PATIENT
INFORMATION LEAFLET
EZETROL 10 mg Tablets
Ezetimibe
PLEASE READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS, EVEN IF
YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE
INFORMATION IN YOUR PREVIOUS LEAFLET MAY HAVE CHANGED.
Keep this leaflet. You may want to
read it again.
In
this leaflet:
-
1. What is Ezetrol and who makes the tablets?
-
2. How does Ezetrol work and what are the
tablets used for?
-
3. What do you have to consider before you take
Ezetrol?
-
4. How should Ezetrol tablets be taken?
-
5. What side effects are possible?
-
6. How should your tablets be stored?
1. WHAT
IS EZETROL AND WHO MAKES THE TABLETS?
Ezetrol is a
selective cholesterol absorption inhibitor, belonging to
a class of medicines called lipid-lowering agents.
The active
ingredient is ezetimibe and each 10 mg tablet contains
10 mg ezetimibe.
The other
non-active ingredients are:
-
croscarmellose sodium
-
lactose monohydrate
-
magnesium stearate
-
microcrystalline cellulose
-
povidone
-
sodium laurylsulphate
Ezetrol® 10
mg Tablets are white to off-white, capsule-shaped
tablets marked with ‘414’ on one side.
2. HOW
DOES EZETROL WORK AND WHAT ARE THE TABLETS USED FOR?
Ezetrol is a
lipid-lowering medicine that works by decreasing the
absorption of cholesterol and other related plant-lipids
from the small intestine. Cholesterol is a kind of lipid
(or fat) vital to the normal functioning of the body,
but if levels of cholesterol in the bloodstream are too
high, it can be deposited in the walls of the arteries.
There it builds up to form plaques which can eventually
block the blood vessel. This is one of the most common
causes of heart disease.
Your doctor
will have conducted some blood tests which show that,
even though you may be on a low-fat diet, you have too
much of certain kinds of lipid in your blood.
Ezetrol 10
mg Tablets can be added to another type of
cholesterol-lowering medicine called statins (a class of
cholesterol-lowering medicines which work in the liver).
Ezetrol adds to the cholesterol lowering effect of
statins.
Ezetrol 10 mg Tablets are usually prescribed for the
following conditions:
-
Primary hypercholesterolaemia (heterozygous
familial and non-familial): Ezetrol may be used
together with a statin when patients are not
appropriately controlled by the statin on its
own. Ezetrol may be prescribed on its own when
treatment with a statin is inappropriate or not
tolerated.
-
Patients with homozygous familial
hypercholesterolaemia: Ezetrol is used together
with a statin and may also be used together with
other cholesterol-lowering treatments.
-
Patients with homozygous sitosterolaemia (phytosterolaemia):
a rare disease where there are elevated blood
levels of plant sterols similar to cholesterol.
In
addition to taking your medicine, you should be
following a standard cholesterol-lowering diet.
3. WHAT
DO YOU HAVE TO CONSIDER BEFORE YOU TAKE EZETROL?
Do
not take Ezetrol if any of the following applies to
you:
-
you are allergic to ezetimibe or any of the
other tablet ingredients
-
you have active liver disease: in this case you
should not take Ezetrol together with a statin.
Take
special note and care if any of the following
applies to you:
Use With
Statins:
-
If you are prescribed Ezetrol and a statin
together, you must also read the information in
the patient information leaflet that comes with
that particular statin before you start to take
your medicine.
-
If you are prescribed Ezetrol and a statin
together, your doctor will want to do some tests
on how your liver is working before you start
the treatment, and according to the instructions
for use of the particular statin.
Patients
With Liver Disease:
Some
patients with liver disease (those with moderate or
severe disease) should not be given Ezetrol. Tell
your doctor if you have or have had liver problems.
Use With
Other Medicines:
It is
important that you always tell your doctor about any
other medications you are taking, including other
cholesterol-lowering medicines and medicines
obtained without a prescription.
The following other medicines
are particularly important:
-
Fibrates (medicines
used to treat high blood lipid levels): the
safety and effectiveness of Ezetrol given
together with fibrates have not been
established. If you are taking fenofibrate and
Ezetrol together, you should be aware of a
possible risk of developing gallstones.
-
Colestyramine (another
type of cholesterol-lowering medicine, also
called a bile acid sequestrant): the use of
colestyramine with Ezetrol may reduce the
effectiveness of Ezetrol tablets. See “4. How
Should Ezetrol tablets be taken?” for advice on
when to take colestyramine or any other bile
acid sequestrant.
-
Ciclosporin (a
medicine used to suppress the immune system):
ciclosporin and Ezetrol may interact with each
other and your doctor should use the two
together with caution.
-
Anticoagulants such as
warfarin and other coumarin anticoagulants and
fluindione (anti-clotting medicines used
to thin the blood and prevent blood clots
forming): the use of Ezetrol may increase the
effectiveness of the anticoagulant and your
doctor may monitor this by performing some blood
tests before starting treatment and while you
are taking anticoagulants and Ezetrol together.
Use In
Pregnancy And Breast Feeding
Pregnancy: Because statins
must not be used during pregnancy, treatment with a
statin and Ezetrol must not be used during
pregnancy, and the patient informations leaflet of
the statin should be consulted.
