Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201508293 · Approved 2015.12.17 · Insurance code 658501820

Summary

Main use
Improvement in symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bed. For 4-6 weeks, administer the 5 mg dose and evaluate clinical response before increasing to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse effects during administration. Underweight female patients over 85 years should not exceed 5 mg daily and require careful monitoring.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Improvement in symptoms of Alzheimer's type dementia

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

This medication is used to alleviate the symptoms of Alzheimer's type dementia. It helps improve various symptoms caused by dementia, such as memory decline and cognitive impairment, thus maintaining the patient's ability to carry out daily activities.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bed. For 4-6 weeks, administer the 5 mg dose and evaluate clinical response before increasing to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse effects during administration. Underweight female patients over 85 years should not exceed 5 mg daily and require careful monitoring.

Child dose

There is no experience using this medication in children.

Precautions

This medicine should not be used by individuals with allergies to specific components. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication. Patients with genetic lactose intolerance issues are also not suitable for this medication. Patients with heart disease or cardiac conduction disorders should be cautious as this medication can cause bradycardia or arrhythmias. Patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs should use this medication carefully due to the risk of gastrointestinal bleeding or worsening ulcers. Patients with asthma or chronic obstructive pulmonary disease should be cautious as bronchoconstriction or increased mucus secretion may exacerbate symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication carefully as there is a risk of symptom exacerbation. This medication contains Yellow No. 5, so caution is needed for those allergic to this ingredient. During treatment, serious side effects such as cardiac irregularities, gastrointestinal bleeding, liver dysfunction, seizures, muscle pain, and respiratory difficulties may occur; consult healthcare providers immediately if any unusual symptoms arise. In the initial treatment phase or during dosage adjustments, symptoms such as dizziness, drowsiness, insomnia, nausea, vomiting, or diarrhea may occur, so caution is advised. It is recommended to be careful with activities requiring attention, such as driving or operating machinery, in the early stages of taking this medication. This medication can interact with various drugs, so if other medications are being taken, it is essential to inform healthcare providers. Particular caution is necessary when used together with heart medications, antibiotics, antidepressants, and antipsychotics. Pregnant or nursing women should avoid using this medication, and if necessary, should consult with a specialist. Safety in children has not been confirmed; thus, it is not to be used in pediatric patients. Overdose may cause severe nausea, vomiting, bradycardia, hypotension, or respiratory depression, requiring immediate medical attention. Store this medication out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in mouth/eyes mucosa, shortness of breath or difficulty breathing, asthma attack, breathing abnormalities accompanied by cough+fever, yellowing of skin or eyes (jaundice), extreme lethargy throughout the body, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urination abnormalities

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • fever
  • insomnia
  • dizziness
  • drowsiness
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  • tremors
  • muscle pain
  • urinary incontinence
  • frequent urination
  • constipation
  • abdominal pain
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • hives
  • increased blood pressure
  • thrombocytopenia
  • lethargy
  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • drowsiness
  • decreased concentration
  • mental dullness
  • insomnia
  • delusions
  • confusion
  • stupor
  • insomnia
  • nightmares
  • neuroticism
  • delusions

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

Storage

This medication should be stored in a sealed container to prevent air or humidity from entering. Additionally, it is best stored at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Yellow 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

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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.