Rojeco Soft Capsule

Adult dose

This medication is administered only to adults, taking 2 to 4 capsules (1,000 mg of Omega-3 Fatty Acid Ethyl Ester/5 mg of Rosuvastatin per capsule) once a day with meals to avoid gastrointestinal disturbances.

This medication should not be administered to certain patients. For example, those allergic to this drug, with severe liver dysfunction, those with muscle diseases, and women who are pregnant or breastfeeding should not use this medication. Additionally, its use should be avoided in patients with severe renal impairment or those taking certain medications together. Women of childbearing potential should employ adequate contraceptive methods to reduce the possibility of pregnancy, and cautious use is advised in cases where pregnancy is a risk. This medication can cause muscle-related side effects such as myalgia, muscle weakness, and in severe cases, rhabdomyolysis, thus it is imperative to consult a doctor immediately if any symptoms of muscle pain or weakness appear. Since it may affect liver function, regular liver function tests should be performed before starting and during treatment with this medication. If symptoms of liver damage (fatigue, jaundice, abdominal pain, etc.) occur, treatment should be discontinued immediately and a healthcare professional consulted. Though this medication is used to manage blood lipid levels, dietary and exercise regimens should also be maintained consistently during treatment. Additionally, regular blood tests to check lipid levels, liver function, and muscle enzyme levels are essential while taking this medication. Taking this medication in conjunction with certain drugs could increase the risk of adverse effects due to interactions; therefore, patients must inform their healthcare provider if they are taking other medications. Women who are pregnant or breastfeeding should not use this medication, and those planning a pregnancy should use adequate contraceptive methods. Safety and efficacy for pediatric patients and adolescents under the age of 18 have not been established, so its use is not recommended in this age group. Careful administration is required for the elderly, and possible side effects should be closely monitored. In cases of overdose, as there is no specific antidote, appropriate treatment must be provided based on symptoms, and liver function and muscle enzyme levels should be monitored. Finally, this medication should be kept out of the reach of children and not transferred to another container.

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, facial paralysis, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome, hepatitis, jaundice, acute renal failure, oliguria, increased serum creatinine, severe myalgia, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe edema, severe allergic reactions, severe skin reactions, difficulty breathing, dyspnea, asthma attacks, chest tightness,

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• myalgia
• arthralgia
• pruritus
• rash
• erythema

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. The appropriate storage temperature is room temperature between 1°C and 30°C, and it should be stored away from direct sunlight.

Appearance

An oval soft capsule filled with a pale yellow oily substance coated with white film.

Package unit

100 capsules - 100 capsules/box [(10 capsules/PTP x 10)]