Medication info
Simbacor Tablet (Simvastatin)

Simbacor Tablet (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Yellow-brown oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200401881 · Notified 2004.01.26 · Insurance code 646201110

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. Reduction of risk for cardiovascular diseases - Initial starting dose: 40 mg once daily 2. Hyperlipidemia - General initial starting dose: 20 mg once daily in the evening - For mild to moderate hypercholesterolemia: may start with 10 mg - Recommended to administer 5 to 40 mg once daily in the evening - Adjust dosage after 4 weeks of treatment and regularly check cholesterol levels Specific Patients
Child dose
3. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) - Recommended initial dose: 10 mg once daily in the evening - Recommended dosage range: 10 to 40 mg once daily - Recommended maximum

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps to reduce the risk of cardiovascular disease. It decreases the risk of coronary heart disease mortality, non-fatal myocardial infarction, and stroke in adult patients with a history of cardiovascular diseases such as coronary artery disease, diabetes, peripheral vascular disease, and stroke. It also reduces the risk that may occur after coronary and non-coronary vascular revascularization. It is used to treat hyperlipidemia, lowering bad cholesterol and triglyceride levels and increasing good cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. It is particularly helpful in controlling blood cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia, in conjunction with dietary therapy. Overall, this medication is used to improve cardiovascular health and reduce risk factors.

How to take

Adult dose

1. Reduction of risk for cardiovascular diseases - Initial starting dose: 40 mg once daily 2. Hyperlipidemia - General initial starting dose: 20 mg once daily in the evening - For mild to moderate hypercholesterolemia: may start with 10 mg - Recommended to administer 5 to 40 mg once daily in the evening - Adjust dosage after 4 weeks of treatment and regularly check cholesterol levels Specific Patients

Child dose

3. Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) - Recommended initial dose: 10 mg once daily in the evening - Recommended dosage range: 10 to 40 mg once daily - Recommended maximum

Precautions

This medication is used to lower blood cholesterol levels. Caution is required when taking this medication due to the risk of muscle problems. There is a higher risk of muscle damage, especially when taking high doses or in conjunction with certain other medications. Patients with liver function problems or abnormally high liver enzyme levels should not take this medication. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant must use contraception during treatment. This medication should not be taken with certain strong medications, as it may increase the risk of muscle damage. Therefore, patients should inform healthcare providers of any other medications being taken. Patients with excessive alcohol intake or liver or kidney diseases should be especially cautious when taking this medication and should undergo regular checks to monitor their condition. Elderly patients and women are at a higher risk of muscle problems, so caution is necessary during treatment. If symptoms like muscle pain, muscle weakness, or discomfort occur while taking this medication, it is important to consult a doctor immediately, and medication can be stopped if necessary. This medication can affect liver function test results, so regular liver function tests are recommended. Furthermore, if prescribed a new medication during the time this medication is taken, it is important to inform healthcare providers and to avoid certain foods such as grapefruit juice. Blood sugar levels may increase while taking this medication, so patients at risk of diabetes should regularly check their blood sugar. Children or adolescents below certain ages should not take this medication, and should consult healthcare providers regarding its impact on growth and development. In case of overdose, contact a medical institution immediately for appropriate treatment. This medication should be kept out of reach of children and should be stored safely in its original container.

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 rashes with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • muscle pain
  • muscle cramps
  • joint pain
  • altered taste
  • eye movement disorders
  • facial paralysis
  • tremors
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve paralysis
  • mental disorders
  • anxiety
  • sleep disturbances
  • nightmares
  • depression
  • cataract progression
  • ophthalmoplegia
  • anemia
  • thyroid dysfunction

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow-brown oval 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.