How does it work?

Crestor tablets contain the active ingredient rosuvastatincalcium, which is a type of medicine called a statin. It works by reducing theproduction of cholesterol by the liver.

For the sake of simplicity, there are two sorts of cholesterol;a 'bad' sort called low density lipoprotein (LDL) and a 'good' sort called highdensity lipoprotein (HDL). LDL is deposited in the arteries and increases therisk of heart disease by clogging and narrowing the arteries, while HDLactually protects the arteries against this.

Rosuvastatin decreases the production of LDL cholesterol byblocking the action of the enzyme in the liver (called HMG-CoA reductase) thatis responsible for its production. This decreases the amount of cholesterol inthe liver cells, which causes them to take up LDL cholesterol from the blood.The decreased cholesterol production and increased removal of LDL cholesterolfrom the blood ultimately results in lowered blood cholesterollevels.

Rosuvastatin also causes a small decrease in the production ofother 'bad fats' in the blood called triglycerides, and a small increase in thelevel of HDL cholesterol. This results in lowered levels of 'bad fats' andraised levels of 'good fats'.

Statins have an important role in the prevention of coronaryheart disease. They reduce the risk of excess cholesterol being deposited inthe major blood vessels of the heart (atherosclerosis). Any blockage in theblood vessels limits the amount of blood and therefore oxygen being carried tothe heart muscle. This can cause chest pain (angina) and in severe cases canresult in a heart attack (myocardial infarction).

Rosuvastatin is used to lower cholesterol in people who havehigh levels either due to genetics (familial hypercholesterolaemia) or as aresult of diet and lifestyle. This helps to reduce the risk of atherosclerosis,angina and heart attacks (coronary heart disease).

It is important to continue to follow a cholesterol-loweringdiet and exercise regime while taking rosuvastatin. Discuss this with yourdoctor.

What is it used for?

• High blood cholesterol levels (primary hypercholesterolaemia).
• Inherited high blood cholesterol levels (familial hypercholesterolaemia).
• Inherited high levels of fat (lipids) in the blood (mixed hyperlipidaemia).
• Preventing heart attacks, strokes or other major cardiovascular problems in people who are assessed to be at high risk of having a cardiovascular problem.

Warning!

• This medicine may cause dizziness. Avoid driving and operating machinery if affected.
• It is recommended that you avoid drinking excessive amounts of alcohol while taking this medicine.
• 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.
• This medicine may very rarely have side effects on the muscles. 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 interstitial 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.

Use with caution in

• Decreased kidney function.
• History of liver disease.
• History of heavy alcohol consumption.
• Underactive thyroid gland (hypothyroidism).
• Personal or family history of hereditary muscle disorders.
• History of muscular side effects during previous treatment with a statin or fibrate medicine.
• People taking a fibrate medicine.
• People aged over 70 years.
• People of Asian origin.

Not to be used in

• Active liver disease.
• Unexplained raised results in liver function tests.
• Severely decreased kidney function.
• Any disease of the muscles (myopathy).
• 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.
• People taking fibrate medicines, such as bezafibrate, gemfibrozil.
• Pregnancy.
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Crestor 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 ofits ingredients. Please inform your doctor or pharmacist if you have previouslyexperienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacistimmediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine should not be used during pregnancy, as it may be harmful to the unborn baby. Women who could get pregnant should use effective method of contraception to prevent pregnancy while taking this medicine. If you fall pregnant while taking this medicine, stop taking it and consult your doctor immediately.
• There is no information available about the safety of this medicine during breastfeeding. It is not known if the medicine passes into breast milk. For this reason, the manufacturer states that it should not be used by women who are breastfeeding. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Dizziness.
• Abdominal pain.
• Constipation.
• Nausea.
• Pain in the muscles (myalgia).
• Weakness or loss of strength (asthenia).
• Presence of protein in the urine (with 40mg Crestor tablets).
• Diabetes mellitus.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Skin reactions such as rash and itch.
• Presence of protein in the urine (with 5mg, 10mg and 20mg Crestor tablets).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Severe allergic reactions, such as swelling of the lips, throat and tongue (angioedema), severe skin rashes or anaphylactic shock.
• Disorder of the muscles (myopathy).
• Muscle breakdown (rhabdomyolysis).
• Inflammation of the pancreas (pancreatitis).
• Alteration in results of liver function tests.

Very rare (affect less than 1 in 10,000 people)

• 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.

Unknown frequency

• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
• Diarrhoea.
• Cough.
• Shortness of breath.
• Interstitial lung disease.
• Depression.
• Sleep disturbances.
• Sexual problems.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

There may be an increased risk of side effects on the muscles(myopathy) if rosuvastatin is taken with any of the followingmedicines:

• other statins for lowering cholesterol
• fibrates for lowering cholesterol, eg bezafibrate, gemfibrozil
• ezetimibe
• nicotinic acid (niacin)
• ciclosporin (people taking ciclosporin must not take rosuvastatin)
• azole antifungals, eg ketoconazole
• protease inhibitors for HIV infection, eg ritonavir (rosuvastatin is not recommended for people taking protease inhibitors)
• macrolide-type antibiotics, eg clarithromycin.

The anti-blood-clotting effect of anticoagulants suchas warfarin may be increased by rosuvastatin. For this reason,if you are taking an anticoagulant your doctor may want to check yourblood-clotting time when you start or stop treatment with rosuvastatin, and ifyour dose is changed.

Antacids for indigestion, such as aluminium andmagnesium hydroxide, may decrease the absorption of rosuvastatin from the gut.This can be avoided if antacids are not taken within two hours of takingrosuvastatin.

Erythromycin may decrease the blood level ofrosuvastatin.

This medicine may increase the blood levels of hormonalcontraceptives or hormone replacementtherapy.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain rosuvastatin as the active ingredient.