Medication info
Donepezil Hydrochloride 5mg Tablets

Donepezil Hydrochloride 5mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)셀비온
Appearance
This medication is a white, round film-coated tablet.
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707537 · Approved 2017.10.20 · Insurance code 055800150

Summary

Main use
Improvement of Alzheimer’s dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 5 mg once daily before bedtime. For the first 4 to 6 weeks, administer a dose of 5 mg, and then evaluate the clinical response before increasing to 10 mg. When increasing to 10 mg daily, administer while monitoring for gastrointestinal adverse reactions. Women over 85 years old who are underweight should not exceed 5 mg daily, and careful monitoring is required.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
(주)셀비온

Efficacy & effects

Improvement of Alzheimer’s dementia symptoms

  • Symptoms of Alzheimer’s dementia
View approved original text

This medication is used for the treatment of Alzheimer’s dementia symptoms. It helps to improve memory decline, cognitive dysfunction, and difficulties in daily activities.

How to take

Adult dose

As Donepezil Hydrochloride, take 5 mg once daily before bedtime. For the first 4 to 6 weeks, administer a dose of 5 mg, and then evaluate the clinical response before increasing to 10 mg. When increasing to 10 mg daily, administer while monitoring for gastrointestinal adverse reactions. Women over 85 years old who are underweight should not exceed 5 mg daily, and careful monitoring is required.

Child dose

There is no experience of use in children.

Precautions

This medication is used to alleviate the symptoms of Alzheimer’s dementia, with Donepezil Hydrochloride as its main ingredient. This medication should not be used by certain patients. For example, individuals who are allergic to this medication or its ingredients, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Additionally, individuals with lactose intolerance or certain genetic metabolic disorders should also avoid this medication. Patients with heart disease or cardiac conduction disorders should be cautious when taking this medication, as bradycardia or arrhythmia might occur. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should use this medication carefully, as it can increase gastric acid secretion and enhance gastrointestinal motility, potentially worsening symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be cautious, as respiratory symptoms may worsen with this medication. Patients with extrapyramidal disorders such as Parkinson's disease should consult their doctor before using this medication, as it may worsen their symptoms. Diverse adverse reactions may occur when using this medication, and in severe cases, cardiac issues, gastrointestinal bleeding, liver dysfunction, cerebrovascular problems, muscle disorders, and respiratory difficulties may arise; if symptoms worsen, medical attention should be sought immediately. Additionally, symptoms such as dizziness, nausea, vomiting, diarrhea, insomnia, hallucinations, and depression may occur, hence caution is advised. This medication is approved for use only in Alzheimer’s dementia patients and should not be used for other types of dementia or memory disorders. While on this medication, regular assessments of treatment efficacy should be performed, and if ineffective or if there are severe side effects, treatment discontinuation should be considered. Patients with heart disease or electrolyte imbalances may require cardiac monitoring. This medication may affect driving or machine operation ability; thus, caution is needed during the initial stages of treatment or if the dosage is changed. This medication may interact with specific drugs, so patients taking other medications should definitely consult their physician or pharmacist. It is safer for pregnant or breastfeeding women to avoid using this medication, and if necessary, breastfeeding should be discontinued. Safety in children has not been established; therefore, it should not be used in children. In the case of an overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory suppression may occur, which requires immediate emergency treatment. This medication must 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

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 attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, and urinary

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • rash
  • itching
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  • muscle pain
  • urinary incontinence
  • increased urination
  • urination disturbances
  • blood pressure fluctuations
  • drowsiness
  • aggressive behavior
  • hallucinations
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • lethargy
  • sweating
  • skin rash
  • thrombocytopenia
  • hives
  • facial swelling
  • abdominal pain
  • hypotension
  • hypertension
  • palpitations
  • atrial fibrillation
  • sinoatrial block
  • atrioventricular block
  • bradycardia
  • and heart

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

Storage

This medication should be stored in a tightly closed container that prevents air from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication’s efficacy and prevents deterioration.

Appearance and packaging

Appearance

This medication is a white, 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.