Indications: Treatment of hypercholesterolaemia: Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Adults, adolescents and children aged 6 years or older with homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. Prevention of Cardiovascular Events: Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event, as an adjunct to correction of other risk factors. Dosage and method of administration: Place patient on a cholesterol lowering diet before and during treatment. Administer orally, at any time of day, with or without food. Treatment of hypercholesterolaemia: recommended start dose of 5 mg (2.5 ml) or 10 mg (5 ml) once daily in statin naïve patients or patients switched from another HMG CoA reductase inhibitor. Starting dose should consider the patient’s cholesterol level, future cardiovascular risk and risk for adverse reactions. Adjust dose, if necessary, after 4 weeks. Only consider titration to 40 mg (20 ml) in patients with severe hypercholesterolaemia at high cardiovascular risk (particularly those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg (10 ml), and perform routine follow up. Specialist supervision recommended when initiating the 40 mg (20 ml) dose. Prevention of cardiovascular events: 20 mg (10 ml) daily. Paediatric population: Paediatric use should only be carried out by specialists. Children and adolescents 6 to 17 years with Heterozygous familial hypercholesterolaemia: start dose of 5 mg (2.5 ml) daily. Usual dose ranges in 6 to 9 year olds of 5-10 mg (2.5-5 ml) daily, in 10 to 17 year olds of 5-20 mg (2.5-10 ml) daily. Titration should be conducted according to the individual response and tolerability. Children and adolescents 6 to 17 years with Homozygous familial hypercholesterolaemia: recommended maximum dose of 20 mg (10 ml) daily. A starting dose of 5 mg (2.5 ml) to 10 mg (5 ml) daily depending on age, weight and prior statin use. Titration to the maximum dose should depend on individual response and tolerability. 40 mg (20 ml) dose is not suitable for use in paediatric patients. Children younger than 6 years: Rosuvastatin is not recommended for use in children younger than 6 years. Elderly patients: start dose of 5 mg (2.5 ml) is recommended in patients >70 years. Renal insufficiency: start dose of 5 mg (2.5 ml) in patients with moderate renal impairment (creatinine clearance <60 ml/min). 40 mg (20ml) dose contraindicated in patients with moderate renal impairment. Contraindicated in severe renal impairment. Hepatic impairment: Increased systemic exposure with Child-Pugh scores of 8 and 9, consider assessment of renal function. Contraindicated in patients with active liver disease. Race: start dose of 5 mg (2.5 ml) for patients of Asian ancestry due to increased systemic exposure, 40 mg (20 ml) dose is contraindicated. Genetic polymorphisms: Patients with specific types of genetic polymorphisms that can lead to increased rosuvastatin exposure are recommended a lower daily dose. Dosage in patients with pre-disposing factors to myopathy: start dose of 5 mg (2.5 ml) in patients with predisposing factors to myopathy. 40 mg (20 ml) dose contraindicated in some of these patients. Concomitant therapy: Risk of myopathy (including rhabdomyolysis) is increased when concomitantly administered with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Consider alternative medications/temporary discontinuation of Rosuvastatin. Consider the benefits and risks of concurrent treatment, and dosing adjustments to Rosuvastatin. Contraindications: hypersensitivity to rosuvastatin or excipients. Active liver disease including unexplained, persistent elevations of serum transaminases and serum transaminase elevation > 3 times the upper limit of normal (ULN). Severe renal impairment (creatinine clearance <30 ml/min). Myopathy. Concomitant combination of sofosbuvir/ velpatasvir/ voxilaprevir. Concomitant ciclosporin. Pregnancy and lactation and in women of childbearing potential not using appropriate contraceptive measures. 40 mg dose is contraindicated in patients with pre-disposing factors for myopathy/rhabdomyolysis: moderate renal impairment (creatinine clearance < 60 ml/min), hypothyroidism, personal or family history of hereditary muscular disorders, history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, situations where an increase in plasma levels may occur, Asian patients, concomitant use of fibrates. Special warnings and precautions for use: Proteinuria observed in patients treated with higher doses of Rosuvastatin, transient or intermittent in most cases. Consider assessment of renal function during routine follow-up of patients treated with doses of 40 mg. Effects on skeletal muscle e.g. myalgia, myopathy and, rarely, rhabdomyolysis have been reported with all doses, particularly >20 mg. Rhabdomyolysis cases have been reported with ezetimibe in combination with HMG-CoA reductase inhibitors, exercise caution with combined use. If Creatine Kinase (CK) levels are significantly elevated at baseline (>5xULN) and are confirmed in a confirmatory test carried out within 5 – 7 days, treatment should not be started. Caution in patients with pre-disposing factors for myopathy/rhabdomyolysis: renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate, alcohol abuse, age >70 years, situations where an increase in plasma levels may occur, and concomitant use of fibrates. The risk of treatment should be considered in relation to possible benefit and clinical monitoring is recommended. Advise patients to report inexplicable muscle pain, weakness or cramps, particularly if associated with malaise or fever. CK levels should be measured in these patients. Therapy should be discontinued if CK levels are markedly elevated (>5xULN) or if symptoms are severe and cause daily discomfort. If symptoms resolve and CK levels return to normal, consider re-introducing Rosuvastatin or an alternative HMG-CoA reductase inhibitor at the lowest dose with close monitoring. Rare reports of an immune-mediated necrotising myopathy (IMNM) during or after treatment with statins, including rosuvastatin. An increase in the incidence of myositis and myopathy has been seen in patients receiving other HMG-CoA reductase inhibitors together with fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors and macrolide antibiotics. Combining Rosuvastatin and gemfibrozil is not recommended. The benefit of further alterations in lipid levels by the combined use of Rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of such combinations. The 40 mg dose is contraindicated with concomitant use of a fibrate. Do not co-administer Rosuvastatin with systemic formulations of fusidic acid or within 7 days of stopping treatment. In patients where the use of systemic fusidic acid is considered essential, statin treatment should be discontinued throughout. Reports of rhabdomyolysis (including some fatalities) in patients receiving fusidic acid and statins in combination. Advice patients to seek medical advice if they experience any symptoms of muscle weakness, pain or tenderness. In exceptional circumstances, where prolonged systemic fusidic acid is needed, e.g. for the treatment of severe infections, the need for co-administration of Rosuvastatin and fusidic acid should only be considered on a case-by-case basis under close medical supervision. Rosuvastatin should not be used in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders; or uncontrolled seizures). Severe cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported, advise and monitor patients of the signs and symptoms. If signs and symptoms suggestive of this reaction appear, discontinue Rosuvastatin immediately. Do not restart treatment in these patients. Use with caution in patients who consume excessive alcohol and/or have history of liver disease. Test liver function prior to treatment initiation and 3 months following. Discontinue or reduce the dose if the level of serum transaminases is greater than 3 times the ULN. Patients with secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome: treat the underlying disease prior to initiating therapy. Increased systemic exposure observed in concomitant use with various protease inhibitors in combination with ritonavir. Consider both the benefit of lipid lowering by use of Rosuvastatin in HIV patients receiving protease inhibitors and the potential for increased rosuvastatin plasma concentrations when initiating and increasing dose in patients treated with protease inhibitors. Concomitant use with certain protease inhibitors is not recommended unless Rosuvastatin dose is adjusted. Interstitial lung disease cases have been reported with statins. Features include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If interstitial lung disease is suspected, discontinue statin therapy. Statins may raise blood glucose in patients at high risk of diabetes (fasting glucose 5.6 to 6.9 mmol/L, BMI >30 kg/m², raised triglycerides, hypertension). This risk is outweighed by the reduction in vascular risk with statins and should not be a reason for stopping statin treatment. Monitor clinically and biochemically. This product contains 100mg/ml of alcohol (ethanol 96%). Interactions: Concomitant administration with medicinal products that inhibit certain transporter proteins including the hepatic uptake transporter OATP1B1 and efflux transporter BCRP may increase plasma concentrations and risk of myopathy. Gemfibrozil, fenofibrate, other fibrates and lipid lowering doses (> or equal to 1 g/day) of niacin (nicotinic acid) increase the risk of myopathy when given concomitantly with HMG-CoA reductase inhibitors. Concomitant use of ezetimibe results in an increase in AUC of rosuvastatin. Simultaneous dosing of Rosuvastatin with antacid suspension containing aluminium and magnesium hydroxide decreases rosuvastatin plasma concentration by ~50%. Concomitant use of Rosuvastatin and erythromycin resulted in decrease in AUC and a decrease in C_max of rosuvastatin. Adjust dose when co-administered with products that increase Rosuvastatin exposure, start with 5 mg daily dose if the expected increase in exposure (AUC) is 2-fold or higher. The maximum daily dose of Rosuvastatin should be adjusted so that the expected exposure would not likely exceed that of a 40 mg daily dose of Rosuvastatin taken without interacting medicinal products. If medicinal product increases rosuvastatin AUC less than 2- fold, the starting dose need not be decreased but use caution if increasing the Rosuvastatin dose above 20mg. Initiation or dosage up-titration when treating concomitantly with vitamin K antagonists (e.g. warfarin or another coumarin anticoagulant) may increase International Normalised Ratio (INR). Discontinuation or down-titration of Rosuvastatin may decrease INR, monitor appropriately. Concomitant use with oral contraceptive results in an increase in ethinyl estradiol and norgestrel AUC. Co-administration with medicines containing propylene glycol or ethanol may lead to ethanol accumulation, particularly in young children. Ability to drive/use machines: consider dizziness that may occur during treatment and that Rosuvastatin oral solution contains alcohol. Fertility, pregnancy and lactation: Rosuvastatin is contraindicated in pregnancy. Women of childbearing potential should use appropriate contraceptive measures. The potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. If a patient becomes pregnant during use of this product, discontinue treatment immediately. Contraindicated in lactation. Undesirable effects: For full list of side effects consult SmPC.  Common (≥ 1/100 to < 1/10): Diabetes mellitus, headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia. Overdose: No specific treatment. Treat symptomatically, liver function and CK levels should be monitored. Haemodialysis is unlikely to be of benefit.  MA number: PL 39307/0127. Cost: £190.40. MAH: SyriMed, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. Legal Category: POM. Date last reviewed: April 2025. Version number:  10103472736  v 1.0