Medication info
Cetpezil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

Cetpezil Tablets 10mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802725 · Approved 2018.06.29 · Insurance code 647303420

Summary

Main use
Improvement of Alzheimer's disease symptoms
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 dosing. Normal levels are reached 15 days after administration, so maintain the 5 mg dosage for 4 to 6 weeks. Afterward, evaluate the clinical response for possible dose increase up to 10 mg. Caution should be observed for gastrointestinal adverse reactions when increasing the dose to 10 mg per day. For underweight females over 85 years old, careful monitoring is needed, and they should not exceed 5 mg daily.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement of Alzheimer's disease symptoms

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

This medication is used to treat symptoms of Alzheimer's type dementia. It improves memory decline and cognitive function, and helps enhance daily living abilities. It helps to slow the progression of dementia and maintain a more stable condition.

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 dosing. Normal levels are reached 15 days after administration, so maintain the 5 mg dosage for 4 to 6 weeks. Afterward, evaluate the clinical response for possible dose increase up to 10 mg. Caution should be observed for gastrointestinal adverse reactions when increasing the dose to 10 mg per day. For underweight females over 85 years old, careful monitoring is needed, and they should not exceed 5 mg daily.

Child dose

There is no experience using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Monohydrate as the main ingredient and is used for the treatment of Alzheimer's type dementia. Before taking this medicine, individuals who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any components of this medication should not take it. Women who are pregnant or may become pregnant, as well as women who are breastfeeding, should also avoid this medication. Additionally, this medication is not administered to patients with genetic issues such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with heart diseases or those with conduction disorders such as sick sinus syndrome, atrioventricular block should use this medication cautiously, as it may slow heart rate or cause arrhythmias. Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or with a history of peptic ulcers should be cautious as increased gastric acid secretion and gastric motility may worsen symptoms. Patients with a history of asthma or obstructive lung disease should also be careful because it may increase bronchoconstriction and mucus secretion worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as it may worsen their symptoms. This medication contains the dye Yellow No. 5, so patients allergic or sensitive to this component should use it carefully. While taking this drug, various side effects such as dizziness, nausea, vomiting, diarrhea, reduced appetite, insomnia, hallucinations, heart problems, liver dysfunction, muscle pain, and shortness of breath may occur. In particular, cardiac side effects such as bradycardia, heart block, and QT interval prolongation may occur, so cardiac disease patients may require regular electrocardiogram examinations. This medication has not been approved as a treatment for other types of dementia or memory decline and should only be used under the supervision of an experienced physician for patients with Alzheimer's type dementia. Since this medication may affect the ability to drive or operate machinery, caution is advised during initial dosing or dose changes. This medication is primarily metabolized in the liver, so caution is necessary for patients with decreased liver function. This medication can interact with various drugs, so if you are taking other medications, you must consult your physician or pharmacist. In particular, caution is needed when used in combination with antiarrhythmic agents, certain antidepressants, antibiotics, beta-blockers, and NSAIDs. Pregnant or breastfeeding women should not take this medication and if necessary, must consult healthcare professionals to stop breastfeeding. Safety has not been established for pediatric use; therefore, this medication is not used in children. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, respiratory depression, and convulsions may occur; immediate medical attention is required, and atropine may be used as an antidote. This medication should be stored out of reach of children and not transferred 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, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (movement disorders, ataxia, abnormal movements, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • rash
  • itching
  • muscle pain
  • urinary incontinence
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  • frequent urination
  • insomnia
  • dizziness
  • drowsiness
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait instability
  • involuntary movement
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • blood disorders
  • fever
  • malaise
  • lethargy
  • urticaria
  • edema
  • dehydration
  • abdominal pain
  • constipation
  • saliva secretion
  • swallowing difficulties
  • fecal incontinence
  • petechiae
  • increased libido
  • talking excessively
  • mania

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 exposure, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the efficacy of the medication and prevents deterioration.

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

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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.