Why is this medication prescribed?

Rosuvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Rosuvastatin is also used to decrease the amount of cholesterol (a fat-like substance) and other fatty substances in the blood in adults and children at least 10 years of age. Rosuvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

How should this medicine be used?

Rosuvastatin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take rosuvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosuvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of rosuvastatin and gradually increase your dose, not more than once every 2 to 4 weeks.

Continue to take rosuvastatin even if you feel well. Do not stop taking rosuvastatin without talking to your doctor.

Other uses for this medicine

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This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

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Before taking rosuvastatin,

tell your doctor and pharmacist if you are allergic to rosuvastatin, any other medications, or any of the ingredients in rosuvastatin tablets. Ask your pharmacist or check the medication guide for a list of the ingredients.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin

(Coumadin); cimetidine (Tagamet); cyclosporine (Neoral, Sandimmune); ketoconazole (Nizoral); other medications for high cholesterol such as clofibrate (Atromid-S), fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (Niaspan, Niacor); certain HIV protease inhibitors including atazanavir (Reyataz), taken with ritonavir (Norvir) and lopinavir and ritonavir (Kaletra); and spironolactone (Aldactone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

if you are taking aluminum and magnesium hydroxide antacids (Mylanta, Maalox), take them at least 2 hours after rosuvastatin.

tell your doctor if you have liver disease. Your doctor will order laboratory tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take rosuvastatin if you have liver disease or if the tests show that you may be developing liver disease.

tell your doctor if you are Asian, if you drink more than 2 alcoholic beverages daily, if you have ever had liver disease, or if you have or have ever had seizures, low blood pressure, or kidney or thyroid disease.

tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking rosuvastatin, call your doctor immediately. Rosuvastatin may harm the fetus.

do not breastfeed while taking rosuvastatin.

you should know that the risk that you will develop serious muscle and kidney problems during your treatment with rosuvastatin is higher if you are 65 years of age or older. Talk to your doctor about the risks of taking rosuvastatin.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rosuvastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking rosuvastatin.

ask your doctor about the safe use of alcoholic beverages while you are taking rosuvastatin. Alcohol can increase the risk of serious side effects.

What special dietary instructions should I follow?

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Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

What should I do if I forget a dose?

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Take the missed dose as soon as you remember it. However, if it is less than 12 hours before your next dose is scheduled, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

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Rosuvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

constipation heartburn dizziness difficulty falling asleep or staying asleep depression joint pain cough memory loss or forgetfulness confusion

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help:

:

muscle pain, tenderness, or weakness lack of energy fever chest pain yellowing of the skin or eyes dark colored urine pain in the upper right part of the abdomen nausea extreme tiredness weakness unusual bleeding or bruising loss of appetite flu-like symptoms sore throat, chills, or other signs of infection rash hives itching difficulty breathing or swallowing swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

hoarseness numbness or tingling in fingers or toes

Rosuvastatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

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Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

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In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

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Keep all appointments with your doctor and the laboratory. Your doctor may order lab tests during your treatment, especially if you develop symptoms of liver damage.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking rosuvastatin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

About rosuvastatin

Type of medicine A lipid-regulating medicine commonly known as a statin

Used forLowering cholesterol and other lipids (fats) in the bloodTo reduce the risk of heart and blood vessel disease

Also called Crestor®Available as Tablets

Lipid is another word for fat. Lipids are easily stored in your body and serve as a source of energy. Cholesterol is a lipid. It is made naturally in your body from the food you eat. When the concentration of cholesterol in your blood is too high, it is called hypercholesterolaemia.

In hypercholesterolaemia, small fatty patches called atheroma develop within the inside lining of your blood vessels. Over time, these patches can make a blood vessel narrower and this is called atherosclerosis or 'hardening of the arteries'. This narrowing reduces the blood flow through the artery and increases the risk of a number of heart and blood vessel diseases, such as heart attack and stroke.

Rosuvastatin reduces the amount of lipids such as cholesterol made by your body. It does this by blocking the action of a certain enzyme which is needed to make cholesterol. This lowers your risk of heart and blood vessel disease. It can also reduce this risk, even if your cholesterol levels are normal, if you are at an increased risk of heart disease.

