Medication info
Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablet 5 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 200605446 · Notified 2006.06.16 · Insurance code 643500340

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing of this medication may be considered. The concentration of Donepezil reaches steady state 15 days post administration, and the frequency of adverse reactions may be influenced by the rate of dose increase, so maintain the dose at 5 mg for 4 to 6 weeks. After assessing clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg per day, caution regarding gastrointestinal adverse reactions should be exercised. If discontinuation of this medication occurs, effects decrease gradually, with no rebound effects seen with sudden cessation.
Child dose
Children: No experience with the use in pediatric patients.

Ingredients

Manufacturer
한미약품(주)

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 helps improve dementia-related symptoms such as memory impairment and cognitive dysfunction, enhancing the quality of daily life.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing of this medication may be considered. The concentration of Donepezil reaches steady state 15 days post administration, and the frequency of adverse reactions may be influenced by the rate of dose increase, so maintain the dose at 5 mg for 4 to 6 weeks. After assessing clinical response during this period, the dose may be increased to 10 mg. When increasing to 10 mg per day, caution regarding gastrointestinal adverse reactions should be exercised. If discontinuation of this medication occurs, effects decrease gradually, with no rebound effects seen with sudden cessation.

Child dose

Children: No experience with the use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is used to treat symptoms of Alzheimer's dementia. Firstly, this medication should not be administered to certain patients. For example, individuals who are allergic to this medication, its components, or similar medications, pregnant women or those who may become pregnant, breastfeeding women, and those with lactose intolerance or specific genetic metabolic disorders should not use this medication. Additionally, individuals with heart disease or conduction disorders must be cautious, as this medication may slow heart rate or cause arrhythmia. Those with a history of gastric ulcers or currently taking anti-inflammatory analgesics should also be careful, as gastrointestinal issues may worsen. Patients with respiratory diseases such as asthma or chronic obstructive pulmonary disease should use this medication cautiously, as it may cause bronchoconstriction or increase mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease also need to be cautious, as symptoms may worsen. While taking this medication, various adverse reactions may occur. Issues related to the heart, gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, neurological issues, muscle problems, and dyspnea have been reported, and in severe cases, medication should be stopped immediately, and medical attention should be sought. Commonly, symptoms such as nausea, vomiting, diarrhea, decreased appetite, dizziness, and insomnia may occur. Adverse reactions may vary depending on the patient's condition, so continuous monitoring of status during treatment is necessary. This medication has not been approved for use in other forms of dementia or cognitive impairment and treatment should be conducted under the supervision of an experienced physician. If there is no therapeutic effect or if side effects are severe, discontinuation should be considered. Additionally, since this medication can affect heart rate, patients with heart disease or electrolyte imbalances may need ECG monitoring. Those with a history of gastrointestinal disorders should also be monitored closely to prevent symptom deterioration. Caution is needed when driving or operating machinery, as symptoms such as dizziness or drowsiness may occur. This medication is primarily metabolized in the liver, so patients with impaired liver function should also be cautious, and its use should be avoided by pregnant or breastfeeding women. Drug interactions must also be considered. Co-administration with certain antibiotics, antidepressants, and antiarrhythmics may alter the effects of this medication, so consultation with a physician or pharmacist is essential. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory distress may occur, and immediate medical attention is required; atropine may be used as an antidote. Finally, this medication should be kept out of reach of children and should not be transferred to other containers.

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 fever, blisters, skin peeling, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by breathing abnormalities with fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • headache
  • fatigue
  • loss of appetite
  • drowsiness
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  • anxiety
  • hallucinations
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • aggressive behavior
  • thrombocytopenia
  • anemia
  • leukopenia
  • petechiae
  • eczema
  • urinary incontinence
  • frequent urination
  • fecal incontinence
  • increased salivation
  • facial flushing
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

White 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.