Rovast EZ 20/10

• Primary Non-familial Hyperlipidemia: As an adjunct to diet to reduce LDL-C. • Homozygous Familial Hypercholesterolemia (HoFH): Alone or as an adjunct to other LDL-C-lowering therapies to reduce LDL-C.

Rosuvastatin: Rosuvastatin lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver and by increasing the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Rosuvastatin reduces LDL production and the number of LDL particles. Ezetimibe: Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, which is involved in the intestinal uptake of cholesterol and phytosterols.

• General Patients: 5/10 mg to 40/10 mg once daily; maximum dose is 40/10 mg once daily. Dose depends on the indication, LDL-C level, and cardiovascular risk. • Severe Renal Impairment (CrCl <30 mL/min) – Not on Hemodialysis: 5/10 mg once daily; maximum dose is 10/10 mg once daily. • Elderly Patients: No dosage adjustment is necessary. • Pediatric Patients: Safety and efficacy have not been established.

• Headache • Nausea • Myalgia (Muscle pain) • Arthralgia (Joint pain) • Dizziness • Asthenia (Weakness) • Constipation • Abdominal pain • Respiratory tract infection • Diarrhea • Sinusitis • Pain in extremity • Fatigue • Influenza • Back pain Serious Side Effects (Rare – Consult Doctor): • Myopathy and Rhabdomyolysis (muscle breakdown) • Elevated liver enzymes • Hepatic failure (rare)

This combination is contraindicated during pregnancy. It can harm the developing baby. Inform your doctor if you are pregnant, planning pregnancy, or suspect pregnancy, and stop the medicine immediately. Do not use this medicine at any stage of pregnancy.

Myopathy and Rhabdomyolysis: • Risk factors include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use with certain other drugs, and higher dosage. • Discontinue the medicine if markedly elevated creatine kinase (CK) levels occur or if myopathy is diagnosed or suspected. • Temporarily discontinue the medicine in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis. Hepatic Dysfunction: • Increases in serum transaminases may occur, and some cases may be persistent. • Rare reports of fatal and non-fatal hepatic failure have been reported. • Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter.

There is no specific treatment in the event of overdose. Overdose may cause muscle pain, muscle weakness, nausea, diarrhea, and liver problems. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Contact a doctor immediately if you take an excessive dose.

Store below 30°C, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date.