Medication info
Silvercept OD Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Silvercept OD Tablet 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.215mg / 1 tablet
Manufacturer / importer
명인제약(주)
Appearance
White round orally disintegrating tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201103909 · Approved 2011.06.22 · Insurance code 651903540

Summary

Main use
Improvement of symptoms in Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, the dose should be maintained at 5 mg, after which it may be increased up to 10 mg based on clinical response. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. The orally disintegrating tablet can be placed on the tongue to dissolve and can be taken with or without water.
Child dose
There is no experience using this medication in pediatric patients.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Improvement of symptoms in Alzheimer's type dementia

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

This medication is used for the treatment of symptoms of Alzheimer's type dementia. It helps when patients experience memory decline or cognitive function impairment, and assists in slowing the progression of symptoms to maintain the ability for daily living.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. For 4 to 6 weeks, the dose should be maintained at 5 mg, after which it may be increased up to 10 mg based on clinical response. When increasing to 10 mg daily, attention should be paid to gastrointestinal adverse reactions. The orally disintegrating tablet can be placed on the tongue to dissolve and can be taken with or without water.

Child dose

There is no experience using this medication in pediatric patients.

Precautions

This drug contains Donepezil Hydrochloride Monohydrate as the active ingredient and is used for the treatment of Alzheimer's type dementia symptoms. This medication should not be used by individuals who are allergic to Donepezil Hydrochloride or piperidine derivatives, or any other ingredients in this medication. Women who are pregnant or may become pregnant, as well as women who are breastfeeding, should not take this medication. Patients with heart disease or heart conduction disorders should be cautious when taking this medication as it may cause heart issues such as bradycardia or arrhythmia. Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or with a history of peptic ulcer should be careful as there is a risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or obstructive lung disease should be cautious as this medication may cause bronchoconstriction and increased mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as symptoms may worsen with this medication. Serious adverse reactions such as fainting, bradycardia, heart block, heart attack, gastrointestinal bleeding, liver function abnormality, vascular disorders, extrapyramidal symptoms, muscle abnormalities, difficulty breathing, acute pancreatitis, acute renal failure, and sudden death may occur; if any of these symptoms appear, consult a doctor immediately. Commonly occurring side effects include nausea, vomiting, diarrhea, dizziness, insomnia, loss of appetite, headache, fatigue, palpitations, and rash, most of which are mild and temporary. This medication can affect heart rate and electrical signals, so patients with heart disease should have their condition regularly monitored with an electrocardiogram. As this medication is metabolized in the liver, caution is required for patients with impaired liver function, and regular liver function tests are recommended. This medication may affect driving or operating machinery, so caution is necessary when starting treatment or changing doses. This drug may interact with other medications, particularly certain antibiotics, antidepressants, antipsychotics, and antiarrhythmics; it is essential to inform the doctor or pharmacist of any medications being taken. Women who are pregnant or breastfeeding should avoid this medication, and in cases of necessity, decisions should be made after consulting a specialist. Safety for children has not been established, so it is not to be used in pediatric patients. In case of overdose, symptoms such as nausea, vomiting, bradycardia, hypotension, respiratory depression, and seizures may occur, requiring immediate hospital treatment. This medication is available in an orally disintegrating tablet form and is best taken by placing it on the tongue to dissolve before swallowing with water or without water.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blistering, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual abnormalities, paralysis, urinary abnormalities.

Mild side effects

  • Headache
  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • dizziness
  • insomnia
  • fatigue
  • muscle pain
  • rash
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  • itching
  • urinary incontinence
  • increased urination
  • swelling
  • fever
  • thrombocytopenia
  • drowsiness
  • anxiety
  • aggressive behavior
  • tremor
  • walking difficulties
  • involuntary movements
  • impaired concentration
  • mental dullness
  • lassitude
  • weakness
  • elevated blood pressure
  • palpitations
  • hypertension
  • hypotension
  • atrial fibrillation
  • heart failure
  • myocardial infarction
  • atrioventricular conduction disorders
  • heart block
  • QT interval prolongation.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. Avoid storing in extremely hot or cold places.

Appearance and packaging

Appearance

White round orally disintegrating 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

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.