Medication info
Donepezil 10 mg Tablets (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg Tablets (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201802748 · Approved 2018.06.29

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 15 days, normal condition is reached, so maintain the 5 mg dose for 4-6 weeks. After evaluating clinical response, the dose can be increased up to 10 mg. If increasing to 10 mg daily, administer while paying attention to gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg daily.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Alzheimer's dementia symptoms
View approved original text

This medication is used for the treatment of Alzheimer's type dementia symptoms. It alleviates symptoms such as memory decline and cognitive dysfunction caused by dementia, helping patients’ daily lives to be smoother. Through this treatment, it slows down the progression of dementia and improves quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 15 days, normal condition is reached, so maintain the 5 mg dose for 4-6 weeks. After evaluating clinical response, the dose can be increased up to 10 mg. If increasing to 10 mg daily, administer while paying attention to gastrointestinal adverse reactions. Underweight elderly women should not exceed 5 mg daily.

Child dose

There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is used for the treatment of Alzheimer's type dementia symptoms. This medication should not be administered to individuals who are allergic to Donepezil Hydrochloride or any components of this medication, to pregnant women or women who may become pregnant, and to lactating women. Patients with heart conditions or conduction disorders should use this medication cautiously as it may slow heart rate or cause arrhythmia. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as this medication may increase gastric acid secretion and promote gastrointestinal motility, potentially worsening symptoms. Patients with a history of asthma or obstructive pulmonary disease should be careful in administering this medication, as it may cause bronchial muscle contraction and increase mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious, as this medication may affect the nervous system and worsen symptoms. Serious side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular accidents, 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, immediate consultation with a physician is advised. Additionally, various side effects such as dizziness, nausea, vomiting, diarrhea, insomnia, hallucinations, anxiety, muscle pain, fatigue have been reported; if these symptoms persist or worsen while taking this medication, it is necessary to seek professional medical care. The use of this medication is not approved for other forms of memory disorders besides dementia, and treatment must be conducted under the supervision of an experienced physician. Patients with heart disease or electrolyte abnormalities should undergo regular ECG tests while taking this medication, and caution is necessary when driving or operating machinery. Since this medication is metabolized in the liver, patients with reduced liver function may require dosage adjustment or monitoring. It is advisable for pregnant or lactating women not to use this medication, and if unavoidable, they should consult with a professional before use. This medication may interact with other drugs; caution is especially needed when used in combination with drugs that affect CYP3A4 or CYP2D6 enzymes, drugs affecting cardiac conduction, anticholinergic drugs, and cholinergic drugs. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions may occur, and immediate medical treatment is required. Keep out of reach of children and do not transfer medication to other containers as it is important for quality maintenance.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reaction), severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain (severe dermatological adverse reactions), shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy (liver abnormalities), sudden and severe headache,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • tremor
  • gait disturbance
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  • involuntary movements
  • drowsiness
  • increased blood pressure
  • edema
  • itching
  • rash
  • muscle pain
  • urinary incontinence
  • frequent urination
  • urinary retention
  • pain
  • facial flushing
  • lethargy
  • weakness
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • eczema
  • petechiae
  • abnormal dreams
  • restlessness
  • infections
  • anxiety
  • hallucinations
  • aggressive behavior

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

Storage

This medication should be stored in an airtight container that is well-ventilated, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

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

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.