Before taking rosuvastatin

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking rosuvastatin it is important that your doctor or pharmacist knows:

If you are pregnant, trying for a baby or breast-feeding. If you have any liver problems, or if you have ever had a disease which has affected your

liver. If you have ever had muscle problems, or if you have repeated or unexplained muscle

aches or pains. If you regularly drink large amounts of alcohol. If you have a thyroid disorder. If you have kidney problems. If you are of Asian origin. If you have ever had an allergic reaction to this or to any other medicine. If you are taking any other medicines, including those available to buy without a

prescription, herbal and complementary medicines.

How to take rosuvastatin

Before you start this treatment, read the manufacturer's printed information leaflet from inside the pack. The leaflet will give you more information about the brand of rosuvastatin you have been given and a full list of possible side-effects from taking it.

Take rosuvastatin once each day exactly as your doctor has told you. Your dose will also be on the label of the pack.

You can take rosuvastatin at any time of day, and either before or after food. However, try to take rosuvastatin at the same time each day as this will help you to remember to take your dose.

If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose. Do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. You will need to have blood tests, particularly when you first start treatment. The tests will check that your liver has not been affected by taking rosuvastatin, and may also measure your cholesterol level.

Your doctor will give you advice about eating a healthy diet, reducing the amount of salt in your diet, stopping smoking and taking regular exercise. Following this advice will also help you to reduce your risk of developing heart and blood vessel disease.

Cut down on the amount of alcohol you normally drink. This is because alcohol can increase the risk of side-effects to your liver.

Women who could become pregnant should not take rosuvastatin unless they are using an effective contraceptive. If this affects you, ask your doctor for advice about suitable contraception.

If you buy any medicines, check with a pharmacist that they are suitable to take with rosuvastatin.

Can rosuvastatin cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

Common rosuvastatin side-effects - these affect less than 1 in 10 people who take this medicine

What can I do if I experience this?

Muscle aches, pains, weakness, or tenderness

Although this may not be anything to be concerned about, you should tell your doctor about this. This is because there is a rare but serious side-effect of rosuvastatin which is a severe form of muscle inflammation

Headache Ask your pharmacist to recommend a suitable painkiller

ConstipationTry to eat a well-balanced diet and drink plenty of water each day

Feeling sick, abdominal pain Stick to bland foods - avoid rich or spicy foodDisturbed sleep, feeling dizzy or tired, forgetfulness, depression, sexual problems

Speak with your doctor if any of these become troublesome

Important: if you experience any of the following rare but serious symptoms, stop taking rosuvastatin and contact your doctor for advice straightaway:

Any unexplained shortness of breath or cough. This is because (in very rare cases), rosuvastatin may cause a disease called interstitial lung disease.

Any swelling of your face or mouth, or a severe skin rash. These may be signs that you are allergic to rosuvastatin.

If you experience any other symptoms which you think may be due to this medicine, discuss them with your doctor or pharmacist.

How to store rosuvastatin

Keep all medicines out of the reach and sight of children. Store in a cool, dry place, away from direct heat and light.

Reference

British National Formulary; 62nd Edition (Sep 2011) British Medical Association and Royal Pharmaceutical Society of Great Britain, London

Manufacturer's PIL, Crestor® 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets ; Manufacturer's PIL, Crestor® 5 mg, 10 mg, 20 mg and 40 mg film-coated tablets, AstraZeneca UK Ltd, electronic Medicines Compendium. Dated September 2011.

Medicine net.com

GENERIC NAME: rosuvastatin

BRAND NAME: Crestor

DRUG CLASS AND MECHANISM: Rosuvastatin is an oral drug for lowering blood cholesterol levels. It belongs to a class of drugs called HMG-CoA reductase inhibitors, more commonly referred to as "statins." Other drugs in this class include simvastatin (Zocor), lovastatin (Mevacor), pravastatin (Pravachol), atorvastatin (Lipitor) and fluvastatin (Lescol). These drugs reduce cholesterol levels by inhibiting HMG-CoA reductase, an enzyme that produces cholesterol in the liver. Rosuvastatin and other statins lower blood total cholesterol as well as blood LDL cholesterol levels. LDL cholesterol is the "bad" type of cholesterol that increases the risk of coronary artery disease (atherosclerosis) and heart attacks. Lowering LDL cholesterol levels slows the progression of coronary artery disease and may even reverse it. Statins also increase HDL cholesterol, the "good" type of cholesterol, and reduce triglycerides. Scientists have discovered that in addition to atherosclerosis, inflammation of the coronary arteries may also contribute to the development of heart attacks. The presence of inflammation can be determined by measuring a chemical in the blood called highly sensitive, C-reactive protein (Hs-CRP). Moreover, Hs-CRP can be used to predict the occurrence of heart attacks, strokes and death. Hs-CRP is, in fact, a better predictor of the risk for heart attacks than LDL cholesterol. Scientists have found that statins reduce the level of Hs-CRP in the body, presumably by reducing inflammation in the coronary arteries, and this may be another mechanism through which statins prevent heart attacks, strokes, and death. More research needs to be conducted, however, to confirm the importance of inflammation and the mechanisms through which statins work. Rosuvastatin was approved by the FDA in August 2003.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Tablets: 5, 10, 20, and 40 mg

