Medication info
Donepezil 5 mg Tablet (Donepezil Hydrochloride Hydrate)

Donepezil 5 mg Tablet (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201903790 · Approved 2019.06.10 · Insurance code 658106330

Summary

Main use
Improvement of Alzheimer-type dementia symptoms
Who takes it
Adults · Children
Adult dose
Donepezil Hydrochloride is given at a dose of 5 mg once a day before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil reaches steady-state concentration after 15 days, and the frequency of adverse reactions may be affected by the rate of increase in dosage, so the 5 mg dose should be administered for 4 to 6 weeks. After evaluating clinical response during this period, the dose can be increased to 10 mg.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of Alzheimer-type dementia symptoms

  • Symptoms of Alzheimer-type dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer-type dementia.

How to take

Adult dose

Donepezil Hydrochloride is given at a dose of 5 mg once a day before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil reaches steady-state concentration after 15 days, and the frequency of adverse reactions may be affected by the rate of increase in dosage, so the 5 mg dose should be administered for 4 to 6 weeks. After evaluating clinical response during this period, the dose can be increased to 10 mg.

Child dose

There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the main ingredient and is used for the treatment of symptoms of Alzheimer-type dementia. This medication should not be used by certain patients, for example, persons who are allergic to this medication or similar substances, women who are pregnant or may become pregnant, and patients with genetic issues such as lactose intolerance should not take this medication. Patients with heart disease or a history of peptic ulcers, patients with a history of asthma or chronic obstructive pulmonary disease, and patients with extrapyramidal disorders such as Parkinson's disease should exercise special caution when using this medication. Additionally, this medication contains a pigment called Tartrazine, and caution should be exercised in individuals with an allergy to this substance. During the use of this medication, serious side effects such as decreased heart rate or arrhythmias, peptic ulcers, liver dysfunction, cerebral hemorrhage, extrapyramidal symptoms, severe muscle pain, and respiratory distress may occur, and immediate consultation with a physician should be sought if symptoms appear. Mild side effects may include nausea, vomiting, diarrhea, dizziness, insomnia, headache, and fatigue, which are mostly temporary and resolve without discontinuation of treatment. This medication is not approved for other types of dementia or memory disorders other than Alzheimer-type dementia and should be administered under the supervision of an experienced physician. Heart disease patients may require an electrocardiogram when taking this medication, and those with a history of peptic ulcers should carefully monitor for symptom exacerbation. This medication may affect driving or the ability to operate machinery, so caution is necessary if fatigue or dizziness occurs early in treatment. Women who are pregnant or breastfeeding are advised not to use this medication, and if absolutely necessary, consultation with a specialist is recommended. This medication may interact with other drugs, so it is essential to inform the physician if taking antibiotics, antidepressants, antiarrhythmics, or anti-inflammatory analgesics. In cases of overdose, symptoms such as severe nausea, vomiting, muscle weakness, and respiratory distress may occur, requiring immediate emergency treatment, with atropine available as an antidote. Finally, this medication should be kept out of reach of children and should not be transferred to another container for safety purposes.

Side effects and when to seek care immediately

Serious side effects

  • Severe allergic reactions (hives, severe swelling)
  • Severe skin adverse reactions (severe rash, blistering, skin peeling, mucosal pain)
  • Respiratory problems (shortness of breath, asthma attacks)
  • Liver issues (jaundice, hepatitis, liver dysfunction)
  • Severe neurological symptoms (severe headache, seizures, altered consciousness, vision abnormalities, paralysis)
  • Severe edema or urinary issues (severe swelling, significant decrease in urine output)
  • Cardiovascular abnormalities (fainting, bradycardia, severe cardiovascular issues)

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • tremors
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  • sweating
  • itching
  • rash
  • muscle pain
  • urinary incontinence
  • frequent urination
  • urination disorders
  • anxiety
  • hallucinations
  • aggressive behavior
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • lethargy
  • thrombocytopenia
  • abnormal laboratory tests
  • etc.

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

Storage

This medication should be stored in a closed container to prevent exposure to air and kept at a temperature between 1 degree and 30 degrees Celsius (34 degrees to 86 degrees Fahrenheit). Storing it this way helps maintain the medication's effectiveness over 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

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.