Medication info
Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201708601 · Approved 2017.12.28 · Insurance code 644502490

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
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 dose, and after evaluating the clinical response, the dose can be increased to 10 mg. When increasing the dose to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions. Women aged 85 and over who are underweight should not exceed 5 mg daily and require careful monitoring.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medicine is used to treat the symptoms of Alzheimer's type dementia. Alzheimer's type dementia is a neurodegenerative disease that includes memory loss and cognitive dysfunction, and this medicine helps alleviate symptoms and maintain the patient's daily functioning. It aims to improve the patient's cognitive abilities and alleviate behavioral and psychological symptoms, enhancing the quality of life. Regular intake can delay the progression of symptoms and allow for stable management of the patient's condition. Therefore, this medicine is used for the treatment of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dose, and after evaluating the clinical response, the dose can be increased to 10 mg. When increasing the dose to 10 mg per day, caution should be exercised regarding gastrointestinal adverse reactions. Women aged 85 and over who are underweight should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience of use in children.

Precautions

This medication contains donepezil hydrochloride as its active ingredient and is used for the improvement of symptoms of Alzheimer's type dementia. First, this medication should not be used in patients who have an allergy to donepezil hydrochloride or piperidine derivatives, or any component of this medicine. Pregnant women, women who may become pregnant, and nursing mothers should also avoid its use. Patients with heart-related diseases, such as sick sinus syndrome or cardiac conduction disorders, should use this medication with caution, as it may stimulate the vagus nerve and cause rhythm problems like bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers need to exercise caution, as increased gastric acid secretion and enhanced gastrointestinal motility can worsen ulcer symptoms. Patients with a history of asthma or chronic obstructive pulmonary disease may experience worsening symptoms due to bronchoconstriction and increased mucus secretion, so care must be taken. Patients with extrapyramidal disorders such as Parkinson's disease should be cautiously treated due to the risk of exacerbation of symptoms caused by the cholinergic activity of this medication. While taking this medication, various adverse reactions may occur. Severe cases have reported fainting, bradycardia, heart block, gastrointestinal bleeding, liver function impairment, cerebrovascular disorders, and motor function disturbances. Mild symptoms may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue. This medication, as a cholinesterase inhibitor, can affect the heart, so patients with heart disease should monitor their condition through ECG examinations while using it. Care should be taken when performing tasks such as driving or operating machinery, as dizziness or fatigue may occur. It is advisable not to use this medication during pregnancy and to avoid administration while nursing or to stop breastfeeding if necessary. As this medication is metabolized in the liver, care is required when administrating it to patients with poor liver function. There are also many drug interactions; therefore, it is important to consult with healthcare providers when taking this medication along with certain antibiotics, antidepressants, or antiarrhythmic agents, as efficacy may vary. In case of overdose, dangerous symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory difficulty, and seizures may appear, necessitating immediate emergency treatment. Lastly, store this medication out of the reach of children, and avoid transferring it to another container as it may negatively affect quality.

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 high fever, blisters, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, coughing with respiratory abnormalities and fever, yellowing of the skin or eyes (jaundice), pronounced lethargy, sudden and severe headache, lightning headache, seizures, consciousness disturbances, visual disturbances, paralysis, changes in urine output

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, headache, fatigue, drowsiness, dizziness, insomnia, anxiety, hallucinations, agitation, nightmare, irritability, rambling, delusions, depression, confusion, apathy, hyperactivity, increased libido, talkativeness, mania, neurological symptoms (tremors, stupor, rigidity, etc.), palpitations, hypertension, hypotension, atrial fibrillation, cardiovascular abnormalities, rash, itching, muscle spasms, myalgia, urinary incontinence, frequent urination

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 exposure to air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round 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.