Medication info

Donepezil Hydrochloride Tablets 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
알파제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201902279 · Approved 2019.04.15

This product's status changed to Expired on 2024.04.15. 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
Administer 5 mg of donepezil hydrochloride once daily before bedtime. For 4 to 6 weeks, administer a 5 mg dosage, and after evaluating clinical responses during this period, it can be increased to 10 mg. When increasing to a daily dosage of 10 mg, caution should be exercised regarding gastrointestinal side effects. Women over 85 years old who are underweight should not exceed 5 mg daily and require careful monitoring.
Child dose
No experience of use in children.

Ingredients

Manufacturer
알파제약(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 for the treatment of symptoms of Alzheimer's type dementia. It helps to improve the decline in memory and cognitive functions resulting from dementia, facilitating the patient's daily life. Additionally, it contributes to enhancing quality of life by slowing down cognitive decline.

How to take

Adult dose

Administer 5 mg of donepezil hydrochloride once daily before bedtime. For 4 to 6 weeks, administer a 5 mg dosage, and after evaluating clinical responses during this period, it can be increased to 10 mg. When increasing to a daily dosage of 10 mg, caution should be exercised regarding gastrointestinal side effects. Women over 85 years old who are underweight should not exceed 5 mg daily and require careful monitoring.

Child dose

No experience of use in children.

Precautions

This medication contains donepezil hydrochloride as its main ingredient and is used for the treatment of symptoms of Alzheimer's type dementia. This medication should not be administered to certain patients, including those who have allergies to donepezil hydrochloride or any components of this medication, women who are pregnant or may become pregnant, and nursing mothers should avoid taking this medication as well. Furthermore, patients with lactose intolerance or genetic lactose metabolism disorders should not take this medication. Patients with heart disease, a history of peptic ulcers or currently taking non-steroidal anti-inflammatory drugs, those with asthma or a history of obstructive pulmonary disease, and patients with extrapyramidal disorders such as Parkinson's disease should use this medication cautiously. This medication can cause various side effects, such as irregular heartbeats, gastrointestinal bleeding, bronchospasm, and movement disorders, so caution is necessary. If serious symptoms such as fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, seizures, muscle abnormalities, or breathing difficulties occur while taking this medication, consult a healthcare professional immediately. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, depression, and others may occur, so it is important to closely monitor any changes in symptoms. This medication may affect heart rhythm, so patients with heart disease may require regular electrocardiogram (ECG) examinations. Furthermore, it can increase stomach acid secretion and worsen peptic ulcers, so it is important to periodically check gastrointestinal health. Be cautious when performing complex tasks such as driving or operating machinery, as this medication can cause dizziness or fatigue, especially during the initial dosage or when changing doses. This medication can interact with various drugs, so if you are currently taking any other medications, be sure to inform your healthcare provider. Caution is especially advised if you are taking heart medications, antibiotics, antidepressants, antipsychotics, or other cholinergic medications. Pregnant or nursing women should avoid this medication, and if it's necessary, a cautious decision should be made after consulting a specialist. Safety for use in children has not been established, so it should not be administered to children. In the case of an overdose, symptoms such as nausea, vomiting, severe muscle weakness, and breathing difficulties may occur, and emergency treatment should be sought immediately, with atropine possibly being used as an antidote. Keep this medication out of reach of children and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, skin peeling, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities plus cough & fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urinary retention

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • dizziness
  • insomnia
  • hallucinations
  • excitement
Show 30 more
  • aggressive behavior
  • anxiety
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • sweating
  • skin rash
  • itching
  • muscle cramps
  • muscle pain
  • urinary incontinence
  • frequent urination
  • fecal incontinence
  • tooth pain
  • eye pain

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

Storage

Store this medication in an airtight, tightly closed container, in a safe temperature range between 1 to 30 degrees Celsius at room temperature. This storage method will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 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.