TotalSant Soft Capsule (Rosuvastatin, Omega-3 Acid Ethyl Ester 90)

Adult dose

This medication is administered only to adults, taken once daily with meals to avoid gastrointestinal discomfort, in a dose of 2-4 capsules (1,000 mg of Omega-3 acid ethyl ester/5 mg of Rosuvastatin per capsule).

This medication should not be used in patients allergic to its components. It should not be administered to patients with active liver disease or severe liver dysfunction. Patients with muscle disorders or myalgia should not use this medication. It may be dangerous when taken with the immunosuppressant cyclosporine, so it should be avoided. Patients with severely impaired renal function, especially those with a creatinine clearance of less than 30 mL/min, should not use this medication. Pregnant or breastfeeding women should not take this medication, and women of childbearing age should use appropriate methods to prevent pregnancy. Patients at higher risk for developing myopathy, such as those with moderate to severe impaired renal function, hypothyroidism, family history of muscle disorders, or those who are alcohol-dependent, should use caution regarding the dosage. Children under 18 years have not had the safety and effectiveness of this drug confirmed, and thus, it should not be used. Patients who consume excessive alcohol or have a history of liver disease should undergo periodic liver function tests before and during the medication use. Any symptoms such as myalgia, muscle weakness, or cramps should be reported to a physician immediately, and blood tests may be necessary to check for muscle damage. The use of this medication should be discontinued in cases of severe trauma, surgery, or acute illnesses such as serious infections. The risk of muscle damage may increase when used in combination with certain other drugs, so consult with a physician about concomitant medications. It is important to periodically check liver function and muscle enzyme levels through blood tests while taking this medication. Use during pregnancy may pose risks to the fetus, so it should be strictly avoided, and its safety during breastfeeding has also not been established, therefore it should not be used during this period. Caution is advised as the safety and effectiveness of this drug has not been thoroughly studied in children or the elderly. In the event of an overdose, as there is no specific antidote, treatment should be based on symptoms, and liver function and muscle enzyme tests may be necessary. This medication should be stored out of reach of children, and care should be taken to maintain its quality as transferring it to another container may affect its quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision disturbances, paralysis, oliguria.

Mild side effects

• Headache
• dizziness
• constipation
• nausea
• abdominal pain
• itching
• rash
• myalgia
• arthralgia
• facial paralysis

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the drug can be maintained for a longer period.

Appearance

An oval soft capsule filled with a yellowish oily substance, coated in white film.

Package unit

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