Medication info
Donepezil Hydrochloride 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

Donepezil Hydrochloride 5 mg Tablets (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
(주)동구바이오제약
Appearance
Yellow round film-coated tablets
Packaging
30 tablets per bottle
Approval status
Active

MFDS item code 201803551 · Approved 2018.08.30 · Insurance code 657307260

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 sleep disturbances occur, consider morning administration. The concentration of Donepezil reaches a steady state after 15 days of administration, so administer 5 mg for 4 to 6 weeks and evaluate the clinical response during this period before increasing to 10 mg. If increasing to 10 mg daily, monitor for gastrointestinal side effects.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used for the treatment of symptoms related to Alzheimer's type dementia. It helps improve memory decline and cognitive function, contributing to improved daily living abilities. It also helps slow the progression of dementia symptoms, maintaining the quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or sleep disturbances occur, consider morning administration. The concentration of Donepezil reaches a steady state after 15 days of administration, so administer 5 mg for 4 to 6 weeks and evaluate the clinical response during this period before increasing to 10 mg. If increasing to 10 mg daily, monitor for gastrointestinal side effects.

Child dose

There is no experience in using this medication in children.

Precautions

This medication is used to alleviate symptoms of Alzheimer's type dementia with Donepezil Hydrochloride as the active ingredient. Firstly, this medication should not be used in certain patients. For instance, individuals who are allergic to this medication or its ingredients, pregnant women or those who may become pregnant, and individuals with genetic disorders causing lactose intolerance should not take this medication. Additionally, patients with heart disease or issues with heart rhythm, those with a history of peptic ulcers or taking non-steroidal anti-inflammatory drugs (NSAIDs), those with a history of asthma or lung disease, patients with extrapyramidal disorders such as Parkinson's disease, and individuals who are allergic to certain dyes included in this medication should use it with caution. When taking this medication, various side effects may occur, so attention is needed. For example, cardiovascular problems, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, breathing difficulties, pancreatitis, renal failure, and sudden death have been reported. In addition, a variety of symptoms such as decreased appetite, nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, muscle pain, skin rashes may occur, and if symptoms are severe or unusual, immediate consultation with a doctor is necessary. This medication can affect the cardiovascular system, potentially causing a slow heart rate or arrhythmias, so patients with heart disease should undergo regular ECG monitoring. It can also affect the digestive system, increasing gastric acid secretion or stimulating gastrointestinal motility, potentially worsening peptic ulcers, so patients with a history of gastrointestinal disease should closely monitor their symptoms. Additionally, it may impact the respiratory system, exacerbating symptoms in patients with asthma or obstructive pulmonary disease, thus requiring caution. Pregnant or breastfeeding women should avoid taking this medication as its safety has not been established; if absolutely necessary, consultation with a healthcare professional is advised. This medication may interact with other drugs, so caution is especially needed when taken with medications metabolized by the liver, drugs affecting the heart, and NSAIDs. Moreover, this medication may impair the ability to drive or operate machinery, so care should be taken at the beginning of treatment or when changing doses. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression may arise; immediate medical attention is required, and atropine can be used as an antidote. Finally, this medication should be stored out of reach of children, and it is advisable not to transfer it 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, perforation of the duodenum, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, seizures, intracerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement dysfunction, ataxia, tremors, etc.), neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death, cardiac arrest, palpitations, atrial fibrillation

Mild side effects

  • Nausea
  • vomiting
  • decreased appetite
  • diarrhea
  • headache
  • fatigue
  • insomnia
  • dizziness
  • drowsiness
  • tremors
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  • skin rash
  • itching
  • muscle pain
  • elevated blood pressure
  • edema
  • fever
  • toothache
  • lethargy
  • weakness
  • incontinence
  • frequent urination
  • urinary retention
  • thrombocytopenia
  • anemia
  • leukopenia
  • petechiae
  • eczema
  • rash
  • hives

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

Storage

This medication should be stored in a sealed container to prevent air ingress and ideally kept at temperatures between 1°C and 30°C. By doing so, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets per 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.