PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ezetimibe 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.

What is in this leaflet

1.    What Ezeti mibe 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 otheinformation

What Ezetimibe is and what it is used for

Ezetimibe contains the active substance ezetimibe.

Ezetimibe is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, this medicine raises levels of "good" cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine.

This medicine works by reducing the cholesterol absorbed in your digestive tract. It does not help you lose weight.

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

Ezetimibe is used in addition to diet if you have:

•    a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial])

This medicine can be taken

-    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.

taking any of the following:

•    ciclosporin (a medicine often used in organ transplant patients)

•    medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)

•    colestyramine (a medicine for lowering cholesterol), because it affects the way ezetimibe works (see also section 3)

•    fibrates (medicines for lowering cholesterol)

(see also section 2: Warnings and precautions).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 are no data available for the use of Ezetimibe without a statin during pregnancy.

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.

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or to use machinery. However, some people may get dizzy after taking Ezetimibe. If this happens to you, do not drive or operate machinery until you feel better.

Ezetimibe contains 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

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.

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. Check with your doctor or pharmacist if you are not sure.

DO NOT take Ezetimibe:

• if you are allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6 and end of section 2).

Before starting this medicine, you should be on a diet to lower your cholesterol.

You should stay on this diet whilst taking this medicine.

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 any allergies.

•    Your doctor should do a blood test before you start taking this medicine 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 this medicine with a statin.

If you have moderate or severe liver problems,

Ezetimibe is not recommended.

The combined use of Ezetimibe and fibrates (medicines for lowering cholesterol) should be avoided since the safety and effectiveness of the combined use of Ezetimibe and fibrates have not been established.

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.

Adults, adolescents and children (10 to 17 years of age):

The dose is one Ezetimibe 1 0 mg tablet by mouth once a day.

Take this medicine at any time of the day. You can take it with or without food.

If your doctor has prescribed Ezetimibe together 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 together with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), 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 take more Ezetimibe than you should.

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

Your cholesterol may rise again if you stop taking this medicine.

The risk of muscle breakdown is greater in some If you have any further questions on the use of this patients taking Ezetimibe with cholesterol lowering medicine, ask your doctor or pharmacist. medicines, like statins.

Children

Ezetimibe is not recommended for children under the age of 10 years.

Other medicines and Ezetimibe

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those obtained without a prescription. In particular, tell your doctor if you are

Continued on the next page >>

4 Possible side effects

5 How to store Ezetimibe

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

Contact your doctor immediately if you experience

•    unexplained muscle pain,

•    muscle 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,

•    dizziness or fainting and unusually fast or irregular heart beat which require treatment immediately, have been reported in general use.

Other side effects reported in clinical trials

When these tablets are taken on their own, the

following side effects were reported:

Common side effects (may affect up to 1 in 10 people):

•    abdominal pain

•    diarrhoea

•    flatulence (breaking wind)

•    feeling tired.

Uncommon side effects (may affect up to 1 in 1 00 people):

•    elevations in some laboratory blood tests of liver (transaminases) or muscle (CK) function

•    cough

•    indigestion

•    heartburn

•    feeling sick

•    joint pain

•    muscle spasms

•    neck pain

•    decreased appetite

•    pain

•    chest pain

•    hot flush

•    high blood pressure.

Additionally, when these tablets are taken with

a statin, the following side effects were reported:

Common side effects (may affect up to 1 in 10 people):

•    elevations in some laboratory blood tests of liver function (transaminases)

•    headache

•    muscle pain/tenderness.

Uncommon side effects (may affect up to 1 in 1 00 people):

•    tingling sensation (pins and needles)

•    dry mouth

•    inflammation of stomach lining

•    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 (for high cholesterol), the following side effect was reported:

Common side effect (may affect up to 1 in 10 people):

•    abdominal pain.

Additionally, the following side effects have been reported in general use (reported once marketed):

Side effects of unknown frequency

(frequency cannot be estimated from the available data):

•    dizziness

•    liver problems

•    allergic reactions including rash, hives, swelling of the face, tongue or throat and fainting

•    raised red rash, sometimes with target - shaped lesions i.e. a pink-red ring around a pale centre

•    muscle pain/tenderness

•    muscle weakness: cramps, stiffness or spasm

•    strong muscle pain or weakness and red-brown urine because of 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.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tablet blister, carton and bottle after EXP. The expiry date refers to the last day of that month.

Blisters: Store in the original package in order to protect from moisture.

Bottles: Keep the container tightly closed in order to protect from moisture.

After first opening: Store below 25°C. Use within nine months.

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.

Contents of the pack and other information

What Ezetimibe contains

•    The active substance is ezetimibe.

Each tablet contains 1 0 milligrams of ezetimibe.

•    The other excipients are lactose monohydrate (see end of the section 2 for further information), hypromellose, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate and magnesium stearate.

What Ezetimibe looks like and contents of the pack

Ezetimibe is a white to almost white, oval tablet (7.4 mm x 4.1 mm) with debossing "1 0" on one side and "EZT" on the other side.

Al/Al blister or PVC/PVDC/Al blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.

HDPE bottle with a polypropylene screw cap: 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR,

United Kingdom.

Manufacturer

Lek Pharmaceuticals d.d.,

Verovskova 57,

1526 Ljubljana,

Slovenia

or

Lek S.A.,

ul. Domaniewska 50 C,

02-672 Warszawa,

Poland

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Salutas Pharma GmbH,

Dieselstrasse 5,

70839 Gerlingen,

Germany

or

S.C. Sandoz, S.R.L.,

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures,

Romania

This leaflet was last revised in 01/2014.

SZ00000LT000