Medication info

Union Donepezil Tablets 23 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 202102969 · Approved 2021.04.07

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, without regard to meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After 4 to 6 weeks of taking 5 mg, the clinical response can be assessed, and it may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. It should be taken at least 10 mg once daily for a minimum of 3 months.

Ingredients

Manufacturer
한국유니온제약(주)

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 for the treatment of symptoms of moderate to severe Alzheimer's-type dementia. It helps improve the patient's memory decline and cognitive dysfunction, thereby enhancing the quality of daily life. Continuous use can contribute to delaying the progression of symptoms and maintaining a stable condition. This medication protects the patient's cognitive function and assists in providing a better living environment.

How to take

Adult dose

This medication should be taken once daily just before bedtime, without regard to meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After 4 to 6 weeks of taking 5 mg, the clinical response can be assessed, and it may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. It should be taken at least 10 mg once daily for a minimum of 3 months.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the active ingredient and is used for the treatment of Alzheimer's-type dementia symptoms. This medication should not be given to certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and those with lactose intolerance or inherited lactose metabolism disorders should not take this medication. Patients with heart diseases or heart conduction disorders should be cautious when taking this medication as bradycardia or arrhythmia may occur. Patients taking non-steroidal anti-inflammatory analgesics or have a history of peptic ulcers should be careful as symptoms may worsen due to increased gastric acid secretion and enhanced gastrointestinal motility. Patients with asthma or obstructive pulmonary disease should also be cautious, as bronchoconstriction and increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, may experience worsening of motor symptoms from this medication. Additionally, this medication contains Tartrazine (Yellow No. 4), and those allergic or sensitive to this ingredient should be cautious. Various adverse reactions may occur while taking this medication, such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, and movement disorders in severe cases. Mild adverse reactions may frequently include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headaches, and fatigue. The occurrence of adverse reactions may increase, particularly at high doses, so patients should be closely monitored when increasing the dosage. This medication is not approved for other forms of memory disorders besides dementia, and treatment should be conducted under the supervision of a physician experienced in this area. This medication can affect heart conduction, so patients with heart diseases require monitoring, including an electrocardiogram. It is recommended that women who are pregnant or breastfeeding do not use this medication. This medication can interact with various drugs, so if other medications are being taken, consult a physician or pharmacist. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical attention, and Atropine can be used as an antidote. This medication should be kept out of reach of children, and transferring it to other containers is discouraged to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, high fever with severe rash, blisters, peeling skin, painful mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough+fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, consciousness disturbances, visual disturbances, paralysis, and urinary issues.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • insomnia
  • hallucinations
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  • agitation
  • aggressive behavior
  • anxiety
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • hypersexuality
  • tremors
  • gait abnormalities
  • involuntary movements
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • rash
  • itching
  • myalgia
  • urinary incontinence
  • frequent urination
  • hives
  • sweating
  • and more.

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 ideally kept at room temperature between 1°C and 30°C. Proper storage will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Red, biconvex, round 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.