Medication info

Donemax Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
코스맥스파마(주)
Appearance
Yellow round film-coated tablets
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Expired

MFDS item code 202100730 · Approved 2021.01.25

This product's status changed to Expired on 2026.01.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bed. The concentration of Donepezil reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose increase, therefore, for 4-6 weeks, a dosage of 5 mg should be administered. After evaluating clinical responses during this period, the dosage may be increased to 10 mg. If the dosage is increased to 10 mg per day, it should be done with caution regarding gastrointestinal side effects.
Child dose
Pediatric patients: No experience in pediatric use.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used in the treatment of symptoms of Alzheimer's type dementia. It helps improve symptoms such as memory loss and cognitive dysfunction caused by Alzheimer's disease to assist the patient's daily life. It helps slow the progression of symptoms and improve the quality of life. It plays an important role in the recovery of the patient's cognitive ability and maintenance of daily activities, allowing for safe administration.

How to take

Adult dose

Adults: Administer 5 mg of Donepezil Hydrochloride once daily before bed. The concentration of Donepezil reaches a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose increase, therefore, for 4-6 weeks, a dosage of 5 mg should be administered. After evaluating clinical responses during this period, the dosage may be increased to 10 mg. If the dosage is increased to 10 mg per day, it should be done with caution regarding gastrointestinal side effects.

Child dose

Pediatric patients: No experience in pediatric use.

Precautions

This medication contains Donepezil Hydrochloride as its active ingredient and is primarily used for the treatment of symptoms of Alzheimer's type dementia. First, this medication should not be administered to certain patients. For example, individuals who are allergic to this medication or its ingredients, women who are pregnant or may become pregnant, and those who are breastfeeding should not take this medication. Additionally, patients with genetic lactase deficiency should avoid this medication due to the lactose it contains. Patients with heart disease or conduction disorders should be cautious as this medication may cause heart issues such as bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer should be careful as this medication may exacerbate symptoms by stimulating gastric acid secretion and gastrointestinal motility. Patients with asthma or chronic obstructive pulmonary disease may experience worsened symptoms due to bronchoconstriction and increased mucus secretion, and caution is needed. Patients with extrapyramidal disorders such as Parkinson's disease should be administered this medication with caution as it may worsen symptoms. This medication contains the dye Tartrazine (yellow 5), so those who are allergic or hypersensitive to this ingredient should exercise caution. When taking this medication, various adverse reactions may occur. Cardiac-related issues, gastrointestinal bleeding, liver function abnormalities, cerebrovascular disorders, neurological issues, muscle problems, and respiratory distress have been reported. In particular, cardiac issues such as fainting, bradycardia, heart block, and myocardial infarction may present, and if any symptoms occur, immediate consultation with healthcare personnel is necessary. Gastrointestinal issues may include nausea, vomiting, diarrhea, abdominal pain, and gastric ulcers. Neurological symptoms may include hallucinations, anxiety, insomnia, depression, confusion, and delusions, requiring attention to any changes in symptoms. This medication may affect driving or machinery operation, so caution is needed when starting treatment or changing dosages. Women who are pregnant or breastfeeding should avoid using this medication unless absolutely necessary, and if it must be taken, consultation with a professional is advised. The safety of this medication in pediatric patients has not been established, so it should not be used in children as a general principle. This medication may interact with other drugs, so patients taking medications that affect the heart or those involved in liver metabolism should consult with a doctor or pharmacist. In cases of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression, and convulsions may occur, requiring immediate treatment, and atropine may be used as an antidote. Finally, this medication should be kept out of the reach of children, and transferring it to another container should be avoided to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcer, perforation of the duodenum, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral convulsions, brain hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuroleptic malignant syndrome (catatonia, extreme rigidity, triad symptoms).

Mild side effects

  • Nausea
  • vomiting
  • dizziness
  • diarrhea
  • insomnia
  • abdominal pain
  • loss of appetite
  • headache
  • fatigue
  • drowsiness
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  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • nightmares
  • nervousness
  • delirium
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • excessive libido
  • tremors
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • petechiae
  • eczema
  • itching
  • urinary incontinence
  • increased urination
  • urinary retention
  • hives
  • facial symptoms.

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 exposure and should be kept at a temperature between 1 and 30 degrees Celsius to ensure safe use.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

Bottle - 30 tablets/bottle, 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.