Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201908483 · Approved 2019.12.17 · Insurance code 663300910

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and after evaluating clinical response, can increase to 10 mg. When increasing to 10 mg once daily, administer cautiously while observing for gastrointestinal side effects. Underweight women over 85 years should not exceed 5 mg per day and require careful monitoring.
Child dose
There is no experience with use in children.

Ingredients

Manufacturer
에스에스팜(주)

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

  • Alzheimer's type dementia symptoms
View approved original text

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

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and after evaluating clinical response, can increase to 10 mg. When increasing to 10 mg once daily, administer cautiously while observing for gastrointestinal side effects. Underweight women over 85 years should not exceed 5 mg per day and require careful monitoring.

Child dose

There is no experience with use in children.

Precautions

This medication should not be used in patients with allergies to certain ingredients. It should not be administered to pregnant women, women who may become pregnant, and nursing mothers. Patients with genetic lactose intolerance should also not be given this medication. Patients with heart diseases should use this medication cautiously, as it may slow down heart rate or cause arrhythmia. Patients with a history of peptic ulcers or who are taking non-steroidal anti-inflammatory drugs should closely monitor gastrointestinal symptoms while using this medication. Patients with asthma or chronic obstructive pulmonary disease should also use this medication cautiously, as symptoms may worsen. Patients with extrapyramidal disorders such as Parkinson's disease should be careful, as this medication may exacerbate symptoms. This medication contains the dye Yellow No. 5, so patients allergic to this ingredient should use it with caution. While taking this medication, serious side effects such as syncope, arrhythmia, gastrointestinal bleeding, liver dysfunction, seizures, muscle disorders, respiratory distress, acute pancreatitis, and renal failure may occur, so immediate consultation with healthcare professionals is advised if any abnormal symptoms appear. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, depression may occur, so symptoms should be closely monitored. This medication is approved for use only in Alzheimer's dementia patients and should not be used for other types of dementia or memory disorders. Patient conditions should be regularly evaluated during the initiation and maintenance of treatment, and if there is no effect or serious side effects, treatment should be discontinued. Patients with heart disease or electrolyte abnormalities may have a risk of arrhythmia with this medication, so an electrocardiogram may be necessary. This medication can stimulate gastric acid secretion, leading to gastrointestinal disturbances, so patients with a history of gastrointestinal diseases should be cautious. Dizziness or fatigue may occur when driving or operating machinery, so caution is advised. This medication may interact with other drugs, so especially when combined with heart medications, antibiotics, antidepressants, or antipsychotics, healthcare professionals must be informed. It is safest for pregnant or nursing women not to use this medication, and if it is absolutely necessary, consultation with experts is required. Safety in children has not been established, so it should not be used in children. In cases of overdose, symptoms such as nausea, vomiting, respiratory depression, and muscle weakness may occur, and immediate medical treatment is necessary. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever with severe rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
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  • nightmares
  • irritability
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • hypersexuality
  • dizziness
  • tremors
  • diarrhea
  • nausea
  • vomiting
  • abdominal disturbances
  • constipation
  • salivation
  • dysphagia
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence
  • increased urination
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • lethargy

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

Storage

This medication should be stored in a sealed container to prevent air from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for longer.

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.