Medication info
Donepezil Hydrochloride Tablets 23 mg

Donepezil Hydrochloride Tablets 23 mg

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
(주)대웅제약
Appearance
Brownish-red, round, biconvex film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201905097 · Approved 2019.07.22

Summary

Main use
Treatment of moderate to severe Alzheimer's disease symptoms
Who takes it
Adults
Adult dose
This medication is taken once daily, right before bedtime, and can be administered regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks and evaluating clinical response, it may be increased up to 10 mg. If increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions should be observed. The patient should take 10 mg once daily for a minimum of 3 months.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Treatment of moderate to severe Alzheimer's disease symptoms

  • Alzheimer's disease symptoms
View approved original text

This medication is used to treat symptoms of Alzheimer's disease, which ranges from moderate to severe. It helps alleviate cognitive decline and difficulties in daily living caused by dementia. It contributes to slowing the progression of symptoms and improving the quality of life for patients. It is important to take it consistently as directed by a physician. This drug aims to alleviate dementia symptoms and stabilize the patient's condition.

How to take

Adult dose

This medication is taken once daily, right before bedtime, and can be administered regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg once daily. After administering 5 mg for 4 to 6 weeks and evaluating clinical response, it may be increased up to 10 mg. If increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions should be observed. The patient should take 10 mg once daily for a minimum of 3 months.

Precautions

This medication should not be used by patients who are hypersensitive to specific ingredients, pregnant or nursing women, or patients with genetic lactose metabolism disorders. Patients with heart disease or cardiac conduction disorders should be cautious as this medication may induce heart problems such as bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication carefully, as it may stimulate gastric acid secretion and exacerbate ulcer symptoms. Patients with a history of asthma or obstructive pulmonary disease should be cautious, as broncho-constriction or increased mucus secretion could worsen their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should administer this medication cautiously, as it could worsen their symptoms. Severe side effects such as fainting, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur. If any unusual symptoms arise, consult a physician immediately. Additionally, various side effects such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, headaches, etc., have been reported, so it is good to monitor any symptoms during the intake. This medication is intended for the treatment of Alzheimer's disease, and if there is no therapeutic effect or if severe side effects occur, the administration may be stopped. Patients with heart disease or electrolyte abnormalities, those with a history of peptic ulcers, or those using neuromuscular blockers need to take special caution during administration, and should regularly undergo ECG tests and symptom monitoring as directed by their physician. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary, and should consult a professional before use. This drug is metabolized by CYP3A4 and CYP2D6 enzymes; thus, its effectiveness may change when combined with certain medications. Therefore, any other medications being taken should be disclosed. In case of overdose, serious symptoms like nausea, vomiting, bradycardia, and respiratory depression may occur, and immediate medical attention is required. This medication should be stored out of reach of children and should not be transferred to a different container for safety. During intake, be cautious when driving or operating machinery, as dizziness or drowsiness may occur.

Side effects and when to seek care immediately

Serious side effects

  • Fainting
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforation of the duodenal wall
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor function disorders
  • ataxia
  • dystonia
  • tremors
  • involuntary movements
  • speech disorders
  • neuroleptic malignant syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cardiac arrest

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headaches
  • fatigue
  • lethargy
  • dizziness
  • drowsiness
  • insomnia
Show 29 more
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rashes
  • thrombocytopenia
  • anemia
  • leukopenia
  • fatigue
  • weight loss
  • weight gain

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 exposure, and should be kept at room temperature between 1 °C and 30 °C. Storing it this way helps maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Brownish-red, round, biconvex 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

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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.