Ezetimibe

• Reduces cholesterol levels
• Tablet for oral use
• Not to be used while breastfeeding

Ezetimibe is a medicine to lower increased levels of cholesterol. Ezetimibe, the active ingredient of Ezetimibe tablets, works by reducing the cholesterol absorbed in your digestive tract. 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 is prescribed to treat various conditions, including:

• A raised cholesterol level in your blood.
• A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood.
• Heart disease (to reduce the risk of heart attack or stroke).

The doctor may also prescribe Ezetimibe together with cholesterol-lowering medicines called statins. Ezetimibe adds to the cholesterol lowering effect of statins.

Take the tablet with a drink of water. You can take your Ezetimibe tablets with food or on an empty stomach, at any time of the day. Before starting Ezetimibe, you should be on a diet to lower your cholesterol.

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

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults: one 10mg tablet once a day.

This medicine is not recommended for children under 18 years of age.

Alcohol/driving

This medicine does not interact with alcohol.

This medicine may cause dizziness. Before you drive a vehicle, use tools or operate machines make sure you know how Ezetimibe affects you.

If you use too much/forget to use/stop using Ezetimibe

If you take more Ezetimibe than you were told to, 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.

Do not stop taking Ezetimibe without consulting a doctor because your cholesterol may rise again.

Ezetimibe is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What Ezetimibe contains').

Do not take Ezetimibe with a statin if:

• You have a liver disease.
• You are pregnant or breastfeeding.

When should this medicine be used with caution?

• 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 (fibrates) have not been established.

Pregnancy and breastfeeding

Pregnancy

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 average 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.

Breastfeeding

Do not take Ezetimibe with a statin if you are breastfeeding, 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.

Other medicines and Ezetimibe

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

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).
• Active ingredients 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).

Like all medicines, this medicine can cause side effects, although some people may not experience any.

Serious side effects

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.

Get emergency medical help if you have signs of a severe allergic reaction (see the package leaflet for more information).

Other side effects of Ezetimibe

When used alone, the following side effects were reported:

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

• Stomach pain, diarrhoea, flatulence.
• Tiredness.

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

• Elevations in some laboratory blood tests of liver function (transaminases) or muscle (CK) function.
• Cough.
• Digestive problems.
• Heartburn, nausea.
• Joint pain.
• Muscle spasms.
• Pain in the neck.
• Decreased appetite.
• Pain.
• Chest pain.
• Hot flashes.
• High blood pressure.

Additionally, when used with a statin, the following side effects were reported:

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

• Elevations in some laboratory blood tests of liver function (transaminases).
• Headache.
• Muscle ache.
• Feeling of weakness.

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

• 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 side effects, see the package leaflet. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

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

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