Experience of the use of ezetimibe alone in pregnant
women is not available. It is important that you
tell your doctor if you are pregnant, could be
pregnant or are planning to become pregnant, before
you start your tablets, or if you become pregnant
during treatment. Your doctor will decide whether
you need to take Ezetrol under these circumstances.
Breast-feeding: Ezetrol
should not be used during breast-feeding, because it
is not known if Ezetrol is secreted in human milk.
Ezetrol must not be used in combination with a
statin during breast-feeding. Consult your doctor
before taking Ezetrol if you are breast feeding, or
planning to breast feed.
Use In
Children
Ezetrol
Tablets are not recommended in children under the
age of 10 years, as sufficient clinical experience
is not available.
Use In
Elderly Patients
Ezetrol
works equally well in and is equally well-tolerated
by older and younger adult patients. No dosage
adjustment is necessary for elderly patients.
What About Driving And
Operating Machinery?
Your
ability to drive or to use machinery is not expected
to be affected by treatment with Ezetrol tablets.
What should you know about the
inactive ingredients in EZETROL?
If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.
4. HOW
SHOULD EZETROL TABLETS BE TAKEN?
Before
starting therapy with Ezetrol, you should be advised to
follow a standard cholesterol-lowering diet and you
should continue with this diet during treatment.
Adults and
children over 10 years: The usual dose is one Ezetrol 10
mg tablet by mouth once a day, either with a statin or
alone, according to what your doctor has prescribed and
for as long as your doctor has prescribed. Ezetrol can
be taken with or without food, at any time of the day.
If Ezetrol
is used together with a statin, the dosage instructions
for that particular statin should be followed. The two
medicines may be taken at the same time.
If your
doctor has prescribed Ezetrol together with a bile-acid
sequestrant (another type of cholesterol lowering
medicine such as colestyramine or colestipol), Ezetrol
should be taken at least 2 hours before or 4 hours after
taking the bile acid sequestrant.
What Should You Do If You Miss
A Dose Or Take Too Much Ezetrol?
It is
important to keep to the dose the doctor has
prescribed. If you miss a dose, leave out that dose
completely, do not take an extra dose to make up and
just resume your usual schedule the following day.
You
should never take more tablets than the doctor
recommends. If you do take too many Ezetrol Tablets,
you should seek medical attention immediately. Make
sure you take the original container of the tablets
with you.
5. WHAT
SIDE EFFECTS ARE POSSIBLE?
Like all
medicines, Ezetrol can have unintended or undesirable
effects, so called side effects.
In clinical
studies the side effects seen were usually mild,
transient and similar in type and frequency to side
effects in patients who were given a placebo (a tablet
without any medication in it). Side effects did not
generally cause patients to stop taking Ezetrol Tablets.
When used
alone, the following common side effects were reported
(where common is occurring in more than 1 patient in 100
but less than in 1 of 10 patients treated): headache,
abdominal pain, and diarrhoea.
When used
with a statin, the following common side effects were
reported: headache, fatigue, abdominal pain,
constipation, diarrhoea, flatulence, nausea, muscle
aches, and elevations in some laboratory blood tests of
liver function.
When used
with fenofibrate, the following common side effect was
reported: abdominal pain.
In addition,
the following rare (where rare is occurring in more than
1 in 10,000 and less than 1 in 1,000 patients treated)
or very rare (occurring in less than 1 in 10,000
patients treated) side effects have been reported in
general use: allergic reactions (requires treatment
right away) including rash (rare), hives (rare) and
swelling of the face, lips, tongue and/or throat that
may cause difficulty in breathing or swallowing (very
rare); nausea (feeling sick) (rare); reduction in blood
cell counts which may cause bruising/bleeding (very
rare); elevations in some laboratory blood tests, which
may be a sign of liver or muscle problems (rare);
inflammation of the liver (rare); gallstones (very
rare); inflammation of the gallbladder (very rare); and
inflammation of the pancreas often with severe abdominal
pain (very rare); joint pain (rare) muscle aches (rare)
and muscle damage (very rare).
Contact your doctor immediately if
you experience unexplained muscle pain, tenderness, or
weakness while taking a statin with Ezetrol or while
taking Ezetrol alone. This is because on very
rare occasions, muscle problems can be serious,
including muscle breakdown which can result in kidney
damage,
Consult your
doctor or seek medical advice if you experience any of
the other above side effects or any other unusual
symptoms you do not understand and particularly if they
are persistent, troublesome or getting worse. It will be
helpful if you make a note of what you experienced, when
it started and how long it lasted.
6. HOW
SHOULD YOUR TABLETS BE STORED?
Keep your
tablets out of the reach and sight of children.
Do not put
the tablets into another container, as they might get
mixed up.
Do not store
above 30°C. Store in the original blister package and do
not remove the tablet from its blister until you are
ready to take it, as the tablets are moisture sensitive.
There are no
other special storage conditions required for this
medicine.
Do not take
the tablets if they are past the expiry date which is
clearly marked on the blister package and carton. Take
any tablets that are out of date back to your
pharmacist.
REMEMBER:
This medicine is for you. Do not share it with anyone
else.
HOW CAN
YOU OBTAIN MORE INFORMATION ABOUT EZETROL?
This leaflet
gives you the most important information about Ezetrol.
If you have any questions after you have read it, ask
your doctor or pharmacist who can give you further
information.
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