Medication info
Donepezil 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201508435 · Approved 2015.12.28 · Insurance code 684501300

Summary

Main use
Improvement of symptoms in Alzheimer's disease
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily before bedtime as donepezil hydrochloride. For 4 to 6 weeks, continue to administer 5 mg, after which clinical response should be evaluated to potentially increase to 10 mg. When increasing to 10 mg per day, monitor for gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg per day.
Child dose
No experience with use in children.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Improvement of symptoms in Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used for the treatment of symptoms associated with Alzheimer's disease.

How to take

Adult dose

Administer 5 mg once daily before bedtime as donepezil hydrochloride. For 4 to 6 weeks, continue to administer 5 mg, after which clinical response should be evaluated to potentially increase to 10 mg. When increasing to 10 mg per day, monitor for gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg per day.

Child dose

No experience with use in children.

Precautions

This medication contains donepezil hydrochloride and is primarily used to treat the symptoms of Alzheimer's disease. This medication should not be used in certain patients. For example, it should not be administered to individuals with allergies to this medication or its components, as well as pregnant or breastfeeding women, and patients with genetic issues such as lactose intolerance. Patients with heart conditions, asthma, chronic obstructive pulmonary disease, or a history of peptic ulcers should be particularly cautious when using this medication, as it may affect heart rhythm and exacerbate gastrointestinal symptoms. Various adverse reactions may occur when using this medication. For instance, cardiovascular problems, gastrointestinal bleeding, liver dysfunction, neurological symptoms, motor function disorders, and serious neurological anomalies have been reported. Therefore, if symptoms are severe or abnormal signs appear, immediate consultation with healthcare professionals is necessary. Additionally, this medication is not approved for memory disorders that are not related to dementia and should be used only under the diagnosis and supervision of a specialist. The therapeutic effect should be regularly evaluated, and if there is no effect, discontinuation should be considered. This medication is primarily metabolized in the liver, thus patients with impaired liver function may require dose adjustments. Furthermore, this medication can interact with other drugs, so it is essential to inform healthcare professionals about any medications being taken. Pregnant or breastfeeding women should not use this medication, and use should only occur after consulting a specialist if absolutely necessary. Safety in children has not been established, and therefore, it should not be administered to children. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, and seizures may occur, requiring immediate treatment, which may include antidotes such as atropine. This medication should be stored out of reach of children, and transferring it to other containers should be avoided as it may affect quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rashes with fever, blisters, skin peeling, pain in oral/eye mucosa, serious skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever associated respiratory problems, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice).

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • hallucinations
  • agitation
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  • aggressive behavior
  • anxiety
  • drowsiness
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequent urination
  • weight loss
  • edema
  • rash
  • itching
  • increased blood pressure
  • palpitations
  • hypertension
  • hypotension
  • thrombocytopenia
  • leukopenia
  • anemia
  • fever
  • vascular dilation
  • skin rash
  • hives
  • pain
  • toothache
  • flushing
  • malaise
  • lethargy
  • sweating
  • concentration issues.

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 exposure and is best kept at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the efficacy of the medication and prevents degradation.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.