ZETIA
®
(EZETIMIBE) TABLETS
PATIENT INFORMATION ABOUT
ZETIA
(zet-e-a)
Generic name: ezetimibe (e-zet'-e-mib)
Read this information carefully before you start taking ZETIA
and each time you get more ZETIA. There may be new information.
This information does not take the place of talking with your
doctor about your medical condition or your treatm ent. If you have
any questions about ZETIA, ask your doctor. Only your doctor
can determine if ZETIA is right for you.
WHAT IS
ZETIA
?
ZETIA is a medicine used to lower levels of total cholesterol and
LDL (bad) cholesterol in the blood. ZETIA is for patients who
cannot control their cholesterol levels by diet and exercise alone.
It can be used by itself or with other medicines to treat high
cholesterol. You should stay on a cholesterol-lowering diet while
taking this medicine.
ZETIA works to reduce the amount of cholesterol your body
absorbs. ZETIA does not help you lose weight. ZETIA has not been
shown to prevent heart disease or heart attacks.
For more information about cholesterol, see the "W ha t should I know
about high cholesterol?" section that follows.
WHO SHOULD NOT TAKE
ZETIA?
• D o not take ZETIA if you are allergic to ezetimibe, the active
ingredient in ZETIA, or to the inactive ingredients. For a list of
inactive ingredients, see the "Inactive ingredients" section
that follows.
• If you have active liver disease, do not take ZETIA while taking
cholesterol-lowering medicines called statins.
• If you are pregnant or breast-feeding, do not take ZETIA while
taking a statin.
• If you are a wom an of childbearing age, you should use an
effective method of birth control to prevent pregnancy while
using ZETIA added to statin therapy.
ZETIA has not been studied in children under age 10.
WHAT SHOULD I TELL MY DOCTOR BEFORE
AND WHILE TAKING
ZETIA?
Tell your doctor about any prescription and non-prescription
medicines you are taking or plan to take, including natural
or herbal remedies.
Tell your doctor about all your medical conditions including allergies.
Tell your doctor if you:
• ever had liver problems. ZETIA may not be right for you.
• are pregnant or plan to become pregnant. Your doctor will discuss with
you whether ZETIA is right for you.
•are breast-feeding. W e do not know if ZETIA can pass to your
baby through your milk. Your doctor will discuss with you w hether
ZETIA is right for you.
• experience unexplained muscle pain, tenderness, or weakness.
HOW SHOULD I TAKE
ZETIA?
• Take ZETIA once a day, with or without food. It may be easier to
remember to take your dose if you do it at the same time every
day, such as with breakfast, dinner, or at bedtime. If you also take
another medicine to reduce your cholesterol, ask your doctor if
you can take them at the same time.
• If you forget to take ZETIA, take it as soon as you remember.
However, do not take more than one dose of ZETIA a day.
• Continue to follow a cholesterol-lowering diet while taking
ZETIA. Ask your doctor if you need diet information.
• Keep taking ZETIA unless your doctor tells you to stop. It is
important that you keep taking ZETIA even if you do not feel sick.
See your doctor regularly to check your cholesterol level and
to check for side effects. Your doctor may do blood tests to
check your liver before you start taking ZETIA with a statin and
during treatment.
WHAT ARE THE POSSIBLE SIDE EFFECTS OF
ZETIA?
In clinical studies patients reported fe w side effects w hile
taking ZET IA . These included diarrhea, joint pains, and
feeling tired.
Patients have experienced severe muscle problems while
taking ZETIA, usually w hen ZETIA w as added to a statin drug.
If you experience unexplained muscle pain, tenderness, or
w eakness while taking ZETIA, contact your doctor immediately.
You need to do this promptly, because on rare occasions, these
muscle problems can be serious, with muscle breakdown
resulting in kidney damage.
Additionally, the following side effects have been reported in
general use: allergic reactions (which may require treatm ent
right away) including swelling of the face, lips, tongue, and/or
throat that may cause difficulty in breathing or swallowing,
rash, and hives; raised red rash, sometimes with target-shaped
lesions; joint pain; muscle aches; alterations in some
laboratory blood tests; liver problems; stom ach pain;
inflam m ation of the pancreas; nausea; dizziness; tingling
sensation; depression; headache; gallstones; inflammation of
the gallbladder.
Tell your doctor if you are having these or any other medical
problems while on ZETIA. For a complete list of side effects,
ask your doctor or pharmacist.
WHAT SHOULD I KNOW ABOUT HIGH CHOLESTEROL?
Cholesterol is a type of fat found in your blood. Your total
cholesterol is made up of LDL and HDL cholesterol.
LDL cholesterol is called "bad" cholesterol because it can build
up in the wall of your arteries and form plaque. Over time, plaque
build-up can cause a narrowing of the arteries. This narrowing
can slow or block blood flow to your heart, brain, and other organs.
High LDL cholesterol is a major cause of heart disease and one of
the causes for stroke.
HDL cholesterol is called "good" cholesterol because it keeps the
bad cholesterol from building up in the arteries.
Triglycerides also are fats found in your blood.
GENERAL INFORMATION ABOUT
ZETIA
Medicines are sometimes prescribed for conditions that are not
mentioned in patient information leaflets. Do not use ZETIA for
a condition for which it was not prescribed. Do not give ZETIA to
other people, even if they have the same condition you have.
It may harm them.
This summarizes the most important information about ZETIA.
If you would like more information, talk with your doctor. You can
ask your pharmacist or doctor for information about ZETIA that
is written for health professionals.
Inactive ingredients:
Croscarmellose sodium, lactose monohydrate, magnesium
stearate, microcrystalline cellulose, povidone, and sodium
lauryl sulfate.
Issued July 2009
REV 21
29480885T
( e z e t i m
i b e ) Tablets
MERCK/Schering-Plough Pharmaceuticals
Manufactured for:
Merck/Schering-Plough Pharmaceuticals
North W ales, PA 19454, USA
20950061(10)(885)-ZET
