Medication info

Donetiasan 5 mg (Donepezil Hydrochloride Hydrate), Donetiasan 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medication경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg
Manufacturer / importer
안국약품(주)
Appearance
White or light yellow powder
Packaging
Donetiasan 5 mg - 30 sachets/box, Donetiasan 10 mg - 30 sachets/box
Approval status
Active

MFDS item code 202501347 · Approved 2025.05.30

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, take 1 sachet (5 mg of Donepezil Hydrochloride) once daily at bedtime. Administer doses of 1 sachet (5 mg of Donepezil Hydrochloride) for 4-6 weeks. After assessing clinical response, increase to 1 sachet (10 mg of Donepezil Hydrochloride). Underweight elderly women (85 years or older) should not exceed 1 sachet (5 mg of Donepezil Hydrochloride) daily. This drug should be taken with water.
Child dose
There is no dosing information available as there is no experience using it in children.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This drug is used for the treatment of symptoms associated with Alzheimer's type dementia. It helps improve symptoms such as memory decline and cognitive impairment, enhancing the quality of daily life.

How to take

Adult dose

As Donepezil Hydrochloride, take 1 sachet (5 mg of Donepezil Hydrochloride) once daily at bedtime. Administer doses of 1 sachet (5 mg of Donepezil Hydrochloride) for 4-6 weeks. After assessing clinical response, increase to 1 sachet (10 mg of Donepezil Hydrochloride). Underweight elderly women (85 years or older) should not exceed 1 sachet (5 mg of Donepezil Hydrochloride) daily. This drug should be taken with water.

Child dose

There is no dosing information available as there is no experience using it in children.

Precautions

This drug contains Donepezil Hydrochloride as its main ingredient and is primarily used for the treatment of Alzheimer's type dementia. People with allergies to Donepezil or other components of this drug, pregnant women or women who may become pregnant, and breastfeeding women should not use this drug. Patients with heart disease, especially those with bradycardia or heart conduction disorders, should use this drug with caution as it may affect heart rhythm. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as there is a risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive pulmonary disease should be cautious, as this drug may induce bronchoconstriction, worsening their symptoms. Patients with extrapyramidal disorders like Parkinson's disease should take this drug under medical supervision as it may exacerbate symptoms. Various adverse reactions may occur when taking this drug; in severe cases, fainting, heart problems, gastrointestinal bleeding, liver dysfunction, cerebrovascular issues, muscle abnormalities, respiratory difficulties, acute pancreatitis, and acute kidney failure have been reported. Common side effects may include nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, palpitations, rashes, muscle pain, headaches, and fatigue. While this drug can help improve symptoms of dementia, it should be considered to discontinue if there is no therapeutic effect, and regular medical evaluations during use are important. Patients with heart health issues or electrolyte imbalances must consult a doctor before taking this medication, and an ECG may be required in some cases. This medication may affect liver and kidney function, so regular monitoring is recommended. Be cautious while driving or operating machinery as attentiveness may be reduced due to side effects of this drug. This drug may interact with other medications, so particularly when taken together with antibiotics, antidepressants, antiarrhythmics, antipsychotics, and anti-inflammatory drugs, consultation with a doctor or pharmacist is essential. Pregnant or breastfeeding women should avoid this drug; if it is necessary to take, a professional consultation is advised, and breastfeeding may need to be discontinued. Safety in children has not been established, so it is not used in pediatric patients. In cases of overdose, severe symptoms such as vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, and immediate medical attention is required. This medication should not be divided, and it should be stored out of reach of children. Transferring to another container may lead to degradation of quality, so caution is needed.

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 fever, blisters, skin peeling, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headaches
  • fatigue
  • dizziness
  • insomnia
  • hallucinations
  • agitation
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  • aggressive behavior
  • anxiety
  • drowsiness
  • increased libido
  • talking more
  • mania
  • nightmares
  • irritability
  • incoherence
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • excessive libido
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • diarrhea
  • constipation
  • fecal incontinence
  • dysphagia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • pain
  • toothache
  • facial flushing
  • malaise
  • insensitivity

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

Storage

This medication is sensitive to light and should be stored in a light-resistant container. Additionally, it is important to keep it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White or light yellow powder

Package unit

Donetiasan 5 mg - 30 sachets/box, Donetiasan 10 mg - 30 sachets/box

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.