Ezetimibe 10 mg Tablets

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 Ezetimibe 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 other information

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
• If you have heart disease, Ezetimibe 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.

Ezetimibe does not help you lose weight.

Do not take Ezetimibe:

• if you are allergic (hypersensitive) to ezetimibe or to any of the other ingredients of Ezetimibe (see section 6:Content of the pack and other information),

Do not take Ezetimibe together with a statin:

• if you currently have liver problems
• if you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezetimibe

• 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 and adolescents

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. Do not give this medicine to children less than 6 years old because there is no information in this age group.

Other medicines and Ezetimibe

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 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. 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 contains sodium

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

If you take more Ezetimibe than you should

Please contact your doctor or pharmacist.

If you forget to take Ezetimibe

Do not 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Ezetimibe

Talk to your doctor or pharmacist because your cholesterol may rise again.

When used alone, the following side effects were reported :

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

• abdominal pain
• diarrhoea
• flatulence
• feeling tired

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

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

• elevations in some laboratory blood tests of liver function (transaminases)
• headache
• muscle pain
• tenderness
• weakness

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

• 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

When used with fenofibrate, 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: 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.

Reporting of side effects

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

You can also report side effects directly via:

Ireland

United Kingdom

By reporting side effects you can help provide more information on the safety of this medicine.

What Ezetimibe contains

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

The other ingredients are:

lactose monohydrate; sodium lauryl sulphate, croscarmellose sodium, povidone K-30 and magnesium stearate.

What Ezetimibe looks like and contents of the pack

Ezetimibe tablets are white to off-white, capsule shaped, approximately 8.0 x 4.0 x 2.6 mm in size, flat, beveled edged uncoated tablets engraved with ‘G’ on one side and “44” on the other side.

Ezetimibe 10 mg tablets are available in PVC/Aclar- aluminium foil blisters of 14, 28, 30, 50, 90, 98 and 100 tablets and HDPE bottles of 100 tablets.

*Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark Ezetimibe Orion

Germany Ezetimib Glenmark

The Netherlands Ezetimibe Glenmark

Sweden Ezetimibe Orion

Czech Republic Ezetimibe Glenmark

Slovakia Ezetimibe Glenmark

Ireland Ezetimibe Tablets

United Kingdom Ezetimibe Tablets

Austria Ezetimib Glenmark

Spain Ezetimibe Viso Farmaceutica

Finland Ezetimibe Orion

Norway Ezetimibe Orion

Poland Ezolip