Medication info
Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201600968 · Approved 2016.02.22 · Insurance code 648603210

Summary

Main use
Improvement of symptoms associated with Alzheimer's type dementia
Who takes it
Adults
Adult dose
For Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider administering this medication in the morning. The concentration of Donepezil reaches a steady state after 15 days of administration, so it is administered at 5 mg for 4 to 6 weeks. After assessing the clinical response during this period, the dose can be increased up to 10 mg. If increasing to 10 mg per day, caution should be exercised with regard to gastrointestinal adverse reactions.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Improvement of symptoms associated with Alzheimer's type dementia

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

This medication is used to improve symptoms of Alzheimer's type dementia. It helps alleviate symptoms associated with dementia such as memory decline and cognitive dysfunction. It can contribute to improving the patient's ability to carry out daily activities. Through stable medication management, it slows the progression of symptoms and enhances quality of life. Therefore, it is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

For Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider administering this medication in the morning. The concentration of Donepezil reaches a steady state after 15 days of administration, so it is administered at 5 mg for 4 to 6 weeks. After assessing the clinical response during this period, the dose can be increased up to 10 mg. If increasing to 10 mg per day, caution should be exercised with regard to gastrointestinal adverse reactions.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is primarily used for the treatment of Alzheimer's type dementia. First, this medication should not be used in certain patients. For example, individuals with allergies to this medication or its ingredients, pregnant women, or nursing mothers should not take this medication. Additionally, because it contains lactose, individuals who are genetically unable to digest lactose should also avoid this medication. This medication must be administered with caution to patients with heart disease or problems with heart conduction, those with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or lung diseases, and patients with extrapyramidal disorders such as Parkinson's disease. This medication can stimulate the vagus nerve, which may slow heartbeats or cause arrhythmias, so patients with heart disease should exercise particular caution. Various adverse reactions may occur during use, ranging from mild nausea, vomiting, and diarrhea to severe cases such as cardiac issues, liver function abnormalities, cerebrovascular disorders, extrapyramidal symptoms, and severe muscle pain. If such symptoms occur, consult a doctor immediately to discontinue or adjust the medication. As a cholinesterase inhibitor, this medication may enhance gastric acid secretion and increase gastrointestinal motility, potentially worsening peptic ulcers; therefore, caution is needed for patients with gastrointestinal diseases. Moreover, this medication can affect driving or operating machinery, so caution should be exercised at the beginning of treatment or with dosage adjustments. This medication can interact with various other drugs, so if you are taking other medications, make sure to inform your doctor or pharmacist. Particularly, caution is required when used in conjunction with medications affecting the heart, antibiotics, antidepressants, or antipsychotics. It is advised that pregnant or nursing women do not use this medication, and if it must be used, it should be discussed with a specialist. Safety in children has not been established, so it is not to be used in pediatric patients. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression may occur, so strict adherence to the prescribed dosage is essential, and emergency treatment should be sought in case of overdose. Finally, this medication should be stored out of reach of children, and it is safer to keep it in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and extremely severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urinary symptoms

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • tremors
  • gait disturbances
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  • involuntary movements
  • drowsiness
  • anxiety
  • hallucinations
  • aggressive behavior
  • confusion
  • sweating
  • skin rash
  • thrombocytopenia
  • urinary incontinence
  • increased urination
  • fecal incontinence
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • falls
  • diarrhea
  • constipation
  • difficulty swallowing
  • increased salivation
  • abdominal symptoms

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 from entering, and it is best to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication.

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.