Medication info
Samsung Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Samsung Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201803555 · Approved 2018.08.30 · Insurance code 642307170

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. Administer a 5 mg dose for 4 to 6 weeks, and after evaluating the clinical response during this period, it may be increased to 10 mg. When increasing the dose to 10 mg daily, administer it while being aware of gastrointestinal adverse reactions. For underweight female patients over 85 years of age, the dosage should not exceed 5 mg per day, requiring close monitoring.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
삼성제약(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 to improve the patient's memory decline and cognitive function, enhancing the quality of daily life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Administer a 5 mg dose for 4 to 6 weeks, and after evaluating the clinical response during this period, it may be increased to 10 mg. When increasing the dose to 10 mg daily, administer it while being aware of gastrointestinal adverse reactions. For underweight female patients over 85 years of age, the dosage should not exceed 5 mg per day, requiring close monitoring.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication is used to treat symptoms of Alzheimer's type dementia with Donepezil Hydrochloride as the main ingredient. First, this medication should not be administered to patients allergic to Donepezil Hydrochloride or any ingredients of this medication, to women who are pregnant or may become pregnant, and to nursing mothers. Patients with heart disease or cardiac conduction disorders should use this medication with caution, as it may slow heart rate or cause arrhythmias. Patients taking nonsteroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful, as this medication may increase gastric acid secretion and promote gastrointestinal motility, worsening symptoms. Patients with asthma or a history of obstructive pulmonary diseases should take care, as this medication can increase bronchial constriction and mucus secretion, exacerbating symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication cautiously, as it may exacerbate neurological symptoms. Furthermore, this medication contains Yellow No. 5, which requires caution in patients allergic to this substance. While taking this medication, symptoms such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver function abnormalities, cerebrovascular problems, and muscle-related symptoms may occur. If any unusual symptoms are found, consult a doctor immediately. As this medication is a cholinesterase inhibitor, it may slow heart rate and affect cardiac conduction, requiring regular ECG monitoring for patients with heart disease. It may affect driving and machine operation abilities, so caution is advised when starting the medication or increasing the dosage. This medication may interact with other drugs, particularly those affecting the CYP3A4 or CYP2D6 enzymes, cardiac-related medications, anticholinergic drugs, and NSAIDs. Always consult with a doctor or pharmacist when using it in combination with other drugs. It is generally recommended that pregnant or nursing women do not use this medication, and if absolutely necessary, they should follow the directions of a healthcare professional. Safety in children has not been established, so it should not be used in pediatric patients. In case of overdose, serious side effects such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment, and antidotes such as atropine may be used. Finally, this medication should be stored out of reach of children and care should be taken not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • muscle pain
  • increased blood pressure
  • palpitations
  • hypertension
  • hypotension
  • petechiae
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • blood and lymphatic abnormalities
  • urinary incontinence
  • frequent urination
  • urinary disorders
  • malaise
  • toothache
  • facial flushing
  • lethargy
  • dehydration
  • hyperlipidemia
  • hypercholesterolemia

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 or moisture from entering, and it is recommended to keep it at room temperature between 1°C and 30°C. Storing it this way will help maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 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.