Medication info

Newtoin Oral Dissolving Film 10 mg (Donepezil Hydrochloride)

Prescription medication경구
Ingredient · strength
Donepezil Hydrochloride›10mg / 1 sheet
Manufacturer / importer
삼진제약(주)
Appearance
Pale yellow rectangular oral dissolving film
Packaging
30 pieces (1 piece/package * 30)
Approval status
Active

MFDS item code 201604197 · Approved 2016.07.07 · Insurance code 647804420

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical responses can be evaluated, and the dose may be increased to 10 mg. When escalating to 10 mg daily, observe for gastrointestinal adverse reactions. This medicine is an oral dissolving film that can be placed on the tongue and taken without water.
Child dose
No experience with pediatric use.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used for the treatment of symptoms of Alzheimer's type dementia. It helps improve memory decline and cognitive function impairment caused by dementia, enabling smoother daily living. It helps protect the patient's cognitive abilities and slows down the progression of symptoms. Ultimately, it focuses on improving the quality of life for both patients and their families.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinical responses can be evaluated, and the dose may be increased to 10 mg. When escalating to 10 mg daily, observe for gastrointestinal adverse reactions. This medicine is an oral dissolving film that can be placed on the tongue and taken without water.

Child dose

No experience with pediatric use.

Precautions

This medicine is used to treat symptoms of Alzheimer's type dementia and contains Donepezil Hydrochloride as its active ingredient. First, this medicine should not be used in individuals allergic to Donepezil Hydrochloride or similar ingredients, women who are pregnant or may become pregnant, and breastfeeding women. Patients with heart disease or conduction disturbances should use this medicine cautiously, as it may cause a slow heart rate or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should observe symptoms as increased gastric acid secretion may exacerbate ulcers. Patients with asthma or obstructive pulmonary disease should be careful, as it may cause bronchoconstriction or increased mucus secretion, worsening symptoms. Patients with extrapyramidal disorders, such as Parkinson's disease, should use this drug carefully, as it may worsen symptoms. While taking this medicine, severe side effects such as fainting, cardiac issues, gastrointestinal bleeding, liver dysfunction, seizures, muscle disorders, difficulty in breathing, acute pancreatitis, and renal failure may occur. If any unusual symptoms develop, consult a medical professional immediately. Generally, side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, decreased appetite, fatigue, headache, etc. may occur and most of these symptoms are temporary. This medicine can affect heart rate, so patients with heart disease may require regular ECG monitoring. Moreover, this medicine can affect liver and kidney functions, so caution is needed for patients with liver or kidney diseases. It is recommended not to use this medicine during pregnancy, and breastfeeding women should also discontinue breastfeeding while taking this medicine. Safety in children has not been established, so it should not be used in children. This medicine may interact with other drugs, so especially if taking medications that affect the heart or are involved in liver metabolism, it is essential to inform the healthcare provider. When taking it, it should dissolve on the tongue without water and should be stored out of reach of children, and since it may discolor due to light, it is best to store it in its unopened packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Decreased appetite
  • nausea
  • vomiting
  • diarrhea
  • headache
  • fatigue
  • insomnia
  • drowsiness
  • dizziness
  • muscle pain
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  • muscle cramps
  • rash
  • itching
  • urinary incontinence
  • increased urination
  • urination difficulties
  • blood pressure fluctuations
  • weight loss
  • edema
  • dehydration
  • hyperlipidemia
  • hypertension
  • hypotension
  • palpitations
  • atrial fibrillation
  • bleeding
  • petechiae
  • constipation
  • abdominal pain
  • dysphagia
  • fecal incontinence
  • liver dysfunction
  • hepatitis
  • liver dysfunction
  • liver dysfunction
  • chest pain
  • thrombocytopenia
  • empty

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

Storage

This medicine must be stored in a tightly closed container to protect it from air and moisture, and it should be kept away from direct sunlight. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow rectangular oral dissolving film

Package unit

30 pieces (1 piece/package * 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

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.