Rolip 10 Sprinkle

• Primary Hyperlipidemia: As an adjunct to diet to reduce elevated total-C, LDL-C, ApoB, non-HDL-C and TG, and increase HDL-C. • Mixed Dyslipidemia: As an adjunct to diet to reduce elevated total-C, LDL-C and ApoB. • Hypertriglyceridemia: As an adjunct to diet to reduce triglycerides. • Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): As an adjunct to diet to reduce lipids. • Homozygous Familial Hypercholesterolemia (HoFH): To reduce LDL-C, total-C and ApoB. • Heterozygous Familial Hypercholesterolemia (HeFH) – Children (10–17 years): To reduce elevated total-C, LDL-C and ApoB after failing diet therapy. • Slowing Atherosclerosis Progression: As an adjunct to diet to lower total-C and LDL-C. • Prevention of MI, Stroke & Arterial Revascularization: In patients without CHD but with multiple risk factors.

Rosuvastatin Calcium is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methyl glutaryl coenzyme A to mevalonate, a precursor of cholesterol. Rosuvastatin Calcium produces its lipid-modifying effects in two ways: First, it increases the number of hepatic LDL receptors on the cell surface to enhance uptake and catabolism of LDL. Second, it inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles. Rosuvastatin Calcium is more potent than other statins and is effective at lower doses.

• Primary Hyperlipidemia: Initial dose 5–10 mg once daily; maximum dose 40 mg once daily. Dose can be increased every 4 weeks. • Mixed Dyslipidemia: Initial dose 5–10 mg once daily; maximum dose 40 mg once daily. Dose should be determined according to the doctor's advice. • Hypertriglyceridemia: Initial dose 5–10 mg once daily; maximum dose 40 mg once daily. Regular lipid profile monitoring is recommended. • Dysbetalipoproteinemia: Initial dose 5–10 mg once daily; maximum dose 40 mg once daily. Use with diet control. • Homozygous Familial Hypercholesterolemia (HoFH): Initial dose 20 mg once daily; maximum dose 40 mg once daily. Preapheresis LDL-C should be assessed. • Very High Cholesterol & High Risk (MI/Stroke): Dose 40 mg once daily; maximum dose 40 mg once daily. For high-risk patients. • Asian Patients: Initial dose 5 mg once daily; maximum dose 20 mg once daily. Start with a lower dose.

Common Side Effects (in 5–10% patients): • Headache • Myalgia (Muscle pain) • Constipation • Asthenia (Weakness) • Abdominal pain • Nausea • Diarrhea • Gas or upset stomach Serious Side Effects (Rare – Consult Doctor): • Yellowing of eyes or skin (jaundice) – sign of liver problems • Dark urine – sign of liver problems • Severe stomach pain – sign of liver problems • Repeated or unexplained muscle pain – sign of myopathy • Muscle weakness or fatigue – sign of myopathy • Rhabdomyolysis (muscle breakdown) – rare but serious • Elevated liver enzymes (SGOT/SGPT) • Memory loss (rare) • Increased blood sugar (in diabetic patients)

Rosuvastatin Calcium is highly unsafe during pregnancy (FDA Category X). Studies on pregnant women and animals have shown significant harmful effects to 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. It should be administered to women of childbearing age only when they are highly unlikely to conceive and have been informed of the potential hazards.

Pregnancy Category: X — always consult a doctor before taking during pregnancy.

• Does not usually affect driving ability. • Follow regular exercise and a low-fat diet (e.g., green leafy vegetables, fruits, whole grains). • Diabetic patients should monitor blood sugar regularly, as this medicine may increase blood sugar. • Perform liver function tests (SGOT, SGPT) before starting treatment, at 12 weeks, and regularly thereafter (e.g., every 6 months). • Inform your doctor if you have kidney disease, liver disease, thyroid problems, or diabetes. • Contraindicated during pregnancy and breastfeeding. • A lower starting dose of 5 mg is recommended for Asian patients. • Patients over 65 years have a higher risk of muscle problems; caution is required. • Perform liver function tests 12 weeks after any dose increase. • Discontinue the medicine if creatine kinase (CK) levels rise significantly or if myopathy is suspected. • Temporarily withhold the medicine in cases of sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic/endocrine/electrolyte disorders, or uncontrolled seizures.

There is no specific treatment in the event of overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures instituted as required. Hemodialysis does not significantly enhance clearance of Rosuvastatin. Contact a doctor immediately if you take an excessive dose.

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