Medication info

Donepezil Hydrochloride 10 mg Tablet (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 202005095 · Approved 2020.07.15

This product's status changed to Expired on 2025.07.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms in Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider taking this medication in the morning. Donepezil's concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be affected by the rate of dose escalation, so administer 5 mg for 4-6 weeks. Assess clinical response during this period.
Child dose
There is no experience using this medication in pediatric patients.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Improvement of symptoms in Alzheimer's type dementia

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

This medicine is used in the treatment of Alzheimer's type dementia. It helps improve major symptoms such as memory decline and cognitive dysfunction, aiding patients in their daily lives. Additionally, it helps slow down the progression of dementia. It contributes to improving the patient's quality of life and supports overall mental function recovery. It is effective in alleviating symptoms when used safely.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider taking this medication in the morning. Donepezil's concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be affected by the rate of dose escalation, so administer 5 mg for 4-6 weeks. Assess clinical response during this period.

Child dose

There is no experience using this medication in pediatric patients.

Precautions

This medication should not be used by women who are allergic to specific ingredients or are pregnant or breastfeeding, and by patients with genetic lactose metabolism disorders. Patients with heart disease or a history of gastrointestinal diseases, asthmatics, or those with a history of specific allergies should be cautious when using this medication. This medication can cause various serious side effects such as slowed heart rate or arrhythmias, worsening of peptic ulcers, liver dysfunction, cerebrovascular issues, and motor disorders, so patients must consult a physician immediately if symptoms occur. Some patients may experience side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, and aggressive behavior, which may require treatment discontinuation or dose adjustment. The effectiveness of this medication may vary depending on the type of dementia, so it should be used under the supervision of a specialist after an accurate diagnosis, and discontinuation should be considered if there is no therapeutic effect. Patients with poor heart health require regular cardiac monitoring, including ECG tests, and those with a history of gastrointestinal disease should carefully monitor for symptom exacerbation. This medication may affect driving or machine operation ability; caution is necessary at the start of treatment or when changing doses. Interactions with other medications may occur, especially when taken with drugs metabolized by the liver or those affecting the heart, so consult a doctor or pharmacist in such cases. It is generally advised that pregnant or breastfeeding women do not use this drug unless absolutely necessary and after consulting a specialist. The safety for children has not been established, so it should not be used in pediatric patients. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical attention.

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, blistering, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory anomalies accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • rash
Show 29 more
  • itching
  • muscle pain
  • urinary incontinence
  • frequency of urination
  • swelling
  • increased blood pressure
  • palpitations
  • thrombocytopenia
  • anemia
  • dehydration
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbance
  • mental dullness
  • drowsiness
  • cardiac arrest
  • facial flushing
  • pain
  • toothache
  • lethargy
  • weakness
  • fever
  • decreased body temperature
  • blood dyscrasia
  • petechiae
  • abnormal dreams
  • pharyngitis

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 at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the drug's effectiveness and safety.

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.

Related searches

Search tags

Suggested searches

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.