Medication info

Megasimba Tablets 10/20 Milligrams

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
White to off-white, double convex, rectangular tablets
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Approval withdrawn

MFDS item code 201903337 · Approved 2019.05.22

This product's status changed to Approval withdrawn on 2023.11.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg, with the generally recommended starting dose being 10/20mg once daily. Patients requiring less reduction in LDL cholesterol may start with 10/10mg once daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg once daily.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication is used to reduce elevated total cholesterol, LDL cholesterol, Apo B protein, and triglycerides in patients with primary hypercholesterolemia, particularly in heterozygous familial and non-familial hypercholesterolemia, and mixed hyperlipidemia, while increasing HDL cholesterol. It is also used as an adjunctive treatment for patients with homozygous familial hypercholesterolemia or as monotherapy when other treatments are ineffective. This medication should be used in conjunction with an appropriate diet and is administered when dietary control and non-drug treatments are insufficient in managing lipid levels. It is important to identify and treat secondary causes of dyslipidemia, such as diabetes and hypothyroidism, prior to treatment. This reduces the risk of atherosclerotic vascular disease from hypercholesterolemia and effectively manages blood lipid levels to improve health.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10mg to 10/40mg, with the generally recommended starting dose being 10/20mg once daily. Patients requiring less reduction in LDL cholesterol may start with 10/10mg once daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg once daily.

Precautions

This medication is used to lower blood cholesterol levels. Caution is necessary as muscle abnormalities may occur while taking this medication. If muscle pain or weakness arises, notify a doctor immediately, and discontinue use if symptoms are severe. This medication may affect liver function, so it should not be administered in cases of liver disease or elevated liver function test results. Pregnant or nursing women should not take this medication, and women of childbearing age must consider the possibility of pregnancy when using it. The risk of muscle abnormalities may increase when taken with certain medications, so inform your physician or pharmacist if you are taking other drugs. Elderly patients, patients with impaired kidney function, and patients with hypothyroidism may be at increased risk of side effects and require caution. Regular blood tests to monitor liver function and muscle condition are recommended during treatment. There is no specific antidote for overdose; treatment will be symptomatic. It is advisable to limit the intake of certain foods, such as grapefruit juice, while taking this medication. Finally, if new symptoms or adverse reactions occur during therapy, consult with medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, angioedema, rash, pancreatitis, cholelithiasis, cholecystitis, anaphylaxis, angioedema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hepatitis, cholestatic jaundice, cirrhosis, fulminant hepatic necrosis, hepatocellular carcinoma, fatal hepatic failure, severe edema, chest tightness, dyspnea, asthma attacks, respiratory difficulties with cough and fever, jaundice of the skin or eyes, generalized malaise.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • indigestion
  • flatulence
  • itching
  • rash
  • facial paresis
  • tremors
  • dizziness
  • paresthesia
  • peripheral neuropathy
  • peripheral nerve paralysis
  • anxiety
  • sleep disturbances
  • depression
  • cough
  • hair loss
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • eye muscle paralysis
  • anemia
  • increased serum creatine phosphokinase.

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

Storage

Store this medication in a tightly closed container to protect from air and moisture. Additionally, it is important to maintain the medication's efficacy by storing it at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white, double convex, rectangular tablets

Package unit

30 tablets (10 tablets/PTP*3)

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.