Medication info
Neoscept 5 mg (Donepezil Hydrochloride Hydrate)

Neoscept 5 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5.215mg / 1 tablet
Manufacturer / importer
Saehan Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 100 tablets/bottle
Approval status
Active

MFDS item code 202002256 · Approved 2020.03.31 · Insurance code 651300800

Summary

Main use
Treatment of symptoms of Alzheimer's disease
Who takes it
Adults · Children
Adult dose
Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning administration of this drug may be considered. Since donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, the 5 mg dose should be administered for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. When this drug is discontinued, its effects gradually diminish, and no rebound effect occurs with abrupt discontinuation. Women aged 85 years or older with low body weight: Adverse reactions occur frequently, so careful monitoring is required. Elderly women with low body weight should not exceed 5 mg daily.
Child dose
Pediatric patients: There is no experience with use in pediatric patients.

Ingredients

Manufacturer
Saehan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer's disease

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

This medication is used to treat symptoms of Alzheimer's type dementia. It helps improve memory impairment and cognitive decline caused by dementia, assisting patients in carrying out daily activities more smoothly.

How to take

Adult dose

Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as unusual dreams, nightmares, or insomnia occur, morning administration of this drug may be considered. Since donepezil concentrations reach steady state 15 days after administration and the frequency of adverse reactions may be affected by the rate of dose escalation, the 5 mg dose should be administered for 4~6 weeks. After assessing the clinical response during this period, the dose may be increased to 10 mg. When increasing the dose to 10 mg daily, administer with caution for gastrointestinal adverse reactions. When this drug is discontinued, its effects gradually diminish, and no rebound effect occurs with abrupt discontinuation. Women aged 85 years or older with low body weight: Adverse reactions occur frequently, so careful monitoring is required. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

Pediatric patients: There is no experience with use in pediatric patients.

Precautions

This medication contains the ingredient Donepezil Hydrochloride, primarily used for the treatment of symptoms of Alzheimer's type dementia. Firstly, this medication should not be administered to certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or might become pregnant, and patients with genetic issues such as lactose intolerance should not use this medication. Moreover, patients with heart disease or conduction disorders, those with a history of peptic ulcers or currently taking nonsteroidal anti-inflammatory drugs, individuals with a history of asthma or obstructive pulmonary disease, patients with extrapyramidal disorders such as Parkinson's disease, and those allergic to the colorants included in this medication should use it with caution. While taking this medication, various adverse reactions may occur. Severe issues may arise that affect heart function, such as fainting, bradycardia, and heart block. Gastrointestinal issues such as peptic ulcers or gastric bleeding may also occur. Liver dysfunction, cerebrovascular problems, and muscle-related abnormal symptoms have been reported as well. Psychological changes may include hallucinations, anxiety, insomnia, and confusion; if these symptoms occur, consult a doctor immediately. This medication requires particular caution in patients with cardiovascular diseases, as it can affect heart rhythms and electrical signals, necessitating electrocardiogram tests. Additionally, this medication may impact driving or machinery operation abilities, so caution is needed at the early stages of use. Women who are pregnant or breastfeeding should ideally not use this medication; if absolutely necessary, they should consult a professional. Safety for children has not yet been established, and therefore it is not used in pediatric patients. This medication can interact with other drugs; thus, it is crucial to inform a doctor or pharmacist, especially when taking heart medications, antidepressants, antibiotics, or anti-inflammatory drugs. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment, and atropine can be used as an antidote. This medication must be kept out of reach of children, and transferring it to other containers is discouraged as it may affect quality.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolongation of QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforation of the duodenum
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • epilepsy
  • seizure
  • intracerebral hemorrhage
  • cerebrovascular disorder
  • motor function disorder
  • ataxia
  • movement disorder
  • dystonia
  • tremor
  • involuntary movement
  • gait disturbance
  • abnormal posture
  • speech impairment
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • rhabdomyolysis
  • myalgia
  • malaise
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • decreased appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorder
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • irritability
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremor
  • stupor
  • chest wall rigidity
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • QT interval prolongation on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorder
  • gastrointestinal bleeding
  • gastric and duodenal ulcer
  • constipation
  • salivation
  • dysphagia
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence
  • increased urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • listlessness
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • falls
  • decreased appetite
  • urinary tract infection
  • petechial hemorrhage
  • abnormal dreams
  • accidents
  • back pain
  • chest pain
  • bleeding
  • syncope
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • eczema
  • urinary incontinence
  • abdominal pain
  • weakness
  • fungal infection
  • influenza-like illness
  • allergies
  • soft tissue infection
  • malaise
  • sepsis
  • facial edema
  • hernia
  • hypotension
  • abnormal ECG
  • heart failure
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • abnormal liver function
  • belching
  • esophagitis
  • anal bleeding
  • diabetes
  • anemia
  • leukocytosis
  • weight loss
  • peripheral edema
  • edema
  • increased LDH
  • increased alkaline phosphatase
  • hypercholesterolemia
  • hypokalemia
  • hypoglycemia
  • weight gain
  • hyperbilirubinemia
  • increased BUN
  • vitamin B12 deficiency anemia
  • cachexia
  • increased creatinine
  • gout
  • hyponatremia
  • hypoproteinemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthropathy
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • restlessness
  • anxiety
  • seizures
  • transient psychosis
  • gait abnormality
  • flat affect
  • delusions
  • dream abnormalities
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • euphoric state
  • vasodilation
  • intracerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • grand mal seizures
  • hemiplegia
  • hypertonia
  • hypokinesia
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcer
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • hives
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • vaginitis
  • urination disorders
  • increased urination
  • proteinuria
  • abdominal pain
  • restlessness
  • cholecystitis
  • confusion
  • hemolytic anemia
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • heart block
  • cardiac arrest

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. It is also advisable to keep it at a temperature between 1 and 30 degrees Celsius (room temperature). Storing it this way helps maintain the medication's efficacy.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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.