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EZETIMIBE 10MG TABLETS

Active substance(s): EZETIMIBE

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Package leaflet: Information for the patient
EZETROL® 10 mg TABLETS
Ezetimibe
The name of your medicine is Ezetrol 10 mg Tablets however, will be
referred to as Ezetrol throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
-

-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1. What EZETROL is and what it is used for
2. What you need to know before you take EZETROL
3. How to take EZETROL
4. Possible side effects
5. How to store EZETROL
6. Contents of the pack and other information
1. WHAT EZETROL IS AND WHAT IT IS USED FOR
EZETROL is a medicine to lower increased levels of cholesterol.
EZETROL lowers levels of total cholesterol, "bad" cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood. In
addition, EZETROL raises levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of EZETROL, works by reducing the
cholesterol absorbed in your digestive tract.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETROL
If you use EZETROL together with a statin, please read the package
leaflet of that particular medicine.
Do not take EZETROL if:
 you are allergic (hypersensitive) to ezetimibe or any of the other
ingredients of this medicine (see Section 6: Contents of the pack and
other information).
Do not take EZETROL together with a statin if:
 you currently have liver problems
 you are pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking EZETROL.
 Tell your doctor about all your medical conditions including allergies.
 Your doctor should do a blood test before you start taking EZETROL
with a statin. This is to check how well your liver is working.
 Your doctor may also want you to have blood tests to check how well
your liver is working after you start taking EZETROL with a statin.
If you have moderate or severe liver problems, EZETROL is not
recommended.
The safety and efficacy of the combined use of EZETROL and certain
cholesterol lowering medicines, the fibrates have not been established.
Children and adolescents
Do not give this medicine to children and adolescents (6 to 17 years of
age) unless prescribed by a specialist because there are limited data on
safety and efficacy. Do not give this medicine to children less than 6 years
old because there is no information in this age group.
Other medicines and EZETROL
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. In particular, tell your doctor if you are
taking medicine(s) with any of the following active ingredients:

EZETROL adds to the cholesterol-lowering effect of statins, a group of
medicines that reduce the cholesterol your body makes by itself.




Cholesterol is one of several fatty substances found in the bloodstream.
Your total cholesterol is made up mainly of LDL and HDL cholesterol.



LDL cholesterol is often called “bad” cholesterol 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 slow or block
blood flow to vital organs such as the heart and brain. This blocking of
blood flow can result in a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps keep
the bad cholesterol from building up in the arteries and protects against
heart disease.
Triglycerides are another form of fat in your blood that may increase your
risk for heart disease.
It is used for patients who cannot control their cholesterol levels by
cholesterol lowering diet alone. You should stay on your cholesterol
lowering diet while taking this medicine.



ciclosporin (often used in organ transplant patients)
medicines with an active ingredient to prevent blood clots, such as
warfarin, phenprocoumon, acenocoumarol or fluindione
(anticoagulants)
colestyramine (also used to lower cholesterol), because it affects the
way EZETROL works
fibrates (also used to lower cholesterol)

Pregnancy and breast-feeding
Do not take EZETROL with a statin if you are pregnant, are trying to get
pregnant or think you may be pregnant. If you get pregnant while taking
EZETROL with a statin, stop taking both medicines immediately and tell
your doctor.
There is no experience from the use of EZETROL without a statin during
pregnancy. Ask your doctor for advice before using EZETROL if you are
pregnant.
Do not take EZETROL with a statin if you are breast-feeding, because it is
not known if the medicines are passed into breast milk.
EZETROL without a statin should not be used if you are breast-feeding.
Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

EZETROL is used in addition to your cholesterol lowering diet if you have:





a raised cholesterol level in your blood (primary
hypercholesterolaemia [heterozygous familial and non-familial])
 together with a statin, when your cholesterol level is not well
controlled with a statin alone
 alone, when statin treatment is inappropriate or is not tolerated
a hereditary illness (homozygous familial hypercholesterolaemia)
that increases the cholesterol level in your blood. You will also be
prescribed a statin and may also receive other treatments
a hereditary illness (homozygous sitosterolaemia, also known as
phytosterolaemia) that increases the levels of plant sterols in your
blood.

If you have heart disease, EZETROL combined with cholesterol-lowering
medicines called statins reduces the risk of heart attack, stroke, surgery to
increase heart blood flow, or hospitalization for chest pain.
EZETROL does not help you lose weight.

Driving and using machines
EZETROL is not expected to interfere with your ability to drive or to use
machinery. However, it should be taken into account that some people
may get dizzy after taking EZETROL.
EZETROL contains lactose.
EZETROL tablets contain a sugar called lactose. If you have been told by
your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. HOW TO TAKE EZETROL
Always take this medicine exactly as your doctor has told you. Continue
taking your other cholesterol-lowering medicines unless your doctor tells
you to stop. You should check with your doctor or pharmacist if you are
not sure.
 Before starting EZETROL, you should be on a diet to lower your
cholesterol.
 You should keep on this cholesterol lowering diet whilst taking
EZETROL.
The recommended dose is one EZETROL 10 mg Tablet by mouth once a
day.
Take EZETROL at any time of the day. You can take it with or without
food.
If your doctor has prescribed EZETROL along with a statin, both
medicines can be taken at the same time. In this case, please read the
dosage instructions in the package leaflet of that particular medicine.
If your doctor has prescribed EZETROL along with another medicine for
lowering cholesterol containing the active ingredient colestyramine or any
other medicine containing bile acid sequestrant, you should take
EZETROL at least 2 hours before or 4 hours after taking the bile acid
sequestrant.
If you take more EZETROL than you should
Please contact your doctor or pharmacist.
If you forget to take EZETROL
Do not take a double dose to make up for a forgotten tablet, just take your
normal amount of EZETROL at the usual time the next day.
If you stop taking EZETROL
Talk to your doctor or pharmacist because your cholesterol may rise
again.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

When used with fenofibrate, the following common side effect was
reported: abdominal pain.
Additionally, the following side effects have been reported in general use:
dizziness; muscle aches; liver problems; allergic reactions including rash
and hives; raised red rash, sometimes with target-shaped lesions
(erythema multiforme); muscle pain, tenderness or weakness; muscle
breakdown; gallstones or inflammation of the gallbladder (which may
cause abdominal pain, nausea, vomiting); inflammation of the pancreas
often with severe abdominal pain; constipation, reduction in blood cell
counts, which may cause bruising/bleeding (thrombocytopaenia); tingling
sensation; depression: unusual tiredness or weakness; shortness of
breath.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE EZETROL




Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or
container after "EXP." The expiry date refers to the last day of that
month.
Do not store EZETROL above 30°C.

Blisters: 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.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What EZETROL contains


Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following terms are used to describe how often side effects have
been reported:
 Very common (may affect more than 1 of 10 patients)
 Common (may affect up to 1 of 10 patients)
 Uncommon (may affect up to 1 of 100 patients)
 Rare (may affect up to 1 of 1,000 patients)
 Very rare (may affect up to 1 of 10,000 patients, including isolated
reports).

The active substance is ezetimibe. Each tablet contains 10 mg
ezetimibe.
 The other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone, croscarmellose sodium, sodium laurylsulfate,
magnesium stearate
What Ezetrol 10mg Tablets looks like and contents of the pack
Ezetrol 10mg Tablets are white capsule shaped tablets marked with 414
on one side and plain on the reverse.
Pack sizes ;
Ezetrol 10mg Tablets is supplied in blister packs of 30 tablets

Contact your doctor immediately if you experience unexplained
muscle pain, tenderness, or weakness. This is because on rare
occasions, muscle problems, including muscle breakdown resulting
in kidney damage, can be serious and may become a potentially lifethreatening condition.

The manufacturer of EZETROL is SP Labo N.V., Industriepark 30 –Zone
A, B-2220 Heist-op-den-Berg, Belgium and procured from within the EU
by the product licence holder, BR Pharma International Limited, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts WD6 1EE

Allergic reactions, including swelling of the face, lips, tongue, and/or throat
that may cause difficulty in breathing or swallowing (which requires
treatment right away) have been reported in general use.

Ezetrol 10 mg Tablets

When used alone, the following side effects were reported:
Common:
abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon:
elevations in some laboratory blood tests of liver
(transaminases) or muscle (CK) function; cough;
indigestion; heartburn; nausea; joint pain; muscle
spasms; neck pain; decreased appetite, pain, chest pain,
hot flush; high blood pressure.
Additionally, when used with a statin, the following side effects were
reported:
Common:
elevations in some laboratory blood tests of liver function
(transaminases); headache; muscle pain, tenderness or
weakness.
Uncommon:
tingling sensation; dry mouth; itching; rash; hives; back
pain; muscle weakness; pain in arms and legs; unusual
tiredness or weakness; swelling, especially in the hands
and feet.

PL No. 16782/0185

® denotes trademark of MSD Singapore Company, LLC
Date of preparation: 29th March 2016

POM

Package leaflet: Information for the patient

EZETIMIBE 10 mg TABLETS

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE

The name of your medicine is Ezetimibe 10 mg Tablets however, will be
referred to as Ezetimibe throughout this leaflet.

If you use EZETIMIBE together with a statin, please read the package
leaflet of that particular medicine.

Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

Do not take EZETIMIBE if:
 you are allergic (hypersensitive) to ezetimibe or any of the other
ingredients of this medicine (see Section 6: Contents of the pack and
other information).

-

-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet
1. What EZETIMIBE is and what it is used for
2. What you need to know before you take EZETIMIBE
3. How to take EZETIMIBE
4. Possible side effects
5. How to store EZETIMIBE
6. Contents of the pack and other information
1. WHAT EZETIMIBE IS AND WHAT IT IS USED FOR
EZETIMIBE is a medicine to lower increased levels of cholesterol.
EZETIMIBE lowers levels of total cholesterol, "bad" cholesterol (LDL
cholesterol), and fatty substances called triglycerides in the blood. In
addition, EZETIMIBE raises levels of "good" cholesterol (HDL
cholesterol).
Ezetimibe, the active ingredient of EZETIMIBE, works by reducing the
cholesterol absorbed in your digestive tract.
EZETIMIBE adds to the cholesterol-lowering effect of statins, a group of
medicines that reduce the cholesterol your body makes by itself.
Cholesterol is one of several fatty substances found in the bloodstream.
Your total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol 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 slow or block
blood flow to vital organs such as the heart and brain. This blocking of
blood flow can result in a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps keep
the bad cholesterol from building up in the arteries and protects against
heart disease.
Triglycerides are another form of fat in your blood that may increase your
risk for heart disease.

Do not take EZETIMIBE together with a statin if:
 you currently have liver problems
 you are pregnant or breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking EZETIMIBE.
 Tell your doctor about all your medical conditions including allergies.
 Your doctor should do a blood test before you start taking
EZETIMIBE with a statin. This is to check how well your liver is
working.
 Your doctor may also want you to have blood tests to check how well
your liver is working after you start taking EZETIMIBE with a statin.
If you have moderate or severe liver problems, EZETIMIBE is not
recommended.
The safety and efficacy of the combined use of EZETIMIBE and certain
cholesterol lowering medicines, the fibrates have not been established.
Children and adolescents
Do not give this medicine to children and adolescents (6 to 17 years of
age) unless prescribed by a specialist because there are limited data on
safety and efficacy. Do not give this medicine to children less than 6 years
old because there is no information in this age group.
Other medicines and EZETIMIBE
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. In particular, tell your doctor if you are
taking medicine(s) with any of the following active ingredients:





ciclosporin (often used in organ transplant patients)
medicines with an active ingredient to prevent blood clots, such as
warfarin, phenprocoumon, acenocoumarol or fluindione
(anticoagulants)
colestyramine (also used to lower cholesterol), because it affects the
way EZETIMIBE works
fibrates (also used to lower cholesterol)

Pregnancy and breast-feeding
Do not take EZETIMIBE with a statin if you are pregnant, are trying to get
pregnant or think you may be pregnant. If you get pregnant while taking
EZETIMIBE with a statin, stop taking both medicines immediately and tell
your doctor.
There is no experience from the use of EZETIMIBE without a statin during
pregnancy. Ask your doctor for advice before using EZETIMIBE if you are
pregnant.

It is used for patients who cannot control their cholesterol levels by
cholesterol lowering diet alone. You should stay on your cholesterol
lowering diet while taking this medicine.

Do not take EZETIMIBE with a statin if you are breast-feeding, because it
is not known if the medicines are passed into breast milk.
EZETIMIBE without a statin should not be used if you are breast-feeding.
Ask your doctor for advice.

EZETIMIBE is used in addition to your cholesterol lowering diet if you
have:

Ask your doctor or pharmacist for advice before taking any medicine.






a raised cholesterol level in your blood (primary
hypercholesterolaemia [heterozygous familial and non-familial])
 together with a statin, when your cholesterol level is not well
controlled with a statin alone
 alone, when statin treatment is inappropriate or is not tolerated
a hereditary illness (homozygous familial hypercholesterolaemia)
that increases the cholesterol level in your blood. You will also be
prescribed a statin and may also receive other treatments
a hereditary illness (homozygous sitosterolaemia, also known as
phytosterolaemia) that increases the levels of plant sterols in your
blood.

If you have heart disease, EZETIMIBE combined with cholesterollowering medicines called statins reduces the risk of heart attack, stroke,
surgery to increase heart blood flow, or hospitalization for chest pain.
EZETIMIBE does not help you lose weight.

