Medication info

Donepezil Orally Disintegrating Tablet 10 Milligrams (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구Approval withdrawn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Approval withdrawn

MFDS item code 201907033 · Approved 2019.10.02

This product's status changed to Approval withdrawn on 2024.03.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 4 to 6 weeks of administration at a dose of 5 mg, evaluate the clinical response and increase to 10 mg if necessary. When increasing to 10 mg daily, administer cautiously with attention to gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue to dissolve and taken with or without water.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

Symptoms of Alzheimer's type dementia include memory decline and cognitive function deterioration. This medication helps improve cognitive impairment caused by Alzheimer's disease and alleviates memory disorders. It may also contribute to enhancing the daily living abilities of patients. In other words, it is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 4 to 6 weeks of administration at a dose of 5 mg, evaluate the clinical response and increase to 10 mg if necessary. When increasing to 10 mg daily, administer cautiously with attention to gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue to dissolve and taken with or without water.

Child dose

There is no experience using this medication in children.

Precautions

This medication should not be used in patients with phenylketonuria, as the artificial sweetener aspartame contained in this medication is metabolized into phenylalanine in the body. Those with hypersensitivity to this medication or allergies to its components should not use it. Pregnant women or those who may become pregnant, as well as nursing mothers, are also advised not to take this medication. Patients with heart disease or conduction disorders should use this medication cautiously, as it may stimulate the vagus nerve and cause bradycardia or arrhythmia. Patients with a history of peptic ulcers or those taking nonsteroidal anti-inflammatory drugs should be cautious as there is a potential for worsening gastrointestinal symptoms. Patients with a history of asthma or obstructive pulmonary disease should use this medication carefully, as it may exacerbate symptoms due to bronchoconstriction and increased mucus secretion. Patients with Parkinson's disease or extrapyramidal disorders should be aware that this medication may worsen their symptoms. This medication contains a dye called Tartrazine (Yellow No. 4), so those allergic to this ingredient should take it with caution. Serious side effects such as syncope, heart block, gastrointestinal bleeding, hepatic dysfunction, seizures, extrapyramidal symptoms, acute pancreatitis, and acute renal failure may occur, so any abnormal symptoms should be reported to a healthcare professional immediately. Additionally, side effects such as nausea, vomiting, reduced appetite, diarrhea, dizziness, insomnia, headaches, and fatigue may commonly occur, so symptoms should be carefully monitored. This medication may affect the ability to drive or operate machinery, so caution is needed at the beginning of treatment or when changing the dosage. Pregnant or nursing women are recommended not to use this medication, and if necessary, they should consult a professional before taking it. This medication may interact with other drugs, so if you are taking heart-related medications, antibiotics, antidepressants, or antipsychotics, you must inform your doctor or pharmacist. In cases of overdose, serious symptoms such as vomiting, bradycardia, and respiratory depression may occur, so strict adherence to the prescribed dosage is necessary, and immediate medical assistance should be sought if any abnormal symptoms arise. This medication is to be dissolved in the mouth, kept out of reach of children, and stored away from direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, gastrointestinal bleeding, peptic ulcer, perforated duodenal ulcer, hepatitis, hepatic dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, dystonia, etc.), neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute renal failure, unexplained sudden death, torsades de pointes

Mild side effects

Nausea, vomiting, reduced appetite, diarrhea, dizziness, insomnia, drowsiness, muscle pain, rash, itching, constipation, abdominal discomfort, urinary incontinence, frequency of urination, fecal incontinence, hematological abnormalities (anemia, leukopenia, thrombocytopenia, etc.), fever, weakness, tremor, anxiety, hallucinations, aggressive behavior, drowsiness, confusion, delusions, movement disorders, chest pain, palpitations, hypotension, hypertension, atrial fibrillation, ECG abnormalities, salivation

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

Storage

This medication should be stored in a tightly closed container to prevent air exposure and kept at a temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness.

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

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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.