Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201908695 · Approved 2019.12.30 · Insurance code 694205860

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
Donepezil Hydrochloride is taken as 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, and after evaluating the clinical response, it can be increased to 10 mg. When increasing to 10 mg per day, monitor for gastrointestinal adverse reactions carefully. Underweight women over 85 years of age should not exceed 5 mg per day and require careful monitoring.
Child dose
There is no experience in using this drug in children.

Ingredients

Manufacturer
정우신약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's-type dementia

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

This medication is used to treat symptoms of Alzheimer's-type dementia. It helps improve various symptoms caused by dementia, such as memory decline and cognitive dysfunction, enhancing the patient's ability to carry out daily activities. Additionally, it contributes to improving the quality of life for patients and their families by slowing the progression of symptoms. By taking this medicine regularly, dementia-related issues can be managed more effectively.

How to take

Adult dose

Donepezil Hydrochloride is taken as 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, and after evaluating the clinical response, it can be increased to 10 mg. When increasing to 10 mg per day, monitor for gastrointestinal adverse reactions carefully. Underweight women over 85 years of age should not exceed 5 mg per day and require careful monitoring.

Child dose

There is no experience in using this drug in children.

Precautions

This medication should not be used by individuals with allergies to certain ingredients, pregnant or breastfeeding women, and those with genetic disorders resulting in lactose intolerance. Individuals with heart disease or heart conduction disorders should be cautious when using this drug, as it may cause bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this drug with caution due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Those with asthma or obstructive pulmonary diseases may experience worsening symptoms due to bronchial contraction and increased mucus production, so caution is advised. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening symptoms, so careful monitoring is necessary. This medication contains certain coloring agents, and individuals allergic to these components should also use it with caution. It may affect the heart and can lead to serious side effects such as syncope, bradycardia, heart block, myocardial infarction, and heart failure, so if symptoms occur, consult a doctor immediately. Serious adverse reactions such as gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, movement disorders, severe muscle spasms or neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death have also been reported, so caution is needed. During the use of this drug, various neuropsychiatric symptoms and adverse reactions involving the cardiovascular, digestive, skin, and musculoskeletal systems may occur, including nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, aggressive behavior, tremors, walking disabilities, involuntary movements, decreased concentration, mental sluggishness, drowsiness, edema, abdominal pain, pain, hives, blood dyscrasia, anemia, dehydration, increased CPK, liver function abnormalities, hepatitis, and jaundice. This medication is not used for other types of memory disturbances unrelated to dementia and must be taken under the diagnosis and supervision of an experienced physician. Patients with heart disease or electrolyte abnormalities may need to undergo an electrocardiogram due to the risk of cardiac arrhythmias when taking this medication. Caution is needed when driving or operating machinery, as symptoms such as dizziness, fatigue, and muscle cramps may occur. This drug is metabolized by specific enzymes, so there may be interactions when taken with other medications; therefore, consult a doctor or pharmacist about concomitant medications. Pregnant or breastfeeding women are advised not to use this medication, and if absolutely necessary, breastfeeding should be discontinued. Safety for pediatric use has not been established, so it should not be used in children. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may arise, requiring immediate emergency treatment. This medication should be stored out of reach of children, and transferring it to another container may degrade its quality, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • muscle pain
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  • rash
  • itching
  • sweating
  • elevated blood pressure
  • lowered blood pressure
  • palpitations
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • walking difficulties
  • involuntary movements
  • decreased concentration
  • mental sluggishness
  • drowsiness
  • edema
  • abdominal pain
  • pain
  • hives
  • blood dyscrasia
  • anemia
  • dehydration
  • increased CPK
  • liver function abnormalities
  • hepatitis
  • jaundice
  • cerebrovascular accidents
  • cerebral hemorrhage

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 and moisture from entering and kept at room temperature between 1 and 30 degrees Celsius. Maintaining this storage condition can help preserve the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

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.