STORAGE: Rosuvastatin should be stored at room temperature between 2-25 C (36-77 F).

PRESCRIBED FOR: Rosuvastatin is used for the reduction of blood total cholesterol, HDL cholesterol and triglyceride levels, and to increase HDL cholesterol levels. Rosuvastatin also is used for reducing the risk of heart attacks, stroke, and arterial revascularization procedures in patients without clinically evident coronary heart disease but with multiple risk factors for heart disease.

DOSING: The starting dose for most adults is 5 mg once daily. The maximum dose is 40 mg daily, and this dose should be reserved for patients who do not adequately respond to a 20 mg dose.

DRUG INTERACTIONS: When administered with cyclosporine, the blood level of rosuvastatin increases seven fold, and this could increase the side effects of rosuvastatin. Rosuvastatin increases the action of the blood thinner warfarin (Coumadin) and could increase the risk of bleeding from warfarin.

Antacids reduce the absorption of rosuvastatin and should be administered two hours after rosuvastatin.

The use of rosuvastatin with nicotinic acid, gemfibrozil (Lopid) or other drugs that may cause liver or muscle injury may increase the incidence of the muscle injury.

PREGNANCY: Statins should not be used by pregnant women because there is a high risk of harm to the fetus.

NURSING MOTHERS: There is no information on whether rosuvastatin is excreted in breast milk.

SIDE EFFECTS: The most common side effects of rosuvastatin are headache, nausea, vomiting, diarrhea and muscle pain. The most serious side effects are liver failure, muscle breakdown (rhabdomyolysis) and kidney failure. Sever liver disease of liver failure caused by statins is very rare. More often, statins cause mild abnormalities in liver tests due to injury to the liver. The abnormalities usually disappear with continued therapy, but if the level is over three times the upper limit of normal or baseline, practitioners usually stop the statin. Liver function tests should be performed at the beginning of treatment then as needed thereafter. Rhabdomyolysis is a very rare but serious side effect of statin therapy. When used alone the frequency of rhabdomyolysis due to statins is less than one percent. Rhabdomyolysis is a process in which there is severe injury to muscles leading to severe pain and the release of muscle protein (myoglobin) into the blood. Myoglobin may cause kidney failure. To prevent the occurrence of rhabdomyolysis, patients taking statins who develop unexplained muscle pain, weakness, or tenderness should report the symptoms to their health care professional.

Rosuvastatin may cause reversible increases in the amount of protein excreted by the kidneys, and in some patients kidney failure has occurred as a result. This effect depends on the dose and occurs more often at the 40 mg dose. Statins have been associated with increases in HbA1c and fasting serum glucose levels, as occur with diabetes. There are also post-marketing reports of memory loss, forgetfulness, amnesia, confusion, and memory impairment. Symptoms may start one day to years after starting treatment and resolve within a median of three weeks after stopping the statin.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking rosuvastatin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily.Dosage is based on your medical condition, response to treatment, age, race, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). If you are of Asian descent, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.Antacids containing aluminum or magnesium can reduce the absorption of this drug. Therefore, if taking this type of antacid, take it at least 2 hours after this medication.Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel

sick.It is very important to continue to follow your doctor's advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

SIDE EFFECTS: Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very small number of people taking rosuvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.Tell your doctor right away if this unlikely but serious side effect occurs: foamy urine.This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rosuvastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with rosuvastatin. Ask your doctor or pharmacist for more information.Older adults may be more sensitive to the side effects of this drug, especially muscle problems.This medication must not be used during pregnancy. Rosuvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as

warfarin).Other medications can affect the removal of rosuvastatin from your body, which may affect how rosuvastatin works. One example is cyclosporine, among others.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose (within 12 hours), skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Medical news today

Crestor (Rosuvastatin) belongs to a class of drugs known as "statins" or "HMG CoA reductase inhibitors". Crestor reduces low-density lipoprotein (LDL) and raises high-density lipoprotein (HDL). The medication is also prescribed to lower triglycerides in the blood.

