Medication info
Genupharm Donepezil Hydrochloride Tablets 5 mg

Genupharm Donepezil Hydrochloride Tablets 5 mg

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603073 · Approved 2016.05.30 · Insurance code 698003140

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Donepezil hydrochloride should be administered as 5 mg once daily before bedtime. For 4 to 6 weeks, 5 mg dosage should be maintained, and after assessing clinical response during this period, the dosage can be increased up to 10 mg. When increasing to 10 mg daily, attention should be given to gastrointestinal adverse reactions. The orally disintegrating tablet can be placed on the tongue to dissolve and can be taken with or without water.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)제뉴파마

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 alleviates dementia-related symptoms such as memory decline and cognitive dysfunction, thereby assisting the patient's daily life. Therefore, it is effective in improving symptoms of Alzheimer's dementia.

How to take

Adult dose

Donepezil hydrochloride should be administered as 5 mg once daily before bedtime. For 4 to 6 weeks, 5 mg dosage should be maintained, and after assessing clinical response during this period, the dosage can be increased up to 10 mg. When increasing to 10 mg daily, attention should be given to gastrointestinal adverse reactions. The orally disintegrating tablet can be placed on the tongue to dissolve and can be taken with or without water.

Child dose

There is no experience in using this medication in children.

Precautions

This medication should not be used by patients with allergies to certain ingredients, women who are pregnant or might become pregnant, and women who are breastfeeding. Patients with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medication. Patients with heart disease or conduction disturbances in the heart should be cautious as this medication may cause bradycardia or arrhythmias. Patients currently taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer disease should use this medication with caution as gastrointestinal side effects may worsen. Patients with asthma or obstructive pulmonary disease should take care as bronchoconstriction and increased mucus secretion may worsen their symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may experience exacerbation of symptoms, therefore caution is required when using this medication. This medication contains Yellow No. 5 dye, and patients allergic to this ingredient should be cautious while taking it. During the course of this medication, serious side effects such as cardiovascular irregularities, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, severe fever, and muscle cramps may occur; if any abnormal signs appear, consult a healthcare professional immediately. Common side effects include dizziness, nausea, vomiting, diarrhea, insomnia, fatigue, and headache, and patients should consult a doctor if these symptoms persist. This medication may slow heart rate or affect cardiac conduction, so patients with heart disease may require regular ECG monitoring. Dizziness or drowsiness may occur while driving or operating machinery, therefore caution is necessary. This medication may interact with other drugs, so patients should inform their healthcare provider of any other medications they are taking. Women who are pregnant or breastfeeding are advised not to take this medication, and if it is deemed necessary, should consult a specialist before proceeding. Safety in children has not been established, so it should not be administered to children. In case of overdose, severe vomiting, sweating, bradycardia, respiratory distress, and seizures may occur, so dosages must be strictly adhered to and in case of overdose, immediate medical attention is essential. This medication should be taken as orally disintegrating tablets, allowing it to dissolve on the tongue before swallowing, and it should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, cardiac arrest, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures (epilepsy, convulsions), cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor function disorders, ataxia, movement disorders, dyskinesia, tremors), neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death.

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, drowsiness, dizziness, insomnia, tremor, anxiety, skin rash, itching, muscle pain, incontinence, urinary disorders, sweating, blood pressure fluctuations, blood and lymphatic system disorders (such as anemia, leukopenia), muscle spasms, weight loss, swelling, malaise, pain, thrombocytopenia, dehydration, hyperlipidemia, liver and kidney function anomalies (including liver dysfunction, hepatitis), hallucinations, aggressive behavior.

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

Storage

This medication should be stored in a tightly sealed container that is impermeable to air, ideally at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents deterioration.

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.