Medication info
Doneil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Doneil Tablet 10 mg (Donepezil Hydrochloride Hydrate)

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

MFDS item code 201903791 · Approved 2019.06.10 · Insurance code 658106340

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4-6 weeks, the 5 mg dose should be administered, and after evaluating clinical response during this period, it may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. Underweight elderly women (85 years and older) should not exceed 5 mg daily, and careful monitoring is required due to the risk of adverse reactions.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
(유)한풍제약

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 Alzheimer's dementia symptoms. It helps improve memory decline and cognitive function, and slows the progression of symptoms. It supports patients in carrying out their daily lives more smoothly. It contributes to the overall improvement of cognitive ability, enhancing the quality of life. Through these effects, it helps stabilize the lives of Alzheimer’s dementia patients.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4-6 weeks, the 5 mg dose should be administered, and after evaluating clinical response during this period, it may be increased to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. Underweight elderly women (85 years and older) should not exceed 5 mg daily, and careful monitoring is required due to the risk of adverse reactions.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication contains Donepezil hydrochloride as its active ingredient and is used for alleviating the symptoms of Alzheimer's dementia. First, this medication should not be used in patients with hypersensitivity to Donepezil or similar compounds, those with specific genetic issues like lactose intolerance, and in women who are pregnant or breastfeeding. Patients with heart disease or heart conduction disorders should be cautious when using this medication, as it may cause heart problems such as bradycardia or arrhythmia. Patients taking nonsteroidal anti-inflammatory drugs or those with a history of peptic ulcers should use this medication carefully, as it can stimulate gastric acid secretion and exacerbate symptoms. Patients with asthma or obstructive pulmonary diseases should be cautious, as bronchoconstriction or increased mucus secretion may worsen their symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, should be administered this medication carefully due to the potential for symptom worsening. This medication contains the dye Yellow No. 5, so patients allergic to this component should be cautious. During the use of this medication, serious side effects including fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizure, movement disorders, muscle tone abnormalities, acute pancreatitis, acute renal failure, etc., may occur. If any unusual symptoms appear, immediate consultation with a doctor is necessary. Additionally, various side effects such as diarrhea, nausea, vomiting, appetite loss, dizziness, insomnia, headache, myalgia, rash, etc. have been reported, and patients should inform medical staff of any symptoms that arise. This medication may affect the cardiovascular system, so patients with a history of heart disease or QT interval prolongation require regular monitoring, including an electrocardiogram. It may impact driving or machine operation, so caution is needed during the initial period of use or when changing doses. This medication can interact with other drugs, especially those affecting CYP3A4 and CYP2D6 enzymes, heart medications, anticholinergic drugs, NSAIDs, etc., so consultation with a doctor or pharmacist is essential when taking them together. Women who are pregnant or breastfeeding should not use this medication, and if necessary, they should follow the expert's instructions. Safety in children has not been established, so it should not be used in pediatric patients. In case of overdose, serious symptoms may occur including nausea, vomiting, bradycardia, hypotension, respiratory depression, and muscle weakness, requiring immediate emergency treatment. This medication should be stored out of the reach of children, and transferring it to another container is not good for maintaining quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, pallor, cold sweat, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, dyspnea or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Loss of appetite
  • nausea
  • vomiting
  • diarrhea
  • dizziness
  • insomnia
  • headache
  • drowsiness
  • fatigue
  • myalgia
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  • rash
  • itching
  • increased blood pressure
  • increased urination
  • urinary incontinence
  • weight loss
  • edema
  • sweating
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • anxiety
  • hallucinations
  • drowsiness
  • confusion
  • lethargy
  • thrombocytopenia
  • anemia
  • leukopenia
  • abdominal pain
  • hives
  • fever
  • toothache
  • flushing
  • vasodilation

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 and moisture from entering, maintaining a temperature between 1 and 30 degrees Celsius to preserve its effectiveness over time.

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

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.