Medication info
Ysept 5 mg (Donepezil Hydrochloride Monohydrate)

Ysept 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTabletOral
Ingredient · strength
Donepezil Hydrochloride Monohydrate›5mg / 1 tablet
Manufacturer / importer
YuYong Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201801432 · Approved 2018.03.30

Summary

Main use
Treatment of symptoms of Alzheimer's-type dementia
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, taking this drug in the morning 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 this drug is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older who are underweight: Because adverse reactions occur more frequently, careful monitoring is required. Elderly women who are underweight should not exceed 5 mg daily.
Child dose
○ Children: There is no experience with use in children.

Ingredients

Manufacturer
YuYong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of Alzheimer's-type dementia

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used to treat symptoms of Alzheimer's disease. It alleviates major symptoms such as memory decline and cognitive dysfunction, and helps improve daily living capabilities. It contributes to enhancing the quality of life of patients and helps slow the progression of dementia. Therefore, it is effectively used for the relief of Alzheimer-related symptoms.

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, taking this drug in the morning 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 this drug is discontinued, its effects gradually diminish, and no rebound effect occurs following abrupt discontinuation. ○ Female patients aged 85 years or older who are underweight: Because adverse reactions occur more frequently, careful monitoring is required. Elderly women who are underweight should not exceed 5 mg daily.

Child dose

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

Precautions

This medication is used for the improvement of Alzheimer's disease symptoms with the active ingredient donepezil hydrochloride. First, this medication should not be used by individuals allergic to this active ingredient or similar medications, women who are pregnant or may become pregnant, and women who are breastfeeding. Patients with heart disease should take caution as this medication may slow heart rate or induce arrhythmia. Additionally, those with peptic ulcers or taking non-steroidal anti-inflammatory drugs should be careful due to the risk of gastrointestinal bleeding. Patients with a history of asthma or chronic obstructive pulmonary disease may experience exacerbation of symptoms due to bronchoconstriction caused by this medication. Patients with extrapyramidal disorders, such as Parkinson's disease, should also use this medication cautiously as their symptoms may worsen. This medication contains Yellow No. 5 dye, hence individuals allergic to this dye should exercise caution. Side effects may include fainting, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, seizures, movement disorders, respiratory distress, acute pancreatitis, and renal failure, albeit rarely. If any unusual symptoms arise, consult a healthcare professional immediately. This medication can assist in improving dementia symptoms, but the treatment effects should be regularly evaluated and discontinuation should be considered if necessary. Patients with heart disease or electrolyte imbalances may require an electrocardiogram due to the risk of arrhythmia. Caution should be exercised when driving or operating machinery as dizziness or fatigue may occur, particularly at the beginning of treatment or after a dose change. This medication may interact with multiple other drugs, therefore individuals taking other medications should consult their doctor or pharmacist. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary and should consult with a professional beforehand. Safety in pediatric patients has not been established, therefore it is not used in children. In cases of overdose, severe side effects such as vomiting, bradycardia, and respiratory depression may occur; immediate medical attention is required, and atropine may be used as an antidote. Finally, this medication should be kept out of reach of children and should not be transferred to other containers.

