Medication info

Simva B tablets (Simvastatin)

Prescription medicationTablet경구Expired
Ingredient · strength
Simvastatin›20mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Yellow-brown oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202001928 · Approved 2020.03.19

This product's status changed to Expired on 2025.03.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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, with a general recommendation of 20 mg for hyperlipidemia patients related to coronary artery disease. For mild to moderate hypercholesterolemia patients, starting at 10 mg may be appropriate, with adjustments possible between 5 mg and 40 mg. Patients should follow a standard cholesterol-lowering diet before and during treatment, and dosages adjusted according to treatment criteria and patient response.
Child dose
For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, administer 10 mg once daily in the evening, with a recommended maximum dose of 40 mg. Dosage adjustments should be made according to the treatment goal over intervals of more than 4 weeks.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary artery disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • non-fatal myocardial infarction
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • primary dysbetalipoproteinemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication is effective in reducing various risks related to cardiovascular disease. It decreases the risk of death from coronary artery disease, non-fatal myocardial infarction, and stroke in adult patients at high risk of cardiovascular events, such as those with coronary artery disease, diabetes, peripheral vascular disease, and stroke. It also reduces the risk of coronary and non-coronary vascular reconstruction. In patients with hyperlipidemia, it is used as an adjunct therapy to lower total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride levels while increasing HDL-cholesterol. It is particularly helpful for patients with genetic dyslipidemia, such as familial hypercholesterolemia. It is also used in children aged 10 to 17 years with heterozygous familial hypercholesterolemia to assist dietary efforts in lowering cholesterol levels. Overall, this drug is used to reduce the risk of cardiovascular disease and improve dyslipidemia.

How to take

Adult dose

This medication is administered once daily in the evening, with a general recommendation of 20 mg for hyperlipidemia patients related to coronary artery disease. For mild to moderate hypercholesterolemia patients, starting at 10 mg may be appropriate, with adjustments possible between 5 mg and 40 mg. Patients should follow a standard cholesterol-lowering diet before and during treatment, and dosages adjusted according to treatment criteria and patient response.

Child dose

For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, administer 10 mg once daily in the evening, with a recommended maximum dose of 40 mg. Dosage adjustments should be made according to the treatment goal over intervals of more than 4 weeks.

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis, especially when taking a high dose of 80 mg. Therefore, patients taking this medication at 80 mg are advised to switch to a lower dose or a different safer statin when taking interacting medications. Patients with allergies to this medication, those with active liver disease, pregnant or nursing women, and those taking certain strong medications should not use this drug. Additionally, patients with genetic issues like lactose intolerance should also avoid this medication. Patients with compromised liver or kidney function, alcohol addiction, hypothyroidism, a history of muscle disease, elderly patients, and women should use this medication with caution, and special care is needed for those with allergies to certain dyes. While taking this medication, side effects such as muscle pain, muscle weakness, abdominal pain, headache, constipation, diarrhea, and nausea may occur, and rare cases of serious muscle damage can happen. If muscle pain or weakness occurs, the doctor should be notified immediately, and the medication should be discontinued if necessary. Liver function abnormalities may also occur, so routine liver function tests should be performed, and the medication should be stopped immediately if symptoms of hepatitis or jaundice occur. This medication can interact with multiple other drugs, so it is essential to inform the doctor or pharmacist of any other medications being taken, especially when combined with certain antibiotics, antifungals, immunosuppressants, calcium channel blockers, niacin, or fusidic acid, as dose adjustments or monitoring may be necessary. Pregnant women or those who might become pregnant should avoid taking this medication and should immediately stop if pregnancy is confirmed. Nursing is also not recommended while taking this medication, thus breastfeeding should be ceased. This drug should not be used in children under 10 or pre-menarchal females and should only be used in limited doses in patients aged 10 to 17. Elderly patients should be cautious as the blood concentration of this drug may increase, increasing the risk of muscle-related side effects. Patients taking this medication should closely watch for muscle-related symptoms and signs of liver function abnormalities, and consult healthcare professionals immediately if any suspicious symptoms arise. Lastly, this medication should be kept out of reach of children, stored in its original container, and beverages that significantly inhibit CYP3A4 enzymes, such as grapefruit juice, should not be consumed in large quantities.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory anomalies associated with coughing and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, consciousness confusion, visual disturbances, paralysis, urine output changes

Mild side effects

  • Abdominal pain
  • weakness
  • constipation
  • diarrhea
  • dyspepsia
  • bloating
  • nausea
  • headache
  • upper respiratory infection
  • atrial fibrillation
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  • gastritis
  • diabetes
  • muscle pain
  • insomnia
  • dizziness
  • bronchitis
  • sinusitis
  • eczema
  • urinary tract infection
  • alopecia
  • pruritus
  • various skin changes
  • flat lichen-planus-like drug rash
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • anemia
  • elevations in aminotransferases
  • ALP
  • γ-GTP
  • and bilirubin levels

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 from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the effect of the medication for a long time.

Appearance and packaging

Appearance

Yellow-brown 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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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.