Medication info
Donepezil Hydrochloride Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Donepezil Hydrochloride Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201908177 · Approved 2019.11.29 · Insurance code 059000090

Summary

Main use
Improvement of symptoms of Alzheimer's-type dementia
Who takes it
Adults · Children
Adult dose
The dosage for donepezil hydrochloride is 5 mg administered once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical response may be assessed, and the dose may be increased up to 10 mg. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. For underweight female patients aged 85 and older, the dosage should not exceed 5 mg daily and careful monitoring is necessary.
Child dose
There is no experience using this medication in children.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improvement of symptoms of Alzheimer's-type dementia

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

Used for the treatment of symptoms of Alzheimer's-type dementia.

How to take

Adult dose

The dosage for donepezil hydrochloride is 5 mg administered once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical response may be assessed, and the dose may be increased up to 10 mg. Caution should be taken for gastrointestinal adverse reactions when increasing to 10 mg daily. For underweight female patients aged 85 and older, the dosage should not exceed 5 mg daily and careful monitoring is necessary.

Child dose

There is no experience using this medication in children.

Precautions

This medication contains donepezil hydrochloride as its main ingredient, used for treating Alzheimer's-type dementia. This medication should not be administered to certain patients. For example, individuals who are allergic to this drug or its components, pregnant women or those who may become pregnant, nursing mothers, and patients with lactose intolerance or specific genetic metabolic disorders should not use this medication. Patients with heart disease, particularly those at risk of bradycardia or arrhythmia, should use this medication cautiously. Additionally, patients with a history of peptic ulcers or who are taking non-steroidal anti-inflammatory drugs, patients with asthma or chronic obstructive pulmonary disease, and those with extrapyramidal disorders such as Parkinson's disease need to be careful. Diverse adverse reactions may occur when taking this medication. Problems related to the heart, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, respiratory difficulties, acute pancreatitis, or renal failure have been reported, and if symptoms are severe, administration should be stopped immediately, and medical advice should be sought. Furthermore, relatively common side effects such as nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, hallucinations, and anxiety may occur. Most of these symptoms are temporary and can improve with dose adjustment. This medication is not approved for other types of dementia or memory disorders aside from Alzheimer's-type dementia, and treatment should be conducted under the diagnosis and supervision of an experienced physician. Patients with cardiovascular diseases may require heart monitoring while taking this medication, and those with a history of peptic ulcers should be cautious of worsening symptoms. This medication may impact driving or operating machinery, so caution is advised especially during the initial dose or when increasing the dosage. Women who are pregnant or nursing should avoid using this medication, and if necessary, it should be decided in consultation with a specialist. Since this medication is metabolized in the liver, the efficacy may change when used in conjunction with certain medications, particularly those that inhibit or promote liver metabolism, so caution is warranted. In the case of overdose, severe vomiting, bradycardia, hypotension, and seizures may occur, and immediate medical treatment should be sought. Atropine can be used as an antidote. Lastly, this medication should be stored out of reach of children, and transferring it to another container may cause quality degradation or accidents; caution is advised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin exfoliation, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, cough with fever concomitant respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • decreased appetite
  • dizziness
  • headache
  • fatigue
  • drowsiness
  • insomnia
  • anxiety
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  • nocturnal behaviors
  • tremors
  • dyspepsia
  • abdominal pain
  • myalgia
  • fever
  • edema
  • rash
  • pruritus
  • thrombocytopenia
  • anemia
  • hematological abnormalities
  • urinary incontinence
  • frequent urination
  • urination disorders
  • involuntary movements
  • gait disturbances
  • drowsiness
  • hallucinations
  • agitation
  • aggressive behavior
  • psychiatric hypersensitivity
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • talking too much
  • mania
  • nightmares
  • irritability

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 is important to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a long time.

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

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.