Medication info
JW Pharmaceutical Donepezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

JW Pharmaceutical Donepezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 200704502 · Notified 2007.04.19 · Insurance code 644902420

Summary

Main use
Improvement of symptoms in Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. Administer at the 5 mg dosage for 4 to 6 weeks, then evaluate the clinical response and may increase to 10 mg if necessary. When increasing to 10 mg per day, care should be taken regarding gastrointestinal adverse effects. Underweight women over 85 years should not exceed 5 mg per day and require careful monitoring.
Child dose
No experience with the use in pediatrics.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of symptoms in 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. Alzheimer's type dementia is characterized by memory decline and cognitive function impairment, which helps to improve the patient's daily living abilities. This drug improves neuro-transmission in the brain to slow the progression of symptoms and enhance the quality of life of the patients.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. Administer at the 5 mg dosage for 4 to 6 weeks, then evaluate the clinical response and may increase to 10 mg if necessary. When increasing to 10 mg per day, care should be taken regarding gastrointestinal adverse effects. Underweight women over 85 years should not exceed 5 mg per day and require careful monitoring.

Child dose

No experience with the use in pediatrics.

Precautions

This drug is used for the treatment of Alzheimer's type dementia, with donepezil hydrochloride hydrate as the active ingredient. This medication should not be administered to certain patients, such as those with known allergies to this drug or any of its components, pregnant women or those who may become pregnant, and nursing mothers. Additionally, patients with genetic disorders affecting lactose should not be administered this drug. Patients with heart diseases or conduction disorders should be cautious when using this drug since it may slow heart rate or cause arrhythmias. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should also be cautious due to an increased risk of gastrointestinal bleeding. Those with asthma or obstructive pulmonary disease may experience exacerbation of symptoms when using this drug, so administration should be done carefully. This drug can affect the central nervous system and may induce or worsen extrapyramidal symptoms, so caution is advised when used in patients with Parkinson's disease. Furthermore, this drug contains the dye Tartrazine (Yellow No. 5), so patients with allergies to this component should be cautious as well. Various adverse reactions may occur while taking this drug. Cardiovascular issues may include syncope, bradycardia, heart block, and myocardial infarction. Gastrointestinal adverse effects may include peptic ulcers, gastrointestinal bleeding, nausea, vomiting, and diarrhea. Severe adverse reactions can also occur such as liver dysfunction, seizures, symptoms of extrapyramidal disorder, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, and acute kidney failure; therefore, immediate consultation with medical personnel should be sought in case of abnormal symptoms. This drug is approved only for use in Alzheimer's type dementia patients, and its use is not recommended for other types of dementia or memory decline. Treatment effects should be regularly evaluated, and if there is no effect, administration may be discontinued. Patients with cardiovascular diseases may need an electrocardiogram due to the risk of arrhythmias when taking this medication. Additionally, this drug may increase gastric acid secretion and worsen symptoms of peptic ulcers, so patients with a history of gastrointestinal disorders should be cautious. Since this medication can affect driving or machinery operation, caution should be exercised if dizziness or fatigue occurs at the beginning of the treatment. This drug can interact with various medications, so those taking other drugs must consult with their doctor or pharmacist. Special caution is needed when used in conjunction with heart-related medications, antibiotics, antidepressants, and antipsychotics. It is safe for pregnant or nursing women to avoid using this drug; if necessary, a decision should be made after consultation with a healthcare professional. The safety of this drug in children has not been established, so it should not be used in pediatrics. In case of overdose, serious side effects such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may occur, requiring urgent medical care. This drug should be kept out of the reach of children and should not be transferred to another container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowish discoloration of skin or eyes (jaundice), profound lethargy, liver abnormalities (jaundice), sudden and severe headache.

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • fever
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  • decreased body temperature
  • skin rash
  • itching
  • myalgia
  • muscle cramps
  • urinary frequency
  • urinary incontinence
  • increased blood pressure
  • sweating
  • thrombocytopenia
  • anemia
  • leukopenia
  • depression
  • confusion
  • hallucinations
  • aggressive behavior
  • anxiety
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • facial swelling
  • hernia
  • hypotension
  • palpitations
  • atrial fibrillation
  • chest tightness.

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

Storage

Store this medication in a tightly sealed container that is well-ventilated and ideally at temperatures between 1°C and 30°C. This way, the efficacy of the medication can be maintained and deterioration can be prevented.

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.