Medication info
Newto Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Newto Tablet 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200709247 · Notified 2007.08.08 · Insurance code 647800240

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
Donepezil hydrochloride is administered once daily at a dose of 5 mg before bedtime. For 4 to 6 weeks, the dose of 5 mg is administered, and after evaluating clinical response, it can be increased to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal side effects. Underweight women aged 85 years and older should not exceed 5 mg daily, and careful monitoring for adverse reactions is necessary.
Child dose
There is no experience of use in children.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Alzheimer's dementia symptoms
View approved original text

This medication is used in the treatment of Alzheimer's dementia symptoms. It helps improve memory decline and cognitive function due to dementia, assisting in the maintenance of the patient's daily living abilities. It is effective in helping to slow the progression of symptoms by improving brain function.

How to take

Adult dose

Donepezil hydrochloride is administered once daily at a dose of 5 mg before bedtime. For 4 to 6 weeks, the dose of 5 mg is administered, and after evaluating clinical response, it can be increased to 10 mg. When increasing to 10 mg daily, caution should be exercised regarding gastrointestinal side effects. Underweight women aged 85 years and older should not exceed 5 mg daily, and careful monitoring for adverse reactions is necessary.

Child dose

There is no experience of use in children.

Precautions

This medicine is used to treat symptoms of Alzheimer's dementia, with donepezil hydrochloride as its active ingredient. This medication should not be used by individuals who are allergic to donepezil hydrochloride or to any of its components, as well as by pregnant women or women who may become pregnant, and by breastfeeding women. Patients with heart disease or cardiac conduction disorders should be cautious when using this medication, as it may cause heart problems such as bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication carefully due to the risk of gastrointestinal bleeding or ulcer exacerbation. Patients with a history of asthma or chronic obstructive pulmonary disease should be cautious, as bronchoconstriction or increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease may experience a worsening of symptoms due to this medication. Serious adverse reactions such as fainting, heart irregularities, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, respiratory distress, acute pancreatitis, and acute kidney failure may occur during treatment, so if any abnormal symptoms arise, medical consultation should be sought immediately. In some patients, side effects such as diarrhea, nausea, vomiting, appetite loss, dizziness, insomnia, headache, and fatigue have been commonly reported. This medication is approved for use only in patients with Alzheimer's disease and should not be used for other forms of dementia or memory decline. Patients with heart disease should have their cardiac status monitored periodically through electrocardiography while on this medication. This medication may affect driving or operating machinery; caution is advised, especially during the initial dosage or if the dosage is changed. Pregnant or breastfeeding women are advised not to use this medication unless absolutely necessary, and consultation with a specialist is recommended prior to use. This medication may interact with other drugs, so caution is advised, especially when used with certain antibiotics, antidepressants, anti-arrhythmics, and antipsychotics. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, and respiratory depression may occur, and immediate medical attention is required.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • difficulty breathing
  • severe allergic reaction
  • hepatitis
  • liver dysfunction
  • jaundice
  • sudden severe headache
  • seizures
  • confusion
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  • visual disturbances
  • paralysis
  • severe edema
  • urinary abnormalities
  • fainting
  • bradycardia
  • heart block
  • QT prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal ulcer
  • gastrointestinal bleeding
  • cerebral seizures
  • cerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal disorders

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • dizziness
  • insomnia
  • appetite loss
  • drowsiness
  • muscle pain
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  • rash
  • itching
  • swelling
  • thrombocytopenia
  • increased blood pressure
  • incontinence
  • frequent urination
  • urination disorders
  • fever
  • decreased body temperature
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • drowsiness
  • palpitations
  • lethargy
  • sweating

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best kept at a temperature between 1 and 30 degrees Celsius. Proper storage conditions will help maintain the medication's effectiveness and prevent deterioration.

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.