Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
케이엠에스제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201600793 · Approved 2016.02.11 · Insurance code 654701640

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If sleep disturbances such as weird dreams, nightmares, or insomnia occur, consider taking this medication in the morning. Donepezil concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose escalation; therefore, administer 5 mg for 4–6 weeks. Assess clinical responses during this period.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
케이엠에스제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used for the treatment of symptoms of Alzheimer's type dementia. It helps improve memory decline and cognitive function, thereby enhancing the quality of daily life.

How to take

Adult dose

As Donepezil Hydrochloride, take 5 mg once daily before bedtime. If sleep disturbances such as weird dreams, nightmares, or insomnia occur, consider taking this medication in the morning. Donepezil concentration reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose escalation; therefore, administer 5 mg for 4–6 weeks. Assess clinical responses during this period.

Child dose

There is no experience of use in children.

Precautions

This medication is used to treat symptoms of Alzheimer's type dementia, with Donepezil Hydrochloride Monohydrate as its active ingredient. This medication should not be administered to certain patients. For example, those who are allergic to this medication or its ingredients, pregnant women or those who may become pregnant, and nursing mothers should not take this medication. Additionally, since it contains lactose, patients with lactose intolerance or genetic lactose-related disorders should not use this medication. Patients with heart diseases, a history of peptic ulcers, those currently taking non-steroidal anti-inflammatory drugs, patients with a history of asthma or obstructive lung disease, and those with extrapyramidal disorders such as Parkinson's disease should use this medication with caution. This medication may cause side effects such as bradycardia, arrhythmias, worsening of peptic ulcers, increased bronchoconstriction, and exacerbation of extrapyramidal symptoms, so caution is required. During treatment, serious adverse reactions such as fainting, heart problems, gastrointestinal bleeding, liver dysfunction, seizures, muscle disorders, respiratory difficulties, acute pancreatitis, acute renal failure, and sudden death may occur; if symptoms appear, immediate consultation with a healthcare professional is necessary. Additionally, this medication can cause various side effects, with common symptoms including nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, and others; psychiatric symptoms and cardiovascular abnormalities have also been reported. This medication is not approved for use in other forms of dementia or memory disorders apart from Alzheimer's type dementia, and the therapeutic effect should be regularly evaluated, with treatment possibly discontinued if ineffective. Patients with heart disease should pay particular attention to cardiac side effects such as bradycardia, heart block, and QT interval prolongation, and should undergo an electrocardiogram if necessary. This medication may increase gastric acid secretion and motility, potentially worsening peptic ulcers; therefore, caution is advised for those with a history of gastric disorders. It may affect the ability to drive or operate machinery, so caution is warranted during such activities, especially at the start of treatment or upon dosage adjustment. Pregnant or nursing women should avoid using this medication, and if absolutely necessary, should use it only after consulting with a healthcare professional. Safety in pediatric use has not been established, hence it is not used in children. This medication may interact with various drugs, so if taking other medications, it is imperative to inform the healthcare professional, especially if on heart-related drugs, antibiotics, antidepressants, or antipsychotics. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment, with atropine available as an antidote. This medication should be kept out of reach of children and should not be stored in a different container, as this may negatively affect quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/conjunctival mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • increased libido
  • talkativeness
  • nightmares
  • nervousness
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • excessive libido
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rashes
  • aggressive behavior
  • thrombocytopenia
  • purpura
  • abnormal dreams
  • eczema
  • incontinence
  • constipation
  • fecal incontinence
  • dysphagia
  • urticaria

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. By doing so, the effectiveness of the medication can be maintained for a longer period.

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

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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.