Rovazet Tablet 10/2.5 mg (Ezetimibe, Rosuvastatin)

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, the dosage range is 10/2.5 mg to 10/20 mg once daily. A starting dose of 10/2.5 mg or 10/5 mg once daily is recommended. The dosage may be adjusted based on the requirement for greater reduction of LDL cholesterol. After starting the treatment or adjusting the dose, blood lipid levels should be checked after an interval of more than 4 weeks.

This medication has been rarely reported to cause rhabdomyolysis, which can result in serious muscle damage; therefore, patients presenting symptoms of acute myopathy or those at high risk for renal failure should temporarily suspend or discontinue its use. This medication should not be administered to individuals with hypersensitivity to its components, active liver disease, muscle disease, severe renal impairment, pregnant women, or nursing mothers. Patients at high risk for myopathy, such as those with poor renal function or hypothyroidism, those with a family history of muscular toxicity from other statins, those with alcohol addiction, and elderly patients should use this medication cautiously. Since this medication contains lactose, it should not be taken by patients with lactose intolerance or certain genetic metabolic disorders. During treatment, if symptoms such as muscle pain, cramps, or weakness occur, inform your physician immediately and check for muscle damage with blood tests. In severe cases, discontinue the medication. Liver function testing should be conducted before and during treatment, and if there are significant elevations in liver enzymes, the medication should be discontinued or the dosage should be reduced. This medication may cause side effects such as headache, dizziness, dyspepsia, myalgia, edema, among others in some patients; if these symptoms persist or worsen, consult a healthcare provider. Women who are pregnant or may become pregnant should use effective contraception while taking this medication as it can harm the fetus; if pregnancy is confirmed, the medication should be stopped immediately. This medication can interact with other drugs, so patients taking anticoagulants, fibrates, certain antibiotics, and antifungals should inform their doctor or pharmacist. Elderly patients or those with decreased renal function are at increased risk for myopathy when taking this medication and should be monitored closely. In the event of an overdose, as there is no specific antidote, treatment should be symptomatic, and liver function and muscle enzyme tests should be performed to assess and manage the condition. Store this medication out of reach of children and do not transfer it to another container.

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or shortness of breath, asthmatic attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues.

Mild side effects

• Headache
• dizziness
• dental discomfort
• arthralgia
• lower limb fractures
• orthostatic dizziness
• diabetes
• hypoglycemia
• chronic cholecystitis
• cholelithiasis

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and best kept at a temperature between 1°C and 30°C. Proper storage will maintain the efficacy of the medication over time.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle