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EZITIMIBE 10 MG TABLETS

Active substance(s): EZETIMIBE

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Ezetrol® 10 mg Tablets

2708
08.08.16[4]

(ezetimibe)
PATIENT INFORMATION 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 side effects not listed in this leaflet. See section 4.
Your medicine is available using the above name but will be referred to as
Ezetrol throughout the following leaflet.
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.
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.
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.
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:
- 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.
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
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 EZETROL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after
"EXPIRY." The expiry date refers to the last day of that month.
Do not store above 30oC.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ezetrol contains
The active substance is ezetimibe.
Each tablet contains 10 mg ezetimibe.
The other ingredients are: lactose monohydrate, microcrystalline cellulose,
povidone, croscarmellose sodium, sodium laurilsulfate, magnesium
stearate.
What Ezetrol looks like and contents of the pack
Ezetrol are white to off-white, capsule-shaped tablets marked with ‘414’ on
one side and plain on the other side of the tablet.
Ezetrol is supplied in blister packs of 28 and 98 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by SP Labo N.V., Industriepark 30 –Zone A, B-2220 Heistop-den-Berg, Belgium. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2708

Leaflet revision and issue date (Ref.) 08.08.16[4]
Ezetrol is a trademark of MSD International GmbH.

Ezetimibe 10 mg Tablets

2708
08.08.16[4]

PATIENT INFORMATION LEAFLET

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.

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 side effects not listed in this leaflet. See section 4.

If you have moderate or severe liver problems, Ezetimibe is not
recommended.

Your medicine is available using the above name but will be referred to as
Ezetimibe throughout the following leaflet.

The safety and efficacy of the combined use of Ezetimibe and certain
cholesterol lowering medicines, the fibrates have not been established.

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

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.

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.
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.
Ezetimibe 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, Ezetimibe 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.
Ezetimibe does not help you lose weight.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE
If you use Ezetimibe together with a statin, please read the package leaflet
of that particular medicine.
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).

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.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
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 Ezetimibe
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 out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after
"EXPIRY." The expiry date refers to the last day of that month.
Do not store above 30oC.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER 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 laurilsulfate, magnesium
stearate.
What Ezetimibe looks like and contents of the pack
Ezetimibe are white to off-white, capsule-shaped tablets marked with ‘414’
on one side and plain on the other side of the tablet.
Ezetimibe is supplied in blister packs of 28 and 98 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by SP Labo N.V., Industriepark 30 –Zone A, B-2220 Heistop-den-Berg, Belgium. Procured from within the EU by Product Licence
holder Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2708

Leaflet revision and issue date (Ref.) 08.08.16[4]

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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