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EZETIMIBE 10MG TABLETS

Active substance(s): EZETIMIBE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ezetimibe is used in addition to your cholesterol lowering diet if you have:
• a raised cholesterol level in your blood (primary hypercholesterolaemiaheterozygous 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.



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 effectiveness of the combined use of Ezetimibe and fibrates
(medicines for lowering cholesterol) have not been established.

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.

Ezetimibe adds to the cholesterol-lowering effect of statins, a group of
medicines that reduce the cholesterol your body makes by itself.

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.

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.

Cholesterol is one of several fatty substances found in the bloodstream. Your
total cholesterol is made up mainly of LDL and HDL cholesterol.

Ezetimibe does not help you lose weight.

Children and adolescents
Do not give this medicine to children and adolescents between 6 and 17 years
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 (a medicine often used in organ transplant patients),
• medicines to prevent blood clots, such as warfarin, phenprocoumon,
acenocoumarol or fluindione (anticoagulants),
• colestyramine (a medicine for lowering cholesterol), because it affects the
way Ezetimibe works,
• fibrates (medicines for lowering cholesterol).

Ask your doctor or pharmacist for advice before taking any medicine.

1. What Ezetimibe is and what it is used for
Ezetimibe is a medicine to lower increased levels of cholesterol.

Ezetimibe 10 mg tablets
Ezetimibe

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, the active ingredient of Ezetimibe, works by reducing the cholesterol
absorbed in your digestive tract.

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

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.

2. 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),
Do not take Ezetimibe 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 Ezetimibe.



Ezetimibe with food and drink
You can take Ezetimibe with or without food.

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.

Ezetimibe without a statin should not be used if you are breast-feeding. Ask
your doctor for advice.

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.

3. How to take Ezetimibe
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 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
Please 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
If you stop taking Ezetimibe, your blood cholesterol may increase again.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.

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:
Common (may affect up to 1 in 10 people):
• abdominal pain;
• diarrhoea;
• flatulence;
• feeling tired.
Uncommon (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:

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.



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

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: http://yellowcard.mhra.gov.uk.
By reporting side effects, you can help provide more information on the safety
of this medicine.

6. 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: sodium laurilsulfate, povidone K30, mannitol (E421),
croscarmellose sodium, microcrystalline cellulose (E460), sodium stearyl
fumarate.
What Ezetimibe looks like and contents of the pack
Tablets are presented as white to off white, capsule shaped tablets with beveled
edges. Tablet dimensions: 8 x 4 mm.
Ezetimibe is available in boxes containing:
• 14, 28, 30, 50, 56, 60, 90, 98 or 100 tablets in blisters (OPA/Alu/PVC//Alu),
• 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 or
100 x 1 tablets in perforated unit dose blisters (OPA/Alu/PVC//Alu).
Not all pack sizes may be marketed.

When used with fenofibrate, the following common side effect was reported:
abdominal pain.

5. How to store Ezetimibe

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Additionally, the following side effects have been reported in general use
(frequency not known):
• 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;

Keep this medicine out of the sight and reach of children.

Distributed by: Consilient Health (UK) Limited. No.1 Church Road, Richmond
upon Thames, Surrey. TW9 2QE

Do not use this medicine after the expiry date which is stated on the packaging
after EXP. The expiry date refers to the last day of that month.

This leaflet was last revised in 10/2016

Store in the original package in order to protect from 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.
P0559

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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