Medication info
Bivozon Donepezil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

Bivozon Donepezil Tablets 5mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201603687 · Approved 2016.06.21 · Insurance code 658203190

Summary

Main use
Improvement of Alzheimer's-type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg orally once daily before bedtime. For 4 to 6 weeks, administer the dose of 5 mg, and after evaluating clinical response, it can be increased to 10 mg. When increasing to 10 mg daily, monitor for gastrointestinal adverse reactions. Underweight females over 85 years of age should not exceed 5 mg daily.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Improvement of Alzheimer's-type dementia symptoms

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

This medication is used to improve memory loss and cognitive dysfunction associated with Alzheimer's-type dementia. It helps maintain the patient's daily living abilities and enhances quality of life. It also helps delay the progression of symptoms, allowing for long-term stable conditions. Therefore, it is effectively used in the treatment of Alzheimer's-type dementia symptoms.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg orally once daily before bedtime. For 4 to 6 weeks, administer the dose of 5 mg, and after evaluating clinical response, it can be increased to 10 mg. When increasing to 10 mg daily, monitor for gastrointestinal adverse reactions. Underweight females over 85 years of age should not exceed 5 mg daily.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the active ingredient and is primarily used to alleviate symptoms of Alzheimer's-type dementia. This medication should not be used in certain patients. For example, it is not safe for individuals who are allergic to this medication or its components, women who are pregnant or may become pregnant, and nursing mothers. Patients with heart conditions or conduction disturbances may need to use this medication with caution as it can cause bradycardia or arrhythmia. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be cautious as increased gastric acid secretion may exacerbate symptoms. Patients with asthma or obstructive lung disease should also be careful, as the actions of this medication can worsen respiratory symptoms. Patients with extrapyramidal disorders such as Parkinson's disease require careful supervision as this medication may worsen symptoms. This medication contains Yellow No. 5 dye, and patients with a known allergy to this compound should inform their healthcare provider before administration. While taking this medication, serious side effects such as cardiac-related abnormal reactions, gastrointestinal bleeding, liver dysfunction, cerebral abnormal symptoms, muscle abnormalities, and shortness of breath may occur; consult healthcare professionals immediately if these symptoms appear. Minor side effects may include nausea, vomiting, diarrhea, headaches, dizziness, insomnia, etc., most of which are temporary and mild. This medication is approved only for the treatment of dementia symptoms and is not authorized for use in other types of memory impairment. Administration should be conducted under the supervision of an experienced physician, and discontinuation should be considered if no therapeutic effect is observed. Patients with cardiovascular disease or suspected QT interval prolongation may require an electrocardiogram when taking this medication, and some drug interactions may increase side effects, so it is essential to inform the physician when taking other medicines. Pregnant women or nursing mothers should not take this medication unless necessary and should consult a specialist before use. Safety in pediatric patients has not been established, so it is not to be administered to children. In cases of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory suppression, and muscle weakness may occur, requiring immediate medical treatment. This medication should be stored out of reach of children, and transferring it to another container may lead to degradation in quality or accidents, so caution is advised.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • breathing problems
  • jaundice
  • hepatitis
  • liver dysfunction
  • severe allergic reactions
  • severe skin reactions
  • severe edema or urination abnormalities
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  • cerebral seizures
  • convulsions
  • intracerebral hemorrhage
  • cerebrovascular accidents
  • fainting
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • neuroleptic malignant syndrome
  • rhabdomyolysis

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headaches
  • fatigue
  • fever
  • dizziness
  • insomnia
  • drowsiness
Show 29 more
  • muscle pain
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • urinary incontinence
  • urination disorders
  • edema
  • itching
  • eczema
  • petechiae
  • dehydration
  • hyperlipidemia
  • hypoglycemia
  • weight loss
  • arthritis
  • arthralgia
  • agitation
  • confusion
  • hallucinations
  • hyponatremia
  • cholecystitis
  • abdominal pain

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

Storage

This medication should be stored in a tightly closed container to prevent air exposure and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's efficacy and prevent deterioration.

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.