Ezetimibe (Ezetrol)

• Cholesterol-lowering medicine
• Active substance: ezetimibe
• Intensifies the effects of statins
• Use together with cholesterol-lowering diet

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.

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 (a type of lipid) 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop.

Before starting EZETROL, you should be on a diet to lower your cholesterol. You should keep on this cholesterol-lowering diet whilst taking EZETROL.

Dosage

The recommended dose is:

• Adults: one EZETROL 10-mg tablet once a day.

This medicine is not suitable for use in children under six years of age. 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.

Use

This medicine can be taken with or without food, at any time of the day.

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 two hours before or four hours after taking the bile acid sequestrant.

If you take more EZETROL than you should or miss a dose

Contact your doctor if you take more tablets than you should.

If you forget to take a dose, 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.

EZETROL is not suitable for everyone and should not be used if:

• You are allergic (hypersensitive) to ezetimibe or any of the other ingredients in this medicine (see section 'What EZETROL contains').

Do not take EZETROL together with a statin if:

• You currently have liver problems.
• You are pregnant or breastfeeding.

When should this medicine be used with caution?

In some situations, you should talk to your doctor before using 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.

Pregnancy and breastfeeding

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

Do not use EZETROL with a statin during pregnancy. 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 breastfeeding, 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.

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).

For more information about warnings, see the package leaflet.

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are some of the side effects that are known to be associated with this medicine.

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

• Stomach pain, diarrhoea, flatulence.
• Tiredness.
• Additionally, when used with a statin: elevations in some laboratory blood tests of liver function (transaminases).
• Headache.
• Muscle pain, tenderness or weakness.

Uncommon (may affect up to 1 in 100 people):

• Coughing.
• Digestive problems.
• Indigestion.
• Nausea.
• Joint pain.
• Muscle spasms.
• Pain in the neck.
• Loss of appetite.
• Chest pain.
• Hot flashes.
• High blood pressure.

Additionally, when used with a statin:

• Tingling sensation.

• Dry mouth.
• Itching, skin rash, hives.
• Back pain, muscle weakness, pain in arms and legs.
• Unusual tiredness or weakness.
• Swelling, especially in the hands and feet.

For a complete list of possible side effects, see the package leaflet. Consult a doctor or pharmacist if you experience any side effects. Contact your doctor immediately if you have a severe allergic reaction or experience unexplained muscle pain, tenderness or weakness.

The active substance is ezetimibe. Each tablet contains 10 mg ezetimibe.

Read the package leaflet before use. The official package leaflet of EZETROL is available for download here.