Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride)

Donepezil Tablets 10 mg (Donepezil Hydrochloride)

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

MFDS item code 201406044 · Approved 2014.12.24 · Insurance code 622802260

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adult: The recommended dose of Donepezil Hydrochloride is 5 mg once daily before bedtime. For the first 4 to 6 weeks, 5 mg should be given, and after assessing the clinical response, the dosage may be increased to 10 mg. If the dosage is increased to 10 mg, caution should be taken regarding gastrointestinal adverse reactions. Underweight women aged 85 years and older should not exceed a daily dosage of 5 mg and require careful monitoring.
Child dose
Pediatric: There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to improve symptoms such as memory decline and cognitive dysfunction in Alzheimer's dementia. It helps reduce difficulties experienced in daily life and enhances the overall quality of life of patients.

How to take

Adult dose

Adult: The recommended dose of Donepezil Hydrochloride is 5 mg once daily before bedtime. For the first 4 to 6 weeks, 5 mg should be given, and after assessing the clinical response, the dosage may be increased to 10 mg. If the dosage is increased to 10 mg, caution should be taken regarding gastrointestinal adverse reactions. Underweight women aged 85 years and older should not exceed a daily dosage of 5 mg and require careful monitoring.

Child dose

Pediatric: There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride as its active ingredient and is primarily used to treat symptoms of Alzheimer's dementia. This medication should not be used in certain patients, such as those who are allergic to this drug or similar components, pregnant or breastfeeding women, and patients with lactose intolerance or specific genetic metabolic disorders. Patients with heart disease or conduction disorders should use this medication with caution as it may slow heart rate and cause arrhythmias. Additionally, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be carefully administered due to the risk of gastrointestinal bleeding. Patients with asthma or obstructive pulmonary disease should be cautious as this medication can increase bronchial contraction and mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also be careful as this medication may exacerbate symptoms. This medication contains a colorant called Tartrazine (Yellow No. 5), and those allergic to this component must inform before use. During the use of this medication, adverse cardiac reactions such as fainting, bradycardia, heart block, myocardial infarction, and heart failure may occur, and any symptoms should be immediately discussed with healthcare providers. Serious adverse reactions such as gastrointestinal bleeding, liver dysfunction, cerebral hemorrhage, seizures, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death may also occur rarely. Additionally, various side effects have been reported, including nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, aggressive behavior, anxiety, drowsiness, headache, fatigue, rash, myalgia, and urinary incontinence, so any unusual symptoms should be reported to healthcare providers. This medication is not approved for use in other types of dementia or memory disorders besides Alzheimer's dementia, and treatment should be conducted under the supervision of an experienced physician. The therapeutic effects should be regularly evaluated, and if ineffective, consideration should be given to discontinuing the medication. Patients with heart disease or electrolyte abnormalities, particularly those with QT interval prolongation or taking medications that affect the QT interval, require cardiac monitoring. This medication may exacerbate peptic ulcers by promoting gastrointestinal motility and gastric acid secretion, so patients with a history of gastrointestinal diseases should be careful. It may affect the ability to drive or operate machinery, so caution is advised at the beginning of treatment or when increasing the dosage. Pregnant or breastfeeding women should not use this medication; if absolutely necessary, a careful decision should be made after consulting a specialist. This medication may interact with other drugs, particularly those that affect CYP3A4 and CYP2D6 enzymes, so caution is required when used concomitantly. Additionally, caution is necessary when combined with drugs affecting cardiac conduction, cholinergic agents, anticholinergic medications, and non-steroidal anti-inflammatory drugs. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate emergency treatment, and atropine can be used as an antidote. This medication should be stored out of reach of children, and transferring to another container is not recommended as it may negatively affect the quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, serious rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • insomnia
  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • fatigue
  • fever
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  • myalgia
  • itching
  • rash
  • abdominal pain
  • weight loss
  • dehydration
  • thrombocytopenia
  • anemia
  • increased or decreased blood pressure
  • palpitations
  • anxiety
  • hallucinations
  • aggressive behavior
  • depression
  • confusion
  • drowsiness
  • tremors
  • involuntary movements
  • gait disturbances
  • excessive talking
  • insomnia
  • delusions
  • hallucinations
  • skin rash
  • swelling
  • urticaria
  • facial flushing
  • blood and lymphatic system issues

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 infiltration. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

Bottle - 30 tablets/bottle, 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

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.