• Lowering high levels of total cholesterol, LDL cholesterol and other fats (called triglycerides and apolipoprotein B) in the blood in adults and children aged 10 years and over with primary hypercholesterolaemia, familial hypercholesterolaemia or mixed hyperlipidaemia. This medicine is used when a low-fat diet and lifestyle changes such as increased exercise have not reduced cholesterol enough.
• Preventing cardiovascular events such as angina, heart attacks, strokes or needing heart bypass surgery, in people with a high risk of heart disease, for example smokers, people who are overweight or obese, or people with diabetes, high blood pressure or a close family history of heart disease. The medicine can be used for this purpose even if your cholesterol levels are normal.

• You will need to take rosuvastatin every day on a long-term basis (unless otherwise directed by your doctor). This is because if you stop taking it, your body will start to make cholesterol again and your cholesterol levels will start to rise again.
• Rosuvastatin tablets should be taken once a day. They can be taken at any time of day, either with or without food.
• The dose of this medicine that is prescribed (how many tablets to take and what strength) will vary from person to person depending on your cholesterol levels, amongst other things. It is important to follow the instructions given by your doctor. These will be printed on the the dispensing label that your pharmacist has put on the packet of medicine.

• It is important that you continue to eat healthily and do regular exercise while you are taking this medicine. Discuss this with your doctor.
• This medicine may cause dizziness. Avoid driving and operating machinery if affected.
• This medicine may rarely cause liver problems. For this reason your doctor will want you to have blood tests to monitor your liver function (liver function tests) before starting treatment and regularly throughout treatment with this medicine. Consult your doctor promptly if you develop unexplained itching, yellowing of the skin or whites of the eyes (jaundice), unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine, as these could be signs of a liver problem.
• It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine, because this may increase the risk of liver problems or side effects on the muscles (see below).
• This medicine may rarely have side effects on the muscles that may progress to cause kidney problems. For this reason, you should inform your doctor immediately if you experience any muscular symptoms such as pain, tenderness, cramps, or weakness while taking this medicine, particularly if it is accompanied by a fever or feeling generally unwell. Your doctor may need to check for side effects on the muscles by taking a blood test to measure the level of a compound called creatinine kinase in your blood. If this is the case, the test should not be done following strenuous exercise.
• Statins may very rarely be associated with a type of lung disease. For this reason, you should consult your doctor if you experience shortness of breath or difficulty breathing, a non-productive cough and deterioration in your general health (eg weight loss, fever, fatigue) while taking this medicine.
• A 40mg dose of this medicine should only be used in people with very high cholesterol levels and a high risk of heart disease, whose cholesterol is not lowered sufficiently with a 20mg dose and who can have regular check-ups with their doctor. A 40mg dose should not be used in people with moderately decreased kidney function, an underactive thyroid gland, a personal or family history of hereditary muscle disorders, or a history of muscle side effects on previous statin or fibrate medicines. A 40mg dose should also not be used in children and adolescents, people of Asian origin, people taking fibrate medicines and people who drink large amounts of alcohol.
• People who are taking a 40mg dose of this medicine should have their kidney function monitored.
• This medicine is not licensed for children under 10 years of age. There is currently only limited experience of the long-term safety of the medicine in children aged 10 to 18 years. If you are concerned about your child taking this medicine you can ask your doctor or pharmacist for more information and advice.

• People aged over 70 years.
• People of Asian origin.
• People with decreased liver function or a history of liver disease.
• People who drink large amounts of alcohol.
• People with decreased kidney function.
• People with an underactive thyroid gland (hypothyroidism).
• Personal or family history of hereditary muscle disorders.
• People who have previously experienced muscular side effects while taking a statin or fibrate medicine.

