Medication info
RotiGum Soft Capsule (Omega-3 Fatty Acid Ethyl Ester 90)

RotiGum Soft Capsule (Omega-3 Fatty Acid Ethyl Ester 90)

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
(주)팜젠사이언스
Appearance
Transparent oblong soft capsule filled with a pale yellow oily substance
Packaging
60 capsules/box[[(10 capsules/PTP*3)/pack]*2/box], 60 capsules/bottle, 30 capsules/bottle
Approval status
Active

MFDS item code 201907394 · Approved 2019.10.22 · Insurance code 670104460

Summary

Main use
Improvement of hypertriglyceridemia and mixed hypercholesterolemia
Who takes it
Adults
Adult dose
Appropriate lipid-lowering dietary therapy must be implemented before this medication is administered and should continue during treatment. This medication should be taken with meals to avoid gastrointestinal disturbances. For hypertriglyceridemia, the usual initial dose is 2g (2 capsules) per day, which may be increased to 4g per day if needed. Administer either once or twice a day.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of hypertriglyceridemia and mixed hypercholesterolemia

  • Endogenous hypertriglyceridemia
  • hypertriglyceridemia
  • hypercholesterolemia
View approved original text

This medicine is used as an adjunct to dietary therapy to reduce elevated triglyceride levels in patients with hypertriglyceridemia. It can be administered alone to patients with hypertriglyceridemia (Type IV) and can be used in conjunction with statin drugs for patients with mixed hypercholesterolemia and hypertriglyceridemia (Type IIb). Moreover, for patients with unmanageable triglyceride levels, combining this drug with statins enhances therapeutic efficacy. This medication effectively improves blood lipid levels and helps reduce the risk of cardiovascular diseases.

How to take

Adult dose

Appropriate lipid-lowering dietary therapy must be implemented before this medication is administered and should continue during treatment. This medication should be taken with meals to avoid gastrointestinal disturbances. For hypertriglyceridemia, the usual initial dose is 2g (2 capsules) per day, which may be increased to 4g per day if needed. Administer either once or twice a day.

Precautions

This medication should not be used by individuals with an allergic reaction to any of its components or by children under 18 years of age. Patients at high risk of bleeding due to severe trauma or surgery, patients with liver dysfunction, and individuals allergic to fish should use this medication with caution. While taking this medication, various adverse reactions such as dyspepsia, headache, dizziness, skin rash, and arthralgia may occur. If symptoms persist or worsen, consult a physician immediately. Before starting treatment, blood tests should be conducted to check whether triglyceride levels are outside the normal range, and periodic tests should be performed during medication use. For those who are overweight or consume alcohol excessively, it is important to manage weight through dietary therapy and exercise. This medication can affect blood clotting, so patients taking anticoagulants or aspirin should closely monitor their risk of bleeding. Women who are pregnant or nursing should use this medication with caution and after consulting a physician since its safety is not firmly established. Elderly patients aged over 65 years have shown safety and efficacy in clinical trials, but caution is advised based on individual conditions. In case of overdose, there is no specific antidote available, so appropriate treatment and supportive care should be provided based on symptoms. Keep this medication out of reach of children, and do not transfer it to another container. Cardiac side effects, such as atrial fibrillation, may occur, so patients with heart diseases should consult a physician before taking it.

Side effects and when to seek care immediately

Serious side effects

  • Rash
  • skin peeling
  • pain in oral/ocular mucous membranes
  • severe edema
  • difficulty breathing
  • asthma attacks
  • jaundice
  • liver abnormalities
  • severe allergic reactions
  • serious neurological symptoms
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  • atrial fibrillation
  • myocardial infarction
  • cardiac arrest
  • sudden death
  • elevated blood pressure
  • hemorrhagic complications
  • severe skin adverse reactions
  • respiratory issues

Mild side effects

  • Back pain
  • cold symptoms
  • infection
  • pain
  • angina
  • dyspepsia
  • belching
  • rash
  • taste disturbances
  • abdominal bloating
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  • fatigue
  • body odor
  • chest pain
  • chills
  • suicidal thoughts
  • fever
  • generalized edema
  • fungal infections
  • malaise
  • throat pain
  • tumors
  • rheumatoid arthritis
  • sudden death
  • viral infections
  • arrhythmia
  • bypass surgery
  • cardiac arrest
  • hyperlipidemia
  • hypertension
  • migraine
  • myocardial infarction
  • myocardial ischemia
  • obstruction
  • peripheral vascular disorders
  • fainting
  • tachycardia
  • loss of appetite

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

Storage

Store this medication in a tightly sealed container to protect it from air and moisture. Additionally, to maintain the medication's efficacy, store it in a cool place below 25 degrees Celsius, taking care not to freeze it.

Appearance and packaging

Appearance

Transparent oblong soft capsule filled with a pale yellow oily substance

Package unit

60 capsules/box[[(10 capsules/PTP*3)/pack]*2/box], 60 capsules/bottle, 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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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.