Medication info
Hi-Silver Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Hi-Silver Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201901797 · Approved 2019.03.26 · Insurance code 644805600

Summary

Main use
Improvement of Alzheimer's disease symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider taking the medication in the morning. Donepezil reaches a normal concentration after 15 days of administration, so during 4 to 6 weeks, a dose of 5 mg should be given. After evaluating the clinical response during this period, the dosage may be increased to 10 mg. When increasing to 10 mg once daily, monitor for gastrointestinal adverse effects.
Child dose
No experience in pediatric use.

Ingredients

Manufacturer
태극제약(주)

Efficacy & effects

Improvement of Alzheimer's disease symptoms

  • Alzheimer's disease symptoms
View approved original text

This medication helps slow the progression of Alzheimer's disease symptoms and aids in memory and cognitive function improvement. It supports patients in maintaining their daily living abilities and is used to delay symptom exacerbation.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider taking the medication in the morning. Donepezil reaches a normal concentration after 15 days of administration, so during 4 to 6 weeks, a dose of 5 mg should be given. After evaluating the clinical response during this period, the dosage may be increased to 10 mg. When increasing to 10 mg once daily, monitor for gastrointestinal adverse effects.

Child dose

No experience in pediatric use.

Precautions

This medication contains the ingredient Donepezil Hydrochloride Hydrate and is used to treat Alzheimer's disease symptoms. This medication should not be used by certain patients. For example, individuals who are allergic to this drug or its components, pregnant women or women who may become pregnant, and those with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with heart disease or a history of gastric ulcers should be particularly cautious when taking this drug, as it may slow the heart rate or put strain on the gastrointestinal tract. Patients with asthma or chronic obstructive pulmonary disease should also exercise caution when using this medication, as it may affect the bronchi and worsen symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, should use this medication cautiously as it may exacerbate symptoms. This medication contains a dye called Yellow No. 5, and individuals allergic to this component should be careful. Various side effects may occur while taking this medication. Rarely reported side effects include heart problems, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, muscle issues, shortness of breath, acute pancreatitis, acute kidney failure, and sudden death. Commonly experienced side effects may include nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, headache, and fatigue. This medication is approved solely for Alzheimer's disease and is not used for other forms of dementia or memory disorders. Patients with heart-related conditions may require regular monitoring such as an ECG when taking this medication. This medication can affect driving or machine operation abilities, so caution is needed during the initial treatment phase or when changing doses. Pregnant or nursing women should avoid taking this medication, and if absolutely necessary, consult a physician before use. The safety for pediatric use has not yet been established, so it should not be used in children. This medication can affect liver and kidney function, so regular testing may be necessary. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory distress, and seizures may occur, requiring urgent medical treatment. Atropine may be used as an antidote in cases of overdose. This medication may interact with other drugs, so if other medications are being taken, it is essential to inform a physician or pharmacist and seek advice. Finally, this medication should be kept out of reach of children and should not be transferred to another container.

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 ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure (epilepsy, convulsion), intracranial hemorrhage, cerebrovascular disorders, extrapyramidal disorder symptoms (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuroleptic malignant syndrome (stupor, rigidity,

Mild side effects

  • Headache
  • dizziness
  • fatigue
  • drowsiness
  • nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • insomnia
  • itching
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  • rash
  • muscle pain
  • muscle cramps
  • urinary incontinence
  • urination disorders
  • increased blood pressure
  • fever
  • thrombocytopenia
  • anemia
  • dehydration
  • weight loss
  • weakness
  • anxiety
  • confusion
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • lethargy
  • vasodilation
  • sweating
  • urticaria
  • facial flushing
  • pain

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

Storage

This medication should be stored in an airtight container to prevent air exposure, and it is best kept at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness 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

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.