Medication info
NPSepT 5mg (Donepezil Hydrochloride)

NPSepT 5mg (Donepezil Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride›5mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201601880 · Approved 2016.04.08 · Insurance code 669906730

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. If unusual dreams, nightmares, or insomnia occur, consider morning dosing. After achieving steady-state Donepezil levels after 15 days, continue administering 5 mg for 4 to 6 weeks. After evaluating clinical response, the dose may be increased to 10 mg, but caution is advised regarding gastrointestinal adverse reactions when increasing to 10 mg daily.
Child dose
No experience with pediatric use.

Ingredients

Manufacturer
대한뉴팜(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 associated with Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. If unusual dreams, nightmares, or insomnia occur, consider morning dosing. After achieving steady-state Donepezil levels after 15 days, continue administering 5 mg for 4 to 6 weeks. After evaluating clinical response, the dose may be increased to 10 mg, but caution is advised regarding gastrointestinal adverse reactions when increasing to 10 mg daily.

Child dose

No experience with pediatric use.

Precautions

This medication uses Donepezil Hydrochloride as its main ingredient to alleviate symptoms of Alzheimer's type dementia. First, individuals who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any components of this medication should not take it. It is also safer for pregnant women, women who might become pregnant, and nursing mothers to avoid using this medication. Additionally, individuals with lactose intolerance or certain genetic lactose metabolic disorders should avoid this medication due to the presence of lactose. Patients with heart conditions need to be cautious while using this medication as bradycardia or arrhythmia might occur. Those taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should consult their doctor to prevent worsening of gastrointestinal issues. Patients with asthma or obstructive pulmonary disease should also be careful as respiratory symptoms may worsen. Patients with extrapyramidal disorders, such as Parkinson's disease, should use this medication cautiously as their symptoms may worsen. This medication may cause various side effects, some severe, like fainting, heart problems, gastrointestinal bleeding, liver dysfunction, neurological symptoms, or motor disorders. If such symptoms occur, stop taking the medication immediately and consult a doctor. Commonly reported side effects include nausea, vomiting, diarrhea, dizziness, insomnia, fatigue, and headaches. Although rare, severe side effects, including cardiac arrest, serious kidney issues, and acute pancreatitis, have also been reported, so caution is advised. This medication is not approved for other forms of dementia or memory impairment outside of Alzheimer's type dementia and must be used under the diagnosis and supervision of an experienced physician. Treatment discontinuation should be considered if there are no therapeutic effects or if side effects are severe. Cardiovascular disease patients may require ECG tests as this medication can affect heart rhythm. Patients with gastrointestinal diseases should be cautious as increased gastric acid secretion can worsen symptoms. Careful observation is needed for patients with mental or neurological symptoms and respiratory diseases to avoid exacerbations. Dizziness or fatigue may occur while driving or operating machinery, so caution is warranted, especially at the start of treatment or during dosage adjustments. This medication is metabolized by specific liver enzymes (CYP3A4, CYP2D6), so caution is needed when taken with other medications that inhibit or induce these enzymes, as this can alter the effects of the medication. Moreover, taking it alongside muscle relaxants or neuromuscular blockers may enhance effects, so it is essential to consult a doctor. Pregnant or nursing women should avoid this medication, and if it is necessary to take it, discontinuing breastfeeding is recommended. Safety in pediatric patients has not been established, and use is not advised. In case of overdose, symptoms such as nausea, vomiting, severe muscle weakness, and respiratory distress may occur, and emergency treatment should be sought immediately. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

  • Fainting
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • epilepsy
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • motor dysfunction
  • ataxia
  • motor disorders
  • dystonia
  • tremors
  • involuntary movements
  • gait disorders
  • abnormal posture
  • speech disorders
  • neuroleptic malignant syndrome
  • akinetic mutism
  • extreme rigidity
  • difficulty swallowing

Mild side effects

  • Cold
  • lack of appetite
  • hallucination
  • agitation
  • aggressive behavior
  • anxiety
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
Show 29 more
  • mania
  • nightmares
  • nervousness
  • gibberish
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremors
  • stupor
  • chest tightness
  • high blood pressure
  • low blood pressure
  • atrial fibrillation
  • diarrhea
  • nausea
  • vomiting
  • constipation
  • salivation
  • difficulty swallowing
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • muscle

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 air and moisture ingress, and it is best to store it at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a long period.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 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.