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Ezetrol 10mg Tablets

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• 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

PATIENT INFORMATION LEAFLET

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.

What is in this leaflet:

1. What EZETROL is and what is it 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.

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

• 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

EZETROL is not recommended for children under age of 10.

Other medicines and EZETROL

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription. 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 monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

EZETROL does not help you lose weight.

3. HOW TO TAKE EZETROL

Always take EZETROL 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.

Adults, adolescents and children (10 to 17 years of age): The 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 an extra dose, just take your normal amount of EZETROL at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

4. POSSIBLE SIDE EFFECTS

6. CONTENTS OF THE PACK AND OTHER INFORMATION

PL No. 16782/0185

Like all medicines, EZETROL 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.

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 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

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

Ezetrol 10 mg Tablets

® denotes trademark of MSD Singapore Company, LLC Date of preparation: 15^th January 2014

POM

PATIENT INFORMATION LEAFLET

EZETIMIBE 10 mg TABLETS

The name of your medicine is Ezetimibe 10 mg Tablets however, will be referred to as Ezetimibe 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 side effects not listed in this leaflet

What is in this leaflet:

1. What EZETIMIBE is and what is it 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.

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.

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

• 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

EZETIMIBE is not recommended for children under age of 10.

Other medicines and EZETIMIBE

• 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 monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

EZETIMIBE does not help you lose weight.

3. HOW TO TAKE EZETIMIBE

Always take EZETIMIBE 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.

Adults, adolescents and children (10 to 17 years of age): The 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 an extra dose, just take your normal amount of EZETIMIBE at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

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.

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, EZETIMIBE can cause side effects, although not everybody gets them.