Medication info
Onapet Tablet 5mg (Donepezil Hydrochloride Monohydrate)

Onapet Tablet 5mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201604053 · Approved 2016.06.29 · Insurance code 644603510

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg daily, administer with caution to monitor for gastrointestinal adverse reactions.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of Alzheimer's dementia symptoms. It helps improve the patient's memory decline and cognitive dysfunction, thereby enhancing the quality of daily life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dosage. After evaluating the clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg daily, administer with caution to monitor for gastrointestinal adverse reactions.

Child dose

There is no experience using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate, which is used for the improvement of Alzheimer's dementia symptoms. First, this medication should not be used in patients who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any components of the drug. Also, it should not be administered to pregnant women or women who may become pregnant, and to breastfeeding women. This medication contains lactose, so patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with heart disease, particularly those with sick sinus syndrome and atrioventricular conduction abnormalities, should use this medication cautiously as it may stimulate the vagus nerve, leading to bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer disease should be cautious as increased gastric acid secretion and enhanced gastrointestinal motility may exacerbate ulcers. Patients with a history of asthma or chronic obstructive pulmonary disease should be cautious as bronchial smooth muscle contraction and mucus secretion may worsen symptoms. Additionally, patients with extrapyramidal disorders such as Parkinson's disease may experience exacerbation of symptoms due to cholinergic stimulation. This medication contains Yellow No. 5 dye, so patients with hypersensitivity or allergy history should be cautious. While taking this medication, cardiovascular adverse reactions such as syncope, bradycardia, heart block, myocardial infarction, or heart failure may occur, and if these symptoms occur, immediate consultation with healthcare providers is recommended. Various adverse reactions such as peptic ulcers, gastrointestinal bleeding, liver dysfunction, cerebral seizures, and extrapyramidal symptoms have been reported, so the patient's condition should be closely monitored. In particular, if muscle pain or weakness occurs, rhabdomyolysis should be suspected and blood and urine tests should be conducted to check for muscle damage. Serious adverse reactions such as respiratory distress, acute pancreatitis, acute kidney failure, and unexplained sudden death have also been reported, requiring caution. This medication may affect driving or machine operation abilities, especially during the initial phase of treatment or dose increase. For pregnant or breastfeeding women, it is advisable to avoid use as the safety of this medication has not been established; decisions should be made in consultation with a specialist if necessary. Safety in children has not been established, so it should not be used in children. This medication can affect liver and kidney function, so regular monitoring may be necessary. In cases of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring prompt treatment. This medication may interact with other drugs, so it is important to inform healthcare providers of all medications being taken, particularly when combined with heart-related medications, antibiotics, antidepressants, or antipsychotic drugs. Finally, this medication should be stored out of reach of children, and it is safe and beneficial for quality maintenance not to change the container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, and urination issues.

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • tremors
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • palpitations
  • lethargy
  • sweating
  • skin rash
  • eczema
  • incontinence
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • hypothermia
  • thrombocytopenia
  • decreased hematocrit
  • leukopenia
  • anemia
  • and other effects.

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

Storage

This medication should be stored in a tightly sealed container that allows for proper air circulation, preferably at room temperature between 1°C and 30°C. Storing it this way can help maintain the medication's effectiveness for a longer period.

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

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.