Medication info
Mega MDual Soft Capsule

Mega MDual Soft Capsule

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

MFDS item code 202008419 · Approved 2020.12.01 · Insurance code 648604160

Summary

Main use
Control of LDL cholesterol with monotherapy of Rosuvastatin and treatment of mixed dyslipidemia.
Who takes it
Adults
Adult dose
Administered to adults only, and to avoid gastrointestinal disturbances, take 2 to 4 capsules once daily with meals (each capsule contains 1,000 mg Omega-3 Ethyl Ester / 5 mg Rosuvastatin).

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Control of LDL cholesterol with monotherapy of Rosuvastatin and treatment of mixed dyslipidemia.

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

This medication effectively controls LDL cholesterol levels when used as monotherapy in adult patients at high risk for coronary artery disease. It is applicable for the treatment of mixed dyslipidemia where triglyceride levels are not completely controlled. This helps reduce the risk of cardiovascular disease and aids in maintaining balanced lipid levels.

How to take

Adult dose

Administered to adults only, and to avoid gastrointestinal disturbances, take 2 to 4 capsules once daily with meals (each capsule contains 1,000 mg Omega-3 Ethyl Ester / 5 mg Rosuvastatin).

Precautions

This medicine should not be used in certain patients. For instance, it should be avoided by anyone allergic to its components, patients with severe liver dysfunction, those with muscle disorders, patients receiving certain immunosuppressants, patients with severely reduced kidney function, women who are pregnant or breastfeeding, and children under the age of 18. This medication can affect liver function, so patients with liver disease or excessive alcohol consumption should undergo liver function tests before taking this medicine and should have regular liver function assessments while on treatment. Additionally, patients with certain conditions like hypothyroidism or nephrotic syndrome must treat those conditions before using this drug. Muscle pain or weakness may occur, so if any muscular abnormalities develop while taking the drug, the doctor should be informed immediately. If muscle-related values become abnormally high, discontinuation of the drug may be necessary. This medication can cause abnormalities in blood test results for some patients, thus regular blood tests and liver function tests are required during treatment. Elderly patients or those with impaired kidney function should be especially cautious. This medication may interact with other drugs, so patients must inform healthcare providers of any current medications. Caution is especially needed when used in conjunction with certain antibiotics, antifungals, immunosuppressants, and anticoagulants. Women who are pregnant or planning to become pregnant should not take this medication, and if pregnancy occurs while taking it, the drug should be discontinued immediately. Nursing mothers are also advised to avoid this medication. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, so its use is not recommended in this population. In cases of overdose, there are no specific antidotes, so appropriate treatment should be administered based on symptoms, and liver function and muscle-related tests should be conducted to monitor the condition. Finally, this medication should be stored out of reach of children, and it should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme tiredness, liver abnormalities (jaundice), sudden and severe headache, thunderclap headaches.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • joint pain
  • weakness
Show 25 more
  • increased alkaline phosphatase in blood
  • increased potassium in blood
  • hypokalemia
  • gallstones
  • cold symptoms
  • indigestion
  • belching
  • altered taste
  • fatigue
  • numbness
  • sensory abnormalities
  • loss of appetite
  • abdominal bloating
  • diarrhea
  • dry mouth
  • chest pain
  • discomfort in the chest
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • low back pain
  • infection
  • pain

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help ensure the efficacy and safety of the medication.

Appearance and packaging

Appearance

An oval-shaped soft capsule filled with a yellowish 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.