Rozduo Tablets 10/5 mg

Adult dose

This drug is administered once daily regardless of meals. The recommended starting dose is 10/5 mg once daily. For patients requiring more reduction in LDL-cholesterol, the dose may be adjusted. After administration or dose adjustment, blood lipid levels should be checked after an interval of at least 4 weeks, and the dose may be adjusted accordingly, with a maximum daily dose of up to 10/20 mg.

This drug has a rare risk of inducing rhabdomyolysis, which can lead to severe muscle damage and acute renal failure. Therefore, if severe muscle pain or weakness occurs, the physician should be notified immediately. In cases with certain risk factors, the administration of this drug should be temporarily suspended or discontinued. This drug should not be used by patients with allergies to the ingredients, liver disease, severe renal failure, or muscle disorders, and by women who are pregnant or nursing. Furthermore, it should be used cautiously in patients with decreased renal function, hypothyroidism, a family history of muscle disorders, alcohol dependence, and in those taking certain medications. Regular liver function and muscle-related tests should be conducted during administration, and if there is a significant increase in liver enzymes or severe muscle pain, treatment should be stopped immediately. Rarely, side effects such as headaches, dyspepsia, edema, myalgia may occur, and serious adverse reactions such as severe skin reactions, liver damage, or myasthenia gravis can occur. Women during pregnancy or those who may become pregnant should ensure appropriate contraception and should discontinue use immediately if pregnancy is confirmed. Special care is needed for the elderly and pediatric patients, as safety in children has not been established and is not recommended. This drug may interact with other medications; therefore, patients should inform their healthcare provider of any medications they are taking, and coagulation status should be periodically monitored if administered with anticoagulants such as warfarin. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms, and liver function and muscle enzyme levels should be monitored. Lastly, keep this medicine out of reach of children and do not transfer it to another container.

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), severe malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, significantly reduced urine output

Mild side effects

• Headache
• dizziness
• dyspepsia
• dry mouth
• increased blood sugar
• muscle pain
• pruritus
• weakness
• joint pain
• fatigue

This medicine may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius in a cool, dry place. This way, the efficacy and safety of the drug can be well preserved.

Appearance

Pink oblong film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTPX3)], 30 tablets/bottle