Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202000005 · Approved 2020.01.02 · Insurance code 057600460

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, typically administer 5 mg once daily in the evening. If disturbances in sleep occur, such as unusual dreams, nightmares, or insomnia, consider morning dosing. Administer the 5 mg dose for 4 to 6 weeks, then assess clinical response before increasing to 10 mg as needed. When increasing to 10 mg daily, monitor for gastrointestinal adverse effects. Underweight female patients aged 85 years and older should not exceed 5 mg daily.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medicine is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, typically administer 5 mg once daily in the evening. If disturbances in sleep occur, such as unusual dreams, nightmares, or insomnia, consider morning dosing. Administer the 5 mg dose for 4 to 6 weeks, then assess clinical response before increasing to 10 mg as needed. When increasing to 10 mg daily, monitor for gastrointestinal adverse effects. Underweight female patients aged 85 years and older should not exceed 5 mg daily.

Child dose

There is no experience of use in children.

Precautions

This drug is used to alleviate symptoms of Alzheimer's type dementia, with donepezil hydrochloride as the main ingredient. First, this medication should not be administered to patients who are allergic to donepezil hydrochloride or piperidine derivatives, or to any other components of this medicine. It is also advisable that women who are pregnant or may become pregnant, as well as breastfeeding women, do not use this medication. Additionally, since it contains lactose, patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Patients with cardiac diseases, particularly those with syncope syndrome or conduction disturbances, should be careful as this medication can slow heart rate or cause arrhythmias. Patients who are taking non-steroidal anti-inflammatory drugs or have a history of peptic ulcers should use this medication cautiously due to increased gastric acid secretion which may worsen ulcers. Patients with a history of asthma or obstructive lung disease may experience exacerbation of symptoms due to bronchoconstriction and increased mucus secretion, thus caution is required. In patients with extrapyramidal disorders such as Parkinson's disease, it should be administered with caution as it may worsen symptoms. Serious adverse effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebral hemorrhage, cerebral seizures, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur during the use of this medication; if any abnormal symptoms occur, consultation with medical personnel should be sought immediately. Commonly, mild or transient side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, headache, muscle pain, and rash may occur. This medication can affect cardiac conduction, hence ECG monitoring is necessary when taken together with other medications that may cause QT interval prolongation or ventricular tachycardia. Pregnant or breastfeeding women are advised to abstain from this medication, and if its use is necessary, consultation with professionals is required. This medication can affect driving or machine operation abilities; therefore, caution is needed during initial usage or when changing dosage. In case of overdose, symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, and respiratory depression may occur, and appropriate medical treatment should be sought immediately. This medication comes in sublingual form, so the correct method of administration should be followed carefully. For child safety, this medication should be stored out of reach of children and should be kept unopened to prevent discoloration by light.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or breathing difficulties, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning-like headaches, seizures, altered consciousness, visual disturbances, paralysis.

Mild side effects

Loss of appetite, nausea, vomiting, diarrhea, dizziness, insomnia, drowsiness, headache, fatigue, fever, increased or decreased blood pressure, palpitations, muscle pain, rash, itching, incontinence, urinary disturbances, edema, anxiety, confusion, hallucinations, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, dehydration, weight loss, thrombocytopenia, anemia, etc. are mild or common adverse reactions.

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

Storage

This medicine should be stored in a tightly sealed container to avoid air or moisture, at a temperature between 1 to 30 degrees Celsius (room temperature). By storing it this way, the medicine's efficacy can be well preserved.

Appearance and packaging

Appearance

White round film-coated tablet

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

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.