Medication info
Bimega Soft Capsule 300mg (Eicosapentanoic Acid Ethyl)

Bimega Soft Capsule 300mg (Eicosapentanoic Acid Ethyl)

Prescription medicationSoft capsuleOral
Ingredient · strength
Ethyl Icosapentate›300mg / 1 capsule
Manufacturer / importer
RP Bio Co., Ltd.
Appearance
Colorless and transparent oval soft capsule containing a colorless or pale yellow transparent liquid.
Packaging
60 capsules/box [(10 capsules/PTP) × 6]
Approval status
Active

MFDS item code 202200791 · Approved 2022.02.21

Summary

Main use
Treatment of hyperlipidemia; improvement of symptoms of arteriosclerosis obliterans (pain, coldness, etc.)
Who takes it
Adults
Adult dose
1. Improvement of ulcers, pain, and coldness caused by obliterative arteriosclerosis Adults: Administer ethyl icosapentate 600mg (2 capsules) orally 3 times daily immediately after meals. 2. Hyperlipidemia Administer ethyl icosapentate 900mg (3 capsules) orally twice daily or 600mg (2 capsules) orally 3 times daily immediately after meals. If an abnormal triglyceride level occurs, the dose may be increased, if needed, to 900mg (3 capsules) 3 times daily.

Ingredients

Manufacturer
RP Bio Co., Ltd.

Efficacy & effects

Treatment of hyperlipidemia; improvement of symptoms of arteriosclerosis obliterans (pain, coldness, etc.)

  • Ulcers
  • pain
  • cold sensations
  • and hyperlipidemia caused by obstructive arteriosclerosis.
View approved original text

This medication is used to improve ulcers, pain, and cold sensations due to obstructive arteriosclerosis and is also used for the treatment of hyperlipidemia.

How to take

Adult dose

1. Improvement of ulcers, pain, and coldness caused by obliterative arteriosclerosis Adults: Administer ethyl icosapentate 600mg (2 capsules) orally 3 times daily immediately after meals. 2. Hyperlipidemia Administer ethyl icosapentate 900mg (3 capsules) orally twice daily or 600mg (2 capsules) orally 3 times daily immediately after meals. If an abnormal triglyceride level occurs, the dose may be increased, if needed, to 900mg (3 capsules) 3 times daily.

Precautions

This medication contains eicosapentanoic acid ethyl, and it is safe not to use in certain patients. Individuals with hypersensitivity to this medication or those with bleeding tendencies may face difficulties in hemostasis if taking this medication and should not receive it. Patients who are menstruating or have bleeding tendencies, scheduled for surgery, have suffered severe trauma, have liver dysfunction, have fish allergies, and those currently taking anticoagulants or antiplatelet drugs should use this medication with caution. This medication may cause serious side effects such as liver dysfunction or jaundice; thus, regular observation of liver condition is necessary, and if abnormalities are detected, it should be discontinued immediately. Additionally, there is a risk of arrhythmias such as atrial fibrillation or atrial flutter, so caution is especially needed in those with a history of heart disease. Various side effects such as skin rash, itching, bleeding, gastrointestinal discomfort, headaches, dizziness, muscle pain, etc., may occur; thus, it is important to consult healthcare professionals if symptoms appear. When used for the treatment of hyperlipidemia, blood lipid levels should be regularly monitored alongside dietary or exercise therapies, and if there is no effect, administration should be discontinued. Patients whose blood pressure is uncontrolled and are taking other antiplatelet agents should be cautious of the risk of hemorrhagic stroke. This medication has antiplatelet effects, and the risk of bleeding may increase if taken together with anticoagulants or antiplatelet drugs. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of this medication, and breastfeeding should be avoided if possible. Safety in children has not been established, and there is no usage experience. It is advised to avoid taking this medication on an empty stomach and to swallow it whole after meals, without chewing it. When storing, keep it out of reach of children and store in a cool, dry place, and it is safe not to transfer it to another container after opening.

Side effects

  • Liver dysfunction
  • jaundice
  • atrial fibrillation
  • atrial flutter
  • hypersensitivity
  • rash
  • itching
  • tendency to bleed
  • subcutaneous hemorrhage
  • hematuria
Show 52 more
  • gingival bleeding
  • retinal hemorrhage
  • epistaxis
  • gastrointestinal bleeding
  • anemia
  • nausea
  • abdominal discomfort
  • diarrhea
  • constipation
  • abdominal distension
  • abdominal pain
  • heartburn
  • vomiting
  • loss of appetite
  • stomatitis
  • polydipsia
  • bloating
  • elevated AST
  • elevated ALT
  • elevated Al-P
  • elevated γ-GTP
  • elevated LDH
  • elevated bilirubin
  • elevated BUN
  • elevated creatinine
  • cough
  • dyspnea
  • headache
  • heaviness in the head
  • dizziness
  • paralysis
  • vertigo
  • drowsiness
  • insomnia
  • arthralgia
  • myalgia
  • limb pain
  • muscle cramps
  • edema
  • elevated uric acid
  • elevated CK
  • hypothermia
  • facial flushing
  • flushing
  • fever
  • frequent urination
  • generalized fatigue
  • elevated blood pressure
  • gynecomastia
  • tinnitus
  • sweating
  • acne

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 best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Colorless and transparent oval soft capsule containing a colorless or pale yellow transparent liquid.

Package unit

60 capsules/box [(10 capsules/PTP) × 6]

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.