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EZETIMIBE 10 MG TABLETS

Active substance(s): EZETIMIBE

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PIL FRONT
Package leaflet: Information for the patient

Ezetrol® 10 mg Tablets
(ezetimibe)

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.
Your medicine is called Ezetrol® 10 mg Tablets but will be referred
to as Ezetrol throughout this 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 breastfeeding. 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.

PIL REVERSE
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 life-threatening 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 which is stated on
the carton after "EXP." The expiry date refers to the last day of
that month.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
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
– 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 tablets are white to off-white, capsule-shaped tablets
marked with code '414' on one side and plain on the other side.
Ezetrol tablets are available in blister packs of 28 tablets.
Manufacturer:
Schering-Plough (SP) Labo N. V., Industriepark 30 – Zone A,
B-2220 Heist-op-den-Berg, Belgium.
Procured from within the EU by the Product
Licence Holder:
Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0143 - Ezetrol® 10 mg Tablets

POM

Revision Date: 25.05.2016
Ref: 819
Ezetrol® is a registered trademark of MSD International GmbH.

PIL FRONT
Package leaflet: Information for the patient

Ezetimibe 10 mg Tablets

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.
Your medicine is called Ezetimibe 10 mg Tablets but will be
referred to as Ezetimibe throughout this leaflet.
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.
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).
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.
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 breastfeeding. 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.

PIL REVERSE
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 life-threatening 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 which is stated on
the carton after "EXP." The expiry date refers to the last day of
that month.
• Do not store above 30°C.
• Store in the original package in order to protect from moisture.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who
will tell you what to do.
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 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 tablets are white to off-white, capsule-shaped tablets
marked with code '414' on one side and plain on the other side.
Ezetimibe tablets are available in blister packs of 28 tablets.
Manufacturer:
Schering-Plough (SP) Labo N. V., Industriepark 30 – Zone A,
B-2220 Heist-op-den-Berg, Belgium.
Procured from within the EU by the Product
Licence Holder:
Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0143 - Ezetimibe 10 mg Tablets
Revision Date: 25.05.2016
Ref: 818

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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