Medication info
Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201502456 · Approved 2015.04.27 · Insurance code 645208750

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults
Adult dose
Administer 5 mg once daily before bedtime as Donepezil hydrochloride. If unusual dreams, nightmares, or sleep disturbances occur, consider administering this medication in the morning. The concentration of Donepezil reaches a steady state 15 days after administration, and the frequency of adverse reactions can be influenced by the rate of dosage increase, so the 5 mg dosage should be administered for 4 to 6 weeks. Evaluate clinical responses during this period.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

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 Alzheimer's dementia symptoms. It helps to alleviate the patient's memory impairment and cognitive dysfunction, thus improving daily living abilities.

How to take

Adult dose

Administer 5 mg once daily before bedtime as Donepezil hydrochloride. If unusual dreams, nightmares, or sleep disturbances occur, consider administering this medication in the morning. The concentration of Donepezil reaches a steady state 15 days after administration, and the frequency of adverse reactions can be influenced by the rate of dosage increase, so the 5 mg dosage should be administered for 4 to 6 weeks. Evaluate clinical responses during this period.

Precautions

This medication contains Donepezil hydrochloride hydrate as the main ingredient and is used to treat symptoms of Alzheimer's dementia. It should not be used in certain patients. For example, individuals with allergies to this medication or its components, pregnant women, or women who may become pregnant, and nursing mothers should avoid taking it. Additionally, as this medication contains lactose, individuals with lactose intolerance or related genetic disorders should not take it. Patients with heart disease, particularly those who may experience bradycardia or arrhythmias, should use this medication with caution, and it is important to monitor their heart condition periodically. Patients with gastrointestinal issues or those taking anti-inflammatory painkillers should be careful as this may exacerbate gastric ulcers or gastrointestinal bleeding. Patients with a history of asthma or obstructive lung diseases should also be cautious, as symptoms may worsen due to bronchoconstriction or increased secretions. Patients with extrapyramidal disorders such as Parkinson's disease may have exacerbated symptoms, so they should consult a doctor before taking this medication. During the use of this medication, various adverse reactions may occur. For example, cardiac-related problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, difficulty breathing, acute pancreatitis, acute renal failure, sudden death have been reported. In addition, various symptoms such as hallucinations, anxiety, insomnia, dizziness, diarrhea, nausea, vomiting, myalgia, rash may occur, and if any abnormal symptoms appear, immediate consultation with a doctor is recommended. This medication is not approved for other forms of memory impairment besides Alzheimer's dementia, and treatment should be initiated and supervised by an experienced physician. Patients with heart disease or a history of QT interval prolongation are at increased risk for cardiac arrhythmias, thus regular ECG monitoring may be necessary. This medication may affect driving or operating machinery, so caution is required when starting the medication or changing the dosage. Pregnant or nursing women should not take this medication, and if absolutely necessary, may need to consult a specialist to discontinue breastfeeding. Safety has not been established in children, so this medication is not used in children. This medication can interact with other drugs, so it's important to inform your doctor or pharmacist, particularly if you are taking drugs that affect CYP3A4 or CYP2D6 enzymes, muscle relaxants, cholinergic drugs, anticholinergic drugs, or cardiovascular medications. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, muscle weakness can occur, requiring immediate medical attention. Atropine may be used as an antidote. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

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 in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • hallucinations
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  • excitement
  • aggressive behavior
  • anxiety
  • sleeplessness
  • tremors
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • increased blood pressure
  • myalgia
  • muscle cramps
  • increased CK in blood and urine
  • skin rash
  • itching
  • fever
  • decreased body temperature
  • swelling
  • hives
  • urinary incontinence
  • frequent urination
  • urination issues
  • thrombocytopenia
  • anemia
  • leukopenia
  • dehydration

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White 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.