Medication info
Silvercept 5 mg (Donepezil Hydrochloride Monohydrate)

Silvercept 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200808985 · Approved 2008.08.26 · Insurance code 651902490

Summary

Main use
Treatment 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, clinically evaluate the response to potentially increase to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. Underweight elderly women should not exceed a dosage of 5 mg daily.
Child dose
There is no experience using this medication in pediatric patients.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Treatment of symptoms of Alzheimer's type dementia

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

Medications for treating symptoms of Alzheimer's type dementia help improve memory decline and cognitive dysfunction. This drug supports delaying the worsening of symptoms and maintaining quality of daily life. It also plays an important role in maximizing patient safety and independence. It is used for treating symptoms of Alzheimer's type dementia.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After administering 5 mg for 4 to 6 weeks, clinically evaluate the response to potentially increase to 10 mg. When increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. Underweight elderly women should not exceed a dosage of 5 mg daily.

Child dose

There is no experience using this medication in pediatric patients.

Precautions

This drug is a medication with Donepezil Hydrochloride Monohydrate as its main ingredient, used for the treatment of symptoms of Alzheimer's type dementia. First, this medication should not be administered to patients who are hypersensitive to Donepezil Hydrochloride, piperidine derivatives, or any components of this drug, as well as to pregnant or potentially pregnant women and nursing mothers. Patients with heart disease or conduction disorders should use this medication cautiously as it may stimulate the vagus nerve, causing bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as this medication may exacerbate ulcer symptoms by promoting gastric acid secretion and gastrointestinal motility. Patients with a history of asthma or obstructive pulmonary disease should be careful, as bronchial smooth muscle contraction and increased mucus secretion may worsen symptoms. This medication may excessively stimulate cholinergic nerves in patients with extrapyramidal disorders such as Parkinson's disease, potentially worsening their symptoms. Serious adverse reactions such as syncope, bradycardia, heart block, gastrointestinal bleeding, hepatic dysfunction, cerebrovascular disorders, extrapyramidal symptoms, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and unexplained sudden death may occur during treatment; if such symptoms arise, consult a physician immediately. Additionally, common side effects reported include nausea, vomiting, diarrhea, dizziness, insomnia, headaches, fatigue, appetite decrease, etc. This medication is approved for use only in Alzheimer's type dementia and should not be used for other forms of dementia or memory disorders. Patients with cardiovascular diseases may require monitoring, such as an electrocardiogram, as this medication can affect heart rhythm. Caution is necessary since this medication may influence driving or operating machinery, especially at initial use or during dosage increases. This drug is metabolized by certain enzymes (CYP3A4, CYP2D6), so caution is advised when it is used in conjunction with other drugs that inhibit or induce these enzymes due to possible changes in therapeutic effects and side effect risks; consultation with a professional is recommended. Pregnant or nursing women should generally avoid this drug, and if necessary, it should be used cautiously under professional judgment. Safety has not been established for children, and it should not be administered to pediatric patients. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and convulsions may appear, requiring immediate emergency treatment, and antidotes such as atropine may be used. Finally, this medication should be stored out of the reach of children, and it is advisable not to transfer it to another container to maintain safety and quality.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • hepatic dysfunction
  • jaundice
  • seizures
  • epilepsy
  • convulsions
  • intracerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal disorders
  • motor function disorders
  • ataxia
  • movement disorders
  • dystonia
  • tremors
  • involuntary movements
  • gait disturbances
  • abnormal postures
  • speech disorders
  • neuroleptic malignant syndrome
  • akinetic mutism
  • extreme muscle

Mild side effects

  • Headache
  • dizziness
  • diarrhea
  • nausea
  • vomiting
  • appetite loss
  • fatigue
  • tremors
  • insomnia
  • drowsiness
Show 29 more
  • myalgia
  • rash
  • itching
  • abdominal pain
  • weakness
  • fever
  • thrombocytopenia
  • anemia
  • blood pressure fluctuations
  • dysphagia
  • urinary incontinence
  • urinary disorders
  • anxiety
  • hallucinations
  • aggressive behavior
  • drowsiness
  • confusion
  • delusions
  • psychomotor agitation
  • infection
  • cold
  • vasodilation
  • sweating
  • dehydration
  • weight loss
  • weight gain
  • thrombocytopenia
  • dehydration
  • edema

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. The storage temperature should ideally be maintained between 1 and 30 degrees Celsius. Proper storage will ensure the medication's effectiveness is safely preserved.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 200 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.