1. 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
Return to top
This medication may be prescribed for other uses; ask your doctor or pharmacist for more
information.
What special precautions should I follow?
Return to top
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

2. (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?
Return to top
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?
Return to top

3. 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?
Return to top
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

4. 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?
Return to top
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
Return to top
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?
Return to top
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 (overthe-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.

5. About rosuvastatin
Type of medicine A lipid-regulating medicine commonly known as a statin
Lowering cholesterol and other lipids (fats) in the blood
Used for
To 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

6. 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 sideeffects - these affect less than 1
in 10 people who take this
medicine
What can I do if I experience this?
Although this may not be anything to be concerned about,
Muscle aches, pains, weakness, or you should tell your doctor about this. This is because there is
tenderness
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

7. Constipation
Feeling sick, abdominal pain
Disturbed sleep, feeling dizzy or
tired, forgetfulness, depression,
sexual problems
Try to eat a well-balanced diet and drink plenty of water each
day
Stick to bland foods - avoid rich or spicy food
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

8. 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.

9. 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

10. 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

11. 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 highdensity 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

12. 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:

13. 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

14. 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

15. 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 musclerelated 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.

16. 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 mg
Each 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 mg
Each 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 mg
Each 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 mg
Each 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

17. 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
02339773
02339781
02339803
CO ROSUVASTATIN 5MG TABLET
CO ROSUVASTATIN 10MG TABLET
CO ROSUVASTATIN 20MG TABLET
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

18. 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, claycoloured 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.

19. 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, nonprescription, 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 breastfeeding 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?

20. 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 CRESTOR
o Feel unusually tired
o 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

21. 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.