Medication info
Donepezil Hydrochloride 10 mg Orally Disintegrating Tablet

Donepezil Hydrochloride 10 mg Orally Disintegrating Tablet

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

MFDS item code 200808880 · Notified 2008.08.20 · Insurance code 641904600

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, 5 mg should be administered once daily before bedtime. Normal state is reached after 15 days, maintaining the 5 mg dosage for 4-6 weeks. May increase to 10 mg after clinical response, and caution should be taken for gastrointestinal adverse reactions at a 10 mg daily dose. The orally disintegrating tablet can be taken by placing it on the tongue and swallowing with or without water.
Child dose
There is no experience regarding its use in children.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's dementia. It is effective in improving memory loss and cognitive dysfunction, thus aiding the daily lives of patients.

How to take

Adult dose

As donepezil hydrochloride, 5 mg should be administered once daily before bedtime. Normal state is reached after 15 days, maintaining the 5 mg dosage for 4-6 weeks. May increase to 10 mg after clinical response, and caution should be taken for gastrointestinal adverse reactions at a 10 mg daily dose. The orally disintegrating tablet can be taken by placing it on the tongue and swallowing with or without water.

Child dose

There is no experience regarding its use in children.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is used to improve symptoms of Alzheimer's dementia. First, this medication should not be used in certain patients. Individuals allergic to donepezil hydrochloride or any components of this medication, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Patients with cardiovascular disease or heart conduction disorders, those with a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease should use this medication with special caution. This medication may cause cardiac issues such as bradycardia or arrhythmia due to vagal stimulation, and may stimulate gastric acid secretion, worsening peptic ulcers. It may also induce bronchoconstriction, exacerbating asthma symptoms, and could worsen motor disorders similar to those seen in Parkinson's disease. During treatment, serious side effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, respiratory distress, acute pancreatitis, or acute renal failure may arise, warranting careful monitoring. Additionally, various side effects have been reported, including nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, muscle pain, headaches, fatigue, among others, and if symptoms are severe, consultation with a physician is advised. This medication may increase the risk of cardiac arrhythmia in patients with heart disease or electrolyte imbalances, and an electrocardiogram may be required. Moreover, this medication can interact with several other drugs, so you must inform your physician or pharmacist if you are taking any other medications. Care must be taken when co-administering drugs that affect CYP3A4 and CYP2D6 enzymes, anticholinergic medications, beta-blockers, NSAIDs, etc. Pregnant or nursing women should ideally avoid this medication and should make a cautious decision based on expert judgment if necessary. The safety in children has not yet been established, so this medication should not be used in pediatric patients. In case of overdose, dangerous symptoms like nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating immediate medical attention for appropriate treatment. When taking this medication, orally disintegrating tablets should be placed on the tongue to dissolve. Keep out of reach of children, as it may discolor due to light exposure, so it is better to store it in unopened packaging. Caution is needed when driving or operating machinery while taking this medication, particularly when starting or increasing the dose, as dizziness or fatigue may occur. The therapeutic effect of this medication should be regularly evaluated, and treatment should be considered for cessation if no effect is observed.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, difficulty breathing, liver dysfunction, jaundice, cerebral seizures, convulsions, syncope, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, duodenal perforation, gastrointestinal bleeding, cerebral hemorrhage, cerebrovascular disorders, neuroleptic malignant syndrome, rhabdomyolysis, acute pancreatitis, acute renal failure, unexplained sudden death, respiratory distress, shortness of breath or difficulty breathing, asthma attacks, cough with fever.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • itching
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  • rash
  • muscle pain
  • increased blood pressure
  • edema
  • thrombocytopenia
  • anemia
  • urinary incontinence
  • urinary disorders
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • vasodilation
  • drowsiness
  • blood and lymphatic system abnormalities
  • dehydration
  • weight loss
  • joint pain
  • muscle cramps
  • skin rash
  • eczema
  • facial

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 ingress. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help ensure the safety of 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

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.