Medication info
Artpezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Artpezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901647 · Approved 2019.03.19 · Insurance code 652904630

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
Donepezil Hydrochloride at a dose of 5 mg should be administered once daily before bedtime. The concentration of Donepezil reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose escalation, so a dose of 5 mg is recommended for 4 to 6 weeks. After evaluating the clinical response during this period, the dose can be increased up to 10 mg. When increasing to a daily dose of 10 mg, caution is advised for gastrointestinal adverse reactions.
Child dose
There is no experience with pediatric use.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of symptoms of Alzheimer's-type dementia

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

This medication helps to slow the progression of Alzheimer's-type dementia symptoms and improve the patient's cognitive function and memory. It supports maintaining the quality of life by reducing difficulties in daily life caused by dementia. Therefore, it is used for the treatment of symptoms of Alzheimer's-type dementia.

How to take

Adult dose

Donepezil Hydrochloride at a dose of 5 mg should be administered once daily before bedtime. The concentration of Donepezil reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose escalation, so a dose of 5 mg is recommended for 4 to 6 weeks. After evaluating the clinical response during this period, the dose can be increased up to 10 mg. When increasing to a daily dose of 10 mg, caution is advised for gastrointestinal adverse reactions.

Child dose

There is no experience with pediatric use.

Precautions

This medication is used to treat symptoms of Alzheimer's-type dementia with Donepezil Hydrochloride as the main active ingredient. This drug should not be used in individuals who are allergic to Donepezil Hydrochloride or its components, pregnant women, women who may become pregnant, or nursing mothers. Additionally, it should not be administered to patients with genetic metabolic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with heart disease or conduction disorders should be cautious as bradycardia or arrhythmia may occur when using this medication. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication with caution due to the risk of increased gastric acid secretion and worsening gastrointestinal symptoms. Patients with a history of asthma or obstructive lung disease should be cautious as symptoms may worsen due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders, such as Parkinson’s disease, should be cautious as there is a risk of symptom exacerbation. During the use of this medication, symptoms such as heart-related irregularities, gastrointestinal bleeding, liver function impairment, neurological abnormalities, muscle pain, and breathing difficulties may occur; if any of these adverse effects arise, immediate consultation with a healthcare professional is necessary. Additionally, this medication may affect the ability to drive or operate machinery, so caution is advised during the early stages of use if dizziness or fatigue appears. This medication can interact with several other drugs; therefore, especially when taking with heart rhythm medications, antibiotics, antidepressants, or antipsychotic drugs, it is essential to inform the healthcare professional. Pregnant or nursing women should generally avoid using this medication, and if necessary, it should be used under strict supervision of a professional. Safety in pediatrics has not been established, so it should not be used in children. In case of an overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment. This medication should be kept out of reach of children and should be stored in its original packaging to prevent discoloration due to light.

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 perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (severe motor dysfunction, dystonia, tremors, dyskinesia, etc.), neuroleptic malignant syndrome (stupor, extreme rigidity, dysphagia, tachycardia, blood pressure fluctuations, sweating, fever), rhabdomyolysis (muscle pain.

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, dizziness, insomnia, drowsiness, hallucinations, agitation, aggressive behavior, anxiety, tremors, muscle pain, urinary incontinence, rash, itching, muscle cramps, pain, swelling, fever, decreased body temperature, blood abnormalities (anemia, leukopenia, thrombocytopenia, etc.), abdominal pain, insomnia, psychiatric symptoms (confusion, delusions, hallucinations, etc.), palpitations, low blood pressure, high blood pressure, atrial fibrillation, ventricular fibrillation.

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 and moisture from entering. The storage temperature should be kept between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

White round film-coated tablet

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.