Medication info
Arizen 5 mg (Donepezil Hydrochloride Monohydrate)

Arizen 5 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201702238 · Approved 2017.04.28 · Insurance code 646203900

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
Donepezil hydrochloride: Administer 5 mg once daily before bedtime. After 15 days, a stable condition is reached, hence maintain the 5 mg dose for 4-6 weeks. After evaluating clinical response, it may be increased to 10 mg. Care should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. Underweight women aged 85 years and older should not exceed 5 mg per day and require careful monitoring.
Child dose
There is no experience of use in pediatric patients, so administration is not recommended.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

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

This medication is used to treat symptoms of Alzheimer's type dementia.

How to take

Adult dose

Donepezil hydrochloride: Administer 5 mg once daily before bedtime. After 15 days, a stable condition is reached, hence maintain the 5 mg dose for 4-6 weeks. After evaluating clinical response, it may be increased to 10 mg. Care should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. Underweight women aged 85 years and older should not exceed 5 mg per day and require careful monitoring.

Child dose

There is no experience of use in pediatric patients, so administration is not recommended.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the main ingredient for the treatment of symptoms of Alzheimer's type dementia. This medication should not be administered to certain patients, including those who are allergic to Donepezil or any of its components, pregnant women, or breastfeeding mothers. Additionally, patients with lactose intolerance or genetic lactose metabolism disorders should not take this medication. Patients with heart disease or conduction disturbances should use this medication cautiously, as it may slow heart rate or cause arrhythmia. Caution is also needed for patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers, as it may increase the risk of gastrointestinal bleeding or worsening of ulcers. Patients with asthma or obstructive pulmonary disease should be careful, as this medication may worsen symptoms due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders like Parkinson's disease should use this medication cautiously as it may worsen their symptoms. Severe side effects such as fainting, heart issues, gastrointestinal bleeding, liver dysfunction, seizures, and movement disorders may occur while taking this medication; if any abnormal symptoms arise, consult a physician immediately. Additionally, common side effects like nausea, vomiting, diarrhea, insomnia, dizziness, headache, and fatigue may occur, so caution is necessary. This medication is not approved for other forms of memory impairment besides Alzheimer's type dementia, and treatment effects should be regularly evaluated. Patients with heart disease or electrolyte imbalances may be at risk for cardiac side effects and may require electrocardiogram testing. As this medication may affect driving or machinery operation, caution is required in the early stages of treatment or following dose adjustments. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary and should consult with a healthcare professional first. This medication may interact with other drugs, particularly heart medications, antidepressants, antibiotics, and anticonvulsants, hence caution is required when used in combination. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical treatment, and antidotes like atropine may be used. This medication should be kept out of reach of children, and transferring it to other containers should be avoided to prevent quality degradation or accidents.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor (severe allergic reaction)
  • Severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa (severe skin adverse reactions)
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever (respiratory issues)
  • Jaundice (yellowing of skin or eyes), extreme lethargy (liver dysfunction)
  • Sudden and very severe

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • muscle pain
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  • rash
  • itching
  • increased blood pressure
  • fever
  • edema
  • petechiae
  • thrombocytopenia
  • anemia
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • urinary incontinence
  • urination disorders
  • urinary retention
  • weight gain and loss
  • dehydration
  • hypercholesterolemia
  • hyperlipidemia
  • diabetes
  • frequent urination
  • constipation
  • abdominal pain

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 air and moisture from entering. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White 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.