Medication info
Donepezil Hydrochloride 5 mg Tablets

Donepezil Hydrochloride 5 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
정우신약(주)
Appearance
White, round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202000092 · Approved 2020.01.07 · Insurance code 694205870

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. Normal levels are reached after 15 days, maintaining a dose of 5 mg for 4-6 weeks. After evaluating the clinical response, the dosage may be increased up to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly women should not exceed a daily dose of 5 mg.
Child dose
There is no experience in using this drug in children.

Ingredients

Manufacturer
정우신약(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 to treat symptoms of Alzheimer's type dementia, helping to improve memory loss and cognitive function impairment. These drugs contribute to enhancing brain function and delaying the progression of symptoms. It aids in reducing difficulties faced by patients in their daily lives and improving their quality of life. It is effective in alleviating symptoms of Alzheimer's type dementia and improving cognitive function.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Normal levels are reached after 15 days, maintaining a dose of 5 mg for 4-6 weeks. After evaluating the clinical response, the dosage may be increased up to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal adverse reactions. Underweight elderly women should not exceed a daily dose of 5 mg.

Child dose

There is no experience in using this drug in children.

Precautions

This medication contains Donepezil Hydrochloride as its active ingredient and is used for improving symptoms of Alzheimer's type dementia. First, this drug should not be used by patients with allergies to Donepezil Hydrochloride or any components of this medication, pregnant women, or women who may become pregnant, and also by nursing mothers. Additionally, since it contains lactose, patients with galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption should not take this drug due to genetic metabolic disorders. Patients with heart diseases or heart conduction disorders should be cautious as this medication may stimulate the vagus nerve, potentially causing bradycardia or arrhythmia. Patients who are taking non-steroidal anti-inflammatory drugs or have a history of peptic ulcers should use this medication carefully, as it may increase gastric acid secretion and gastrointestinal motility, exacerbating ulcer symptoms. Patients with a history of asthma or obstructive pulmonary disease should be aware that this drug may cause bronchoconstriction and increased mucus secretion, potentially worsening their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may find that this medication exacerbates neurological symptoms. A variety of adverse reactions may occur while taking this drug, and in severe cases, symptoms such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular accidents, and extrapyramidal symptoms may arise. Additionally, symptoms of rhabdomyolysis, such as muscle pain or weakness, should be monitored closely, along with reports of dyspnea, acute pancreatitis, acute renal failure, and unexplained sudden death. Common side effects generally include nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, headaches, and fatigue. This medication may affect the heart, so patients with heart disease may require ECG monitoring. This medication is not recommended for use during pregnancy, and nursing mothers should also avoid using it. Safety in children has not been established; therefore, it is not used in this population. This drug may affect liver and kidney function, so regular clinical tests may be necessary. In the event of overdose, symptoms may include nausea, vomiting, excessive salivation, bradycardia, hypotension, respiratory depression, and seizures, requiring immediate medical attention for appropriate treatment. This medication may interact with several other drugs; therefore, patients taking other medications should consult with their healthcare provider. Finally, this medication should be kept out of the reach of children, and transferring it to another container may lead to quality degradation or accidents.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, torsades de pointes, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, intracerebral hemorrhage, cerebrovascular accidents, extrapyramidal disorders (movement dysfunction, ataxia, motor disturbances, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disturbances), neuroleptic malignant syndrome.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • muscle cramps
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  • muscle pain
  • weight loss
  • sweating
  • fever
  • constipation
  • abdominal pain
  • fecal incontinence
  • lethargy
  • thrombocytopenia
  • anemia
  • blood pressure changes
  • skin rash
  • itching
  • facial flushing
  • urinary incontinence
  • frequent urination
  • urinary retention
  • hives
  • pain
  • toothache
  • facial flushing
  • weakness
  • talkativeness
  • increased libido
  • aggressive behavior
  • hallucinations
  • confusion
  • delirium.

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 entry, ideally at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White, 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

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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.