Driving and using machines
EZETIMIBE is not expected to interfere with your ability to drive or to use
machinery. However, it should be taken into account that some people
may get dizzy after taking EZETIMIBE.
EZETIMIBE contains lactose.
EZETIMIBE tablets contain a sugar called lactose. If you have been told
by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. HOW TO TAKE EZETIMIBE
Always take this medicine exactly as your doctor has told you. Continue
taking your other cholesterol-lowering medicines unless your doctor tells
you to stop. You should check with your doctor or pharmacist if you are
not sure.
 Before starting EZETIMIBE, you should be on a diet to lower your
cholesterol.
 You should keep on this cholesterol lowering diet whilst taking
EZETIMIBE.
The recommended dose is one EZETIMIBE 10 mg Tablet by mouth once
a day.
Take EZETIMIBE at any time of the day. You can take it with or without
food.
If your doctor has prescribed EZETIMIBE along with a statin, both
medicines can be taken at the same time. In this case, please read the
dosage instructions in the package leaflet of that particular medicine.
If your doctor has prescribed EZETIMIBE along with another medicine for
lowering cholesterol containing the active ingredient colestyramine or any
other medicine containing bile acid sequestrant, you should take
EZETIMIBE at least 2 hours before or 4 hours after taking the bile acid
sequestrant.
If you take more EZETIMIBE than you should
Please contact your doctor or pharmacist.
If you forget to take EZETIMIBE
Do not take a double dose to make up for a forgotten tablet, just take your
normal amount of EZETIMIBE at the usual time the next day.
If you stop taking EZEMITIBE
Talk to your doctor or pharmacist because your cholesterol may rise
again.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The following terms are used to describe how often side effects have
been reported:
 Very common (may affect more than 1 of 10 patients)
 Common (may affect up to 1 of 10 patients)
 Uncommon (may affect up to 1 of 100 patients)
 Rare (may affect up to 1 of 1,000 patients)
 Very rare (may affect up to 1 of 10,000 patients, including isolated
reports).
Contact your doctor immediately if you experience unexplained
muscle pain, tenderness, or weakness. This is because on rare
occasions, muscle problems, including muscle breakdown resulting
in kidney damage, can be serious and may become a potentially lifethreatening condition.
Allergic reactions, including swelling of the face, lips, tongue, and/or throat
that may cause difficulty in breathing or swallowing (which requires
treatment right away) have been reported in general use.
When used alone, the following side effects were reported:
Common:
abdominal pain; diarrhoea; flatulence; feeling tired.
Uncommon:
elevations in some laboratory blood tests of liver
(transaminases) or muscle (CK) function; cough;
indigestion; heartburn; nausea; joint pain; muscle
spasms; neck pain; decreased appetite, pain, chest pain,
hot flush; high blood pressure.
Additionally, when used with a statin, the following side effects were
reported:
Common:
elevations in some laboratory blood tests of liver function
(transaminases); headache; muscle pain, tenderness or
weakness.
Uncommon:
tingling sensation; dry mouth; itching; rash; hives; back
pain; muscle weakness; pain in arms and legs; unusual
tiredness or weakness; swelling, especially in the hands
and feet.

When used with fenofibrate, the following common side effect was
reported: abdominal pain.
Additionally, the following side effects have been reported in general use:
dizziness; muscle aches; liver problems; allergic reactions including rash
and hives; raised red rash, sometimes with target-shaped lesions
(erythema multiforme); muscle pain, tenderness or weakness; muscle
breakdown; gallstones or inflammation of the gallbladder (which may
cause abdominal pain, nausea, vomiting); inflammation of the pancreas
often with severe abdominal pain; constipation, reduction in blood cell
counts, which may cause bruising/bleeding (thrombocytopaenia); tingling
sensation; depression: unusual tiredness or weakness; shortness of
breath.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE EZETIMIBE




Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or
container after "EXP." The expiry date refers to the last day of that
month.
Do not store EZETIMIBE above 30°C.

Blisters: 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.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What EZETIMIBE contains


The active substance is ezetimibe. Each tablet contains 10 mg
ezetimibe.
 The other ingredients are: lactose monohydrate, microcrystalline
cellulose, povidone, croscarmellose sodium, sodium laurylsulfate,
magnesium stearate
What Ezetimibe 10mg Tablets looks like and contents of the pack
Ezetimibe 10mg Tablets are white capsule shaped tablets marked with
414 on one side and plain on the reverse.
Pack sizes ;
Ezetimibe 10mg Tablets is supplied in blister packs of 30 tablets
The manufacturer of EZETIMIBE is SP Labo N.V., Industriepark 30 –Zone
A, B-2220 Heist-op-den-Berg, Belgium and procured from within the EU
by the product licence holder, BR Pharma International Limited, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts WD6 1EE

Ezetimibe 10 mg Tablets

PL No. 16782/0185

Date of preparation: 29th March 2016

POM

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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