Medication info
Neocept Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Neocept Tablet 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›10.43mg / 1 tablet
Manufacturer / importer
Sae Han Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablets
Packaging
Bottle package - 30 tablets/bottle, bottle package - 100 tablets/bottle
Approval status
Active

MFDS item code 202002257 · Approved 2020.03.31 · Insurance code 651300810

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 abnormal 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 incidence of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating 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. If administration of this drug is discontinued, its effects gradually decrease, and no rebound effect occurs with abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
Sae Han 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 slow the progression of symptoms of Alzheimer's type dementia and to improve memory and cognitive function.

How to take

Adult dose

○ Adults: Administer donepezil hydrochloride 5 mg once daily at bedtime. If sleep disturbances such as abnormal 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 incidence of adverse reactions may be affected by the rate of dose escalation, administer the 5 mg dose for 4~6 weeks. After evaluating 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. If administration of this drug is discontinued, its effects gradually decrease, and no rebound effect occurs with abrupt discontinuation. ○ Female patients aged 85 years or older with low body weight: Careful monitoring is required because adverse reactions occur more frequently. Elderly women with low body weight should not exceed 5 mg daily.

Child dose

○ Children: There is no experience with use in children.

Precautions

This medication contains donepezil hydrochloride and is primarily used to treat symptoms of Alzheimer's type dementia. This medication should not be used in certain patients. For example, individuals allergic to this medication or its components, women who are pregnant or may become pregnant, and nursing women should not take this medication. Additionally, patients with lactose intolerance or specific genetic conditions should not take this medication. Patients with heart disease or cardiac conduction disorders should use this medication with caution, as it may slow heart rate or cause arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcer should be cautious of gastric bleeding or worsening of ulcers while taking this medication. Patients with asthma or chronic obstructive pulmonary disease may experience worsening respiratory symptoms while taking this medication. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as this medication may worsen symptoms. This medication contains the dye Yellow No. 5, so individuals allergic to this component should also be cautious. While taking this medication, serious side effects such as fainting, heart problems, gastrointestinal bleeding, liver function abnormalities, cerebral hemorrhage, extrapyramidal symptoms, acute pancreatitis, or acute renal failure may occur, and immediate consultation with healthcare professionals is advisable if symptoms develop. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, hallucinations, anxiety, muscle pain, have been reported, so patients should report any abnormal symptoms during use. This medication is used for dementia treatment, but it is not approved for other types of dementia or memory impairment, so it should be used after accurate diagnosis. Patients with cardiovascular disease or a history of QT prolongation need to be monitored for heart rhythm abnormalities while taking this medication. This medication can stimulate gastric acid secretion and increase gastrointestinal motility, which may worsen peptic ulcers, so caution is advised for patients with a history of gastrointestinal disease. This medication may affect the central nervous system and carry a risk of worsening Parkinson's symptoms or seizures, so caution is necessary for patients with neurological disorders. Caution is required when using this medication during the initial period or dose increase due to its potential impact on driving or machinery operation. This medication should not be used during pregnancy except in special cases, and breastfeeding women are also advised against using it. Safety has not been established for pediatric use, and children should not take this medication. This medication may affect liver and kidney function, and regular monitoring may be necessary. In cases of overdose, severe symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, necessitating immediate medical treatment. This medication may interact with other drugs, so it is essential to inform healthcare professionals about other medications being taken, especially in conjunction with heart medications, antibiotics, and antidepressants.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal ulcer
  • gastrointestinal bleeding
  • hepatitis
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  • liver function impairment
  • jaundice
  • cerebral seizure
  • epilepsy
  • convulsions
  • cerebral hemorrhage
  • cerebrovascular disorders
  • movement disorders
  • ataxia
  • motility disorders
  • dystonia
  • tremor
  • involuntary movements
  • gait disturbances
  • abnormal posture
  • speech disorders
  • akinetic mutism
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • myoglobinuria
  • renal impairment
  • rhabdomyolysis
  • myalgia
  • weakness
  • increased CK in blood and urine
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • sudden death
  • cold
  • loss of appetite
  • hallucinations
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • incoherence
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • dizziness
  • tremor
  • seizures
  • delirium
  • pleurisy
  • bradycardia
  • palpitations
  • sinoatrial block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • torsades de pointes
  • prolonged QT interval on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disturbances
  • gastrointestinal bleeding
  • gastric and duodenal ulcers
  • constipation
  • salivation
  • dysphagia
  • fecal incontinence
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequency of urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • falls
  • petechiae
  • abnormal dreams
  • reduced appetite
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • eczema
  • urinary incontinence
  • abdominal pain
  • weakness
  • fungal infection
  • influenza-like syndrome
  • allergy
  • soft tissue infection
  • malaise
  • septicemia
  • facial edema
  • hernia
  • hypotension
  • abnormal ECG
  • heart failure
  • constipation
  • gastroenteritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal bloating
  • 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
  • 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
  • convulsions
  • transient mental disturbances
  • gait abnormalities
  • apathy
  • delusions
  • dream disturbances
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • altered euphoria
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • generalized tonic-clonic seizures
  • hemiplegia
  • tension
  • hypokinesia
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • rhinitis
  • asthma
  • skin ulcers
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • vaginitis
  • urination disorders
  • proteinuria
  • abdominal pain
  • anxiety
  • cholecystitis
  • confusion
  • hemolytic anemia
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, preferably at a cool room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

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