IMPORTANT : PLEASE READ
This leaflet is part III of a three-part “Product What it does:
Monograph” published when EZETROL® was EZETROL® works by decreasing the absorption of
approved for sale in Canada and is designed cholesterol in the small intestine.
specifically for Consumers. This leaflet is a summary
and will not tell you everything about EZETROL®. When it should not be used:
Contact your doctor or pharmacist if you have any • Patients who are hypersensitive (allergic) to
questions about the drug. ezetimibe or any of the nonmedicinal
ingredients should not take EZETROL®.
Remember that your doctor has prescribed this • Patients with liver disease, active or
medicine for you. Never give it to anyone else. unexplained increases in liver enzymes
(blood tests of liver function) should not take
ABOUT THIS MEDICATION EZETROL® together with a statin.
• Patients who are pregnant should not take
What the medication is used for: EZETROL® together with a statin.
EZETROL® helps to reduce the amount of cholesterol
and triglycerides in your blood in conjunction with • Patients who are nursing should not take
lifestyle changes including exercise, diet, and weight EZETROL® together with a statin.
management, when a response to such changes has
been inadequate. What the medicinal ingredient is:
Cholesterol is one of several fatty substances found in
What the important nonmedicinal ingredients are:
the bloodstream. Your total cholesterol is made up
Croscarmellose sodium, lactose monohydrate,
mainly of low density lipoprotein cholesterol and high
magnesium stearate, microcrystalline cellulose,
density lipoprotein cholesterol (LDL and HDL
povidone, and sodium lauryl sulfate.
What dosage forms it comes in:
LDL cholesterol is often called “bad” cholesterol Tablet 10 mg (white to off-white).
because it can build up in the walls of your arteries
forming plaque. Eventually this plaque build-up can
lead to a narrowing of the arteries. This narrowing can WARNINGS AND PRECAUTIONS
slow or block blood flow to vital organs such as the
heart and brain. This blocking of blood flow can result Serious Warnings and Precautions
in a heart attack or stroke.
• Liver disease (Hepatitis)
• Pancreas disease (Pancreatitis)
HDL cholesterol is often called “good” cholesterol
• Muscle pain (Myopathy/Rhabdomyolysis,
because it helps keep the bad cholesterol from building
up in the arteries and protects against heart disease.
• Severe allergic reaction (Anaphylaxis)
Triglycerides are another form of fat in your blood that
may increase your risk for heart disease. Before you use EZETROL® talk to your doctor if you:
EZETROL may be taken alone or with other • are pregnant, plan to become pregnant or think
cholesterol-lowering medicines known as statins or you might be pregnant.
with another medicine known as fenofibrate, in
addition to diet and other lifestyle changes (see • are breast-feeding. EZETROL® may be passed in
INTERACTIONS WITH THIS MEDICATION). your milk to your baby.
EZETROL® adds to the cholesterol-lowering effect of
statins and fenofibrate. Statins and fenofibrate lower • have now or have had in the past any medical
cholesterol in a different way; they work in the liver. problems (including liver disease or liver problems).
Registered trademark used under license by Merck Frosst-Schering Pharma, G.P.
INTERACTIONS WITH THIS MEDICATION SIDE EFFECTS AND WHAT TO DO ABOUT THEM
You should always tell your doctor about all drugs that EZETROL® is generally well tolerated.
you are taking or plan to take as well as those
obtained without a prescription. • When used alone, the following common side
effects have been reported: abdominal pain,
Drugs that may interact with EZETROL® include: diarrhea, tiredness, viral infection, throat infection
(pharyngitis), nose infection (sinusitis), joint pain
• Cyclosporine (arthralgia), back pain, and coughing.
• Cholestyramine (a resine/bile acid sequestrant) • When used with a statin, the following common
or any other bile acid sequestrant. In that case, side effects have been reported: headache,
EZETROL® should be taken at least 2 hours tiredness, abdominal pain, diarrhea, joint pain
before or 4 hours after taking the bile acid (arthralgia), muscle pain (myalgia), back pain,
sequestrant. throat infection (pharyngitis), nose infection
(sinusitis), upper chest infection (respiratory tract),
• Fibrates and changes in certain laboratory blood tests.
