Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201907992 · Approved 2019.11.19 · Insurance code 654005570

Summary

Main use
Improvement of symptoms of Alzheimer's dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. After administering 5 mg for 4 to 6 weeks, evaluate clinical response to consider increasing the dose up to 10 mg. When increasing the dose to 10 mg, caution should be taken regarding gastrointestinal adverse reactions. Underweight women over 85 years old should not exceed 5 mg per day and require careful monitoring.
Child dose
Pediatric use: There is no experience in pediatric use.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. After administering 5 mg for 4 to 6 weeks, evaluate clinical response to consider increasing the dose up to 10 mg. When increasing the dose to 10 mg, caution should be taken regarding gastrointestinal adverse reactions. Underweight women over 85 years old should not exceed 5 mg per day and require careful monitoring.

Child dose

Pediatric use: There is no experience in pediatric use.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the active ingredient and is primarily used to treat symptoms of Alzheimer's dementia. This medication should not be used in certain patients. For example, individuals who are allergic to this medication or its components, women who are pregnant or may become pregnant, and patients with genetic issues such as lactose intolerance should not take this medication. Patients with heart diseases or conduction disorders should be cautious when using this medication as bradycardia or arrhythmias may occur. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should be careful as gastrointestinal bleeding or aggravation of ulcers may occur. Patients with asthma or a history of obstructive lung disease should be cautious as bronchoconstriction and increased mucus secretion may worsen the symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be careful as the cholinergic effects of this medication may worsen their symptoms. This medication contains Yellow No. 5 dye, so individuals allergic to this component should exercise caution. Various adverse reactions may occur during treatment, with severe cases including syncope, cardiac issues, gastrointestinal bleeding, liver dysfunction, intracranial hemorrhage, movement disorders, muscle abnormalities, respiratory distress, acute pancreatitis, acute renal failure, and sudden death. Commonly, symptoms such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, and loss of appetite may occur. This medication is not approved for other forms of dementia or memory disorders besides Alzheimer's dementia, and diagnosis and treatment should be carried out under the supervision of an experienced physician. Patients with heart disease or a history of QT interval prolongation may need heart monitoring. Caution is advised during driving or operating machinery as fatigue, dizziness, and muscle cramps may occur as side effects. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary, and should consult a specialist. Safety in children has not been established, so it is not used in this population. This medication may interact with other drugs, so caution is especially necessary when used in combination with certain antibiotics, antidepressants, antiarrhythmics, antipsychotics, antifungals, and anticonvulsants. In the case of overdose, severe nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, and appropriate medical treatment should be sought immediately. This medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • QT prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforation of the duodenum
  • gastrointestinal bleeding
  • hepatitis
Show 19 more
  • liver dysfunction
  • jaundice
  • seizures
  • epilepsy
  • convulsions
  • intracranial hemorrhage
  • cerebrovascular disorders
  • symptoms of extrapyramidal disorders
  • neuroleptic malignant syndrome
  • akinetic mutism
  • extreme rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • rhabdomyolysis
  • muscle pain
  • weakness
  • increase of CK in blood and urine

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • diarrhea
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • muscle pain
Show 23 more
  • rash
  • itching
  • fever
  • decreased body temperature
  • swelling
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia
  • thrombocytopenia

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 exposure to air and moisture, and should be kept at a temperature between 1 to 30 degrees Celsius. Proper storage maintains the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablets

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

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.