Medication info
Alsezil Tablet 5mg (Donepezil Hydrochloride Hydrate)

Alsezil Tablet 5mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
영풍제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201307725 · Approved 2013.06.17 · Insurance code 661904170

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. The concentration of Donepezil reaches a steady state after 15 days of administration, so maintain the dosage of 5 mg for 4 to 6 weeks. After evaluating clinical response during this period, the dose can be increased to 10 mg. When increasing to a daily dose of 10 mg, caution should be taken regarding gastrointestinal adverse reactions.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
영풍제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

Alzheimer's type dementia symptoms are accompanied by memory decline and cognitive dysfunction, and this medication helps alleviate these dementia symptoms to improve the patient's daily living capabilities. It is mainly used to enhance cognitive function and control behavioral symptoms, and is therefore used to treat symptoms of Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, morning dosing may be considered. The concentration of Donepezil reaches a steady state after 15 days of administration, so maintain the dosage of 5 mg for 4 to 6 weeks. After evaluating clinical response during this period, the dose can be increased to 10 mg. When increasing to a daily dose of 10 mg, caution should be taken regarding gastrointestinal adverse reactions.

Child dose

There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the active ingredient and is used for the treatment of Alzheimer's type dementia. First, this medication should not be used in certain patients. For example, individuals who are allergic to this medication or its components, pregnant women or women who may become pregnant, and patients with lactose intolerance or certain genetic metabolic disorders should not take this medication. In addition, patients with heart disease, those with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs, individuals with a history of asthma or obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease should be particularly cautious when using this medication, as it can slow heart rate or irritate the gastrointestinal tract. While taking this medication, various side effects may occur; therefore, if symptoms such as dizziness, nausea, vomiting, diarrhea, cardiac irregularities, liver function abnormalities, seizures, muscle pain, or respiratory difficulties occur, consult a physician immediately. This medication may affect the heart, and patients with heart disease or electrolyte abnormalities may require regular electrocardiogram monitoring. Moreover, because this medication increases gastric acid secretion, it could worsen peptic ulcers, necessitating caution in patients with gastrointestinal disease history. Pregnant or nursing women are advised not to use this medication unless absolutely necessary and should seek expert advice. Safety in children has not been established, so this medication should not be used in this population. When taking this medication, interactions with other medications should be monitored closely. Specifically, taking it with drugs that affect enzymes that metabolize drugs in the liver or medications that influence the heart can increase the risk of side effects, so it is essential to consult a physician or pharmacist. During treatment, symptoms such as fatigue, dizziness, and muscle cramps may occur, necessitating caution when driving or operating machinery. In the case of overdose, symptoms such as nausea, vomiting, severe muscle weakness, or respiratory difficulties may occur, and immediate medical attention is required. Lastly, this medication should be stored out of the reach of children, and transferring it to other containers should be avoided.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, prolonged QT interval, Torsade de pointes, myocardial infarction, heart failure, peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures (epilepsy, convulsions, etc.), cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory difficulties, acute pancreatitis, acute renal failure, unexplained sudden death.

Mild side effects

  • Headache
  • dizziness
  • diarrhea
  • nausea
  • vomiting
  • loss of appetite
  • insomnia
  • drowsiness
  • muscle pain
  • fatigue
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  • fever
  • rash
  • itching
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • anemia
  • leukopenia
  • urinary incontinence
  • frequent urination
  • fecal incontinence
  • increased blood pressure
  • palpitations
  • hypotension
  • hypertension
  • atrial fibrillation
  • heart failure
  • myocardial infarction
  • gastrointestinal bleeding
  • duodenal ulcer
  • liver dysfunction.

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

Storage

Store this medication in a tightly closed container to prevent air exposure, and keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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

No questions yet.

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.