Medication info
Zobacco Tablet (Simvastatin)

Zobacco Tablet (Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Brownish-yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200401687 · Notified 2004.10.04 · Insurance code 665503800

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
This medication is administered once daily in the evening. The initial starting dose for reducing cardiovascular disease risk is 40 mg. For hyperlipidemia treatment, the general initial starting dose is 20 mg, and patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg. There are dosage limitations in certain patient populations; for example, in patients taking verapamil, diltiazem.
Child dose
For pediatric patients aged 10 to 17 years, the recommended initial dose is 10 mg once daily, with a recommended dose range of 10 to 40 mg. The dose should be adjusted appropriately based on therapeutic goals, and intervals of 4 weeks or longer are recommended for dose adjustments.

Ingredients

Manufacturer
한국유니온제약(주)

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 reduces the risk of cardiovascular disease in adults with a history of vascular-related diseases such as coronary heart disease, diabetes, peripheral vascular disease, and stroke. It also lowers the risk of death due to coronary heart disease, non-fatal myocardial infarction, and stroke, and decreases the risk associated with vascular interventions. In the treatment of hyperlipidemia, it lowers bad cholesterol levels and increases good cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, thereby improving the balance of blood lipids. In children with familial hypercholesterolemia, it helps effectively manage cholesterol levels in conjunction with dietary therapy. Overall, these effects support the prevention and management of cardiovascular diseases.

How to take

Adult dose

This medication is administered once daily in the evening. The initial starting dose for reducing cardiovascular disease risk is 40 mg. For hyperlipidemia treatment, the general initial starting dose is 20 mg, and patients with mild to moderate hypercholesterolemia may start with 10 mg. The dosage can be adjusted within the range of 5 to 40 mg. There are dosage limitations in certain patient populations; for example, in patients taking verapamil, diltiazem.

Child dose

For pediatric patients aged 10 to 17 years, the recommended initial dose is 10 mg once daily, with a recommended dose range of 10 to 40 mg. The dose should be adjusted appropriately based on therapeutic goals, and intervals of 4 weeks or longer are recommended for dose adjustments.

Precautions

This medication may cause muscle abnormalities, so if muscle pain or weakness occurs, consult a doctor immediately. Especially when taken at high doses or in combination with certain drugs, the risk of myopathy may increase. Patients with liver dysfunction or liver disease should exercise caution as this medication may worsen liver function. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. When taken with drugs that inhibit specific liver metabolic enzymes, blood concentration may increase, raising the risk of side effects; thus, consultation with a doctor is essential before combining medications. Patients who consume large amounts of alcohol or have liver impairment should exercise additional caution when taking this medication. Elderly patients and women have a higher risk of developing myopathy, requiring careful monitoring during use. This medication contains lactose, so patients with lactose intolerance should not take it. Regular liver function tests and muscle-related tests are recommended while taking this medication. If unexplained muscle pain, tenderness, or weakness occurs during use, stop taking it immediately and inform a doctor. Grapefruit juice may increase the concentration of this medication, so it should be avoided. If prescribed new medications while taking this medication, inform healthcare providers of this usage. In case of overdose, seek appropriate medical treatment immediately. Keep out of reach of children and store in the original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, oral/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, coughing with fever and abnormal breathing, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urinary problems

Mild side effects

  • Headache
  • fatigue
  • abdominal pain
  • constipation
  • diarrhea
  • indigestion
  • bloating
  • nausea
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • myalgia
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • alopecia
  • pruritus
  • skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • oculomotor weakness
  • anemia
  • sensory disturbances
  • peripheral neuropathy
  • peripheral nerve palsy
  • psychiatric disorders
  • anxiety
  • sleep disorders
  • depression
  • dizziness
  • photophobia

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 ingress, at a temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Brownish-yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.