Rovius-EZ 5/10 10 mg + 5 mg Tablet

Rovius-EZ 5/10 10 mg + 5 mg tablet by DBL Pharmaceuticals Limited is a lipid-lowering medicine that contains Ezetimibe + Rosuvastatin. In Bangladesh, it is mainly used along with diet and lifestyle measures to help lower high LDL cholesterol when a combination treatment is considered appropriate by a doctor.

Ezetimibe + Rosuvastatin works in two ways: ezetimibe reduces absorption of cholesterol from the intestine, while rosuvastatin reduces cholesterol production in the liver. A key caution is that rosuvastatin can rarely cause serious muscle injury or liver problems, so unexplained muscle pain, weakness, dark urine, or yellowing of the eyes should be reported promptly.

• Adjunct to diet for adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, when additional LDL cholesterol reduction is needed.
• Adjunct to diet for mixed dyslipidaemia when treatment with both ezetimibe and rosuvastatin is appropriate.
• May be used in homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments, as directed by a specialist.

The dose and strength are individualized according to LDL cholesterol level, cardiovascular risk, previous lipid-lowering therapy, kidney and liver status, and tolerability. It is usually taken once daily, with or without food, at the same time each day. Do not change the dose or stop treatment without consulting the prescribing doctor.

• Common or less serious effects may include headache, nausea, abdominal pain, constipation, diarrhoea, tiredness, dizziness, and muscle or joint pain.
• Blood tests may show increased liver enzymes or changes in blood sugar in some patients.
• Serious but uncommon effects include severe muscle pain or weakness, rhabdomyolysis, liver injury, allergic reactions, and pancreatitis. Seek urgent medical help for severe muscle symptoms, dark urine, yellowing of the skin or eyes, swelling of the face or throat, or difficulty breathing.

Use caution in people with a history of liver disease, heavy alcohol use, kidney impairment, untreated hypothyroidism, previous statin-related muscle problems, older age, or use of medicines that increase statin levels. People of Asian ancestry may have higher exposure to rosuvastatin and may need careful dose selection. Liver function and lipid levels may need monitoring. Use this medicine only under the guidance of a registered doctor or pharmacist.

• Cyclosporine can greatly increase rosuvastatin exposure and requires specialist management or avoidance.
• Gemfibrozil, other fibrates, high-dose niacin, and some antivirals or protease inhibitors can increase the risk of muscle injury.
• Warfarin and other coumarin anticoagulants may need closer INR monitoring when therapy is started, stopped, or changed.
• Antacids containing aluminium or magnesium can reduce rosuvastatin absorption; dosing separation may be advised.
• Bile acid sequestrants such as cholestyramine can reduce ezetimibe absorption; they should be taken at separated times if prescribed together.
• Inform the doctor about all prescription medicines, over-the-counter medicines, and supplements before use.

• Known hypersensitivity to ezetimibe, rosuvastatin, or any component of the tablet.
• Active liver disease or unexplained persistent elevation of liver enzymes.
• Pregnancy or planned pregnancy.
• Breastfeeding.
• Use of certain strengths may be unsuitable in severe kidney impairment; follow the product label and doctor's advice.

Ezetimibe + Rosuvastatin should not be used during pregnancy or breastfeeding. Cholesterol-lowering with statins is generally stopped if pregnancy occurs or is planned. Women who are pregnant, trying to conceive, or breastfeeding should consult a doctor for safer management options.

Store tablets in the original packaging at room temperature, protected from moisture, heat, and direct sunlight. Keep out of reach of children and do not use after the expiry date.