LDL (low density lipoprotein) - also known as "bad cholesterol". LDL carries cholesterol from the liver to cells. If too much LDL is carried, more than the cells can use, there can be a harmful accumulation of LDL, which raises the risk of arterial disease. Human blood contains about 70% LDL - although this can vary.

Crestor, like other statins, prevents the production of LDL by suppressing HMG-CoA reductase, an enzyme in the liver that plays a crucial role in cholesterol production. By doing this, the medication helps prevents coronary artery diseases, and other cardiovascular diseases, such as heart attack, stroke and angina.

Crestor can lower LDL production by up to 52% (at 10mg dose compared to 7% with placebo), according to pharmaceutical company AstraZeneca. The company adds that for greatest results, Crestor treatment should be accompanied by a diet low in saturated fats and cholesterol and regular physical exercise.

HDL (high density lipoprotein) - also known as "good cholesterol". According to experts, HDL protects us from arterial disease; it takes cholesterol away from cells and returns it to the liver, in effect doing the opposite of LDL. Cholesterol is either broken down in the liver or expelled from

the body as waste.

Crestor also raises blood levels of HDL.

Triglycerides - these are chemicals, consisting of three molecules of fatty acid combined with a molecule of the alcohol glycerol, and are the major forms of fat stored in the human body. Triglycerides are present in blood plasma. Together with cholesterol, triglycerides form the blood fats (plasma lipids). When our body requires energy and there is no food as an energy source, hormones are released which in turn release triglycerides from fat cells, these are then used as energy. When triglyceride levels are too high, there is a greater risk of developing atherosclerosis (hardening of the arteries) and inflammation of the pancreas.

Crestor has been proven to slow down the progression of atherosclerosis, when taken along with a special diet and exercise.

A 2009 study found that Crestor reduced the risk of venous thromboembolism (blood clots) by 43% when given to healthy adults

Crestor's primary medical use

Crestor's primary medical use is for treating dyslipidemia - a lipoprotein metabolism disorder which results in high triglyceride and LDL concentrations, and low levels of HDL in the blood. According to the US FDA (Food and Drug Administration), it should only be prescribed if other measures have not worked, such as losing weight, changing diet, and doing exercise.

Crestor indications

Crestor has been approved in the USA for the treatment of:

Dyslipidemia Hypercholesterolemia - high total cholesterol Hypertriglyceridemia - high triglycerides For the primary prevention of cardiovascular events - including congenital heart disease,

disorders of the peripheral vascular system, arteriosclerosis, hypertension, arrhythmia, heart valve disease, orthostatic hypotension, endocarditis, heart failure, diseases of the aorta and its branches, and coronary artery disease.

Crestor was first approved in the USA in August 2003. By 2004 it was approved in 154 countries and marketed in 56.

Important information regarding Crestor

The following people should not take Crestor:

Those who are allergic to rosuvastatin Pregnant mothers. If you become pregnant, stop taking Crestor and tell your doctor. Breastfeeding mothers Patients with liver disease

The following groups of people should make sure their doctors know before being prescribed Crestor:

Patients with kidney disease Individuals with liver disease People with diabetes Patients with a thyroid disorder Those with Chinese ancestry People who consume more than two alcoholic drinks each day

Tell your doctor immediately if you have unexplained weakness or muscle pain, experience unexplained tiredness, lose your appetite, have upper belly pain, produce dark urine, or develop jaundice. All these are signs and symptoms of rare put potentially serious side effects.

Patients taking Crestor run a very slight risk of developing rhabdomyolysis, breakdown of the skeletal muscles which release certain proteins, including myoglobin into the bloodstream. Myoglobin can damage the kidneys and cause kidney failure. Anybody suspected of developing rhabdomyolysis should stop taking Crestor immediately.

Diet - Crestor will be less effective if the patient does not follow a cholesterol-lowering diet plan. Patients must avoid foods that are high in cholesterol and fat.

Alcohol can raise triglyceride levels, as well as raising the chance of liver damage. Alcohol should be avoided.

Other medications - certain medications may increase the risk of medical problems and complications if taken together with Crestor. Examples include, cyclosporine, gemfibrozil, drugs that contain niacin, some HIV medications (atazanavir, ritonavir, lopinavir/ritonavir, and saquinavir), and fenofibrate.

What are the side effects of Crestor?

