Medication info
Romaco Soft Capsule (Omega-3 Ethyl Ester 90)

Romaco Soft Capsule (Omega-3 Ethyl Ester 90)

Prescription medicationSoft capsule
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
(주)인트로바이오파마
Appearance
Transparent rectangular soft capsules filled with a pale yellow oily substance
Packaging
60 capsules/PTP [(10 capsules/PTP*6)], 30 capsules/bottle, 60 capsules/bottle
Approval status
Active

MFDS item code 201901842 · Approved 2019.03.27 · Insurance code 052401270

Summary

Main use
Treatment for lowering triglyceride levels in hypertriglyceridemia and combined hyperlipidemia.
Who uses it
Adults
Adult dosage
The initial dose is 2g (2 capsules) per day and may be increased to 4g per day if necessary. Administer once or twice a day. Prior to administration, an appropriate lipid-lowering diet must be followed and continued during the treatment period. To avoid gastrointestinal disturbances, take with meals.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment for lowering triglyceride levels in hypertriglyceridemia and combined hyperlipidemia.

  • Hypertriglyceridemia
  • hypercholesterolemia
View approved original text

This medication is used as an adjunct to dietary therapy to lower elevated triglyceride levels in patients with hypertriglyceridemia (Type IV). Additionally, in cases where both hypercholesterolemia and hypertriglyceridemia are present (Type IIb), it can be used in conjunction with statin drugs to enhance therapeutic effects. It also helps improve serum lipid levels in patients with uncontrolled combined form when used with statins. This treatment effectively manages dyslipidemia, contributing to the prevention of cardiovascular diseases. Therefore, this medication is used for the treatment of hypertriglyceridemia and combined dyslipidemia.

Dosage and Administration

Adult dosage

The initial dose is 2g (2 capsules) per day and may be increased to 4g per day if necessary. Administer once or twice a day. Prior to administration, an appropriate lipid-lowering diet must be followed and continued during the treatment period. To avoid gastrointestinal disturbances, take with meals.

Precautions

This medication should not be used by individuals who are allergic to any of its ingredients. It is advisable not to administer this medication to children under 18 years of age. Patients at high risk of bleeding due to severe trauma or surgery, those with impaired liver function, and individuals allergic to fish should exercise caution when using this medication. While taking this medication, various side effects such as dyspepsia, skin rash, cold symptoms, and back pain may occur, so caution is advised. In particular, heart-related issues such as atrial fibrillation may arise, so patients with cardiovascular diseases or those at high risk should use this medication more carefully. Before taking this medication, it is essential to check triglyceride levels with blood tests, and regular monitoring should continue during treatment. Individuals who are overweight or consume excessive alcohol should also engage in dietary and exercise regimens to enhance the effectiveness of drug therapy. As there is limited experience using this medication in conjunction with certain lipid-lowering agents, caution is advised during combination therapy, and regular checking of liver function and cholesterol levels is necessary. When taken with anticoagulants, there is an increased risk of bleeding, so coagulation levels must be monitored in this case. Pregnant women should consider the potential risks to the fetus and therapeutic effects carefully, as the safety of this medication during pregnancy is not confirmed. Breastfeeding women should also be cautious, as it is unclear whether this medication is excreted in breast milk. This medication is not recommended for children and special caution is needed for elderly patients aged 65 years and older. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms. This medication should be stored out of reach of children, and transferring it to other containers should be avoided as it may impair quality.

Side effects and when to seek care immediately

Serious side effects

  • Generalized edema
  • chest pain
  • sudden death
  • cardiac arrest
  • myocardial infarction
  • myocardial ischemia
  • occlusion
  • fainting
  • hypotension
  • gastrointestinal bleeding
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  • asthma
  • dyspnea
  • atrial fibrillation

Mild side effects

  • Back pain
  • cold symptoms
  • infections
  • pain
  • dyspepsia
  • belching
  • rash
  • taste disturbance
  • abdominal bloating
  • weakness
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  • body odor
  • chest pain
  • chills
  • fever
  • fatigue
  • sore throat
  • rheumatoid arthritis
  • arrhythmia
  • hyperlipidemia
  • hypertension
  • migraine
  • fainting
  • tachycardia
  • loss of appetite
  • constipation
  • dry mouth
  • dysphagia
  • colitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gastrointestinal disturbances
  • increased appetite
  • bowel obstruction
  • black stools
  • pancreatitis
  • postprandial discomfort
  • vomiting
  • nausea

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. Maintain storage temperature below 25 degrees Celsius and avoid freezing. This will help preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

Transparent rectangular soft capsules filled with a pale yellow oily substance

Package unit

60 capsules/PTP [(10 capsules/PTP*6)], 30 capsules/bottle, 60 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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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.