PROPER USE OF THIS MEDICATION • In general use, the following side effects have
been reported: raised red rash, sometimes with
target-shaped lesions, dizziness, depression and
• EZETROL® should be taken as directed. Take
one 10 mg tablet by mouth each day, preferably • You should contact your doctor if you develop
at the same time of day. EZETROL® can be persistent and severe muscle aches or pains with
taken with or without food. no obvious explanation at any time after starting
to take EZETROL®.
• Continue taking your other cholesterol-lowering
medicines known as statins or fenofibrate If you are prescribed EZETROL® with a statin, your
unless your doctor tells you to stop. doctor will order routine blood tests to check your
liver function before and after starting treatment.
• If you are taking a statin or fenofibrate,
EZETROL® can be taken at the same time. Talk to your doctor anytime you have a medical
problem you think may be related to EZETROL®.
• Even if you are taking medication to treat high
cholesterol, it is important to have your
cholesterol measured regularly. You should
also know your cholesterol levels and goals.
Take EZETROL® only as prescribed for you. If you
take more EZETROL® than you were prescribed,
contact your doctor or pharmacist.
For management of a suspected drug overdose,
contact your regional Poison Control Centre.
If you miss a dose, just resume the usual schedule of
one tablet daily.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HOW TO STORE IT
HAPPEN AND WHAT TO DO ABOUT THEM
Keep your medicine between 15°C and 30°C.
Symptoms / effects Talk with your Stop taking Protect from moisture.
doctor or drug and
pharmacist call your Keep EZETROL® and all medicines out of the reach
doctor or of children.
Only if In all pharmacist
severe cases Do not use this medicine after the date shown
• Muscle aches following EX (or EXP) on the container.
(Myopathy/ REPORTING SUSPECTED SIDE EFFECTS
• Sudden severe
To monitor drug safety, Health Canada through the
√ Canada Vigilance Program collects information on
(swelling of the serious and unexpected side effects of drugs. If
face, lips, you suspect you have had a serious or unexpected
tongue, and/or reaction to this drug you may notify Canada
throat that may Vigilance:
cause difficulty in
breathing or By toll-free telephone: 1-866-234-2345
swallowing, rash By toll-free fax: 1-866-678-6789
• Symptoms of By email: CanadaVigilance@hc-sc.gc.ca
(severe By regular mail:
abdominal pain, Canada Vigilance National Office
especially if felt Marketed Health Products Safety and
on the upper Effectiveness Information Bureau
right side below Marketed Health Products Directorate
the ribs, dark Health Products and Food Branch
nausea or Tunney’s Pasture, AL 0701C
vomiting, pale Ottawa ON K1A 0K9
of skin or eyes) or Merck Frosst-Schering Pharma, G.P.:
• Symptoms of √ By toll-free telephone: 1-800-567-2594
gallstones or By toll-free fax: 1-877-428-8675
the gallbladder By regular mail:
Merck Frosst-Schering Pharma, G.P.
nausea, P.O. Box 1005
vomiting) Pointe-Claire - Dorval, QC H9R 4P8
• Symptoms of √
NOTE: Should you require information related
pancreas to the management of the side effect, please
problems (severe contact your health care provider before
abdominal pain) notifying Canada Vigilance. The Canada
Vigilance Program or Merck Frosst-Schering
This is not a complete list of side effects. For any Pharma, G.P. do not provide medical advice.
unexpected effects while taking EZETROL®, contact
your doctor or pharmacist.
You may obtain further information from your doctor
This document plus the full product monograph,
prepared for health professionals can be found at:
or by contacting the sponsor, Merck Frosst-Schering
Pharma, G.P., at: 1-800-567-2594
This leaflet was prepared by Merck Frosst-Schering
Last revised: October 19, 2009