Medication info
Bielpe Tablet 10mg (Donepezil Hydrochloride Hydrate)

Bielpe Tablet 10mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)씨엘팜
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202005299 · Approved 2020.07.23 · Insurance code 622600450

Summary

Main use
Improvement of Alzheimer’s-type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning dosing of this medication can be considered. For the first 4 to 6 weeks, administer the 5 mg dose, and after assessing the clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, administer with caution regarding gastrointestinal adverse reactions. Underweight patients aged 85 years or older should not exceed a daily dose of 5 mg.
Child dose
There is no experience with the use in children.

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. It helps alleviate key symptoms such as memory impairment and cognitive decline, aiding patients in improving their daily life. Positive effects are expected in slowing the progression of symptoms and maintaining quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning dosing of this medication can be considered. For the first 4 to 6 weeks, administer the 5 mg dose, and after assessing the clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, administer with caution regarding gastrointestinal adverse reactions. Underweight patients aged 85 years or older should not exceed a daily dose of 5 mg.

Child dose

There is no experience with the use in children.

Precautions

This medication should not be used by patients who are allergic to certain ingredients or who have hypersensitivity to Donepezil Hydrochloride or piperidine derivatives. It is advisable for women who are pregnant, may become pregnant, or are breastfeeding to avoid taking this medicine. Patients with genetic problems such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Patients with heart disease or cardiac conduction disorders should be cautious as this medication may cause heart problems like bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication cautiously, as it may increase gastric acid secretion and gastrointestinal motility, worsening their symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be careful, as this medication may increase bronchoconstriction and mucus secretion, worsening their symptoms. Patients with extrapyramidal disorders such as Parkinson’s disease should take this medication with careful monitoring as it may worsen their symptoms. This medication contains Yellow No. 5 dye, so it should be administered cautiously to patients with hypersensitivity or a history of allergy to it. If serious side effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, movement disorders, or neuroleptic malignant syndrome occur, discontinue use immediately and seek medical attention. This medication may cause various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, depression, and cardiac arrhythmias, so if symptoms are severe or persistent, consult a doctor. The effectiveness for other memory impairments apart from dementia has not been established, so it should only be used for patients with Alzheimer’s-type dementia, and discontinuation should be considered if no therapeutic effect is observed. Patients with cardiovascular diseases may experience abnormalities in heart rhythm upon taking this medication, requiring regular ECG monitoring. As this medication may affect driving or machinery operation, caution is needed during the initial stages of treatment or when changing doses. There are many potential interactions with other drugs, so particular attention should be paid to changes in efficacy when taken with medications that inhibit or induce CYP3A4 or CYP2D6. Pregnant or breastfeeding women should avoid this medication, and if it must be taken, it is recommended to discontinue breastfeeding. Safety in children has not been established, so it is not used in children. In cases of overdose, serious symptoms such as nausea, vomiting, respiratory depression, and bradycardia may arise, necessitating immediate medical treatment; atropine may be used as an antidote. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • 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
  • movement disorders
  • ataxia
  • motor dysfunction
  • dystonia
  • tremors
  • involuntary movements
  • gait disorders
  • abnormal posture
  • speech impairment
  • neuroleptic malignant syndrome
  • akinetic mutism
  • extreme muscular rigidity
  • difficulty swallowing
  • tachycardia
  • blood pressure changes

Mild side effects

  • Loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talking excessively
  • mania
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  • nightmares
  • nervousness
  • inappropriate speech
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • insomnia
  • tremors
  • weakness
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • abdominal discomfort
  • constipation
  • saliva secretion
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • muscle

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 and moisture from entering and is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

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

No questions yet.

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.