Side effects

  • Syncope
  • bradycardia
  • heart block
  • prolonged QT interval
  • myocardial infarction
  • heart failure
  • peptic ulcer
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • cerebral seizure
  • cerebral hemorrhage
  • cerebrovascular disorder
  • motor dysfunction
  • ataxia
  • movement disorders
  • dystonia
  • tremor
  • involuntary movement
  • gait disturbance
  • abnormal posture
  • speech disorder
  • catatonia
  • extreme muscle rigidity
  • dysphagia
  • tachycardia
  • blood pressure fluctuations
  • sweating
  • rhabdomyolysis
  • myalgia
  • weakness
  • increased CK in blood and urine
  • dyspnea
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cold
  • loss of appetite
  • hallucination
  • agitation
  • aggressive behavior
  • anxiety disorders
  • insomnia
  • drowsiness
  • increased libido
  • talkativeness
  • mania
  • nightmares
  • nervousness
  • nonsensical speech
  • delusions
  • depression
  • confusion
  • indifference
  • hyperactivity
  • increased sexual desire
  • hypersexuality
  • dizziness
  • tremor
  • seizures
  • stupor
  • chest wall stiffness
  • bradycardia
  • palpitations
  • sinus node block
  • atrioventricular block
  • hypertension
  • hypotension
  • atrial fibrillation
  • Torsades de Pointes
  • prolonged QT interval on ECG
  • diarrhea
  • nausea
  • vomiting
  • abdominal disorder
  • gastric ulcer
  • constipation
  • salivation
  • fecal incontinence
  • liver dysfunction including hepatitis
  • rash
  • pruritus
  • muscle cramps
  • myalgia
  • incontinence
  • frequent urination
  • urinary retention
  • headache
  • fatigue
  • pain
  • toothache
  • facial flushing
  • malaise
  • lethargy
  • edema
  • fever
  • decreased body temperature
  • decreased hematocrit
  • leukopenia
  • anemia
  • thrombocytopenia
  • petechiae
  • abnormal dreams
  • decreased appetite
  • urinary tract infection
  • increased CPK
  • dehydration
  • hyperlipidemia
  • insomnia
  • hostility
  • irritability
  • drowsiness
  • depression
  • confusion
  • emotional instability
  • personality disorder
  • eczema
  • incontinence
  • abdominal pain
  • weakness
  • fungal infection
  • influenza-like illness
  • allergy
  • soft tissue infection
  • malaise
  • sepsis
  • facial swelling
  • hernia
  • hypotension
  • abnormal ECG
  • heart failure
  • myocardial infarction
  • angina
  • atrial fibrillation
  • congestive heart failure
  • peripheral vascular disease
  • supraventricular ectopic beats
  • ventricular ectopic beats
  • cardiac hypertrophy
  • constipation
  • gastritis
  • fecal incontinence
  • dyspepsia
  • increased γ-GT
  • gastritis
  • dysphagia
  • periodontitis
  • gastric ulcer
  • periodontal abscess
  • abdominal distension
  • abnormal liver function
  • belching
  • esophagitis
  • rectal 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
  • hypoalbuminemia
  • iron deficiency anemia
  • increased AST
  • increased ALT
  • arthritis
  • arthrosis
  • bone fracture
  • arthralgia
  • leg cramps
  • osteoporosis
  • myalgia
  • restlessness
  • anxiety
  • tremor
  • spasms
  • mood disorder
  • gait abnormalities
  • apathy
  • dizziness
  • delusions
  • dream disorders
  • cerebrovascular abnormalities
  • increased salivation
  • ataxia
  • ecstatic experiences
  • vasodilation
  • cerebral hemorrhage
  • cerebral infarction
  • cerebral ischemia
  • dementia
  • extrapyramidal symptoms
  • grand mal seizures
  • hemiplegia
  • hypertonia
  • decreased motor function
  • pharyngitis
  • pneumonia
  • increased cough
  • bronchitis
  • respiratory distress
  • rhinitis
  • asthma
  • rash
  • skin ulcer
  • itching
  • psoriasis
  • skin discoloration
  • shingles
  • dry skin
  • sweating
  • urticaria
  • vesicular rash
  • conjunctivitis
  • glaucoma
  • visual disturbances
  • ear pain
  • tear abnormalities
  • urinary tract infection
  • cystitis
  • hematuria
  • diabetes
  • vaginitis
  • urination disorders
  • frequent urination
  • proteinuria
  • abdominal pain
  • restlessness
  • cholecystitis
  • confusion
  • spasms
  • hallucinations
  • heart block
  • hemolytic anemia
  • hepatitis
  • hyponatremia
  • neuroleptic malignant syndrome
  • pancreatitis
  • rash
  • nausea
  • vomiting
  • excessive salivation
  • sweating
  • hypotension
  • respiratory depression
  • weakness
  • spasms
  • symptoms of muscle weakness

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 air or moisture from entering, and it is safest to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

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

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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.