Medication info
Hwanin Donepezil Tablet 5mg (Donepezil Hydrochloride Hydrate)

Hwanin Donepezil Tablet 5mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
White round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/PTP [(10 tablets/PTP×3)]
Approval status
Active

MFDS item code 200802325 · Notified 2008.02.29 · Insurance code 657201240

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, evaluate clinical response and may increase to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. For underweight women aged 85 and older, close monitoring to ensure not exceeding 5 mg daily is required.
Child dose
There is no experience with use in pediatric patients.

Ingredients

Manufacturer
환인제약(주)

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. It helps alleviate symptoms such as memory impairment and cognitive decline, assisting the patient in daily activities and improving quality of life. It is expected to slow disease progression or prevent worsening of symptoms. Therefore, it is actively utilized to improve symptoms in patients with Alzheimer's-type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, evaluate clinical response and may increase to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. For underweight women aged 85 and older, close monitoring to ensure not exceeding 5 mg daily is required.

Child dose

There is no experience with use in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient, used to alleviate Alzheimer's-type dementia symptoms. First, it should not be used by individuals who are allergic to this drug or similar components, women who are pregnant or may become pregnant, and women who are nursing. Patients with heart disease or conduction disorders need to be cautious when using this drug, as there may be a risk of bradycardia or arrhythmias. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be careful, as this medication may stimulate gastric acid secretion and gastrointestinal motility, worsening ulcer symptoms. Patients with asthma or obstructive pulmonary disease should use this drug with caution, as it may worsen symptoms due to bronchoconstriction and increased mucus secretion. In cases of extrapyramidal disorders like Parkinson's disease, caution is necessary as this drug may exacerbate symptoms. Serious side effects such as fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, cerebral hemorrhage, seizures, movement disorders, and severe muscle cramps may occur during the treatment; thus, immediate consultation with a physician is required if symptoms appear. Various side effects have also been reported, including nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, depression, myalgia, and fatigue; any abnormal symptoms during treatment should be reported to healthcare professionals. This medication can affect the heart, so patients with heart disease or electrolyte imbalances may require regular electrocardiogram tests. Caution should be exercised regarding driving or operating machinery, especially during the initial stages of treatment or when changing dosages. This drug may interact with other medications; therefore, consultation with a physician or pharmacist is recommended, especially if taking drugs related to CYP3A4 or CYP2D6. Women who are pregnant or nursing should avoid using this drug, and if necessary, breastfeeding should be discontinued. Safety in children has not been established, so it should not be used in pediatric patients. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, and immediate emergency treatment is required. This medication should be kept out of the reach of children and should not be transferred to other containers for safety purposes.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory problems with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination changes

Mild side effects

  • Loss of appetite
  • cold-like symptoms
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
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  • mania
  • nightmares
  • irritability
  • gibberish
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive libido
  • dizziness
  • seizures
  • confusion
  • chest tightness
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • diarrhea
  • nausea
  • vomiting
  • abdominal discomfort
  • constipation
  • salivation
  • difficulty swallowing
  • defecation

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

Storage

This medication should be stored in a sealed container that is well-ventilated, ideally maintaining a temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/PTP [(10 tablets/PTP×3)]

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.