IMPORTANT INFORMATION
ABOUT CRESTOR®(ROSUVASTATIN
CALCIUM)
Please read this summary carefully and then ask your health care professional about CRESTOR. No advertisement can provide all the information needed to determine
if a drug is right for you. This advertisement does not take the place of careful discussions with your health care professional. Only your healthcare professional has the
training to help weigh the risks and benefits of a prescription drug.
WHAT IS CRESTOR?
CRESTOR is a prescription medicine that belongs to a
group of cholesterol-lowering medicines called statins.
Along with diet. CRESTOR lowers "bad” cholesterol
(LDL-C) and increases "good" cholesterol (HDL-C).
CRESTOR also slov/s the progression of atherosclerosis
in adults with high cholesterol, as part of a treatment plan
to lower cholesterol to goal.
WHAT IS CHOLESTEROL?
Cholesterol is a fatty substance, also called a lipid,
normally found in your bloodstream. Your body needs a
certain amount of cholesterol to function property. But high
cholesterol can lead to health problems. LDL-C is called
bad cholesterol because if you have too much in your
bloodstream, it can become a danger to your health and
can lead to potentially serious conditions. HDL-C is known
as good cholesterol because it may help remove excess
cholesterol. Common health factors such as diabetes, high
blood pressure, smoking, obesity, family history of early
heart disease, and age can make controlling your choles-
terol even more important.
WHAT IS ATHEROSCLEROSIS?
Atherosclerosis is the progressive buildup of plaque in
the arteries over time. One major cause is high levels
of LDL-C. Other health factors, such as family history,
diabetes, high blood pressure, or if you smoke or are
overweight, also play a role in the formation of plaque
in arteries. Often this plaque starts building up in arteries
in early adulthood and gets worse over time.
HOW DOES CRESTOR WORK?
Most of the cholesterol in your blood is made in the liver.
CRESTOR works by blocking an enzyme in the liver.
Blocking this enzyme causes the liver to make less
cholesterol. CRESTOR helps the liver absorb and use
more cholesterol from the blood.
WHO SHOULD NOT TAKE CRESTOR?
Do not take CRESTOR if you
■ have had an allergic reaction to CRESTOR or are
allergic to any of its ingredients. The active ingredient
is rosuvastatin calcium. The inactive ingredients are:
microcrystalline cellulose, lactose monohydrate,
tribasic calcium phosphate, crospovidone, magnesium
stearate, hypromellose. triacetin. titanium dioxide,
yellow ferric oxide, and red ferric oxide
■ have liver problems
■ are pregnant or think you may be pregnant, or are
planning to become pregnant. CRESTOR may harm
your unborn baby. If you become pregnant, stop
taking CRESTOR and call your health care
professional right away
■ are breast-feeding. CRESTOR can pass into your
breast milk and may harm your baby
The safety and effectiveness of CRESTOR have not been
established in children.
HOW SHOULD I TAKE CRESTOR?
■ Take CRESTOR exactly as prescribed by your health
care professional. Do not change your dose or stop
CRESTOR without talking to your health care profes-
sional. even if you are feeling well
■ Your health care professional may do blood tests to
check your cholesterol levels during your treatment
with CRESTOR. Your dose of CRESTOR may be
changed based on these blood test results
■ CRESTOR can be taken at any time of day. with or
without food
■ Swallow the tablets whole
■ Your health care professional should start you on a
cholesterol-lowering diet before giving you CRESTOR.
Stay on this diet when you take CRESTOR
■ Wait at least 2 hours after taking CRESTOR to take an
antacid that contains a combination of aluminum and
magnesium hydroxide
■ If you miss a dose of CRESTOR. take it as soon as you
remember. However, do not take 2 doses of CRESTOR
within 12 hours of each other
■ If you take too much CRESTOR or overdose, call your
health care professional or a Poison Control Center
right away or go to the nearest emergency room
WHAT SHOULD I TELL MY
HEALTH CARE PROFESSIONAL
BEFORE TAKING CRESTOR?
Tell your health care professional if you
■ have diabetes, thyroid, liver or kidney problems
■ are pregnant or think you may be pregnant, or are
planning to become pregnant
■ are breast-feeding
■ have a history of muscle pain or weakness
■ drink alcoholic beverages
■ are of Asian ancestry
Tell your health care professional about all medicines you
take or plan to take, including prescription and nonpre-
scription medicines, vitamins, and herbal supplements.
Some medicines may interact with CRESTOR, causing
side effects. It is particularly important to tell your health
care professional if you are taking or plan to take
- cyclosporine (used after organ transplants)
- gemfibrozil (used to lower cholesterol)
- fibrates (used to lower cholesterol)
- niacin (used to lower cholesterol)
- warfarin (used for thinning blood)
- lopinavir/ritonavir combination (used to treat HIV/AIDS)
- birth control pills that contain ethinyl estradiol
or norgestrel
- antacids containing aluminum and magnesium
hydroxide (used for heartburn)
Know all of the medicines you take and what they look
like. It’s always a good idea to check that you have the
right prescription before you leave the pharmacy and
before you take any medicine.
Keep a list of your medicines with you to show your
health care professional. If you need to go to the hospital
or have surgery, tell all of your health care professionals
about all medicines that you are taking.
WHAT ARE THE POSSIBLE SIDE
EFFECTS OF CRESTOR?
CRESTOR can cause side effects in some people.
Serious side effects may include:
Muscle problems. Call your health care professional
right away if you experience unexplained muscle pain,
tenderness, or weakness, especially with fever. This
may be an early sign of a rare muscle problem that
could lead to serious kidney problems. The risk of
muscle problems is greater in people who are 65
years of age or older or who already have thyroid or
kidney problems. The chance of muscle problems may
be increased if you are taking certain other medicines
with CRESTOR.
Liver problems. Your health care professional should
do blood tests before you start taking CRESTOR and
during treatment to check for signs of possible
liver problems.
The most common side effects may include: headache,
muscle aches and pains, abdominal pain, weakness,
and nausea.
This is not a complete list of side effects of CRESTOR.
Talk to your health care professional for a complete list
or if you have side effects that bother you or that do not
go away.
HOW SHOULD I STORE CRESTOR?
Store your medication at room temperature, in a dry
place. If your health care professional tells you to stop
treatment or if your medicine is out of date, throw the
medicine away. Keep CRESTOR and all medicines in a
secure place and out of the reach of children.
WHERE CAN I GET MORE
INFORMATION ABOUT CRESTOR?
Talk to your health care professional. Full Prescribing
Information is available on www.CRESTOR.com or by
calling 1-800-CRESTOR.
GENERAL ADVICE
It is important to take CRESTOR as prescribed and to
discuss any health changes you experience while taking
CRESTOR with your health care professional. Do not use
CRESTOR for a condition for which it was not prescribed.
Do not give CRESTOR to other people, even if they have
the same medical condition. It may harm them. Keep
CRESTOR and all medicines away from children. This
summary provides important information about
CRESTOR. For more information, please ask your health
care professional about the full Prescribing Information
and discuss it with him or her.
Visit www.CRESTOR.com. Or call the Information Center
at AstraZeneca toll-free at 1-800-CRESTOR.
CRESTOR was licensed try AstraZeneca from Stw nogi S Co. LTD. Osaka. Japan. CRESTOR
«
a registered tradem ark o f the AstraZeneca group o f companies.
0 2 0 0 8 AstraZeneca Pharmaceuticals LP. AH rig hts reserved. AstraZeneca Pharmaceuticals IP, W ilm ington. D E 19850. Rev: 01/08 258864
A O «
C R EST O R
rosuvastatin calcium
AstraZeneca
