Medication info
Alzheimer's Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Alzheimer's Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
유니메드제약(주)
Appearance
Yellow circular film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200709157 · Notified 2007.08.07 · Insurance code 649501570

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. The 5 mg dose should be used for 4 to 6 weeks. After evaluating clinical responses during this period, it may be increased up to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years old with low body weight should not exceed 5 mg per day.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's dementia. It helps improve memory decline and cognitive function impairment due to dementia, contributing to the improvement of the patient's daily living abilities. By taking it regularly, it can slow the progression of symptoms and enhance the quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. The 5 mg dose should be used for 4 to 6 weeks. After evaluating clinical responses during this period, it may be increased up to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years old with low body weight should not exceed 5 mg per day.

Child dose

There is no experience of use in children.

Precautions

This drug contains Donepezil Hydrochloride Hydrate as the active ingredient for the treatment of Alzheimer's dementia symptoms. This medication should not be used in certain patients. For example, individuals who are allergic to this drug or its ingredients, pregnant or potentially pregnant women, and nursing mothers should not take this medication. Caution is advised in patients with heart disease, especially those with sick sinus syndrome or heart conduction disorders, as this drug may slow heart rate or cause arrhythmias. Patients with a history of peptic ulcer disease or those taking non-steroidal anti-inflammatory drugs may need to be careful as increased gastric acid secretion and enhanced gastrointestinal motility can worsen their symptoms. Patients with asthma or chronic obstructive pulmonary disease should be administered cautiously, as there may be bronchoconstriction and increased mucus secretion that could exacerbate their symptoms. Caution is also warranted in patients with extrapyramidal disorders such as Parkinson's disease, as the cholinergic effects of this drug may worsen symptoms. This medication contains Yellow No. 5 dye, and care should be taken if there is an allergy to that component. During the use of this medication, serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular accidents, seizures, extrapyramidal symptoms, respiratory distress, acute pancreatitis, renal failure, and sudden death may occur, and immediate consultation with a doctor is advised if any symptoms arise. Additionally, various side effects like diarrhea, nausea, vomiting, reduced appetite, dizziness, insomnia, myalgia, rash, etc., may occur, and any unusual symptoms should be reported. This medication may affect heart rate, necessitating regular ECG checks for patients with heart disease. Pregnant or nursing women are advised not to use this medication, and if necessary, consultation with a physician is essential. Safety in children has not been established, so this drug is not intended for pediatric use. There may be interactions when this medication is taken in conjunction with other drugs, especially cardiac medications, antibiotics, antidepressants, antipsychotics, and analgesics, so consultation with a physician or pharmacist is essential when co-administering. Dizziness or drowsiness may occur, so caution is needed when driving or operating machinery. In case of overdose, symptoms like nausea, vomiting, bradycardia, hypotension, respiratory depression, or seizures may occur, so immediate contact with a healthcare facility is necessary, and atropine may be used as an antidote. This medication should be stored out of reach of children, and transferring 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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, confusion of consciousness, vision problems, paralysis, urination.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • reduced appetite
  • headache
  • fatigue
  • myalgia
  • dizziness
  • insomnia
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • lethargy
  • increased blood pressure
  • fever
  • rash
  • itching
  • dehydration
  • muscle cramps
  • urinary incontinence
  • increased urination
  • voiding disorders
  • thrombocytopenia
  • anemia
  • blood disorders
  • edema
  • flushing
  • pain
  • toothache
  • decreased blood pressure
  • palpitations
  • atrial fibrillation
  • sinus node block
  • cardiac arrest.

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 and moisture from entering. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the drug's effectiveness over time.

Appearance and packaging

Appearance

Yellow circular 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

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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.