Medication info
Silvercept 23 mg (Donepezil Hydrochloride Hydrate)

Silvercept 23 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›24mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
Red, bi-convex, round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201600568 · Approved 2016.01.28 · Insurance code 651904330

Summary

Main use
Treatment of moderate to severe symptoms of Alzheimer's disease
Who takes it
Adults
Adult dose
This medication is taken once daily just before bedtime and can be taken regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg taken once daily. After 15 days, a steady state is reached, and after administering 5 mg for 4 to 6 weeks, clinical response evaluation will be done to increase the dosage up to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. Take at least one dose of 10 mg daily for 3 months.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Treatment of moderate to severe symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used to treat moderate to severe symptoms of Alzheimer's disease. It helps alleviate memory decline and cognitive impairment, enhancing the patient's daily living abilities. Additionally, it delays the deterioration of behavioral and psychiatric symptoms, improving the quality of life for both patients and families. When taken consistently, it is expected to slow the progression of symptoms. The dosage and administration may be adjusted according to each patient's condition, so it is important to closely follow the instructions of healthcare professionals. For these reasons, it is used in the treatment of symptoms of Alzheimer's disease.

How to take

Adult dose

This medication is taken once daily just before bedtime and can be taken regardless of meals. The initial recommended dose of Donepezil Hydrochloride is 5 mg taken once daily. After 15 days, a steady state is reached, and after administering 5 mg for 4 to 6 weeks, clinical response evaluation will be done to increase the dosage up to 10 mg. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. Take at least one dose of 10 mg daily for 3 months.

Precautions

This medication is used for the treatment of symptoms of Alzheimer's disease, with Donepezil Hydrochloride Hydrate as the main ingredient. However, it should not be administered to certain patients. For example, it should not be used in individuals allergic to this drug or its components, pregnant women, breastfeeding women, and patients with genetic lactose intolerance issues. Patients with heart disease, history of peptic ulcers, asthma, chronic obstructive pulmonary disease, and extrapyramidal disorders like Parkinson's disease should use this medication with caution. In particular, patients with heart-related conditions may experience bradycardia or arrhythmias, necessitating careful attention. This medication can cause various side effects, which can be severe, including syncope, heart block, gastrointestinal bleeding, liver dysfunction, seizures, and movement disorders. Additionally, it may commonly cause mild side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, skin rash, among others. In particular, when taken at high doses, nausea and vomiting may occur more frequently, and side effects often appear within one month of starting treatment, so patients should be closely monitored. This medication affects the cardiovascular system and can induce disturbances in heart rhythm, so patients with a history of heart disease or those at risk of QT interval prolongation need regular monitoring, including electrocardiograms. Additionally, since this medication is metabolized by CYP3A4 and CYP2D6 enzymes, care should be taken when taken with drugs that inhibit or induce these enzymes, as the drug's effects may change. It is advisable for pregnant or breastfeeding women not to use this medication, and it should only be used after careful consultation with specialists if absolutely necessary. Its safety in children has not been established, so it should not be used in this population. In case of overdose, symptoms may include nausea, vomiting, bradycardia, and respiratory depression, and immediate medical treatment is required. Antidotes such as atropine may be used. While this drug is effective for dementia treatment, always consult with a doctor beforehand, and periodically check for side effects and the patient's condition during treatment. Finally, this medication should be stored out of the reach of children, and transferring it to another container is not advisable to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, difficulty breathing or shortness of breath, asthma attack, respiratory irregularities with coughing and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning-like headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • headache
  • fatigue
  • lethargy
  • dizziness
  • insomnia
  • drowsiness
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  • rash
  • itching
  • myalgia
  • urinary incontinence
  • fever
  • thrombocytopenia
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremor
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • hives
  • facial flushing
  • sweating
  • weight loss
  • dehydration
  • hypotension
  • hypertension
  • palpitations
  • atrial fibrillation
  • heart failure
  • myocardial infarction
  • heart block
  • cardiac arrest
  • syncope

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 ideally kept at a temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

Red, bi-convex, 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

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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.