Medication info
Omega One Plus Soft Capsule

Omega One Plus Soft Capsule

Prescription medicationSoft capsule경구
Ingredient · strength
Omega-3-Acid Ethyl Esters 90›Strength being verifiedRosuvastatin Calcium›Strength being verified
Manufacturer / importer
하나제약(주)
Appearance
White film-coated soft capsule filled with a light yellow oily substance
Packaging
100 capsules/box[(10 capsules/PTP)*10)]
Approval status
Active

MFDS item code 202006953 · Approved 2020.10.12 · Insurance code 657807670

Summary

Main use
Control of LDL cholesterol and treatment of mixed dyslipidemia
Who takes it
Adults
Adult dose
For adults, administer 2 to 4 capsules once daily during meals to avoid gastrointestinal discomfort (1,000 mg of Omega-3 Ethyl Ester and 5 mg of Rosuvastatin per capsule).

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Control of LDL cholesterol and treatment of mixed dyslipidemia

  • Coronary heart disease
  • dyslipidemia
View approved original text

This medication effectively lowers LDL cholesterol levels in adult patients at high risk of coronary heart disease, helping to reduce the risk of cardiovascular disease. However, in cases of mixed dyslipidemia with elevated triglyceride levels, triglyceride control may be difficult with single therapy alone, necessitating additional treatment. In such situations, this medication is used to manage LDL cholesterol levels stably and improve cardiovascular health.

How to take

Adult dose

For adults, administer 2 to 4 capsules once daily during meals to avoid gastrointestinal discomfort (1,000 mg of Omega-3 Ethyl Ester and 5 mg of Rosuvastatin per capsule).

Precautions

This medication should not be used in certain patients. For instance, patients allergic to any component of this medication, those with severely impaired liver function, those with significantly reduced kidney function, or individuals with muscular disorders should not take this medication. Additionally, pregnant or breastfeeding women, and fertile women who are not using appropriate contraception must consult a doctor before taking this medication and may only use it when it is deemed highly unlikely that they are pregnant. Patients at high risk for muscle-related side effects, such as those with moderate to severe kidney impairment, those with hypothyroidism, a history of genetic muscle diseases, or those who consume alcohol excessively should use this medication with caution. Children under the age of 18 are not recommended to use this medication as its safety and efficacy have not been sufficiently established. Before and during treatment with this medication, liver function tests and muscle health assessments should be conducted regularly. Symptoms such as muscle pain, weakness, or fatigue should be reported immediately to healthcare providers. Interactions may occur when taken in conjunction with other medications, so it is crucial to inform healthcare providers of any currently taken medications, especially when taken with anticoagulants or certain antibiotics, antifungals, or immunosuppressants. Women who are pregnant or planning to become pregnant should avoid using this medication as it may pose risks to the fetus, and its safety has not been established during breastfeeding. Elderly individuals or those with impaired liver or kidney function may require dosage adjustments and monitoring for side effects. In case of overdose, there is no specific antidote, so one must seek medical care immediately and have their liver function and muscle enzyme levels assessed. This medication should be kept out of reach of children, and transferring it to other containers may adversely affect its quality, so care should be taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or breathing difficulty, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • gastric inflammation
  • rash
  • muscle pain
  • joint pain
  • increased tear production
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  • presbyopia
  • nasopharyngitis
  • periodontitis
  • upper respiratory infection
  • increased serum alkaline phosphatase
  • increased serum potassium
  • hypokalemia
  • cholelithiasis
  • cold symptoms
  • pain
  • indigestion
  • belching
  • altered taste
  • low back pain
  • abdominal distension
  • asthenia
  • body odor
  • chest pain
  • chills
  • malaise
  • throat pain
  • rheumatoid arthritis
  • headache
  • drowsiness

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius. Proper storage will help preserve the medication's effectiveness and safety for an extended period.

Appearance and packaging

Appearance

White film-coated soft capsule filled with a light yellow oily substance

Package unit

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.