Medication info
Hypezil 10mg (Donepezil Hydrochloride Hydrate)

Hypezil 10mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200605443 · Notified 2006.06.22 · Insurance code 642002750

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Adults: Administer donepezil hydrochloride 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dose, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal side effects. Females over 85 years old who are underweight should not exceed 5 mg daily and require close monitoring.
Child dose
Pediatric: There is no experience in using this medication in children.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medicine is used for the treatment of symptoms of Alzheimer's dementia. Alzheimer's dementia is a condition characterized by memory loss and cognitive decline, and this medicine helps alleviate such symptoms and improve the patient's ability to carry out daily activities. It is effective in slowing the progression of dementia in patients and enhancing their quality of life.

How to take

Adult dose

Adults: Administer donepezil hydrochloride 5 mg once daily before bedtime. For 4 to 6 weeks, administer the 5 mg dose, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg daily, caution should be taken regarding gastrointestinal side effects. Females over 85 years old who are underweight should not exceed 5 mg daily and require close monitoring.

Child dose

Pediatric: There is no experience in using this medication in children.

Precautions

This medicine contains Donepezil Hydrochloride Hydrate as the main ingredient and is used for the treatment of Alzheimer's dementia symptoms. First of all, this medicine should not be used in patients who are allergic to any of its ingredients or to Donepezil Hydrochloride or piperidine derivatives. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medicine. Patients with heart diseases, such as bradycardia or cardiac conduction disorders, should use this medicine with caution as it may slow heart rate or cause arrhythmias. Additionally, caution should be exercised when administering this medication to patients with a history of peptic ulcers or those taking non-steroidal anti-inflammatory drugs due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive pulmonary disease should also take care as this medicine may exacerbate symptoms by increasing bronchoconstriction and mucus secretion. Patients with extrapyramidal disorders, such as Parkinson's disease, may also need to be cautious as this medication could worsen symptoms. This medicine contains a dye called Yellow No. 5, and patients who are allergic to this substance should take it with caution. While taking this medicine, there may be heart-related adverse reactions such as syncope, bradycardia, heart block, myocardial infarction, and if symptoms occur, the patient should consult a physician immediately. Furthermore, serious side effects such as gastrointestinal bleeding, liver dysfunction, cerebrovascular accidents, extrapyramidal disorder symptoms, muscle disorders, respiratory distress, acute pancreatitis, and acute renal failure may rarely occur, so caution is necessary. Common side effects include nausea, vomiting, diarrhea, anorexia, dizziness, insomnia, headaches, fatigue, skin rashes, and if unusual symptoms persist, patients should inform the healthcare staff. This medicine is approved solely for patients with Alzheimer's dementia and should not be used for other forms of dementia or memory disorders. Treatment should be conducted under the supervision of an experienced physician, and regular assessments of treatment efficacy should be made to consider discontinuation if necessary. Patients with heart diseases or a history of QT interval prolongation may require an electrocardiogram due to the risk of arrhythmias. This medication can affect driving or operating machinery, so caution should be exercised during the initial stage of treatment or when the dose is changed. This medicine can interact with several drugs, so special care should be taken when taken with drugs that affect CYP3A4 or CYP2D6 metabolism, neuromuscular blockers, cholinergic drugs, anticholinergic drugs, and drugs that affect cardiac conduction, including NSAIDs. Pregnant or nursing mothers are advised not to take this medicine, and if absolutely necessary, breastfeeding should be discontinued. Safety in children has not been established, so it is not to be used in pediatric patients. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required; antidotes such as atropine may be used. This medication should be kept out of reach of children and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, torsades de pointes, myocardial infarction, heart failure, gastrointestinal bleeding, peptic ulcer, perforated duodenal ulcer, hepatitis, liver dysfunction, jaundice, seizures, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorder symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, sudden death, severe allergic reactions (hives, severe swelling, chest tightness, trouble breathing)

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • anorexia
  • headaches
  • fatigue
  • drowsiness
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  • fever
  • blood pressure changes
  • itching
  • muscle pain
  • urinary incontinence
  • constipation
  • fecal incontinence
  • dehydration
  • hyperlipidemia
  • agitation
  • anxiety
  • hallucinations
  • aggressive behavior
  • insomnia
  • drowsiness
  • thrombocytopenia
  • skin rash
  • sweating
  • reduced concentration
  • mental dullness
  • lethargy
  • anxiety disorders
  • verbosity
  • depression
  • confusion
  • delusion
  • hallucination
  • mania
  • tremor
  • gait disturbance
  • akathisia

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

Storage

This medicine should be stored in a tightly closed container that does not allow air to enter and should be kept at room temperature, between 1 to 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent 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.