Medication info
Donepezil Tablets 10mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 10mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 200807873 · Notified 2008.07.17 · Insurance code 645402660

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Take 5 mg of donepezil hydrochloride once daily before going to bed. If unusual dreams, nightmares, or sleep disturbances occur, consider taking it in the morning. The concentration of donepezil reaches a normal state 15 days after administration, so for 4-6 weeks, a dose of 5 mg should be administered. After this period, clinical responses should be evaluated to increase the dose to 10 mg; when administering 10 mg daily, attention should be paid to gastrointestinal adverse effects.
Child dose
Children: There is no experience of use in pediatrics.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat symptoms of Alzheimer's dementia. It helps improve cognitive function and memory in patients, enhancing their quality of daily life. It also slows the progression of dementia symptoms, supporting a stable lifestyle. This medication plays an important role in reducing the burden on patients and their families, thus continuous use is necessary. It effectively assists in the treatment of symptoms of Alzheimer's dementia.

How to take

Adult dose

Adults: Take 5 mg of donepezil hydrochloride once daily before going to bed. If unusual dreams, nightmares, or sleep disturbances occur, consider taking it in the morning. The concentration of donepezil reaches a normal state 15 days after administration, so for 4-6 weeks, a dose of 5 mg should be administered. After this period, clinical responses should be evaluated to increase the dose to 10 mg; when administering 10 mg daily, attention should be paid to gastrointestinal adverse effects.

Child dose

Children: There is no experience of use in pediatrics.

Precautions

This medication should not be used by individuals with allergies to specific ingredients. Especially those who have had hypersensitivity reactions to the components of this drug or to donepezil hydrochloride, piperidine derivatives should not take it. It is also safer for pregnant or possibly pregnant women, as well as nursing mothers, to avoid this medication. This medication contains lactose, so it should not be administered to patients with lactose intolerance or certain genetic issues. Caution is needed for those with heart disease or heart rhythm disorders when using this medication, as it can slow the heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication cautiously, as it may increase gastric acid secretion and enhance gastrointestinal motility, worsening symptoms. Patients with asthma or obstructive pulmonary disease should also be cautious, as symptoms may worsen when taking this medication. Those with extrapyramidal disorders such as Parkinson's disease should definitely consult before using this medication, as it may exacerbate symptoms. Individuals allergic to the dye included in this medication should also take precautions. Serious side effects such as fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, seizures, and movement disorders may occur during use, so any unusual symptoms should be reported to a doctor immediately. This medication is used for the treatment of memory disorders but is not effective for other types of dementia or cognitive decline, and treatment should be supervised by a specialist. For those with heart disease or electrolyte imbalances, regular electrocardiograms may be necessary due to an increased risk of heart-related side effects. Caution is required when driving or operating machinery as dizziness or fatigue may occur. Interactions with other medications are possible, so it is essential to inform about any current medications, especially heart-related drugs, antibiotics, and antidepressants, as caution is needed when combined. Women who are pregnant or breastfeeding should avoid this medication unless necessary and should discuss with experts regarding stopping breastfeeding if it must be taken. Safety has not been established for children, so it is not used in pediatric cases. In cases of overdose, symptoms such as nausea, vomiting, heart problems, and difficulty breathing may appear, so the dosage must be strictly adhered to; in case of overdose, immediate contact with a medical institution is necessary. This medication should be stored out of reach of children and it is important not to transfer it to other containers to maintain product quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain of the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • fever
  • drowsiness
  • dizziness
  • insomnia
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  • tremors
  • gait disturbances
  • involuntary movements
  • confusion
  • hallucinations
  • aggressive behavior
  • anxiety
  • insomnia
  • delusions
  • depression
  • drowsiness
  • muscle pain
  • urinary incontinence
  • constipation
  • abdominal pain
  • dehydration
  • weight loss
  • hypotension
  • hypertension
  • palpitations
  • atrial fibrillation
  • myocardial infarction
  • heart failure
  • sinoatrial block
  • atrioventricular block
  • myocardial infarction
  • torsades de pointes
  • QT interval prolongation.

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 the entry of air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness for a longer time.

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

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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.