Medication info
Simcol Tablet (Simvastatin)

Simcol Tablet (Simvastatin)

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

MFDS item code 200308855 · Notified 2003.01.14 · Insurance code 657801200

Summary

Main use
Reduction of cardiovascular disease risk and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended initial starting dose for this drug is 40 mg once daily, typically for patients with hyperlipidemia, 20 mg in the evening. Mild to moderate hypercholesterolemic patients can start with 10 mg. Generally, 5 to 40 mg is administered in the evening once a day, and the dose is adjusted based on pre-treatment LDL cholesterol level, treatment goal, and patient response. For specific patient populations,
Child dose
The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg administered once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Reduction of cardiovascular disease risk and improvement of hyperlipidemia

  • Coronary heart disease
  • diabetes
  • peripheral vascular disease
  • stroke
  • other cerebrovascular diseases
  • non-fatal myocardial infarction
  • hypercholesterolemia
  • dyslipidemia
  • hypertriglyceridemia
  • heterozygous familial hypercholesterolemia
  • early cardiovascular disease
View approved original text

This medicine helps reduce the risk of cardiovascular disease. It can lower the risk of death from coronary heart disease, non-fatal myocardial infarction, and stroke in adult patients with a history of coronary heart disease, diabetes, peripheral vascular disease, or stroke. It also reduces the associated risks related to coronary and non-coronary vascular interventions. For patients with hyperlipidemia, it is used to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, while increasing HDL cholesterol levels. In pediatric patients aged 10 to 17 years with specific criteria of heterozygous familial hypercholesterolemia, it helps effectively manage cholesterol levels in conjunction with diet. This drug is used to reduce the risk of cardiovascular disease and improve blood lipid levels.

How to take

Adult dose

The recommended initial starting dose for this drug is 40 mg once daily, typically for patients with hyperlipidemia, 20 mg in the evening. Mild to moderate hypercholesterolemic patients can start with 10 mg. Generally, 5 to 40 mg is administered in the evening once a day, and the dose is adjusted based on pre-treatment LDL cholesterol level, treatment goal, and patient response. For specific patient populations,

Child dose

The recommended initial dose for pediatric patients (10 to 17 years) with heterozygous familial hypercholesterolemia is 10 mg administered once daily in the evening. The recommended dosage range is 10 to 40 mg per day, with a maximum dose of

Precautions

This medication can cause muscle problems; therefore, if symptoms such as muscle pain or weakness occur, you must inform your doctor immediately. Extra caution is needed, especially when taking high doses, as the risk of myopathy is increased. Women who are pregnant, breastfeeding, allergic to this drug, or have liver disease should not take this medication. Additionally, if taken with certain other drugs, the risk of myopathy may increase, so be sure to consult your doctor or pharmacist if you are taking any other medications. Patients with poor liver function or those who consume large amounts of alcohol should have their liver health checked regularly while taking this drug. Patients with impaired kidney function, hypothyroidism, muscle disorders, or a history of muscle problems should also take caution while using this drug. Elderly individuals and women have a higher risk of developing myopathy and should be used even more cautiously. As this drug is metabolized in the liver, its administration may need to be adjusted or discontinued if liver function tests are abnormal. Women who are pregnant or may become pregnant must use contraception, and if pregnancy is confirmed, the medication should be stopped immediately. It is recommended that women who are breastfeeding discontinue nursing while taking this drug. If unexplained muscle pain, tenderness, or weakness persists while taking this drug, you should consult a healthcare professional immediately. This drug has many drug interactions, so when receiving a new prescription or taking new medications, be sure to inform your healthcare provider that you are taking this drug. In case of overdose, seek medical attention immediately. Lastly, this medication should be stored out of the reach of children and kept 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 rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever-related respiratory issues, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizure, confusion, visual disturbance, paralysis, urination issues

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
  • anemia
  • alopecia
  • itching
  • skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract progression
  • ocular muscle paralysis
  • thyroid dysfunction
  • elevated serum creatine kinase
  • abnormal liver function tests
  • cognitive impairment (memory loss, etc.)

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

Storage

This drug is sensitive to air and moisture and must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help maintain the effectiveness and safety of the medication for a longer duration.

Appearance and packaging

Appearance

Yellow-brown oval film-coated 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

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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.