Medication info
Neopezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Neopezil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201604311 · Approved 2016.07.13 · Insurance code 647204220

Summary

Main use
Improvement of Alzheimer's disease symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily at bedtime. After 15 days, the concentration reaches a steady state, and clinical response is assessed while maintaining the 5 mg dosage for 4–6 weeks. Afterward, the dose can be increased to 10 mg, but caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg. Underweight women over 85 years of age should not exceed 5 mg daily and require careful monitoring.
Child dose
There is no experience with pediatric use.

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

Improvement of Alzheimer's disease symptoms

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's disease. It helps improve the patient's memory impairment and cognitive dysfunction.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily at bedtime. After 15 days, the concentration reaches a steady state, and clinical response is assessed while maintaining the 5 mg dosage for 4–6 weeks. Afterward, the dose can be increased to 10 mg, but caution should be exercised regarding gastrointestinal adverse reactions when increasing to 10 mg. Underweight women over 85 years of age should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience with pediatric use.

Precautions

This medication is used to relieve symptoms of Alzheimer's disease, containing Donepezil Hydrochloride as the main ingredient. This medication should not be used by patients who are allergic to Donepezil Hydrochloride or other components of this medication, women who are pregnant or may become pregnant, and women who are breastfeeding. Additionally, as it contains lactose, it should not be administered to patients with genetic metabolic disorders such as galactose intolerance, lactase deficiency, and glucose-galactose malabsorption. Patients with heart disease or conduction disorders should use this medication cautiously, as it may slow down the heart rate or induce arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful when administering this medication, as it can increase gastric acid secretion and gastrointestinal motility, potentially worsening ulcer symptoms. Patients with asthma or obstructive pulmonary disease should also be cautious, as it may increase bronchoconstriction and mucus secretion, exacerbating symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may need to exercise caution, as this medication may worsen symptoms. This medication contains Yellow No. 5 dye, so those allergic to this component should use it carefully. Serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, extrapyramidal symptoms, rhabdomyolysis, and respiratory distress may occur during the use of this medication, so consult a doctor immediately if any abnormal symptoms arise. Various side effects have been reported, such as diarrhea, nausea, vomiting, dizziness, insomnia, headache, fatigue, muscle pain, rash, itching, urinary incontinence, increased urination, blood pressure fluctuations (hypertension, hypotension), edema, constipation, abdominal pain, dehydration, hives, sweating, hematological abnormalities (anemia, leukopenia, etc.), hallucinations, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, and lethargy. It is important to inform medical personnel if such symptoms occur. This medication can affect heart conduction; thus, patients with heart disease or a history of QT interval prolongation should have their heart condition regularly checked through ECG tests. Caution is advised when driving or operating machinery, as dizziness or drowsiness may occur. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist if taking any medications that affect CYP3A4 or CYP2D6, anticholinergic drugs, cardiac medications, NSAIDs, etc. Pregnant or breastfeeding women are generally advised not to use this medication; if necessary, a careful decision should be made after consulting a healthcare professional. Safety in pediatric use has not been established, and its use in children is not recommended. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may occur, necessitating immediate treatment, and antidotes such as atropine might be used. This medication should be stored out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

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

Mild side effects

Nausea, vomiting, diarrhea, decreased appetite, headache, fatigue, drowsiness, dizziness, insomnia, rash, itching, muscle pain, urinary incontinence, increased urination, blood pressure fluctuations (hypertension, hypotension), edema, constipation, abdominal pain, dehydration, hives, sweating, blood abnormalities (anemia, leukopenia, etc.), hallucinations, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, lethargy

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 ingress and kept at room temperature between 1 to 30 degrees Celsius. Proper storage ensures the maintenance of the drug's efficacy and prevents degradation.

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.