Medication info
Bielpezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Bielpezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(주)씨엘팜
Appearance
Yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202005298 · Approved 2020.07.23 · Insurance code 622600460

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
As donepezil hydrochloride, the recommended dosage is 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing. Administer 5 mg for 4-6 weeks, and thereafter evaluate clinical response to increase to 10 mg if necessary. When increasing to 10 mg daily, exercise caution regarding gastrointestinal adverse reactions. Underweight female patients over 85 years should receive only 5 mg daily.

Ingredients

Manufacturer
(주)씨엘팜

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

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

This medication is used to treat symptoms of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, the recommended dosage is 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning dosing. Administer 5 mg for 4-6 weeks, and thereafter evaluate clinical response to increase to 10 mg if necessary. When increasing to 10 mg daily, exercise caution regarding gastrointestinal adverse reactions. Underweight female patients over 85 years should receive only 5 mg daily.

Precautions

This medication should not be used by patients with allergies to specific ingredients, or by pregnant or breastfeeding women. Additionally, patients with lactose intolerance or certain genetic issues should avoid taking this medication. Patients with heart disease or problems with heart rhythm should be cautious as this medication may cause bradycardia or arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful of gastrointestinal bleeding or worsening of ulcers. Patients with asthma or obstructive pulmonary disease should also be cautious as symptoms may worsen due to bronchoconstriction and increased mucus production. Patients with extrapyramidal disorders like Parkinson's disease need to be cautious as their symptoms may worsen. While taking this medication, serious side effects such as slowed heart rate, fainting, heart attack, gastrointestinal bleeding, liver dysfunction, seizures, and muscle disorders may occur; if symptoms arise, consult a healthcare professional immediately. Furthermore, various side effects like nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, depression, and muscle pain may occur, so it's important to carefully monitor for unusual symptoms. This medication is used solely for the treatment of dementia and is not approved for other forms of cognitive impairment. Periodic evaluation of treatment effectiveness should be conducted and discontinuation considered if necessary. This medication can affect heart rhythm, so it should be used cautiously in patients with heart disease or those with prolonged QT intervals, and an ECG may be required. Since it may affect driving or machinery operation abilities, caution is required at the start of treatment or when adjusting dosage. It is advisable not to use this medication during pregnancy or breastfeeding; if it is absolutely necessary, consult a specialist. This medication may interact with specific drugs, so if you are taking other medications, it is crucial to inform your healthcare provider and exercise caution. In case of overdose, serious symptoms such as nausea, vomiting, breathing difficulties, and muscle weakness may occur, and immediate emergency treatment is required, with atropine available as an antidote. When storing, keep it out of reach of children and do not transfer the medication to another container as a safety measure.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures (epilepsy, convulsions, etc.), cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement disorders, ataxia, motor dysfunction, dystonia, tremors, involuntary movements, gait disturbances, abnormal postures, speech disorders), neuroleptic malignant syndrome (stupor, extreme muscle stiffness)

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • rash
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  • itching
  • muscle pain
  • incontinence
  • frequent urination
  • edema
  • thrombocytopenia
  • blood abnormalities
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • fever
  • thrombocytopenia
  • petechiae
  • dehydration
  • edema
  • urticaria
  • vesicular rash
  • etc.

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

Storage

This medication should be stored in an airtight container and at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness over time.

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

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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.