Medication info
Beasept 23 mg (Donepezil Hydrochloride Hydrate)

Beasept 23 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201708553 · Approved 2017.12.22 · Insurance code 694001570

Summary

Main use
Treatment of moderate to severe symptoms of Alzheimer's type dementia
Who takes it
Adults
Adult dose
This medicine is taken once daily just before bedtime, and can be administered regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4-6 weeks and assessing clinical response, the dose may be increased to 10 mg. When increasing the dose to 10 mg, gastrointestinal adverse reactions should be monitored. It is taken at a dose of 10 mg once daily for a minimum of 3 months.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment of moderate to severe symptoms of Alzheimer's type dementia

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

This medicine is used to treat symptoms of Alzheimer's type dementia ranging from moderate to severe.

How to take

Adult dose

This medicine is taken once daily just before bedtime, and can be administered regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4-6 weeks and assessing clinical response, the dose may be increased to 10 mg. When increasing the dose to 10 mg, gastrointestinal adverse reactions should be monitored. It is taken at a dose of 10 mg once daily for a minimum of 3 months.

Precautions

This medicine is used to treat symptoms of Alzheimer's type dementia with Donepezil Hydrochloride as the main ingredient. First, this medicine should not be administered to patients with allergies to Donepezil Hydrochloride or its components, pregnant women or women of childbearing potential, and nursing mothers. Patients with genetic lactose intolerance or lactose enzyme deficiency, and glucose-galactose malabsorption should also not take this medicine. Patients with heart disease or heart conduction disorders should use this medicine cautiously, as it may stimulate the vagus nerve and cause bradycardia or arrhythmia. Patients currently taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious, as it may increase gastric acid secretion and enhance gastrointestinal motility, worsening symptoms. Patients with a history of asthma or obstructive lung disease should also be careful, as bronchoconstriction and increased mucus secretion may exacerbate symptoms. In patients with extrapyramidal disorders, this medicine may worsen symptoms, requiring careful administration. Serious adverse reactions such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, extrapyramidal symptoms, malignant neuroleptic syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death may occur while taking this medicine, so if any abnormal symptoms appear, consult a healthcare professional immediately. Commonly, side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, drowsiness, muscle pain, headache, and fatigue; these symptoms are usually mild or temporary. This medicine may affect the heart, so patients with a history of heart disease or prolonged QT interval may require an electrocardiogram. Additionally, it may affect liver function, necessitating caution in patients with liver diseases. Pregnant or nursing women are advised not to use this medicine unless absolutely necessary, in which case they should consult with a healthcare professional. The safety of this medicine in children has not been established, hence it is not used in children. While taking this medicine, caution is needed when operating vehicles or machinery, especially at the start of treatment or dose increases, where dizziness, fatigue, muscle cramps, etc., may occur. This medicine may interact with other drugs, so it is important to be cautious, especially when taken with certain antibiotics, antidepressants, antiarrhythmics, antipsychotics, and anti-inflammatory analgesics, and to inform healthcare professionals of any medications being taken. In case of overdose, symptoms like nausea, vomiting, excessive salivation, sweating, bradycardia, hypotension, respiratory depression, weakness, and convulsions may occur, requiring immediate emergency treatment, and antidotes like atropine may be used. Finally, this medicine should be kept out of the reach of children, and transferring to other containers is not recommended for quality maintenance and safety.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforated duodenal ulcer
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal symptoms
  • malignant neuroleptic syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cardiac arrest
  • Torsades de Pointes.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • insomnia
  • tremors
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  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • drowsiness
  • sweating
  • skin rash
  • aggressive behavior
  • hallucinations
  • excitement
  • anxiety
  • drowsiness
  • talkativeness
  • mania
  • nightmares
  • neuroticism
  • uttering nonsense
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • increased libido
  • hypersexuality
  • eczema
  • rash
  • itching
  • urinary incontinence
  • frequent urination
  • bowel

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

Storage

This medicine should be stored in a sealed container to prevent air infiltration, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medicine.

Appearance and packaging

Appearance

Red-brown, bilaterally convex, 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.