Medication info
Newdon Pilsu Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Newdon Pilsu Tablets 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201802158 · Approved 2018.05.24 · Insurance code 053600750

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, the 5 mg dose should be administered. After evaluating the clinical response during this period, the dose can be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised for gastrointestinal adverse reactions. Underweight women over 85 years should not exceed 5 mg per day.
Child dose
There is no experience in pediatric use.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used for the treatment of symptoms of Alzheimer's type dementia. It helps alleviate symptoms such as memory decline and cognitive dysfunction, allowing patients to carry out daily activities more smoothly. It assists in slowing the progression of symptoms and improving quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, the 5 mg dose should be administered. After evaluating the clinical response during this period, the dose can be increased to 10 mg. When increasing to 10 mg per day, caution should be exercised for gastrointestinal adverse reactions. Underweight women over 85 years should not exceed 5 mg per day.

Child dose

There is no experience in pediatric use.

Precautions

This medication should not be used by individuals who are allergic to certain ingredients, pregnant or nursing women, or patients with genetic lactose intolerance. Patients with heart disease or a history of peptic ulcers, asthma or obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease should exercise special caution when using this medication. It may slow heart rate or cause arrhythmias and has the risk of worsening gastrointestinal bleeding or ulcers, so changes in symptoms need to be monitored closely. Additionally, serious side effects such as liver dysfunction, cerebrovascular issues, muscle abnormalities, respiratory distress, acute pancreatitis, and renal failure may occur, and if any unusual symptoms arise, immediate consultation with healthcare professionals is required. This drug can affect driving or machine operation ability, so caution is necessary at the beginning of treatment or during dosage adjustments. Pregnant or nursing women are advised not to take this medication and should consult a professional in case of necessity. This medication may interact with other drugs, especially those affecting liver metabolism or cardiovascular drugs, and caution should be taken in such cases. In case of overdose, severe nausea, vomiting, muscle weakness, and respiratory distress may occur, requiring immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, epilepsy, convulsions, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremor, involuntary movement, gait disturbance, abnormal posture, speech impairment), neuroleptic malignant syndrome (akinetic mutism, severe muscle rigidity)

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • sweating
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  • itching
  • rash
  • myalgia
  • edema
  • thrombocytopenia
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremor
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • weakness
  • fluctuations in blood pressure
  • fever
  • urticaria
  • facial flushing
  • lethargy
  • pain
  • toothache
  • dehydration
  • hyperlipidemia
  • hypertension
  • hypotension
  • palpitations

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. This helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Dark 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

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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.