Medication info
Donepezil Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Red, round, biconvex film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102916 · Approved 2021.04.05 · Insurance code 657807540

Summary

Main use
Treatment of moderate to severe Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
This medication should be taken once daily just before bedtime, regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg administered once daily. After 15 days of administration, stable conditions are reached, and for 4-6 weeks, 5 mg should be administered. After evaluating the clinical response, the dosage may be increased up to 10 mg, and patients who have taken 10 mg once daily for at least 3 months may receive 23 mg once daily.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment of moderate to severe Alzheimer's type dementia symptoms

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

This medication is used to treat symptoms of moderate to severe Alzheimer's type dementia.

How to take

Adult dose

This medication should be taken once daily just before bedtime, regardless of food. The initial recommended dose of Donepezil Hydrochloride is 5 mg administered once daily. After 15 days of administration, stable conditions are reached, and for 4-6 weeks, 5 mg should be administered. After evaluating the clinical response, the dosage may be increased up to 10 mg, and patients who have taken 10 mg once daily for at least 3 months may receive 23 mg once daily.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the main ingredient and is primarily used for the treatment of Alzheimer's type dementia symptoms. First, this medication should not be administered to certain patients. For example, individuals who are allergic to this medication or its components, pregnant women or women who may become pregnant, and breastfeeding women should not use this medication. Additionally, since it contains lactose, patients with genetically determined galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should also refrain from taking this medication. Secondly, patients with certain diseases should use this medication with caution. Patients with heart disease need to be careful as this medication may slow heart rate or induce arrhythmias. Furthermore, patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should be monitored closely due to the risk of gastrointestinal bleeding or ulcer exacerbation. Those with a history of asthma or chronic obstructive pulmonary disease may experience worsening bronchoconstriction, so caution is advised. Patients with extrapyramidal disorders such as Parkinson's disease should also be wary as their symptoms may worsen, and patients allergic to tartrazine (Yellow No. 4) contained in this medication should use it carefully. This medication can cause various adverse reactions. Serious but rare side effects include syncope, bradycardia, heart block, myocardial infarction, hepatitis, cerebral hemorrhage, extrapyramidal symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death, and others. Common side effects include anorexia, nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue. This medication can cause cardiac rhythm abnormalities in patients with heart disease, and an electrocardiogram may be needed. Furthermore, it may burden the gastrointestinal tract, therefore patients with a history of gastric ulcers should be particularly cautious. It may also affect bladder function potentially leading to urinary disorders. It can impact the central nervous system, worsening Parkinsonian symptoms or seizures, so patients with neurological disorders should exercise caution. Patients with asthma or obstructive pulmonary disease should also be careful as bronchoconstriction can worsen their symptoms. Pregnant or breastfeeding women should preferably not use this medication, and if it is absolutely necessary, they should consult a healthcare professional and consider stopping breastfeeding. This medication may interact with other drugs, particularly those related to CYP3A4 and CYP2D6, muscle relaxants, cholinergic drugs, anticholinergic drugs, beta-blockers, NSAIDs, and drugs that prolong the QT interval should be used with caution. Lastly, if this medication is overdosed, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression, and seizures may occur, and immediate medical treatment should be sought, with atropine being a possible antidote. During treatment with this medication, it is important to regularly check your condition according to your doctor's instructions and consult immediately if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and very severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

Loss of appetite, nausea, vomiting, diarrhea, headache, fatigue, lethargy, dizziness, insomnia, drowsiness, muscle cramps, urinary incontinence, thrombocytopenia, anemia, petechiae, rash, itching, myalgia, pain, dental pain, facial flushing, fatigue, abnormal blood pressure (hypertension, hypotension), palpitations, atrial fibrillation, atrioventricular and bundle branch block, heart failure, bradycardia, syncope, seizures, movement disorder, gait disturbance, speech disorder, confusion, anxiety.

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

Storage

Store this medication in a tightly closed container to prevent air or moisture from entering. It is safe to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Red, round, biconvex film-coated tablets

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.