The most common side effects linked to Crestor therapy include:

Abdominal pain Blurred vision Clay-colored stools Confusion Dark urine Drowsiness Fever

Headache Jaundice Memory problems Muscle aches Nausea Swelling Weakness, muscle pain, tenderness Weight gain

Crestor is licensed from Shionogi & Co, Ltd, Japan, and is manufactured and marketed by AstraZeneca.

n this factsheet:

How does CO Rosuvastatin work? What will it do for me? How should I use CO Rosuvastatin? What form(s) does CO Rosuvastatin come in? Who should NOT take CO Rosuvastatin? What side effects are possible with CO Rosuvastatin? Are there any other precautions or warnings for CO Rosuvastatin? What other drugs could interact with CO Rosuvastatin?

DIN (Drug Identification Number)

02339765 CO ROSUVASTATIN 5MG TABLET

02339773 CO ROSUVASTATIN 10MG TABLET

02339781 CO ROSUVASTATIN 20MG TABLET

02339803 CO ROSUVASTATIN 40MG TABLET

How does CO Rosuvastatin work? What will it do for me?

Rosuvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins"). It is used, along with a healthy diet and exercise program, to improve cholesterol levels by lowering bad cholesterol and raising good cholesterol. It is also used to treat people who have certain inherited cholesterol disorders.

Rosuvastatin works by blocking the enzyme that helps make cholesterol in the body. People with high blood cholesterol levels have a higher risk of heart diseases such as heart attacks. When cholesterol levels are lowered with a combination of medication, diet, and exercise, the risk of

heart disease is lowered, too. It takes 2 to 4 weeks to see the maximum effect of this medication on cholesterol levels in blood tests.

It can also be used to reduce the risk of heart attacks, stroke, and angioplasty for people who have at least 2 risk factors for cardiovascular disease.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use CO Rosuvastatin?

Before starting rosuvastatin, you should be following a cholesterol-lowering diet. If appropriate, a program of weight control and physical exercise should also be implemented.

The recommended dose of rosuvastatin ranges between 5 mg and 40 mg once daily. For most people, the usual recommended starting dose of rosuvastatin is 10 mg once daily. It may be taken in the morning or in the evening, with or without food. If necessary, the dose may be increased to a maximum of 40 mg daily. People who require the maximum dose of 40 mg per day should consult a specialist.

For people with severely reduced liver function, the maximum daily dose is 20 mg.

For people with severely reduced kidney function, the maximum daily dose is 10 mg.

A starting dose of 5 mg daily is recommended for people of Asian descent (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin) and those who have severe kidney problems. This low dose should also be considered for people who do not need aggressive cholesterol-lowering effects and for people who may be at a greater risk of experiencing muscle-related problems.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is very important to take this medication exactly as prescribed by the doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and carry on with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does CO Rosuvastatin come in?

5 mgEach yellow, film-coated, round, biconvex, tablet with a symbol on one side and "RU5" on the other side contains rosuvastatin calcium equivalent to 5 mg rosuvastatin. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium carbonate monohydrate, sodium dodecyl sulphate, iron oxide yellow, polyethylene glycol, polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide.

10 mgEach pink, film-coated, round, biconvex, tablet with a symbol on one side and "RU10" on the other side contains rosuvastatin calcium equivalent to 10 mg rosuvastatin. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium carbonate monohydrate, sodium dodecyl sulphate, FD&C Blue No. 2, FD&C Red No. 40, iron oxide red, iron oxide yellow, polyethylene glycol,  polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide.

20 mgEach pink, film-coated, round, biconvex, tablet with a symbol on one side and "RU20" on the other side contains rosuvastatin calcium equivalent to 20 mg rosuvastatin. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium carbonate monohydrate, sodium dodecyl sulphate, FD&C Blue No. 2, FD&C Red No. 40, iron oxide red, iron oxide yellow, polyethylene glycol,  polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide.

40 mgEach pink, film-coated, round, biconvex, tablet with a symbol on one side and "RU40" on the other side contains rosuvastatin calcium equivalent to 40 mg rosuvastatin. Nonmedicinal ingredients: crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium carbonate monohydrate, sodium dodecyl sulphate, FD&C Blue No. 2, FD&C Red No. 40, iron oxide red, iron oxide yellow, polyethylene glycol,  polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide.

Who should NOT take CO Rosuvastatin?

