Medication info

JW Donepezil Solution 5mg, 10mg (Donepezil Hydrochloride Hydrate)

Prescription medicationSolution경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 packet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
A colorless or light yellow solution contained in an aluminum foil pouch.
Packaging
30 sachets/box [5ml/sachet x 30], 30 sachets/box [10ml/sachet x 30]
Approval status
Active

MFDS item code 202202999 · Approved 2022.07.18 · Insurance code 644915091,644915101

Summary

Main use
Improvement of symptoms of Alzheimer's disease
Who takes it
Adults · Children
Adult dose
Adult: As Donepezil Hydrochloride, administer 5mL (5 mg) once daily before bedtime. For 4 to 6 weeks, administer 5mL (5 mg) and evaluate clinical response before potentially increasing to 10mL (10 mg). Underweight women aged 85 years and older should not exceed 5mL (5 mg) per day, and administration should be conducted with attention to adverse reactions.
Child dose
Pediatric: Experience with use in children is lacking.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used to treat symptoms of Alzheimer's disease. It helps alleviate cognitive decline and memory loss in patients, potentially improving quality of daily life.

How to take

Adult dose

Adult: As Donepezil Hydrochloride, administer 5mL (5 mg) once daily before bedtime. For 4 to 6 weeks, administer 5mL (5 mg) and evaluate clinical response before potentially increasing to 10mL (10 mg). Underweight women aged 85 years and older should not exceed 5mL (5 mg) per day, and administration should be conducted with attention to adverse reactions.

Child dose

Pediatric: Experience with use in children is lacking.

Precautions

This medicine contains Donepezil Hydrochloride as the main ingredient and is used for the treatment of Alzheimer's disease. This medication should not be used in individuals with hypersensitivity to Donepezil Hydrochloride, piperidine derivatives, or any other components of this medication. It is also advisable for women who are pregnant, may become pregnant, or are breastfeeding to avoid using this medication. Patients with heart diseases or those who have cardiac conduction disorders should use this medication cautiously as it may induce bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious due to the potential for increased gastric acid secretion and gastrointestinal motility, which may worsen ulcer symptoms. Patients with a history of asthma or obstructive pulmonary disease should also be administered with caution as bronchoconstriction and increased mucus secretion may exacerbate symptoms. Patients with Parkinson's disease or extrapyramidal disorders may experience exacerbation of symptoms due to the cholinergic effects of this medication, requiring careful monitoring. Serious adverse reactions such as fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular accidents, symptoms of extrapyramidal disorders, muscle abnormalities, respiratory difficulties, acute pancreatitis, acute renal failure, and sudden death may occur during use; patients should consult a doctor immediately if any of these symptoms arise. Nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, headaches, fatigue, skin rashes, among other side effects, may also occur, and it is essential to be aware of symptom changes. This medication is not approved for treating other forms of dementia or memory impairment other than Alzheimer's disease and must be used under the diagnosis and supervision of an experienced physician. Patients with heart disease or electrolyte imbalances may be at risk for arrhythmias and need regular cardiac check-ups. As it may affect driving or machine operating abilities, caution should be taken at the start of treatment or when the dosage is changed. This medication is metabolized by specific liver enzymes, so potential interactions with other drugs might occur, and it is advised to consult a physician or pharmacist. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary and after consulting a specialist. The safety in children has not been established, and thus it should not be used in pediatric patients. In case of overdose, serious symptoms like nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures may appear; immediate medical attention is required. The dosage of this medication is fixed, so it is essential to check the indicated dosage and not to divide the sachet for intake. Keep out of reach of children and do not transfer to another container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, shortness of breath, cold sweat, paleness (severe allergic reactions)
  • Severe rash with high fever, blisters, skin peeling, mucous membrane pain in the mouth/eyes (severe skin reactions)
  • Difficulty breathing or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever (respiratory issues)
  • Yellowing of the skin or eyes (jaundice), extreme lethargy (liver dysfunction)
  • Sudden and severe .

Mild side effects

  • Nausea
  • vomiting
  • loss of appetite
  • diarrhea
  • dizziness
  • insomnia
  • tremors
  • headaches
  • fatigue
  • edema
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  • itching
  • rash
  • incontinence
  • drowsiness
  • anxiety
  • increased blood pressure
  • thrombocytopenia
  • anemia
  • myalgia
  • abdominal pain
  • weakness
  • sweating
  • hematological disorders
  • decreased concentration
  • mental sluggishness
  • drowsiness
  • blood pressure fluctuations
  • fever
  • decreased body temperature
  • thrombocytopenia
  • dehydration
  • hypotension
  • hypertension
  • palpitations
  • atrial fibrillation
  • heart failure
  • myocardial disease.

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

Storage

This medication should be stored in a securely closed container to prevent air or moisture from entering. It is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

A colorless or light yellow solution contained in an aluminum foil pouch.

Package unit

30 sachets/box [5ml/sachet x 30], 30 sachets/box [10ml/sachet x 30]

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.