Medication info
Entidonepezil Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Entidonepezil Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201906136 · Approved 2019.08.29 · Insurance code 623005590

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4–6 weeks, assess the clinical response and may increase to 10 mg. When increasing the dose to 10 mg daily, caution should be taken for gastrointestinal side effects. The maximum dosage is 10 mg. For underweight female patients aged 85 or older, the dose should not exceed 5 mg per day.
Child dose
There is no experience with pediatric use.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

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

This medication is used for the treatment of Alzheimer’s type dementia and helps improve memory decline and cognitive function disorders. It supports brain function, slows the progression of symptoms, and facilitates daily living. Additionally, it stabilizes the patient’s overall mental state and contributes to functional recovery. This treatment plays a crucial role in enhancing the patient's quality of life. Hence, it is effective for the treatment of Alzheimer’s type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4–6 weeks, assess the clinical response and may increase to 10 mg. When increasing the dose to 10 mg daily, caution should be taken for gastrointestinal side effects. The maximum dosage is 10 mg. For underweight female patients aged 85 or older, the dose should not exceed 5 mg per day.

Child dose

There is no experience with pediatric use.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as its main ingredient and is primarily used to improve Alzheimer's type dementia symptoms. First, this medication should not be administered to certain patients. For example, patients allergic to this medication, Donepezil Hydrochloride, piperidine derivatives, or any of its components, pregnant women or those who may become pregnant, and nursing mothers should not be given this medication. Moreover, it contains lactose, so patients with genetic issues such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also avoid taking it. Secondly, patients with heart problems, a history of peptic ulcer or those taking non-steroidal anti-inflammatory drugs (NSAIDs), patients with asthma or a history of obstructive pulmonary disease, patients with extrapyramidal disorders such as Parkinson's disease, and those allergic to tartrazine should use this medication with caution. Various side effects may occur while taking this medication. Cardiac issues such as bradycardia, heart block, and myocardial infarction have been reported, as well as gastrointestinal bleeding or peptic ulcers. In addition, there can be serious side effects such as liver dysfunction, seizures, symptoms of extrapyramidal disorders, severe muscle pain like rhabdomyolysis, acute pancreatitis, acute renal failure, and shortness of breath; thus, it is crucial to consult healthcare personnel immediately if any symptoms arise. As a cholinesterase inhibitor, this medication can stimulate the vagus nerve, lowering heart rate and potentially causing arrhythmias; therefore, careful attention is required for patients with heart issues. Moreover, it increases gastric acid secretion and motility, which may exacerbate symptoms of peptic ulcers, so patients with a history of peptic ulcers should exercise caution while taking this medication. This medication affects the central nervous system, which can worsen extrapyramidal symptoms or induce seizures, and may also exacerbate respiratory symptoms in patients with asthma or obstructive pulmonary disease. Pregnant or nursing women are advised against using this medication, and if deemed necessary, consultation with a specialist is required. This medication may interact with other drugs; caution is especially needed when taken with drugs that inhibit or induce CYP3A4 and CYP2D6 enzymes, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, beta-blockers, NSAIDs, and drugs that prolong the QT interval. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring prompt treatment and antidotes. This medication may affect driving ability or operating machinery, so caution should be exercised during initial consumption or dose adjustments. Lastly, keep this medication out of reach of children, do not transfer it to another container, and take it regularly as directed by healthcare personnel; consult immediately if any unusual symptoms occur.

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, seizure, intracranial hemorrhage, cerebrovascular disorder, extrapyramidal disorders (motor dysfunction, ataxia, movement disorder, dystonia, tremor, involuntary movement, gait disturbance, abnormal posture, speech disorder), neuroleptic malignant syndrome, rhabdomyolysis, shortness of breath, acute pancreatitis, and acute

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • decreased appetite
  • headache
  • fatigue
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • insomnia
  • tremor
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental sluggishness
  • sweating
  • skin rash
  • eczema
  • itching
  • incontinence
  • fever
  • decreased body temperature
  • thrombocytopenia
  • anemia
  • frequent urination
  • urinary retention
  • dehydration
  • muscle pain
  • muscle cramps
  • weakness
  • increased CK in blood and urine
  • thrombocytopenia

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

Storage

This medication should be stored in a tightly closed container to prevent air ingress, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and ensure safety.

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

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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.