Medication info

Euromega Soft Capsule 5/1000mg (Atorvastatin, Omega-3 Acid Ethyl Ester 90)

Prescription medicationSoft capsule
Ingredient · strength
Atorvastatin Calcium Trihydrate›5.425mg / 1 capsuleOmega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
건일바이오팜주식회사
Appearance
White film-coated, yellowish soft capsule filled with oily substance containing active ingredients.
Packaging
80 capsules/box [(8 capsules/AluAlu*10)], 100 capsules/box [(10 capsules/PTP*10)]
Approval status
Active

MFDS item code 202202840 · Approved 2022.07.08

Summary

Main use
Control of LDL cholesterol and treatment of dyslipidemia in high-risk adults with coronary heart disease.
Who uses it
Adults
Adult dosage
For adults, to avoid gastrointestinal disorders, administer 4 capsules once daily with meals (1,000mg Omega-3 Acid Ethyl Ester/5mg Atorvastatin per capsule).

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Control of LDL cholesterol and treatment of dyslipidemia in high-risk adults with coronary heart disease.

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

This drug is used for the treatment of mixed dyslipidemia (Type IIb) where triglyceride levels are not adequately controlled despite efficient LDL cholesterol management with a single treatment of 20mg atorvastatin in adult patients at high risk for coronary heart disease.

Dosage and Administration

Adult dosage

For adults, to avoid gastrointestinal disorders, administer 4 capsules once daily with meals (1,000mg Omega-3 Acid Ethyl Ester/5mg Atorvastatin per capsule).

Precautions

This drug may cause muscle problems, so if muscle pain or weakness occurs, or if there is a significant increase in creatine kinase (CK) levels on blood tests, the medication should be discontinued immediately. Additionally, patients with conditions that may worsen muscle damage, such as severe infections, major surgery, trauma, and electrolyte imbalances, may need to temporarily discontinue this medication. This drug is contraindicated in certain patients, such as those allergic to the drug or its components, individuals with severe liver impairment, those with muscle diseases, pregnant women or women who may become pregnant, children under 18 years of age, and those currently taking specific antiviral medications. Patients with a history of alcohol dependence or liver disease, decreased kidney function, hypothyroidism, a family or personal history of muscle disorders, and those over 70 years of age should consult with a doctor before taking this medication and should exercise caution. This drug may cause various side effects, including liver dysfunction, digestive disorders, muscle pain, headaches, dizziness, and skin rashes; any abnormal symptoms should be reported to a healthcare professional immediately. Notably, if muscle pain, weakness, fever, or fatigue occurs during treatment with this drug, a doctor's evaluation should be sought promptly, and blood tests should be conducted to assess for muscle damage. Pregnant or breastfeeding women should not take this drug, and women of childbearing potential should use reliable contraception during treatment. The safety and efficacy of this drug in children and adolescents have not been established, hence it should not be used in these populations. Elderly patients should be monitored closely for liver function and muscle condition while taking this drug. There is no specific antidote for overdose; treatment should be symptomatic based on symptoms, and liver function and muscle enzyme levels should be regularly monitored. This drug may interact with other medications, so patients should inform healthcare providers of any other medications they are taking, especially those that may affect liver metabolism.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, shortness of breath, cold sweats, pallor, severe rash with high fever, blisters, skin desquamation, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

  • Constipation
  • esophagitis
  • ALT elevation
  • CPK elevation
  • TG elevation
  • blood sugar elevation
  • osteoarthritis
  • back pain
  • limb pain
  • diabetic neuropathy
Show 22 more
  • fourth cranial nerve palsy
  • contusions
  • upper limb fractures
  • acute otitis media
  • erectile dysfunction
  • cough
  • papules
  • hearing loss
  • fatty liver
  • hematuria
  • weakness
  • lethargy
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
  • abdominal discomfort.

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

Storage

This drug should be stored in a tightly sealed container as it may be sensitive to air or moisture. It is advisable to maintain a storage temperature between 1°C and 30°C to keep its efficacy and safety intact for as long as possible.

Appearance and packaging

Appearance

White film-coated, yellowish soft capsule filled with oily substance containing active ingredients.

Package unit

80 capsules/box [(8 capsules/AluAlu*10)], 100 capsules/box [(10 capsules/PTP*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.