Uses: Treat high blood cholesterol

Chemical Name: Ezetimibe

Quantity: 28 Tabs

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.

What is in this leaflet

1. What EZETROL is and what it is used for2. What you need to know before you take EZETROL3. How to take EZETROL4. Possible side effects5. How to store EZETROL6. 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 hospitalisation 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.

ed 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.

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.

EZETROL contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free.

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.

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.