Rosuvastatin should not be taken by anyone who:

is allergic to rosuvastatin or to any of the ingredients of the medication

is pregnant is breast-feeding is taking cyclosporine has active liver disease or has unexplained increases in certain liver function tests

The 40 mg strength of rosuvastatin should not be taken by anyone who:

is of Asian descent (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin)

is taking niacin or a fibrate (e.g., gemfibrozil, fenofibrate) has alcoholism or consumes large quantities of alcohol has an inherited muscle disorder or a family history of these disorders has had muscle damage with another statin medication (e.g., lovastatin, pravastatin,

simvastatin) has hypothyroidism has other medical conditions or is taking other medications that would increase blood

levels of rosuvastatin (check with your doctor or pharmacist to see if this applies to you) has severely reduced liver or kidney function

DIN (Drug Identification Number)

02339765 CO ROSUVASTATIN 5MG TABLET02339773 CO ROSUVASTATIN 10MG TABLET02339781 CO ROSUVASTATIN 20MG TABLET02339803 CO ROSUVASTATIN 40MG TABLET

What side effects are possible with CO Rosuvastatin?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

constipation dizziness headache nausea stomach pain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)

symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine - especially if you also have a fever or a general feeling of being unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)

symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for CO Rosuvastatin?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

January 24, 2013

Health Canada has issued new restrictions concerning the use of rosuvastatin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Kidney problems: People with decreased kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Your doctor will perform regular tests to check your liver function. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. People with a history of liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Muscle damage: In rare cases, serious muscle damage been associated with the use of statin medications, especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

are of Asian ancestry (Chinese, Filipino, Japanese, Korean, Vietnamese, or Asian-Indian origin) are over the age of 70 are taking other cholesterol-lowering medication such as fibrates (e.g., gemfibrozil, fenofibrate)

or niacin are taking other medications (as drug interactions are possible), including prescription, non-

prescription, and natural health products do excessive physical exercise have diabetes have a family history of muscular disorders have had any past problems with muscles (pain, tenderness) after taking a statin have kidney or liver problems have thyroid problems have undergone surgery or other tissue injury regularly drink 3 or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: This medication should not be taken during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if rosuvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, if may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: There is limited experience with the use of this medication by children. Its safety and effectiveness have not been established for this age group. If rosuvastatin is to be used by a child, the treatment should be supervised by a specialist.

Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.

What other drugs could interact with CO Rosuvastatin?

There may be an interaction between rosuvastatin and any of the following:

antacids (if taken within 2 hours of taking rosuvastatin) anticoagulants (e.g., warfarin) antifungal agents (e.g.,, itraconazole, ketoconazole) birth control pills cyclosporine fenofibrate gemfibrozil lopinavir - ritonavir macrolide antibiotics (e.g., erythromycin, clarithromycin) niacin (nicotinic acid) warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications, change one of the medications to another, change how you are taking one or both of the medications, or leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Important Safety Information about CRESTOR® (rosuvastatin calcium) Tablets

CRESTOR is not right for everyone. Do not take CRESTOR if you are nursing, pregnant or may become pregnant; have liver problems; or have had an allergic reaction to CRESTOR

Your doctor should do blood tests to check your liver before starting treatment with CRESTOR and if you have symptoms of liver problems while taking CRESTOR

Call your doctor right away if you: o Have unexplained muscle pain or weakness, especially with fever o Have muscle problems that do not go away even after your doctor told you to stop

taking CRESTORo Feel unusually tiredo Have loss of appetite, upper belly pain, dark urine, or yellowing of skin or eyes

These could be signs of rare but serious side effects

Elevated blood sugar levels have been reported with statins, including CRESTOR Side effects: The most common side effects may include headache, muscle aches, abdominal

pain, weakness, and nausea. Memory loss and confusion have also been reported with statins, including CRESTOR

Tell your doctor and pharmacist about other medicines you are taking

Talk to your doctor about prescription CRESTOR.

Approved Uses for CRESTOR

When diet and exercise alone aren't enough, adding CRESTOR can help.

In adults, CRESTOR is prescribed along with diet to lower high cholesterol and to slow the buildup of plaque in arteries as part of a treatment plan to lower cholesterol to goal.

Prescribing Information with Patient Information (PDF - 152k)

The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions, talk to your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

CRESTOR is licensed from SHIONOGI & CO, LTD, Osaka, Japan.

CRESTOR is a registered trademark, and CRESTOR 360° and AZ&Me are trademarks of the AstraZeneca group of companies.