Medication info
Arit Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Arit Tablet 23 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Red, double convex, round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle
Approval status
Active

MFDS item code 202008358 · Approved 2020.11.30

Summary

Main use
Treatment of moderate to severe Alzheimer's type dementia symptoms
Who takes it
Adults
Adult dose
This medication should be taken once daily just before bedtime, irrespective of food intake. The recommended initial dose of donepezil hydrochloride is 5 mg taken once daily, maintained for 4 to 6 weeks. After that, a dose increase to 10 mg may be made based on clinical response, and after at least 3 months of taking 10 mg, a dose of 23 mg may be administered once daily. It should not be split, crushed, or chewed.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment of moderate to severe Alzheimer's type dementia symptoms

  • Alzheimer's type dementia symptoms
View approved original text

This medication is used to treat moderate to severe symptoms of Alzheimer's type dementia. It helps improve memory decline and cognitive function to maintain the ability to perform daily activities. It contributes to slowing the progression of symptoms and improving the quality of life for patients and caregivers. Therefore, it effectively works on Alzheimer’s dementia to alleviate symptoms.

How to take

Adult dose

This medication should be taken once daily just before bedtime, irrespective of food intake. The recommended initial dose of donepezil hydrochloride is 5 mg taken once daily, maintained for 4 to 6 weeks. After that, a dose increase to 10 mg may be made based on clinical response, and after at least 3 months of taking 10 mg, a dose of 23 mg may be administered once daily. It should not be split, crushed, or chewed.

Precautions

This medication contains donepezil hydrochloride hydrate as its main component and is used to improve symptoms of Alzheimer's type dementia. There are cases where this medication should not be used by certain patients. For example, patients who are allergic to this medication or its components, women who are pregnant or may become pregnant, and those who are breastfeeding should not take this drug. Additionally, patients with lactose intolerance or certain genetic metabolic disorders should not use this medication. Patients with heart disease or cardiac conduction disorders should exercise caution when using this medication, as it may cause heart problems such as bradycardia or arrhythmias. Patients with a history of gastrointestinal ulcers or those taking non-steroidal anti-inflammatory drugs should use this medication with care, as it may worsen gastrointestinal bleeding or ulcers. Patients with asthma or chronic obstructive pulmonary disease should also be cautious, as bronchoconstriction or increased mucus secretion may worsen their symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, may experience worsening symptoms, so caution is required when taking this medication. This medication contains Yellow No. 4 dye, so patients who are allergic to this component should also be careful. Various side effects may occur when taking this medication, with the most severe cases reported as syncope, heart problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, movement disorders, neuroleptic malignant syndrome, and rhabdomyolysis. Additionally, various symptoms such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headache, and fatigue may occur. This medication may interact with other drugs, so especially when taken with certain antibiotics, antidepressants, antiarrhythmics, muscle relaxants, or anticholinergic drugs, it is critical to follow the doctor's instructions. In principle, pregnant or breastfeeding women should not take this medication, and in essential cases, they should consult with a specialist. Safety has not been established for use in children, so it is not used in pediatric patients. During the intake of this medication, caution is required when driving or operating machinery, especially at the beginning of treatment or when changing dosages, as patients may experience dizziness or fatigue. In cases of overdose, symptoms such as nausea, vomiting, severe muscle weakness, and respiratory distress may occur, necessitating an immediate visit to a medical institution, and atropine may be used as an antidote. Lastly, this medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, intracerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, motor disorders, dyskinesia, tremor, involuntary movement, gait disturbance, abnormal posture, speech disorder), neuroleptic malignant syndrome (stupor, extreme rigidity, swallowing difficulty,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • drowsiness
  • insomnia
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  • rash
  • itching
  • muscle pain
  • muscle cramps
  • urinary incontinence
  • elevated blood pressure
  • palpitations
  • hypotension
  • hypertension
  • atrial fibrillation
  • heart block
  • sinus node block
  • atrioventricular block
  • heart failure
  • ventricular tachycardia
  • QT interval prolongation
  • myocardial infarction
  • fever
  • urticaria
  • dehydration
  • weight loss
  • petechiae
  • thrombocytopenia
  • leukopenia
  • anemia

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 air exposure. Additionally, it is advisable to store it at room temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be well maintained.

Appearance and packaging

Appearance

Red, double convex, round film-coated tablet

Package unit

For domestic use - 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.