Medication info
Megaloreban Soft Capsules 5/1000 mg

Megaloreban Soft Capsules 5/1000 mg

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
경동제약(주)
Appearance
Oval soft capsules filled with a pale yellow oily substance, coated in white film.
Packaging
100 capsules/box [(10 capsules/PTP x 10)]
Approval status
Active

MFDS item code 202008416 · Approved 2020.12.01 · Insurance code 648104600

Summary

Main use
Regulation of LDL cholesterol and treatment of mixed dyslipidemia
Who takes it
Adults
Adult dose
This medication is given only to adults, and to avoid gastrointestinal discomfort, it is administered once daily with meals at a dose of 2-4 capsules (1,000 mg of Omega-3 Acid Ethyl Ester/5 mg of Rosuvastatin per capsule).

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Regulation of LDL cholesterol and treatment of mixed dyslipidemia

  • Coronary artery disease
  • dyslipidemia
View approved original text

This medication effectively regulates LDL cholesterol levels in adult patients at high risk for coronary artery disease when used as monotherapy. However, it is suitable for the treatment of mixed dyslipidemia where triglyceride levels are not fully controlled. It helps regulate blood lipid levels, thereby contributing to a reduced risk of cardiovascular disease. Thus, this drug is used to improve dyslipidemia management.

How to take

Adult dose

This medication is given only to adults, and to avoid gastrointestinal discomfort, it is administered once daily with meals at a dose of 2-4 capsules (1,000 mg of Omega-3 Acid Ethyl Ester/5 mg of Rosuvastatin per capsule).

Precautions

This drug should not be used in certain patients. Patients with an allergy to any of this drug's components, unexplained liver dysfunction, muscle disorders, those taking specific immunosuppressants, patients with severe renal impairment, pregnant or breastfeeding women, and children under 18 years of age should not receive this medication. Particular caution is required for patients at high risk for muscle disorders, who may have multiple risk factors such as decreased kidney function, hypothyroidism, family history of muscle disorders, alcohol dependence, or concomitant use of certain medications. Before and during the use of this medication, regular liver function tests should be conducted, and if symptoms such as muscle pain, muscle weakness, fatigue, or fever occur, immediate consultation with healthcare professionals is advised. If these symptoms are severe or muscle enzyme levels rise significantly, discontinuation of the medication may be necessary. This drug should also be used with caution in patients with liver disease, following severe trauma or surgery, or at high risk of bleeding, and care is needed if there is an allergy to fish. As this medication may interact with other drugs, it is crucial to inform healthcare providers of any other medications being taken, particularly with blood thinners, immunosuppressants, and fibric acid derivatives. Women of childbearing potential should employ appropriate birth control methods, and it is safest not to use this medication during pregnancy or breastfeeding. For elderly patients and children, extra caution is necessary as safety and efficacy have not been sufficiently confirmed. In the case of overdose, as there is no specific antidote, immediate consultation with healthcare professionals and symptomatic treatment is required. Finally, this medication should be stored out of reach of children and it is best not to transfer it to different containers.

Side effects and when to seek care immediately

Serious side effects

Hives, allergic reactions including angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities, sudden and severe headache, lightning headache

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • gastritis
  • itching
  • rash
  • muscle pain
  • joint pain
Show 22 more
  • increased tearing
  • presbyopia
  • weakness
  • increased alkaline phosphatase in blood
  • increased potassium in blood
  • hypokalemia
  • gallstones
  • cold symptoms
  • dyspepsia
  • belching
  • taste distortion
  • lower back pain
  • nasopharyngitis
  • periodontitis
  • upper respiratory infection
  • facial paralysis
  • Parkinsonism
  • elevated ALT
  • elevated AST
  • elevated γ-GT
  • edema
  • thrombocytopenia

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Oval soft capsules filled with a pale yellow oily substance, coated in white film.

Package unit

100 capsules/box [(10 capsules/PTP x 10)]

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.