Medication info
Arigen 10 mg (Donepezil Hydrochloride Hydrate)

Arigen 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201702237 · Approved 2017.04.28 · Insurance code 646203910

Summary

Main use
Improvement of symptoms of Alzheimer's dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride: Administer 5 mg once daily at bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil concentration reaches normal levels after 15 days of administration and may be influenced by the rate of dose escalation, therefore administer 5 mg for 4 to 6 weeks. After assessing the clinical response during this period, the dose may be increased up to 10 mg. When escalating to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Improvement of symptoms of Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used to treat the symptoms of Alzheimer's dementia. It alleviates symptoms such as memory decline and cognitive dysfunction, helping patients lead their daily lives more smoothly. It contributes to slowing the progression of symptoms and improving the quality of life.

How to take

Adult dose

As Donepezil Hydrochloride: Administer 5 mg once daily at bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil concentration reaches normal levels after 15 days of administration and may be influenced by the rate of dose escalation, therefore administer 5 mg for 4 to 6 weeks. After assessing the clinical response during this period, the dose may be increased up to 10 mg. When escalating to 10 mg daily, care should be taken regarding gastrointestinal adverse reactions.

Child dose

There is no experience using this medication in children.

Precautions

This medication should not be used by individuals who are allergic to certain components or by women who are pregnant or breastfeeding. Patients who are genetically unable to digest lactose should also avoid this medication. Patients with heart disease or arrhythmia must exercise caution when using this medication, as bradycardia or arrhythmia may occur. Patients with a history of gastric ulcers or those taking nonsteroidal anti-inflammatory drugs should be cautious due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Asthma patients or those with obstructive pulmonary disease should be cautious as bronchospasm may occur, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should use this medication with caution as symptoms may worsen. Rarely, serious side effects such as fainting, heart attack, liver function abnormalities, cerebrovascular disorders, muscle issues, and respiratory distress may occur, and should any abnormal symptoms arise, immediate consultation with healthcare professionals is required. This medication may impair driving or machine operation capabilities, so caution is advised. There may be drug interactions, so it is essential to inform healthcare providers about any other medications being taken, especially when used with heart-related medications or nonsteroidal anti-inflammatory drugs, as expert guidance is necessary. Pregnant or breastfeeding women should avoid using this medication, and if necessary, should consult with a specialist beforehand. It is advisable not to use this medication in children as its safety has not been established. In case of overdose, severe vomiting, bradycardia, and respiratory depression may occur, necessitating immediate emergency treatment, with atropine being a possible antidote. This medication should be stored out of the reach of children, and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure (epilepsy, convulsion), cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (severe motor dysfunction, etc.), neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, unexplained sudden death, severe allergic reactions

Mild side effects

  • Fatigue
  • headache
  • dizziness
  • insomnia
  • nausea
  • vomiting
  • diarrhea
  • constipation
  • abdominal pain
  • muscle pain
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  • muscle cramps
  • drowsiness
  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • lethargy
  • sweating
  • skin rash
  • itching
  • fever
  • decreased body temperature
  • thrombocytopenia
  • anemia
  • reduced platelets
  • urinary incontinence
  • frequent urination
  • urinary retention
  • toothache
  • facial flushing
  • blood pressure changes
  • palpitations
  • hypotension
  • hypertension
  • bradycardia
  • atrial fibrillation
  • ECG changes

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and safety.

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.