Medication info

Mega-Sam Soft Capsule (Omega-3 Ethyl Ester 90)

Prescription medicationSoft capsuleApproval withdrawn
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
대한뉴팜(주)
Appearance
A transparent oblong soft capsule filled with pale yellow oily substance
Packaging
100 Capsules/Box[[10 Capsules/PTP X 2)/Pack] X 5/Box]
Approval status
Approval withdrawn

MFDS item code 202003721 · Approved 2020.05.21

This product's status changed to Approval withdrawn on 2024.09.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect of reducing triglyceride levels in mixed hypertriglyceridemia and hypercholesterolemia.
Who uses it
Adults
Adult dosage
Before administration, an appropriate lipid-lowering diet must be strictly followed and continued throughout the treatment period. To avoid gastrointestinal discomfort, take with food. The usual initial dose is 2g (2 capsules) per day, which may be increased to 4g per day if necessary. Administer either once or twice a day.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

Effect of reducing triglyceride levels in mixed hypertriglyceridemia and hypercholesterolemia.

  • Hypertriglyceridemia
  • Hypercholesterolemia
View approved original text

This medication is used to lower elevated triglyceride levels in patients with endogenous hypertriglyceridemia. It is effective alone in the treatment of hypertriglyceridemia (Type IV), and in mixed (Type IIb) conditions with both hypercholesterolemia and hypertriglyceridemia, it is used in combination with statin medications. Additionally, it is beneficial as combination therapy for patients whose triglyceride levels are not controlled. Therefore, this medication is used effectively for hypertriglyceridemia and its mixed forms to improve blood lipid levels.

Dosage and Administration

Adult dosage

Before administration, an appropriate lipid-lowering diet must be strictly followed and continued throughout the treatment period. To avoid gastrointestinal discomfort, take with food. The usual initial dose is 2g (2 capsules) per day, which may be increased to 4g per day if necessary. Administer either once or twice a day.

Precautions

This medication should not be used in individuals with allergic reactions to any component of this medication or in children under 18 years of age. Patients with a high risk of bleeding due to severe trauma or surgery, poor liver function, and those with fish allergies should use this medication with extra caution. Various side effects can occur with this medication; commonly experienced symptoms include dyspepsia, belching, skin rash, altered taste, back pain, cold symptoms, and more. Less commonly reported are heart-related problems, gastrointestinal disorders, myalgia, dizziness, respiratory issues, hair loss, and itching. It is essential to regularly check liver function and lipid levels through blood tests during the treatment with this medication. In particular, this medication may affect blood coagulation, so using it alongside blood thinners can increase the risk of bleeding. Women who are pregnant or breastfeeding should carefully consider the safety and risks of this medication since its safety has not been sufficiently established. Furthermore, this medication is not recommended for children, and special caution is required for older adults aged 65 years and above. In case of overdose, appropriate treatment should be administered according to the symptoms, and this medication should be kept out of reach of children. Lastly, combining this medication with a diet and exercise is beneficial for enhancing treatment effectiveness.

Side effects and when to seek care immediately

Serious side effects

Rash, generalized swelling, sudden death, increased risk of atrial fibrillation, severe allergic reactions such as urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, painful oral/ocular mucosa, severe skin abnormal reactions, difficulty breathing or shortness of breath, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice of the skin or eyes.

Mild side effects

  • Back pain
  • cold symptoms
  • infection
  • pain
  • dyspepsia
  • belching
  • altered taste
  • abdominal bloating
  • weakness
  • body odor
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  • chest pain
  • chills
  • suicidal thoughts
  • fever
  • lethargy
  • throat pain
  • tumors
  • rheumatoid arthritis
  • viral infections
  • arrhythmias
  • bypass surgery
  • cardiac arrest
  • hyperlipidemia
  • hypertension
  • migraines
  • myocardial infarction
  • myocardial ischemia
  • occlusion
  • peripheral vascular disorders
  • syncope
  • tachycardia
  • loss of appetite
  • constipation
  • dry mouth
  • swallowing difficulties
  • colitis
  • stool change

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

Storage

This medication should be stored in a sealed container to prevent air and moisture exposure. Additionally, it should be kept in a cool place below 25 degrees Celsius, taking care not to freeze.

Appearance and packaging

Appearance

A transparent oblong soft capsule filled with pale yellow oily substance

Package unit

100 Capsules/Box[[10 Capsules/PTP X 2)/Pack] X 5/Box]

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.