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 infor-
mation does not take the place of talking with your doctor about your
medical condition or your treatment. 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 “What should I know
about high cholesterol?” section that follows.
Who should not take ZETIA?
* Do not take ZETIA if you are allergic to ezetimibe, the active ingredi-
ent in ZETIA, or to the inactive ingredients. For a list of inactive ingre-
dients, 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 woman 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. We do not know if ZETIA can pass to your baby
through your milk. Your doctor will discuss with you whether 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 few side effects while taking ZETIA.
These included diarrhea, joint pains, and feeling tired.
Patients have experienced severe muscle problems while taking ZETIA,
usually when ZETIA was added to a statin drug. If you experience unex-
plained muscle pain, tenderness, or weakness while taking ZETIA, con-
tact 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 treatment right away)
including swelling of the face, lips, tongue, and/or throat that may
cause difficulty in breathing or swallowing, rash, and hives; joint pain;
muscle aches; alterations in some laboratory blood tests; liver prob-
lems; inflammation of the pancreas; nausea; dizziness; tingling sensa-
tion; depression; gallstones; inflammation of the gallbladder.
Tell your doctor if you are having these or any other medical prob-
lems while on ZETIA. For a complete list of side effects, ask your doc-
tor 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 men-
tioned 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.
J
l
MERCK / Schering-Plough Pharm aceuticals
Manufactured for:
Merck/Schering-Plough Pharmaceuticals
North Wales, PA
19454
, USA
By:
Schering Corporation
Kenilworth, NJ
07033
, USA
or Merck & Co., Inc., Whitehouse Station, NJ
08889
, USA
Issued June
2008
REV
17
29480842
T
COPYRIGHT © Merck/Schering-Plough Pharmaceuticals,
2001
,
2002
,
2007
,
2008
. All rights reserved.
Printed in USA. U.S. Patent Nos.
5
,
846
,
966
;
7
,
030,106
and RE
37
,
721
.
20950061
(
1
)(
842
)-ZET
