Medication info

Hypezil 5 mg (Donepezil Hydrochloride Hydrate), Hypezil 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medication
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.44mg / 1 packet
Manufacturer / importer
현대약품(주)
Appearance
This medication is a white powder.
Packaging
30 sachets/box [0.5 g/sachet x 30], 30 sachets/box [1 g/sachet x 30]
Approval status
Active

MFDS item code 202201524 · Approved 2022.04.11 · Insurance code 642004851,642004861

Summary

Main use
Improvement of Alzheimer's disease symptoms
Who uses it
Adults · Children
Adult dosage
As donepezil hydrochloride, administer 1 sachet (5 mg) once daily before bedtime. After 15 days, reach the normal state and continue to administer 1 sachet (5 mg) for 4-6 weeks. After evaluating clinical responses during this period, the dosage may be increased to 1 sachet (10 mg). Caution should be taken when increasing the dosage to watch for gastrointestinal adverse reactions. Underweight female patients aged over 85 should not exceed 1 sachet (5 mg) per day.
Children's dosage
There is no experience with pediatric use.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of Alzheimer's disease symptoms

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's disease. It helps relieve dementia symptoms such as memory decline and cognitive dysfunction, thereby improving the patient's daily life.

Dosage and Administration

Adult dosage

As donepezil hydrochloride, administer 1 sachet (5 mg) once daily before bedtime. After 15 days, reach the normal state and continue to administer 1 sachet (5 mg) for 4-6 weeks. After evaluating clinical responses during this period, the dosage may be increased to 1 sachet (10 mg). Caution should be taken when increasing the dosage to watch for gastrointestinal adverse reactions. Underweight female patients aged over 85 should not exceed 1 sachet (5 mg) per day.

Children's dosage

There is no experience with pediatric use.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is used to treat Alzheimer's disease. It should not be used in patients who are allergic to donepezil hydrochloride, piperidine derivatives, or any of the other components of this medication. It is recommended that women who are pregnant or may become pregnant, as well as breastfeeding women, do not take this medication. This medication contains lactose, so patients with hereditary diseases such as galactose intolerance, LAPP lactose deficiency, or glucose-galactose malabsorption should not take it. Patients with heart disease or those with bradycardia syndrome, atrial and ventricular conduction block should be cautious as this medication may stimulate the vagus nerve and potentially cause bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication cautiously, as it may increase gastric secretion and gastrointestinal motility, worsening ulcers. Those with a history of asthma or obstructive pulmonary disease should be cautious as symptoms may worsen due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease should take this medication with caution due to the potential for worsening symptoms. Severe side effects such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, vascular abnormalities, and muscle cramps may occur during treatment. If any unusual symptoms appear, consult a doctor immediately. Common side effects can also include nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, and more. Patients with heart disease or a history of QT interval prolongation may require electrocardiogram monitoring due to the risk of arrhythmias. This medication is metabolized by the CYP3A4 and CYP2D6 enzymes, hence caution should be taken when used with medications that inhibit or induce these enzymes, as they may alter drug effectiveness. Additionally, combining this medication with other cholinergic or anticholinergic drugs may lead to interactions, so inform your doctor or pharmacist. Be cautious while driving or operating machinery, as dizziness or drowsiness may occur, especially during the initial treatment or when changing dosages. It is advisable not to use this medication during pregnancy, and if breastfeeding, it is safer to stop breastfeeding or avoid taking it. Safety in pediatric patients has not been established, so it is not used in this group. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate medical attention. Atropine may be used as an antidote. This medication should not be divided when taking one sachet and should be stored out of reach of children. Also, transferring the medication to another container may lead to a deterioration in quality or accidents, so be cautious.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforating duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, brain hemorrhage, cerebrovascular disorders, extrapyramidal disorders, malignant neuroleptic syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, unexplained sudden death, cardiac arrest, severe allergic reactions (hives, severe swelling, chest tightness).

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • dizziness
  • insomnia
  • drowsiness
  • headache
  • fatigue
  • fever
Show 30 more
  • rash
  • itching
  • muscle pain
  • urinary incontinence
  • frequent urination
  • edema
  • thrombocytopenia
  • anemia
  • anxiety
  • hallucinations
  • excitement
  • aggressive behavior
  • tremors
  • walking disorders
  • involuntary movements
  • decreased concentration
  • mental dullness
  • palpitations
  • lethargy
  • sweating
  • insomnia
  • confusion
  • delusions
  • depression
  • stupor
  • muscle cramps
  • pain
  • toothache
  • facial flushing
  • fatigue.

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

Storage

This medication should be stored in a tightly closed container that can block light, at a temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

This medication is a white powder.

Package unit

30 sachets/box [0.5 g/sachet x 30], 30 sachets/box [1 g/sachet x 30]

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.