Medication info
Silvercept Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Silvercept Tablet 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200600249 · Approved 2006.03.20 · Insurance code 651901550

Summary

Main use
Improvement of Alzheimer's dementia symptoms
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, take 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, then based on clinical response assessment, the dose can be increased to 10 mg. If disturbances in sleep such as strange dreams, nightmares, or insomnia occur, morning administration may be considered. Underweight women patients over 85 years old should not exceed 5 mg daily and require careful monitoring.
Child dose
No experience in pediatric usage.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Improvement of Alzheimer's dementia symptoms

  • Symptoms of Alzheimer's dementia
View approved original text

This medication is used for the treatment of Alzheimer's dementia symptoms.

How to take

Adult dose

As donepezil hydrochloride, take 5 mg once daily before bedtime. Administer 5 mg for 4-6 weeks, then based on clinical response assessment, the dose can be increased to 10 mg. If disturbances in sleep such as strange dreams, nightmares, or insomnia occur, morning administration may be considered. Underweight women patients over 85 years old should not exceed 5 mg daily and require careful monitoring.

Child dose

No experience in pediatric usage.

Precautions

This medication contains donepezil hydrochloride as the active ingredient and is used for the treatment of Alzheimer's dementia symptoms. First, this medication should not be administered to certain patients. For example, patients who are allergic to this medication or its components, pregnant women or women who may become pregnant, and nursing mothers should not use this medication. Additionally, patients with heart diseases or conduction disorders, a history of peptic ulcers or those currently taking non-steroidal anti-inflammatory drugs, patients with asthma or obstructive pulmonary disease histories, and patients with extrapyramidal disorders such as Parkinson's disease should exercise special caution when using this medication. This medication may stimulate the vagus nerve, potentially causing a decrease in heart rate, increasing gastrointestinal motility leading to exacerbation of peptic ulcer symptoms, and may provoke bronchoconstriction worsening respiratory symptoms. During treatment, serious side effects such as syncope, bradycardia, heart block, gastrointestinal bleeding, liver dysfunction, cerebrovascular disorders, symptoms of extrapyramidal disorder, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death may occur, so if symptoms appear, immediate consultation with healthcare professionals is essential. Also, various side effects such as nausea, vomiting, diarrhea, loss of appetite, dizziness, insomnia, hallucinations, anxiety, drowsiness, palpitations, skin rash, myalgia, etc., have been reported, so caution is required when these symptoms occur. This medication may have side effects related to heart rate, thus patients with heart diseases may require monitoring through electrocardiogram testing. Furthermore, this medication increases gastric acid secretion and promotes gastrointestinal motility, potentially causing symptoms to worsen in patients with peptic ulcers, so caution is advised. It can affect the ability to drive or operate machinery; therefore, initial doses or dosage changes may lead to symptoms like fatigue, dizziness, and muscle cramps requiring attention. This medication may interact with various drugs, so particularly when used together with medications affecting CYP3A4 and CYP2D6 enzymes, drugs affecting cardiac conduction, cholinergic drugs, or anticholinergic drugs, consult healthcare professionals. Pregnant or nursing women should avoid using this medication, and in cases where it is deemed necessary, consultation with a specialist should be undertaken before making a decision. Safety in children has not been established, and this medication should not be used in pediatric patients. Overdosage may present symptoms such as nausea, vomiting, sweating, bradycardia, hypotension, respiratory depression, and seizures; therefore, appropriate medical treatment should be sought immediately. Lastly, this medication should be stored out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions
  • Severe rash with fever, blisters, skin peeling, pain in mouth/eyes membranes, severe skin adverse reactions
  • Shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever
  • Yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice)
  • Sudden and severe headache

Mild side effects

  • Dizziness
  • diarrhea
  • nausea
  • vomiting
  • headache
  • fatigue
  • fever
  • body aches
  • insomnia
  • hallucinations
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  • agitation
  • aggressive behavior
  • anxiety
  • drowsiness
  • loss of appetite
  • insomnia
  • tremors
  • confusion
  • palpitations
  • constipation
  • salivation
  • swallowing difficulties
  • fecal incontinence
  • rash
  • itching
  • muscle cramps
  • myalgia
  • urinary incontinence
  • frequent urination
  • urinary retention
  • headache
  • pain
  • toothache
  • facial flushing
  • asthenia
  • lethargy
  • edema
  • thrombocytopenia
  • dehydration
  • hyperlipidemia
  • hypercholesterolemia

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 from entering, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow 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.