Medication info
Hwanin Donepezil Tablets 23mg (Donepezil Hydrochloride Hydrate)

Hwanin Donepezil Tablets 23mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›23.99mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Biconvex round film-coated tablets in red-brown color
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201502363 · Approved 2015.04.17 · Insurance code 657202810

Summary

Main use
Treatment of moderate to severe symptoms of Alzheimer's type dementia
Who takes it
Adults
Adult dose
This medication is taken once daily immediately before bedtime and can be taken regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5mg once daily. After 15 days of administration, a steady state is reached, and 5mg is maintained for 4 to 6 weeks. After assessing clinical response, the dose may be increased to 10mg, and caution should be taken regarding gastrointestinal side effects at a dose of 10mg daily. For a minimum of 3 months, a dose of 10mg is taken once daily.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of moderate to severe symptoms of 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 ranging from moderate to severe. It improves the patient's cognitive dysfunction and memory loss, helping to maintain daily living abilities. This treatment contributes to improving the patient's quality of life.

How to take

Adult dose

This medication is taken once daily immediately before bedtime and can be taken regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5mg once daily. After 15 days of administration, a steady state is reached, and 5mg is maintained for 4 to 6 weeks. After assessing clinical response, the dose may be increased to 10mg, and caution should be taken regarding gastrointestinal side effects at a dose of 10mg daily. For a minimum of 3 months, a dose of 10mg is taken once daily.

Precautions

This medication is composed of Donepezil Hydrochloride and is used to alleviate the symptoms of Alzheimer's type dementia. Firstly, this medication should not be used in certain patients. Those allergic to Donepezil Hydrochloride or any of the components of this medication, pregnant women or women who may become pregnant, nursing mothers, and patients with genetic lactose intolerance or specific genetic digestive disorders should not take this medication. Patients with heart conditions, particularly those with sick sinus syndrome, conduction disturbances, or bradycardia, should use this medication cautiously, as it may affect heart rhythm. Patients currently taking non-steroidal anti-inflammatory drugs (NSAIDs) or with a history of peptic ulcers should exercise caution, as this medication may promote gastric acid secretion and increase gastrointestinal motility, potentially worsening symptoms. Patients with a history of asthma or obstructive pulmonary diseases may experience worsening symptoms due to bronchoconstriction and increased mucus secretion. Additionally, patients with extrapyramidal disorders such as Parkinson's disease should be administered this medication cautiously, as it may exacerbate symptoms. This medication contains Yellow No. 4, so patients with allergic reactions to this ingredient should be cautious. While taking this medication, various adverse reactions may occur. For example, heart-related issues (syncope, bradycardia, heart block), gastrointestinal problems (peptic ulcers, gastrointestinal bleeding), liver dysfunction, neurological issues (seizures, intracerebral hemorrhage), movement disorders, muscular issues, respiratory distress, acute pancreatitis, acute renal failure, and sudden death have been reported. Additionally, symptoms such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, confusion, fatigue, headache, and others may occur, with these symptoms usually being mild or temporary. Since this medication may have side effects related to heart rhythm, patients with a history of heart disease may need ECG monitoring. It is advisable for pregnant women not to use this medication, and nursing mothers should avoid taking it or stop breastfeeding. Safety in children has not been established, so it is not used in pediatric patients. This medication is primarily metabolized by the liver, so caution is required in patients with liver dysfunction. In case of overdose, symptoms may include nausea, vomiting, bradycardia, hypotension, respiratory depression, muscle weakness, seizures, and immediate medical treatment is required. Antidotes such as atropine sulfate may be used. This medication may interact with other drugs, so caution is required when taking it concurrently with drugs that significantly affect CYP3A4 and CYP2D6 enzymes, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, and medications that affect cardiac conduction. Dizziness or fatigue may occur while driving or operating machinery during the course of this medication, so caution is advised. Store in a sealed container to prevent air or moisture ingress, and keep at room temperature between 1 to 30 degrees Celsius. This storage method maintains the efficacy of the medication and prevents deterioration.

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 ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, convulsions (epilepsy, seizures), intracerebral hemorrhage, cerebrovascular disorders, extrapyramidal symptoms (movement disorders, ataxia, motor dysfunction, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuroleptic malignant syndrome (stupor, extreme

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • asthenia
  • dizziness
  • insomnia
  • drowsiness
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  • fever
  • itching
  • rash
  • urticaria
  • myalgia
  • muscle cramps
  • urinary incontinence
  • constipation
  • abdominal pain
  • weight loss
  • thrombocytopenia
  • anemia
  • hypertension
  • palpitations
  • hypotension
  • hypertension
  • atrial fibrillation
  • myocardial infarction
  • heart failure
  • sinoatrial block
  • atrioventricular block
  • bradycardia
  • QT interval prolongation on ECG
  • torsades de pointes
  • hallucinations
  • confusion

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress, and it is best kept at room temperature between 1 to 30 degrees Celsius. This way of storing will help maintain the effectiveness and prevent deterioration of the medication.

Appearance and packaging

Appearance

Biconvex round film-coated tablets in red-brown color

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.