• People with active liver disease.
• People with unexplained raised results in liver function tests.
• People with severely decreased kidney function.
• People with any disease of the muscles (myopathy).
• People with acute, serious conditions that suggest to the doctor you may have a muscle disease, or are predisposed to kidney failure secondary to breakdown of muscle cells.
• People taking the medicine ciclosporin.
• Pregnancy.
• Breastfeeding.
• People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Rosuvastatin tablets contain lactose).
• There is insufficient information regarding the safety and efficacy of this medicine in children under 10 years of age. It is not recommended for children aged under 10 years. This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

•Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• This medicine should not be used during pregnancy because it may be harmful to a developing baby. Pregnancy should also be avoided for one month after stopping treatment. Women who could get pregnant should use an effective method of contraception to prevent pregnancy both during treatment with this medicine and for one month after stopping treatment. Talk to your doctor straight away if you think you could be pregnant while taking this medicine, or want to try for a baby.
• It is not known if this medicine passes into breast milk. However, because it has the potential to cause serious side effects in a nursing infant, the manufacturer states that it should not be taken by women who are breastfeeding. Women who need to take this medicine should not breastfeed their babies and use formula instead. Seek further medical advice from your doctor.

•Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
• Headache.
• Dizziness.
• Abdominal pain.
• Constipation.
• Feeling sick.
• Pain in the muscles (myalgia).
• Feeling weak.
• Diabetes mellitus. Your doctor will monitor your blood sugar while you are taking this medicine.
• Presence of protein in the urine (with the 40mg dose).
• Skin reactions such as rash, itching and hives.
• Presence of protein in the urine (with the 5mg, 10mg or 20mg dose).
• Muscle problems such as inflammation of the muscles (myositis) or muscle breakdown (rhabdomyolysis) - see warning section above for symptoms to look out for and report to your doctor.
• Severe allergic reactions, such as swelling of the lips, throat and tongue (angioedema), severe skin rashes or anaphylactic shock.
• Inflammation of the pancreas (pancreatitis).
• Alteration in results of liver function tests.
• Pain in the joints (arthralgia).
• Inflammation of the liver (hepatitis).
• Yellowing of the skin and eyes (jaundice).
• Memory loss.
• Damage to nerves causing numbness in the arms and legs.
• Blood in the urine.
• Breast enlargement in men (gynaecomastia).
• Unknown frequency
• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
• Diarrhoea.
• Cough.
• Shortness of breath.
• Swelling due to fluid retention (oedema).
• The following side effects have been reported with other statins and may also be possible with rosuvastatin:
• Sleep disturbances, including difficulty sleeping or nightmares.
• Interstitial lung disease (see warning section above).
• Depression.
• Sexual problems.
• Tendon injury. The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

•It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe. There may be an increased risk of side effects on the muscles (myopathy) if any of the following medicines are taken in combination with rosuvastatin:
• ciclosporin (people taking ciclosporin must not take rosuvastatin)
• colchicine
• daptomycin
• ezetimibe
• fibrates for lowering cholesterol, eg bezafibrate, gemfibrozil
• fusidic acid (this is not recommended with rosuvastatin - if you need to take a course of this antibiotic your doctor may recommend that you temporarily stop taking rosuvastatin during the course and not start it again until seven days after you finish the course of fusidic acid)
• nicotinic acid (niacin)
• other statins for lowering cholesterol
• protease inhibitors for HIV infection, eg atazanavir, nelfinavir, lopinavir, indinavir, ritonavir, tipranavir (rosuvastatin is not recommended for people taking protease inhibitors). If you are prescribed any of the medicines listed above in combination with your rosuvastatin, it is important to let your doctor know if you experience any unexplained muscle symptoms, such as pain or tenderness, muscle weakness or muscle cramps. The anti-blood-clotting effect of anticoagulants such as warfarin may be increased by rosuvastatin. For this reason, if you are taking an anticoagulant your doctor may want to check your blood-clotting time when you start or stop treatment with rosuvastatin, and if your dose is changed. Antacids for indigestion, such as aluminium and magnesium hydroxide, may decrease the absorption of rosuvastatin from the gut. This can be avoided if antacids are not taken within two hours of taking rosuvastatin. Erythromycin may decrease the blood level of rosuvastatin.

•Read the package insert and/or patient product information sheet that comes with your prescription.
• Most medications should be stored in a dry place away from heat and humidity.
• Some medications also have special instructions for storage. Check for special instructions on your prescription label.
• If your medication needs to be protected from light, it should be stored in a container that filters out light, such as a clean film canister.
• If your medication needs to be refrigerated, and you do not have a fridge available (for example, if you are working outside or on the road all day), try using a cooler with an ice pack. An ordinary cooler found at hardware or sporting goods stores will do.

•Consult your doctor for further instructions and also read the package insert and/or patient product information sheet that comes with your prescription.