Medication info
Rosumega Soft Capsules

Rosumega Soft Capsules

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsuleRosuvastatin Calcium›5.2mg / 1 capsule
Manufacturer / importer
건일제약(주)
Appearance
Oblong soft capsule filled with a whitish film-coated yellowish oily substance
Packaging
32 capsules (8 capsules/PTP X4) 56 capsules (8 capsules/PTP X7) 80 capsules (8 capsules/PTP X10) 96 capsules (8 capsules/PTP X12) 100 capsules (10 capsules/PTP X10) 30 capsules/bottle
Approval status
Active

MFDS item code 201706394 · Approved 2017.07.31 · Insurance code 646802860

Summary

Main use
Management of LDL cholesterol and treatment of dyslipidemia with rosuvastatin monotherapy
Who takes it
Adults
Adult dose
This medication is administered to adults only and should be taken once daily with meals, 2 to 4 capsules (1,000mg Omega-3 Fatty Acid Ethyl Ester/5mg Rosuvastatin per capsule) to avoid gastrointestinal disturbances.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Management of LDL cholesterol and treatment of dyslipidemia with rosuvastatin monotherapy

  • Coronary heart disease
  • abnormal LDL cholesterol levels
  • abnormal triglyceride levels
  • mixed dyslipidemia
View approved original text

Rosuvastatin monotherapy effectively lowers LDL cholesterol levels in high-risk adult patients with coronary heart disease, helping to reduce the risk of cardiovascular disease. However, this treatment may have limitations in controlling triglyceride levels, and additional treatment or lifestyle modifications may be necessary for patients with mixed dyslipidemia. This medication is used to improve the management of bad cholesterol in the blood to enhance cardiovascular health.

How to take

Adult dose

This medication is administered to adults only and should be taken once daily with meals, 2 to 4 capsules (1,000mg Omega-3 Fatty Acid Ethyl Ester/5mg Rosuvastatin per capsule) to avoid gastrointestinal disturbances.

Precautions

This medication should not be used in patients with allergies to its components. Patients with severely impaired liver function or unknown causes of elevated liver enzymes should also refrain from using this medication. Patients with muscle diseases or muscle issues should avoid this medication and should not take it in conjunction with certain immunosuppressants. Patients with severe renal impairment, pregnant or breastfeeding women, and fertile women not using appropriate contraceptive methods should not take this medication. Especially, high doses are prohibited for patients at high risk of muscle disease. Children under 18 years old are not recommended to use this product, as its safety and efficacy have not been established. Patients consuming excessive alcohol or with a history of liver disease need to have frequent liver function tests while on this medication, and those with hypothyroidism or nephrotic syndrome should first receive treatment for these conditions. If symptoms like muscle pain, weakness, or cramps occur, inform healthcare personnel immediately, and blood tests should be conducted to check for muscle damage. Discontinue this medication if there are acute conditions like severe trauma, major surgery, or serious infections. Caution should be taken as the risk of muscle damage may increase when taken with certain specific medications. While taking this medication, it is important to maintain weight control, limit alcohol consumption, and follow an appropriate diet and exercise regimen. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraceptive methods. Use in elderly patients or children is limited, so consult with healthcare personnel. In cases of overdose, since there is no specific antidote, treatment should be symptomatic, and liver and muscle function tests are needed.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, painful mucous membranes of the mouth/eyes, severe dermatological reactions, asthma attacks, respiratory abnormalities accompanied by cough and fever, dyspnea, shortness of breath or difficulty breathing, jaundice, yellowing of the skin or eyes, extreme lethargy, liver abnormalities, sudden

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, gastritis, erythema, myalgia, arthralgia, increased tear secretion, presbyopia, rhinitis, periodontitis, upper respiratory infection, hypokalemia, increased alkaline phosphatase in the blood, increased potassium in the blood, asthenia, itching, rash, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction,

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

Storage

This medication is susceptible to air and moisture, so it must be stored in a tightly sealed container. Furthermore, it should be kept at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold environments.

Appearance and packaging

Appearance

Oblong soft capsule filled with a whitish film-coated yellowish oily substance

Package unit

32 capsules (8 capsules/PTP X4) 56 capsules (8 capsules/PTP X7) 80 capsules (8 capsules/PTP X10) 96 capsules (8 capsules/PTP X12) 100 capsules (10 capsules/PTP X10) 30 capsules/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.