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Active substance(s): EZETIMIBE

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Package leaflet: Information for the patient
Ezetimibe 10 mg tablets
Read all of this leaflet carefully before you starts 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:

What Ezetimibe is and what it is used for
What you need to know before you take Ezetimibe
How to take Ezetimibe
Possible side effects
How to store Ezetimibe
Contents of the pack and other information


What Ezetimibe is and what it is used for

Ezetimibe is a medicine to lower increased levels of cholesterol.
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
Ezetimibe, the active ingredient of Ezetimibe, works by reducing the cholesterol absorbed in your digestive
Ezetimibe 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.
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 nonfamilial])
• 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 hospitalization for chest pain.
Ezetimibe does not help you lose weight.

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.
Do not take Ezetimibe
• if you are allergic to ezetimibe or any of the other ingredients of this medicine (listed in section 6:
Contents 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
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 if you are breast-feeding, because it is not known if the medicines are passed into
breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Some people may get dizzy after taking Ezetimibe. This should be taken into account when driving
vehicles or operating machines.
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 medicine.


How to take Ezetimibe

Always take this medicine exactly as your doctor has told you. Continue taking your other cholesterollowering medicines unless your doctor tells you to stop. Check with your doctor or pharmacist if you are
not sure.
• Before starting to take Ezetimibe, you should be on a diet to lower your cholesterol.
• You should keep on this cholesterol lowering diet whilst taking Ezetimibe.
The recommended dose is one Ezetimibe 10 mg tablet, by mouth, once a day.
Take Ezetimibe at any time of the day. You can take it with or without food.


If your doctor has prescribed Ezetimibe 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 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 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimibe than you should
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.
If you stop taking Ezetimibe
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.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:
• Very common (may affect more than 1 of 10 patients)
• Common (may affect up to 1 of 10 patients)
• Uncommon (may affect up to 1 of 100 patients)
• Rare (may affect up to 1 of 1,000 patients)
• Very rare (may affect up to 1 of 10,000 patients, including isolated reports).
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.
Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty in
breathing or swallowing (which requires treatment right away) have been reported in general use.
When used alone, the following side effects were reported:

abdominal pain; diarrhoea; flatulence; feeling tired
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:
elevations in some laboratory blood tests of liver function (transaminases); headache;
muscle pain, tenderness or weakness
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 follow side effect was reported:
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 the Yellow Card Scheme, Website:
By reporting side effects you can help provide more information on the safety of this medicine.

How to store Ezetimibe

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 carton or blister after "EXP." The
expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original
package in order to protect form moisture.
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 protect the environment.


Contents of the pack and other information

What Ezetimibe contains
- The active substance is ezetimibe. Each tablet contains 10 mg ezetimibe.
- The other ingredients are: lactose monohydrate, crospovidone (type B), copovidone, sodium
laurilsulfate, microcrystalline cellulose and magnesium stearate.

What Ezetimibe looks like and contents of the pack
Ezetimibe tablets are white to off-white round convex tablets, of approximately 6 mm of diameter
Pack sizes:
Push-through blisters of transparent Triplex (PVC-PE-PVDC) /Aluminium in packs of 7, 10, 14, 20,
28, 30, 50, 84, 90, 98, 100, or 300 tablets.
Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2, Ireland
Laboratorios Liconsa S.A.
Avda. Miralcampo,
Nº7, Poligono Industiral Miralcampo,
Azuqueca de Henares,
Laboratorios Liconsa S.A.
Gran Via Carlos III,
98, 7º,
This leaflet was last revised in: June 2017


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.