Medication info
Donepezil 5 mg Tablet (Donepezil Hydrochloride Hydrate)

Donepezil 5 mg Tablet (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201908299 · Approved 2019.12.09 · Insurance code 670501950

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who uses it
Adults · Children
Adult dosage
Administer 5 mg of Donepezil Hydrochloride once a day before bedtime. Initially maintain a dosage of 5 mg for 4-6 weeks, then evaluate clinical response to increase to 10 mg if necessary. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions.
Children's dosage
No experience in pediatric use.

Ingredients

Manufacturer
(주)보령바이오파마

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. It can help improve memory loss, cognitive function decline, and difficulties in daily life. Regular use may contribute to slowing the progression of symptoms and enhancing quality of life.

Dosage and Administration

Adult dosage

Administer 5 mg of Donepezil Hydrochloride once a day before bedtime. Initially maintain a dosage of 5 mg for 4-6 weeks, then evaluate clinical response to increase to 10 mg if necessary. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions.

Children's dosage

No experience in pediatric use.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its main ingredient and is used for the treatment of symptoms of Alzheimer's-type dementia. This medication should not be used in certain patients. For example, individuals with allergies to this medication, its components, or similar ingredients, pregnant women or those who may become pregnant, and nursing mothers should not take this medication. Additionally, individuals sensitive to lactose, those with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, should also not take this medication. Patients with heart disease should use this medication cautiously, as it may cause a slowing of the heart rate or arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should observe caution due to potential gastrointestinal issues. Patients with a history of asthma or chronic obstructive pulmonary disease may experience bronchoconstriction or increased mucus secretion, leading to worsened symptoms when taking this medication. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening of symptoms. This medication contains a dye called Yellow No. 5, so caution should be exercised by those who are allergic to this component. During treatment with this medication, a variety of adverse reactions may occur. For example, heart-related issues (bradycardia, heart block, myocardial infarction), gastrointestinal issues (peptic ulcers, gastrointestinal bleeding), liver function abnormalities, seizures, movement disorders, muscle issues, difficulty breathing, acute pancreatitis, acute renal failure, and sudden death have been reported. Additionally, symptoms such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, aggressive behavior, depression, confusion, palpitations, rashes, myalgia, and others may also occur. This medication may affect the heart, so patients with a history of heart disease or QT interval prolongation should undergo an ECG to monitor their condition. It may influence the gastrointestinal system, increasing gastric acid secretion, so those with a history of peptic ulcers should observe whether symptoms worsen. This medication may affect the ability to drive or operate machinery; therefore, caution is advised when starting treatment or changing the dosage. Pregnant or nursing women are advised not to use this medication unless absolutely necessary and after consulting a professional. This medication may interact with various drugs; thus, individuals taking other medications should consult their physician or pharmacist. In case of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, respiratory depression, seizures, and immediate medical attention is required.

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, pain in mucous membranes of mouth/eyes, difficulty or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • myalgia
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  • rash
  • itching
  • increased blood pressure
  • frequent urination
  • incontinence
  • constipation
  • lethargy
  • sweating
  • confusion
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • anemia
  • leukopenia
  • hyponatremia
  • fever
  • decreased body temperature
  • dehydration
  • anxiety
  • hostility
  • irritability
  • depression
  • confusion.

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 or moisture from entering, and it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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.