Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201602261 · Approved 2016.04.22 · Insurance code 658501970

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. Administer the 5 mg dose for 4–6 weeks, and after clinical response evaluation, it may be increased to 10 mg. In case of increasing the dose to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly females should not exceed 5 mg daily and require careful monitoring.
Child dose
There is no experience with pediatric use.

Ingredients

Manufacturer
익수제약(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 for the treatment of symptoms of Alzheimer's-type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer the 5 mg dose for 4–6 weeks, and after clinical response evaluation, it may be increased to 10 mg. In case of increasing the dose to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly females should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience with pediatric use.

Precautions

This medication is used to treat symptoms of Alzheimer's-type dementia, with Donepezil Hydrochloride as the active ingredient. First, this medication should not be used by those allergic to Donepezil Hydrochloride, piperidine derivatives, or any components of this medication. Additionally, it should not be given to pregnant women, women who may become pregnant, or nursing mothers. This medication contains lactose; thus, individuals with genetic disorders such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with heart diseases, especially those with bradycardia syndrome or heart conduction disorders, should use this medication with caution, as it may stimulate the vagus nerve and cause heart problems such as bradycardia or arrhythmia. Those taking non-steroidal anti-inflammatory drugs (NSAIDs) or with a history of peptic ulcers need to be cautious due to increased gastric acid secretion and gastrointestinal motility that could worsen symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be careful, as this medication may increase bronchoconstriction and mucus secretion, exacerbating symptoms. Patients with Parkinson's disease or similar extrapyramidal disorders require careful administration due to the possibility of worsening symptoms. Various adverse reactions may occur while taking this medication. Reported cases include fainting, heart block, myocardial infarction, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute renal failure, and sudden death. Additionally, symptoms such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, aggressive behavior, depression, palpitations, skin rashes, and myalgia may also occur. If any of these adverse reactions occur, it is essential to consult a doctor immediately, and treatment may need to be stopped if necessary. This medication is not approved for other types of dementia or memory disorders other than Alzheimer's-type dementia and should be administered under the diagnosis and supervision of an experienced physician. The treatment effect should be evaluated regularly, and discontinuation should be considered if ineffective. Patients with heart disease need to periodically check their heart status, including ECG tests, as this medication may affect heart rhythm. Moreover, this medication may affect driving and machinery operation abilities, so caution is necessary when changing or starting to take it at the beginning. This medication can interact with specific drugs; thus, it is crucial to inform your doctor or pharmacist if you are taking other medications. Caution is particularly needed when combined with medications that affect CYP3A4 or CYP2D6 enzymes, drugs influencing heart conduction, and NSAIDs. Pregnant or nursing women should ideally not use this medication unless absolutely necessary, in which case consultation with a specialist is required. Safety in children has not been confirmed, so it is not used in pediatric patients. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, necessitating immediate medical care. Finally, this medication must be stored out of reach of children, and transferring it to other containers can adversely affect its quality.

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 the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough+fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • anxiety
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  • hallucinations
  • excitement
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • verbosity
  • mania
  • nightmares
  • irritability
  • rambling
  • hypersexuality
  • agitation
  • animosity
  • confusion
  • emotional instability
  • personality changes
  • impaired concentration
  • mental dullness
  • sweating
  • skin rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence

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

Storage

Store this medication in a sealed container to prevent exposure to air and moisture, ideally at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.