Medication info
Rosuvastatin CombiGel Soft Capsule 5/1000 mg (Rosuvastatin, Omega-3 Ethyl Ester 90)

Rosuvastatin CombiGel Soft Capsule 5/1000 mg (Rosuvastatin, Omega-3 Ethyl Ester 90)

Prescription medicationSoft capsule경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 capsuleOmega-3-Acid Ethyl Esters 90›1000mg / 1 capsule
Manufacturer / importer
한국유나이티드제약(주)
Appearance
Translucent brownish oval soft capsule filled with pale yellow oily substance and white round film-coated tablet.
Packaging
Box - 30 capsules/box [10 capsules/PTP * 3EA]
Approval status
Active

MFDS item code 202303366 · Approved 2023.12.19 · Insurance code 644309740

Summary

Main use
Treatment of hyperlipidemia and LDL-cholesterol control with rosuvastatin monotherapy.
Who takes it
Adults
Adult dose
This medication is to be administered only to adults, taking it once daily with meals to avoid gastrointestinal discomfort, at a dose of 2-4 capsules (1,000 mg Omega-3 Ethyl Ester / 5 mg Rosuvastatin per capsule).

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Treatment of hyperlipidemia and LDL-cholesterol control with rosuvastatin monotherapy.

  • Coronary artery disease
  • elevated LDL-cholesterol levels
  • elevated triglyceride levels
  • combined hyperlipidemia
View approved original text

This medication helps effectively lower LDL-cholesterol levels when used alone in adults at high risk of coronary artery disease. However, it does not adequately control triglyceride levels in cases of combined hyperlipidemia where triglycerides are also elevated. Therefore, it is suitable for treatment focused on reducing LDL-cholesterol, playing an important role in reducing the risk of cardiovascular events. This medication is used for the prevention and management of cardiovascular diseases.

How to take

Adult dose

This medication is to be administered only to adults, taking it once daily with meals to avoid gastrointestinal discomfort, at a dose of 2-4 capsules (1,000 mg Omega-3 Ethyl Ester / 5 mg Rosuvastatin per capsule).

Precautions

This medication should not be used in certain patients. For instance, individuals allergic to any of the components in this medication, those with severe liver dysfunction, individuals with muscle disorders, those taking certain immunosuppressants, individuals with severe renal impairment, pregnant or nursing women, and children under 18 years old should not take this medication. In addition, patients should undergo regular liver function tests and muscle-related tests before and during the use of this medication. If symptoms like muscle pain, weakness, fatigue, or fever occur, they should inform their doctor immediately, and if necessary, discontinue the medication. This medication may affect liver function; therefore, individuals with a history of liver disease or excessive alcohol consumption should exercise increased caution. It should also be used carefully in cases of hypothyroidism or renal impairment. This medication may interact with other drugs; therefore, individuals taking immunosuppressants, certain antibiotics, antifungals, fibrates, or anticoagulants should consult with their doctor or pharmacist. Women of childbearing age must use appropriate contraception before taking this medication, and those who are pregnant or nursing should not take it. This medication may rarely cause side effects such as skin rash, itching, headache, dizziness, indigestion, muscle aches, etc., and if these symptoms persist or worsen, consultation with a healthcare professional is necessary. Additionally, the safety and effectiveness of this medication have not been sufficiently confirmed in children and the elderly, so special caution is required in these age groups. During the intake of this medication, regular blood tests and liver function tests should be conducted to monitor the condition, and if any unusual symptoms occur, immediate consultation with healthcare personnel is required. Finally, this medication should be kept out of the reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (skin or eyes turning yellow), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision abnormalities, paralysis, urine changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • gastritis
  • itching
  • rash
  • nasopharyngitis
  • periodontitis
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  • upper respiratory infection
  • muscle pain
  • joint pain
  • increased tear production
  • presbyopia
  • ovarian cancer
  • increased ALT
  • increased AST
  • increased γ-GT
  • increased serum alkaline phosphatase
  • increased serum potassium
  • hypokalemia
  • cholecystitis
  • taste disorder
  • indigestion
  • belching
  • cough
  • diarrhea
  • thrombocytopenia
  • jaundice (rarely)
  • hepatitis (rarely)

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

Storage

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

Translucent brownish oval soft capsule filled with pale yellow oily substance and white round film-coated tablet.

Package unit

Box - 30 capsules/box [10 capsules/PTP * 3EA]

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.