Medication info

Donepezil 23 mg Tablets (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
(주)휴온스생명과학
Appearance
Red, round, biconvex film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202103140 · Approved 2021.04.15

Summary

Main use
Treatment of moderate to severe Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
This medication should be taken once daily just before bedtime, and can be taken regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated, and dosage may be increased to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Patients taking 10 mg once daily for a minimum of 3 months may receive 23 mg once daily.

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Treatment of moderate to severe Alzheimer's type dementia symptoms

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

This medication is used to treat symptoms of moderate to severe Alzheimer's type dementia. It helps alleviate symptoms such as memory impairment and cognitive dysfunction and improves activities of daily living. This contributes to enhancing the quality of life of patients.

How to take

Adult dose

This medication should be taken once daily just before bedtime, and can be taken regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks, clinical response should be evaluated, and dosage may be increased to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Patients taking 10 mg once daily for a minimum of 3 months may receive 23 mg once daily.

Precautions

This drug is used to improve symptoms of Alzheimer's type dementia with Donepezil Hydrochloride Monohydrate as its main component. This medication should not be administered to certain patients. For instance, it should be avoided by those who are allergic to this drug or its components, pregnant or nursing women, and patients with genetic issues such as lactose intolerance. Patients with heart disease or a history of peptic ulcers, asthma, or obstructive pulmonary disease, as well as those with extrapyramidal disorders such as Parkinson's disease, should take special caution when using this medication. This drug can cause serious side effects, such as bradycardia or arrhythmia, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, and respiratory distress; patients should notify their doctor immediately if any of these symptoms occur. Additionally, relatively common side effects such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue may also occur and should be monitored. Particular caution is required for patients with pre-existing conditions such as heart disease, liver dysfunction, peptic ulcers, or asthma. Regular medical oversight and testing while on this medication is recommended. Pregnant or nursing women are advised against using this drug unless absolutely necessary and should consult a professional before making any decisions. This medication may interact with other drugs, particularly those affecting the heart, antibiotics, antidepressants, antipsychotics, and NSAIDs, so patients must inform their doctor or pharmacist when taking these medications together. Dizziness or fatigue may occur while driving or operating machinery, especially during the initial stages of usage or when dosage changes occur; therefore, caution is warranted. In case of overdose, severe symptoms such as severe nausea, vomiting, hypotension, bradycardia, and respiratory depression may appear, requiring an immediate visit to a medical facility. Antidotes such as atropine may be used. This drug is not recommended for use in children, and it should be stored out of reach of children in a safe place.

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 mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and very severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • drowsiness
  • insomnia
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  • rash
  • itching
  • muscle pain
  • urinary incontinence
  • constipation
  • fecal incontinence
  • difficulty swallowing
  • increased blood pressure
  • thrombocytopenia
  • anemia
  • leukopenia
  • bleeding diathesis
  • dehydration
  • hyperlipidemia
  • weight loss
  • weight gain
  • malaise
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremor
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental lethargy
  • drowsiness

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

Storage

This medication should be stored in a closed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Red, round, biconvex 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

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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.