ATOZET ? 10 mg / 20 mg (? Ezetimibe / Atorvastatin )?30 film-coated tablets

Package leaflet: Information for the user

ATOZET? 10 mg/10 mg film-coated tablets

ATOZET? 10 mg/20 mg film-coated tablets

ATOZET? 10 mg/40 mg film-coated tablets

ATOZET? 10 mg/80 mg film-coated tablets

ezetimibe and atorvastatin

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 ATOZET is and what it is used for

2. What you need to know before you take ATOZET

3. How to take ATOZET

4. Possible side effects

5. How to store ATOZET

6. Contents of the pack and other information

1.What ATOZET is and what it is used for

ATOZET is a medicine to lower increased levels of cholesterol. ATOZET contains ezetimibe and

atorvastatin.

ATOZET is used in adults to lower levels of total cholesterol, ?bad? cholesterol (LDL cholesterol), and

fatty substances called triglycerides in the blood. In addition, ATOZET raises levels of ?good? cholesterol

(HDL cholesterol).

ATOZET works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your

digestive tract, as well as 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.

ATOZET is used for patients who cannot control their cholesterol levels by diet alone. You should stay

on a cholesterol-lowering diet while taking this medicine.

ATOZET 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]) or elevated fat levels in your blood (mixed hyperlipidaemia)

? that is not well controlled with a statin alone;

? for which you have used a statin and ezetimibe as separate tablets.

?a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level

in your blood. You may also receive other treatments.

?heart disease. ATOZET reduces the risk of heart attack, stroke, surgery to increase heart blood flow,

or hospitalisation for chest pain.

ATOZET does not help you lose weight.

2.What you need to know before you take ATOZET

Do not take ATOZET if

? you are allergic to ezetimibe, atorvastatin or any of the other ingredients of this medicine (listed in

section 6)

? you have or have ever had a disease that affects the liver

? you have had any unexplained abnormal blood tests for liver function

? you are a woman able to have children and are not using reliable contraception

? you are pregnant, trying to become pregnant or are breast-feeding

Warnings and precautions

Talk to your doctor or pharmacist before taking ATOZET if

? you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the

brain from previous strokes

? you have kidney problems

? you have an under-active thyroid gland (hypothyroidism)

? you have had repeated or unexplained muscle aches or pains, a personal history or family history of

muscle problems

? you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g.

other ?statin? or ?fibrate? medicines)

? you regularly drink a large amount of alcohol

? you have a history of liver disease

? you are older than 70 years

? you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this product

? you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial

infection) orally or by injection. The combination of fusidic acid and ATOZET can lead to serious

muscle problems (rhabdomyolysis)

Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness

while taking ATOZET. This is because on rare occasions, muscle problems can be serious, including

muscle breakdown resulting in kidney damage. Atorvastatin is known to cause muscle problems, and

cases of muscle problems have also been reported with ezetimibe.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and

medicines may be needed to diagnose and treat this.

Check with your doctor or pharmacist before taking ATOZET

? if you have severe respiratory failure.

If any of these apply to you (or you are not sure), talk to your doctor or pharmacist before taking

ATOZET because your doctor will need to carry out a blood test before and possibly during your

ATOZET treatment to predict your risk of muscle-related side effects. The risk of muscle-related side

effects, e.g. rhabdomyolysis, is known to increase when certain medicines are taken at the same time (see

section 2 ?Other medicines and ATOZET?).

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of

developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars

and fats in your blood, are overweight and have high blood pressure.

Tell your doctor about all your medical conditions including allergies.

The combined use of ATOZET and fibrates (medicines for lowering cholesterol) should be avoided since

the combined use of ATOZET and fibrates has not been studied.

Children

ATOZET is not recommended for children and adolescents.

Other medicines and ATOZET

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,

including those obtained without prescription.

There are some medicines that may change the effect of ATOZET or their effect may be changed by

ATOZET (see section 3). This type of interaction could make one or both of the medicines less effective.

