Medication info
Romega Soft Capsule

Romega Soft Capsule

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
건일바이오팜주식회사
Appearance
Soft capsules with a film coating that are white and filled with a pale yellow oily substance, in oval shape
Packaging
PTP - 100 capsules/PTP[(10 capsules/PTP x 10)]
Approval status
Active

MFDS item code 202008418 · Approved 2020.12.01 · Insurance code 073000260

Summary

Main use
LDL-cholesterol control and treatment of dyslipidemia in high-risk adults with coronary artery heart disease
Who takes it
Adults
Adult dose
This medication is administered only to adults, and to avoid gastrointestinal disturbances, it is to be taken once daily with meals, 2 to 4 capsules (1,000 mg of omega-3 ethyl ester/5 mg of rosuvastatin per capsule).

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

LDL-cholesterol control and treatment of dyslipidemia in high-risk adults with coronary artery heart disease

  • LDL-cholesterol levels
  • triglyceride levels
  • mixed dyslipidemia
View approved original text

In adult patients at high risk of coronary artery heart disease, rosuvastatin monotherapy helps effectively control LDL-cholesterol levels. However, triglyceride levels may not be sufficiently controlled with monotherapy. This medication is mainly used for the treatment of mixed dyslipidemia. Therefore, it plays an important role in managing LDL-cholesterol levels and reducing the risk of cardiovascular diseases.

How to take

Adult dose

This medication is administered only to adults, and to avoid gastrointestinal disturbances, it is to be taken once daily with meals, 2 to 4 capsules (1,000 mg of omega-3 ethyl ester/5 mg of rosuvastatin per capsule).

Precautions

This medication should not be used in certain patients. For example, those who are allergic to the ingredients contained in this medication, those with unexplained abnormal liver function, those with muscle disorders, and those with severe renal impairment should not take it. Additionally, women who are pregnant, nursing, or of childbearing age without proper contraception should avoid using this medication. Particularly, those at high risk for muscle disorders are prohibited from using it at high doses. When using this medication, liver function and muscle status must be periodically monitored, and individuals with a history of liver disease or excessive alcohol consumption should take extra caution. Symptoms such as muscle pain, weakness, or cramps should be reported to a doctor immediately, and if necessary, medication can be discontinued. After vigorous exercise, muscle test results may show elevated levels, so caution should be exercised during testing. This medication can affect the liver and muscles, so if symptoms of liver damage or muscle abnormalities appear, use should be discontinued immediately. Particularly, patients with severe muscle weakness or severe liver function impairment should not use it. Additionally, caution is warranted in situations with a high risk of bleeding or in cases of severe trauma or post-surgery. This medication may interact with other medications, so it is essential to inform your doctor or pharmacist of any other medications being taken. Extra caution is especially needed when taking with certain antibiotics, antifungals, antivirals, immunosuppressants, or anticoagulants. Women who are pregnant or nursing should not take this medication, and women of childbearing potential should use appropriate contraception methods. Children, especially those under 18, should avoid use as the safety and efficacy of this medication have not been established. The safety and efficacy of this medication have not been adequately confirmed for the elderly, so caution is necessary when prescribing it to older patients. There is no specific antidote for overdose, so treatment is symptomatic and liver function and muscle enzyme tests should be conducted to monitor condition. This medication should be stored out of reach of children, and transferring it to another container is not recommended as it can affect quality.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), severe cutaneous adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, skin

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • arthralgia
  • weakness
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  • upper respiratory infections
  • nasopharyngitis
  • periodontitis
  • gastritis
  • increased tear secretion
  • presbyopia
  • increased blood alkaline phosphatase
  • increased potassium levels
  • hypokalemia
  • cholelithiasis
  • dyspepsia
  • belching
  • taste disturbance
  • hair loss
  • eczema
  • sweating
  • sensory abnormalities
  • diarrhea
  • dry mouth
  • chest pain
  • chest discomfort
  • fatigue
  • malaise
  • weight loss

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 exposure to air or moisture and should be kept at room temperature between 1°C and 30°C. Storing this way will help maintain the medication's effectiveness for a longer time.

Appearance and packaging

Appearance

Soft capsules with a film coating that are white and filled with a pale yellow oily substance, in oval shape

Package unit

PTP - 100 capsules/PTP[(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.