Rosuduo Tablet 10/10 mg (Ezetimibe, Rosuvastatin Calcium)

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, an initial dose of 10/5 mg once daily is recommended, with a dosage range from 10/5 mg to 10/20 mg once daily. The dose may be adjusted for patients requiring greater reductions in LDL-cholesterol. After administration, lipid levels should be checked at intervals of more than 4 weeks before adjusting the dose, with a maximum of 10/20 mg once daily.

This medication may affect muscles, so if severe muscle pain or weakness occurs, consult a physician immediately. Care should be taken as rhabdomyolysis, a severe muscle damage condition, can occur rarely. Patients with severe infections, hypotension, major surgery, trauma, metabolic abnormalities, and other conditions that present a high risk of muscle damage may need to temporarily discontinue this medication. Patients with allergies to any of the ingredients in this medication or those with significantly impaired liver function, muscle disorders, severely reduced kidney function, and those who are pregnant or breastfeeding should not take this medication. Additionally, the risk of muscle damage may increase when taken with certain medications, so if you are taking other drugs, be sure to inform your physician. This medication may affect liver function, so liver function tests should be performed before and during treatment, and any symptoms of liver function abnormalities should be reported immediately. Elderly patients or those with hypothyroidism, renal function impairment, etc., have a higher risk of muscle damage and should be monitored closely. This medication should not be administered to pregnant women or those who may become pregnant, and women of childbearing age should use appropriate contraception during treatment. Symptoms such as dizziness or headache may occur, so caution is needed when driving or operating machinery. If muscle pain, fatigue, or fever accompanies symptoms while taking this medication, you should inform healthcare personnel immediately, and blood tests may be needed to check for muscle damage. This medication is not recommended for children as safety and efficacy have not been adequately established. In case of overdose, since no specific antidote is available, appropriate treatment and supportive care based on symptoms are necessary, and liver function and muscle-related tests should be performed. This medication should be kept out of the reach of children, and it is recommended not to transfer it to another container.

Serious side effects

Urticaria, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral or ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme body fatigue, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis.

Mild side effects

• Headache
• dizziness
• nasopharyngitis
• arthralgia
• edema
• elevated bilirubin levels
• acneiform dermatitis
• pruritus
• myalgia
• dizziness

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help ensure the safety and effectiveness of the medication.

Appearance

White to nearly white round film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP × 3]