Medication info
Arit Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Arit Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201706209 · Approved 2017.07.28 · Insurance code 663607220

Summary

Main use
Improvement of symptoms of Alzheimer's disease
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil's concentration reaches a steady state after 15 days of administration, so administer 5 mg for 4-6 weeks. After this period, evaluate clinical response and may increase to 10 mg. When increasing to a daily dose of 10 mg, monitor for gastrointestinal side effects.
Child dose
There is no experience with usage in pediatric patients.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medicine is used to treat the symptoms of Alzheimer's disease. It helps improve various symptoms caused by Alzheimer's dementia, such as memory impairment, cognitive decline, and difficulties in daily life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, morning dosing may be considered. Donepezil's concentration reaches a steady state after 15 days of administration, so administer 5 mg for 4-6 weeks. After this period, evaluate clinical response and may increase to 10 mg. When increasing to a daily dose of 10 mg, monitor for gastrointestinal side effects.

Child dose

There is no experience with usage in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as its main ingredient and is used for the treatment of Alzheimer's disease. First, this medication should not be used in certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and women who are breastfeeding should not take this medication. Furthermore, patients with genetic disorders such as galactose intolerance, lactase deficiency, and glucose-galactose malabsorption should also avoid taking this medication as it contains lactose. Secondly, patients with heart disease, a history of peptic ulcers, asthma or chronic obstructive pulmonary disease, and those with extrapyramidal disorders like Parkinson's disease should use this medication cautiously. This medication may slow heart rate or cause arrhythmias and can increase gastric acid secretion, which may worsen ulcer symptoms. Additionally, it may lead to bronchospasm or increased mucus secretion, potentially worsening respiratory symptoms and exacerbating Parkinson's disease symptoms. During treatment with this medication, various side effects may occur. In severe cases, symptoms such as syncope, heart block, myocardial infarction, gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, movement disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, and acute renal failure may arise, so it is important to consult a doctor immediately if these symptoms occur. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, muscle pain, and rash, which should also be monitored closely. This medication may affect the heart, so patients with heart disease or abnormal heart rhythms may need regular electrocardiogram tests. Patients with gastrointestinal disorders should carefully monitor for worsening symptoms. Caution is required when engaging in complex tasks such as driving or operating machinery, as this medication may cause dizziness or fatigue. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist about all medications you are taking during treatment. Caution is particularly needed when used with medications affecting the heart, antibiotics, antidepressants, antipsychotics, and drugs that inhibit or induce specific enzymes. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary and must make decisions after consulting with a specialist. Safety for use in children has not been established, so it is not to be used in pediatric patients. In the event of an overdose, symptoms such as nausea, vomiting, decreased heart rate, respiratory depression, and seizures may occur, and immediate medical attention should be sought for appropriate treatment. Finally, this medication should be stored out of reach of children, and transferring it to another container should be avoided as it may cause deterioration in quality or lead to accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough+fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
  • dizziness
  • insomnia
  • rash
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  • itching
  • muscle pain
  • muscle cramps
  • urinary incontinence
  • frequent urination
  • urinary disturbances
  • petechiae
  • thrombocytopenia
  • anemia
  • blood and lymphatic system disorders
  • hypertension
  • palpitations
  • anxiety
  • confusion
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • decreased body temperature
  • pain
  • lethargy
  • weakness

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 maintain the storage temperature between 1 degree and 30 degrees Celsius.

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.