Alternatively it could increase the risk or severity of side effects, including the important muscle wasting

condition known as ?rhabdomyolysis? described in section 4:

? ciclosporin (a medicine often used in organ transplant patients)

? erythromycin, clarithromycin, telithromycin, fusidic acid,** rifampicin (medicines for bacterial

infections)

? ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines for fungal infections)

? gemfibrozil, other fibrates, nicotinic acid, derivatives, colestipol, colestyramine (medicines for

regulating lipid levels)

? some calcium channel blockers used for angina or high blood pressure, e.g., amlodipine, diltiazem

? digoxin, verapamil, amiodarone (medicines to regulate your heart rhythm)

? medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the

combination of tipranavir/ritonavir, etc. (medicines for AIDS)

? some medicines used in the treatment of hepatitis C, e.g., telaprevir

**If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop

using this medicine. Your doctor will tell you when it is safe to restart ATOZET.

Taking ATOZET with fusidic acid may rarely lead to muscle weakness, tenderness or pain

(rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

?Other medicines known to interact with ATOZET

? oral contraceptives (medicines for preventing pregnancy)

? stiripentol (an anticonvulsant medicine for epilepsy)

? cimetidine (a medicine used for heartburn and peptic ulcers)

? phenazone (a painkiller)

? antacids (indigestion products containing aluminium or magnesium)

? warfarin, phenprocoumon, acenocoumarol or fluindione (medicines to prevent blood clots)

? Hepatitis C antiviral agents such as boceprevir, elbasvir, or grazoprevir (medicines used to fight

against hepatitis C infection)

? colchicine (used to treat gout)

? St John’s Wort (a medicine to treat depression)

ATOZET with food and alcohol

See section 3 for instructions on how to take ATOZET. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of

grapefruit juice can change the effects of ATOZET.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See Section 2 ?Warnings and precautions?

for details.

Pregnancy and breast-feeding

Do not take ATOZET if you are pregnant, are trying to get pregnant or think you may be pregnant. Do not

take ATOZET if you are able to become pregnant unless you use reliable contraceptive measures. If you

get pregnant while taking ATOZET, stop taking it immediately and tell your doctor.

Do not take ATOZET if you are breast-feeding.

The safety of ATOZET during pregnancy and breast-feeding has not yet been proven.

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

Driving and using machines

ATOZET 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 ATOZET.

ATOZET contains lactose

ATOZET 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.

3.How to take ATOZET

Always take this medicine exactly as your doctor has told you. Your doctor will determine the appropriate

tablet strength for you, depending on your current treatment and your personal risk status. Check with

your doctor or pharmacist if you are not sure.

?Before starting ATOZET, you should be on a diet to lower your cholesterol.

?You should keep on this cholesterol-lowering diet while taking ATOZET.

How much to take

The recommended dose is one ATOZET tablet by mouth once a day.

When to take

Take ATOZET at any time of the day. You can take it with or without food.

If your doctor has prescribed ATOZET along with colestyramine or any other bile acid sequestrant

(medicines for lowering cholesterol), you should take ATOZET at least 2 hours before or 4 hours after

taking the bile acid sequestrant.

If you take more ATOZET than you should

Please contact your doctor or pharmacist.

If you forget to take ATOZET

Do not take an extra dose; just take your normal amount of ATOZET at the usual time the next day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, ATOZET can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking your tablets and tell your

doctor immediately or go to the nearest hospital accident and emergency department.

?serious allergic reaction which causes swelling of the face, tongue and throat that can cause

great difficulty in breathing

?serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes

genitals and fever; skin rash with pink-red blotches especially on palms of hands or soles of

feet, which may blister

?muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or

have a high temperature it may be caused by an abnormal muscle breakdown which can be lifethreatening and lead to kidney problems

You should consult your doctor as soon as possible if you experience problems with unexpected or

unusual bleeding or bruising, because this may be suggestive of a liver complaint.

