Medication info
Donepezil 10 mg Tablet (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg Tablet (Donepezil Hydrochloride Hydrate)

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

MFDS item code 200500231 · Approved 2005.12.13 · Insurance code 658600090

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider morning administration. For 4 to 6 weeks, administer 5 mg before assessing clinical response, and it may be increased to 10 mg. When increasing to 10 mg daily, monitor for gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg per day.
Child dose
There is no experience of using this medication in pediatric patients.

Ingredients

Manufacturer
이연제약(주)

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

  • Symptoms of Alzheimer's type dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider morning administration. For 4 to 6 weeks, administer 5 mg before assessing clinical response, and it may be increased to 10 mg. When increasing to 10 mg daily, monitor for gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg per day.

Child dose

There is no experience of using this medication in pediatric patients.

Precautions

This medication contains donepezil hydrochloride as its active ingredient and is primarily used to treat symptoms of Alzheimer's type dementia. First, this medication should not be administered to certain patients. For example, individuals who are allergic to this medication or any of its components, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Additionally, since this medication contains lactose, patients with hereditary lactose intolerance or certain enzyme deficiencies related to lactose breakdown should also avoid this medication. Patients with heart disease or conduction disorders should be cautious, as the use of this medication may lead to heart-related adverse reactions such as bradycardia or arrhythmia. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication carefully, as increased gastric acid secretion may worsen their symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be cautious, as bronchoconstriction or increased mucus secretion may exacerbate 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 the dye Yellow No. 5, and those allergic to this component should use it with caution. During treatment with this medication, various adverse reactions may occur. Heart-related issues may include syncope, bradycardia, heart block, and myocardial infarction; gastrointestinal issues may include peptic ulcers, gastrointestinal bleeding, nausea, vomiting, and diarrhea. Central nervous system effects may include hallucinations, insomnia, dizziness, seizures, and confusion, and muscle-related adverse reactions may include myalgia, tremors, and movement disorders. Severe adverse effects such as liver dysfunction, acute pancreatitis, and acute renal failure have also been reported, so patients should consult their healthcare provider immediately if symptoms occur. This medication may affect the ability to drive or operate machinery, so caution is needed during initial use or when changing doses. Pregnant or nursing women are advised to avoid this medication, and if it must be taken, careful consideration should be given after consulting a healthcare professional. This medication may interact with other medications, so be sure to inform your doctor or pharmacist if combining with heart medications, antibiotics, antidepressants, or antipsychotic drugs. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, necessitating immediate emergency treatment, and atropine may be used as an antidote. Lastly, this medication should be kept out of reach of children, and transferring it to other containers is not recommended as it may compromise quality.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, hepatic dysfunction, jaundice, cerebral seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, movement disorders, abnormal muscle tone, tremors, involuntary movements, gait disturbances, abnormal posturing, speech disorders), neuroleptic malignant syndrome (stiffness, extreme rigidity, dysphagia,

Mild side effects

Nausea, vomiting, dizziness, diarrhea, insomnia, abdominal pain, loss of appetite, headache, fatigue, drowsiness, sweating, skin rash, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, weakness, fever, decreased body temperature, hematologic abnormalities (decreased hematocrit, leukopenia, anemia, thrombocytopenia), muscle cramps, myalgia, urinary incontinence, frequent urination, urinary retention, toothache, facial flushing, malaise, falls, eczema, itching,

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. The storage temperature should be maintained between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/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

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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.