with drugs that affect CYP3A4 or CYP2D6 enzymes. Pregnant or breastfeeding women should avoid using this medication and, if necessary, should consult with healthcare professionals before making a decision. The safety of this medication in children has not been established, and it should not be used in pediatric patients. In cases of overdose, severe nausea, vomiting, bradycardia, and respiratory depression may occur, and immediate emergency treatment is required; atropine may be used as an antidote. This medication is an orally disintegrating tablet that should be placed on the tongue to dissolve and swallowed with saliva or water. Finally, store this medication out of the reach of children, away from direct sunlight, and in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, convulsions, cerebral hemorrhage, cerebrovascular accidents, extrapyramidal symptoms (motor function disorder, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech difficulties), neuroleptic malignant syndrome (stupor, extreme rigidity, dysphagia).

Mild side effects

  • Nausea
  • vomiting
  • decreased appetite
  • diarrhea
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • rash
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  • itching
  • muscle pain
  • urinary incontinence
  • swelling
  • fever
  • thrombocytopenia
  • decreased hematocrit
  • anemia
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • drowsiness
  • increased blood pressure
  • low blood pressure
  • hypertension
  • palpitations
  • torsades de pointes
  • QT interval prolongation on ECG
  • constipation
  • fecal incontinence.

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 air or moisture from entering, and it is advisable to keep it at room temperature between 1°C and 30°C. Storing it this way will help maintain the effectiveness of the medication over time.

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

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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.