The following common side effects were reported (may affect up to 1 in 10 people):

? diarrhoea

? muscle aches

5.The following uncommon side effects were reported (may affect up to 1 in 100 people):

? the flu

? depression; trouble sleeping; sleep disorder

? dizziness; headache; tingling sensation

? slow heart beat

? hot flush

? shortness of breath

? abdominal pain; abdominal bloating; constipation; indigestion; flatulence; frequent bowel

movements; inflammation of the stomach; nausea; stomach discomfort; upset stomach

? acne; hives

? joint pain; back pain; leg cramps; muscle fatigue, spasms, or weakness; pain in arms and legs

? unusual weakness; feeling tired or unwell; swelling especially in the ankles (oedema)

? elevations in some laboratory blood tests of liver or muscle (CK) function

? weight gain

Additionally, the following side effects have been reported in people taking ATOZET, or ezetimibe or

atorvastatin tablets:

? allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause

difficulty in breathing or swallowing (which requires treatment immediately)

? raised red rash, sometimes with target-shaped lesions

? liver problems

? cough

? heartburn

? decreased appetite; loss of appetite

? high blood pressure

? skin rash and itching; allergic reactions including rash and hives

? tendon injury

? gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea,

vomiting)

? inflammation of the pancreas often with severe abdominal pain

? reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia)

? inflammation of the nasal passages; nose bleed

? neck pain; pain; chest pain; pain in the throat

? increases and decreases in blood sugar levels (if you have diabetes you should continue careful

monitoring of your blood sugar levels)

? having nightmares

? numbness or tingling in the fingers and toes

? reduction of sensation to pain or touch

? change in sense of taste; dry mouth

? loss of memory

? ringing in the ears and/or head; hearing loss

? vomiting

? belching

? hair loss

? raised temperature

? urine tests that are positive for white blood cells

? blurred vision; visual disturbances

? gynecomastia (breast enlargement in men and woman).

6.Possible side effects reported with some statins

? sexual difficulties

? depression

? breathing problems including persistent cough and/or shortness of breath or fever

? diabetes. This is more likely if you have high levels of sugars and fats in your blood, are

overweight and have high blood pressure. Your doctor will monitor you while you are taking this

medicine.

? muscle pain, tenderness, or weakness that is constant and particularly if, at the same time, you

feel unwell or have a high temperature that may not go away after stopping ATOZET (frequency

not known).

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 (see details below). By reporting side effects

you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1

6762517. Website: www.hpra.ie; E-mail: [email protected]

5.How to store ATOZET

Keep this medicine out of the sight and reach of children.
Do not take ATOZET after the expiry date stated on the carton or container after ?EXP.? The expiry date refers to the last day of that month.
Store in the original package in order to protect from oxygen.
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 to protect the environment.

6.Contents of the pack and other information

What ATOZET contains

The active substances are ezetimibe and atorvastatin. Each film-coated tablet contains 10 mg ezetimibe

and 10 mg, 20 mg, 40 mg, or 80 mg atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients are: calcium carbonate; silica, colloidal anhydrous; croscarmellose sodium;

hydroxypropylcellulose; lactose monohydrate; magnesium stearate; cellulose, microcrystalline;

polysorbate 80; povidone; sodium laurilsulfate.

The film coating contains: hypromellose, macrogol 8000, titanium dioxide (E171), talc.

What ATOZET looks like and contents of the pack

Capsule-shaped, biconvex, film-coated tablets, white to off white.

ATOZET 10 mg/10 mg tablets: ?257? debossed on one side

ATOZET 10 mg/20 mg tablets: ?333? debossed on one side

ATOZET 10 mg/40 mg tablets: ?337? debossed on one side

ATOZET 10 mg/80 mg tablets: ?357? debossed on one side

7.Pack sizes:

Packs of 10, 30, 90, and 100 film-coated tablets in nitrogen-purged aluminium/aluminium (oPA-Al-PVC

cavity with Al lidding) blisters.

Packs of 30 x 1 and 45 x 1 film-coated tablets in unit dose, nitrogen-purged aluminium/aluminium (oPAAl-PVC cavity with Al lidding) blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem,

The Netherlands

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

names:

ATOZET

Austria, Belgium, Bulgaria, Croatia, Denmark, Germany, Iceland, Ireland, Italy, Luxembourg, Malta,

The Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden,

United Kingdom

LIPTRUZET

Cyprus, France, Greece, Hungary

ZOLETORV

Czech Republic

This leaflet was last revised in July 2016

? Merck Sharp & Dohme Limited 2016. All rights reserved.

Merck Sharp & Dohme Limited.

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK.

PIL.ATZ.16.UK.4848-WS-335

8.Further information

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

Medical Disclaimer

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