Medication info
Donepezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Tablets 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906859 · Approved 2019.09.26 · Insurance code 679601240

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who uses it
Adults · Children
Adult dosage
As donepezil hydrochloride, administer 5 mg once a day before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and afterwards, it may be increased to 10 mg based on clinical response. When increasing the dose to 10 mg per day, caution should be exercised to monitor gastrointestinal adverse reactions. Female patients over 85 years old who are underweight should not exceed 5 mg per day.
Children's dosage
There is no experience in using this medication in children.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Alzheimer's-type dementia symptoms
View approved original text

This medication is used for the treatment of Alzheimer's-type dementia symptoms. It improves symptoms such as memory decline and cognitive function weakening, thereby reducing difficulties in daily life. Additionally, it supports brain function and helps delay the progression of symptoms. With consistent use, it can contribute to the enhancement of the patient's quality of life.

Dosage and Administration

Adult dosage

As donepezil hydrochloride, administer 5 mg once a day before bedtime. For 4 to 6 weeks, administer the 5 mg dosage, and afterwards, it may be increased to 10 mg based on clinical response. When increasing the dose to 10 mg per day, caution should be exercised to monitor gastrointestinal adverse reactions. Female patients over 85 years old who are underweight should not exceed 5 mg per day.

Children's dosage

There is no experience in using this medication in children.

Precautions

This medication contains donepezil hydrochloride as its main component and is primarily used for the treatment of Alzheimer's-type dementia symptoms. This medication should not be used by certain patients, particularly those allergic to this drug or similar components, pregnant women or women who may become pregnant, and nursing mothers. Patients with genetic problems such as lactose intolerance should also avoid this medication. Patients with heart disease, a history of peptic ulcers, those taking nonsteroidal anti-inflammatory drugs, patients with a history of asthma or chronic obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease should use this medication with caution. This medication may cause bradycardia or arrhythmias, gastrointestinal bleeding, liver function abnormalities, seizures, and various muscle-related adverse effects, so if any unusual symptoms occur, immediate consultation with a physician is necessary. It is important to regularly monitor the patient's heart condition during treatment, especially since ECG abnormalities such as QT interval prolongation may occur. This medication can interact with other drugs, particularly with drugs that are metabolized in the liver, potentially altering its effects, so it is essential to inform healthcare providers about any other medications being taken. Pregnant or nursing women should avoid this medication as a rule, and if absolutely necessary, they should follow the guidance of a specialist. Safety for pediatric use has not been established, so it is not used in children. Additionally, this medication may affect driving or machine operation abilities, so caution is required during the initial stages of dosing or when adjusting the dose. In the case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate hospital treatment. Finally, this medication should be stored out of the reach of children, and transferring it to another container is not advisable for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, difficulty breathing or getting air, asthma attacks, respiratory disturbances with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headache, seizures, disorientation, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • insomnia
  • dizziness
  • fever
  • itching
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  • muscle pain
  • incontinence
  • frequent urination
  • swelling
  • tremors
  • anxiety
  • hallucinations
  • confusion
  • drowsiness
  • aggressive behavior
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • thrombocytopenia
  • blood pressure fluctuations
  • sweating
  • dehydration
  • weight loss
  • vasodilation
  • skin rash
  • eczema
  • purpura
  • hives
  • blood pressure fluctuations
  • facial flushing

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, and it should be kept at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness of the medication and prevents deterioration.

Appearance and packaging

Appearance

White 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.