Medication info
Hysilver Donepezil 5mg (Donepezil Hydrochloride Monohydrate)

Hysilver Donepezil 5mg (Donepezil Hydrochloride Monohydrate)

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

MFDS item code 201901796 · Approved 2019.03.26 · Insurance code 644805590

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. Maintain the 5 mg dose for 4-6 weeks to evaluate clinical response before increasing to 10 mg. When increasing the dose to 10 mg, pay attention to gastrointestinal adverse reactions. Women over 85 years old with low body weight should not exceed a daily dose of 5 mg and require careful monitoring.
Child dose
There is no experience in using this medication in children.

Ingredients

Manufacturer
태극제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used in the treatment of symptoms of Alzheimer's dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. Maintain the 5 mg dose for 4-6 weeks to evaluate clinical response before increasing to 10 mg. When increasing the dose to 10 mg, pay attention to gastrointestinal adverse reactions. Women over 85 years old with low body weight should not exceed a daily dose of 5 mg and require careful monitoring.

Child dose

There is no experience in using this medication in children.

Precautions

This medication is primarily composed of Donepezil Hydrochloride Monohydrate and is used to treat symptoms of Alzheimer's dementia. This medication should not be administered to certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and those with genetic issues such as lactose intolerance should not take this medication. Patients with a history of heart disease or peptic ulcers, those with asthma or chronic obstructive pulmonary disease, patients with extrapyramidal disorders such as Parkinson's disease, and individuals allergic to dyes included in this medication should take this medication cautiously. Various side effects may occur when taking this medication, so attention is needed. For example, cardiac-related issues (bradycardia, heart block, etc.), gastrointestinal problems (peptic ulcers, gastrointestinal bleeding, etc.), liver function abnormalities, neurological symptoms, muscular issues, respiratory distress, acute pancreatitis, acute renal failure, and sudden death have been reported. Additionally, this medication can cause various common side effects such as drowsiness, dizziness, nausea, vomiting, diarrhea, insomnia, headache, fatigue, rash, etc.; therefore, changes in symptoms during use should be closely monitored. This medication is only used for the treatment of Alzheimer's dementia and is not recommended for other types of dementia or memory disorders. Treatment should always be conducted under the diagnosis and supervision of a specialist, and the therapeutic effect should be evaluated regularly. Patients with heart conditions or those taking heart-related medications may require cardiac monitoring while taking this medication. Those with a history of peptic ulcers or who are currently taking nonsteroidal anti-inflammatory drugs should carefully observe their gastrointestinal status. This medication may affect the ability to drive or operate machinery, so caution is needed in the initial stages of treatment or when increasing the dosage. Women who are pregnant or breastfeeding should avoid taking this medication; if it is absolutely necessary, a decision should be made after consulting with a specialist. This medication can interact with other drugs, so caution is required, especially when taken with certain antibiotics, antidepressants, or antiarrhythmic agents. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, respiratory depression may occur, so you should contact a healthcare institution immediately, and atropine can be used as an antidote. Finally, this medication should be kept out of the reach of children, and it is safe not to change the storage container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pale skin, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucous membranes, difficulty catching breath or shortness of breath, asthma attack, abnormal breathing accompanied by cough+fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and very severe headache, thunderclap headache, seizure, confusion, vision abnormalities, paralysis, urination issues

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • dizziness
  • insomnia
  • drowsiness
  • headache
  • fatigue
  • muscle pain
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  • rash
  • itching
  • fever
  • anxiety
  • insomnia
  • tremor
  • gait disorder
  • involuntary movement
  • decreased concentration
  • mental dullness
  • increased libido
  • excessive libido
  • insomnia
  • nonsensical speech
  • delusion
  • depression
  • confusion
  • apathy
  • hyperactivity
  • personality changes
  • hallucination
  • agitation
  • aggressive behavior
  • drowsiness
  • cold
  • pharyngitis
  • bronchitis
  • rhinitis
  • asthma
  • urinary incontinence
  • empty string

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

Storage

This medication should be stored in a sealed container that does not allow air to enter, and the storage temperature should be maintained between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness.

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.