Rosu-Mjet Tablet 10/20 Milligrams (Ezetimibe, Rosuvastatin)

Adult dose

This medication is administered once daily, regardless of meals. For primary hypercholesterolemia, treatment starts at 10/5 mg daily, and the dosage may be adjusted up to a maximum of 10/20 mg daily if needed. Blood lipid levels should be checked at intervals of 4 weeks or more after starting treatment or adjusting the dose to modify the dosage accordingly.

This medication may rarely cause rhabdomyolysis, which can result in severe muscle damage, so patients with acute serious myopathy symptoms or those at risk for renal failure should temporarily stop or discontinue this medication. This medication should not be administered to patients with allergies to the active ingredient or excipients, active liver disease, unexplained liver enzyme abnormalities, muscle disorders, severe renal failure, pregnant women, or breastfeeding women. Special caution is required when administering to patients at high risk of myopathy or rhabdomyolysis, such as those with renal dysfunction, hypothyroidism, a history of muscle disorders, or a history of muscle toxicity with other statins or fibrates. Patients experiencing symptoms such as muscle pain, cramps, weakness, fatigue, fever, etc. while taking this medication should inform their physician immediately, and if necessary, blood tests should be performed to assess muscle damage. As liver function abnormalities may occur, liver function tests should be conducted before starting this medication, and symptoms of liver damage or changes in liver enzyme levels should be monitored regularly during treatment. Patients who consume large amounts of alcohol or have a history of liver disease should be cautious as this may increase the risk of liver damage while taking this medication. This medication should not be used during pregnancy or breastfeeding as it may harm the fetus or infant, and women of childbearing potential should use appropriate contraception. Safety in children and adolescents has not been established, so use is not recommended. Elderly patients (65 years and older) are at increased risk of myopathy and should be cautious during use, but dose adjustments are generally not necessary. This medication may interact with other drugs, particularly those including cyclosporine, fibrate drugs, anticoagulants, certain antibiotics, or antifungal agents, so consult a physician or pharmacist if you are taking these medications. In case of overdose, as there is no specific antidote, appropriate treatment and supportive therapy based on symptoms are necessary, and tests related to liver function and muscle damage should be performed. This medication should be kept out of the reach of children and should not be transferred to other containers.

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, pain in mouth/eyes mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

• Pharyngitis
• arthralgia
• headache
• dizziness
• upper respiratory infection
• myalgia
• fatigue
• numbness
• paresthesia
• nausea

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it should be stored at room temperature between 1°C and 30°C, avoiding extremely hot or cold environments.

Appearance

Pink rectangular film-coated tablets

Package unit

30 tablets/box [10 tablets/PTP x 3]