Medication info
Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201508436 · Approved 2015.12.28 · Insurance code 684501320

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated for a possible increase to 10 mg. For dosage increase to 10 mg per day, caution is required regarding gastrointestinal adverse reactions. Underweight women over 85 years should not exceed 5 mg per day, and careful monitoring for adverse reactions is required.
Child dose
There is no experience with the use in children.

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used to treat symptoms of Alzheimer's type dementia. It helps improve memory decline and cognitive function impairment due to dementia symptoms, thereby enhancing patients' ability to carry out daily activities. It also supports brain function and has the effect of slowing the progression of symptoms. Consistent administration allows for stable management of symptoms, making therapeutic efficacy achievable.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated for a possible increase to 10 mg. For dosage increase to 10 mg per day, caution is required regarding gastrointestinal adverse reactions. Underweight women over 85 years should not exceed 5 mg per day, and careful monitoring for adverse reactions is required.

Child dose

There is no experience with the use in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is used for the treatment of symptoms of Alzheimer's type dementia. This medication should not be used in certain patients. For instance, individuals who are allergic to this medication or its components, pregnant women or those who may become pregnant, breastfeeding women, and patients with lactose intolerance or specific genetic lactose metabolism disorders should not take this medication. Patients with heart disease or heart conduction disorders need to take caution when using this medication, as it may slow down the heart rate or cause arrhythmias. Patients taking nonsteroidal anti-inflammatory drugs or with a history of peptic ulcer disease should also be careful when using this medication, as there is a possibility of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive lung disease should use cautiously, as bronchoconstriction or increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson’s disease may experience worsening symptoms, and caution is required. This medication contains Yellow No. 5 dye, which may cause allergic reactions in some individuals. When taking this medication, various adverse reactions may occur. Cardiac issues such as fainting, bradycardia, and heart block may happen, and gastrointestinal bleeding or ulcers, liver dysfunction, cerebral hemorrhage, seizures, muscular abnormalities, respiratory distress, pancreatitis, and renal failure have been reported. Additionally, side effects such as hallucinations, anxiety, insomnia, dizziness, diarrhea, nausea, vomiting, loss of appetite, headache, fatigue, skin rashes may occur. If there is no treatment effect for dementia, it is recommended to discontinue use, and treatment should occur under the supervision of an experienced physician. This medication can affect heart rhythm, so patients with heart diseases or a history of prolonged QT interval should be particularly cautious, and an electrocardiogram may be necessary in some cases. Caution is advised when driving or operating machinery, especially during the initial dose or dosage increase. Pregnant or breastfeeding women are advised against using this medication and should consult specialists if necessary. This medication can interact with various drugs, so it is essential to inform the physician or pharmacist of any other medications being taken. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions may occur, and immediate medical attention is necessary. This medication should be kept out of the reach of children, and transferring it to other containers should be avoided.

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 fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme body weakness, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • anxiety
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  • hallucinations
  • excitability
  • aggressive behavior
  • nightmares
  • irritability
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • nervousness
  • hostility
  • confusion
  • emotional instability
  • personality changes
  • eczema
  • rash
  • itching
  • muscle spasms
  • myalgia
  • incontinence
  • frequent urination
  • urinary retention
  • hives
  • sweating
  • facial flushing
  • lethargy

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 or moisture from entering. It is recommended to store it at room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness over time.

Appearance and packaging

Appearance

Yellow circular 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.