Medication info

Icept Tablet 23 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 202104019 · Approved 2021.05.21

Summary

Main use
Treatment of moderate to severe symptoms of Alzheimer's dementia
Who takes it
Adults
Adult dose
This medication is taken once daily just before bedtime, regardless of meals. The initial recommended dose of donepezil hydrochloride is 5 mg once daily. After 4 to 6 weeks of taking 5 mg, the dosage may be increased to 10 mg based on clinical response. When increasing to 10 mg per day, attention should be paid to gastrointestinal adverse reactions. The minimum duration for taking 10 mg is 3 months.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment of moderate to severe symptoms of Alzheimer's dementia

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of moderate to severe symptoms of Alzheimer's dementia. It helps improve various symptoms caused by dementia, such as memory impairment and cognitive dysfunction, assisting in enhancing the patient's daily functional capabilities.

How to take

Adult dose

This medication is taken once daily just before bedtime, regardless of meals. The initial recommended dose of donepezil hydrochloride is 5 mg once daily. After 4 to 6 weeks of taking 5 mg, the dosage may be increased to 10 mg based on clinical response. When increasing to 10 mg per day, attention should be paid to gastrointestinal adverse reactions. The minimum duration for taking 10 mg is 3 months.

Precautions

This medication is primarily composed of donepezil hydrochloride and is used to alleviate the symptoms of Alzheimer's dementia. This medication should not be administered to specific patients. For instance, patients who are allergic to this medication or its ingredients, women who are pregnant or may become pregnant, and women who are breastfeeding should not use this medication. Additionally, patients with lactose intolerance or genetic lactose-related disorders should not take this medication. Patients with heart diseases or arrhythmia, those with a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs, patients with asthma or a history of obstructive pulmonary disease, patients with extrapyramidal disorders such as Parkinson's disease, and those allergic to yellow No. 4 (tartrazine) contained in this medication should use this medication with caution. During the use of this medication, various adverse reactions may occur, and in severe cases, immediate consultation with a doctor is advised. Common adverse reactions include fainting, arrhythmias, exacerbation of peptic ulcers, liver dysfunction, cerebrovascular issues, motor function disorders, muscle abnormalities, respiratory distress, acute pancreatitis, and acute renal failure. Furthermore, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, depression, myalgia, skin rashes, and other issues have been reported. This medication is not approved for other forms of memory disorders aside from dementia and treatment should be conducted under the supervision of an experienced physician. Additionally, this medication may increase the risk of cardiac arrhythmias, thus patients with heart disease may require regular electrocardiograms. Since this medication is primarily metabolized in the liver, patients with impaired liver function require close monitoring, and drug interactions may affect efficacy; thus, it is essential to inform the doctor of any other medications being taken. Women who are pregnant or breastfeeding are advised not to use this medication unless it is absolutely necessary and decided cautiously by a specialist. Safety for pediatric use has not been established, so it is not to be used in children. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and muscle weakness may occur, requiring immediate medical attention, and atropine may be used as an antidote. This medication should be stored in a tightly sealed container away from children's reach and transferring it to another container should be avoided to maintain quality.

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 ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, seizures, intracranial hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, motor disturbances, dystonia, tremor, involuntary movements, gait disorders, abnormal posture, speech disorders), neuroleptic malignant syndrome (akinesia, extreme rigidity, dysphagia,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • loss of appetite
  • dizziness
  • drowsiness
  • insomnia
  • tremor
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  • anxiety
  • aggressive behavior
  • hallucinations
  • delusions
  • depression
  • confusion
  • lethargy
  • thrombocytopenia
  • anemia
  • leukopenia
  • fever
  • edema
  • skin rash
  • itching
  • myalgia
  • hives
  • sweating
  • urinary incontinence
  • micturition disorders
  • constipation
  • abdominal pain
  • dehydration
  • weight loss
  • insomnia
  • vasodilation
  • drowsiness
  • irritability
  • insomnia
  • cerebrovascular anomalies
  • ataxia

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, at a temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Red, double-sided convex 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.