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1. What INEGY is and what it is used for

2. What you need to know before you take INEGY

Do not take INEGY if:

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

XXXXXXX/XX-X    3875,3876

Package leaflet: Information for the patient

INEGY® 10 mg/20 mg, 10 mg/40 mg, or 10 mg/80 mg Tablets

Ezetimibe and simvastatin

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 INEGY is and what it is used for

2.    What you need to know before you take INEGY

3.    How to take INEGY

4.    Possible side effects

5.    How to store INEGY

6.    Contents of the pack and other information

INEGY contains the active substances ezetimibe and simvastatin. INEGY is a medicine used to lower levels of total cholesterol, "bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of "good” cholesterol (HDL cholesterol).

INEGY works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class of "statins” inhibits the production of 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.

INEGY 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.

INEGY 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, INEGY reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.

INEGY does not help you lose weight.

•    you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in Section 6: Contents of the pack and other information)

•    you currently have liver problems

•    you are pregnant or breast-feeding

•    you are taking medicine(s) with one or more than one of the following active ingredients:

•    itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)

•    erythromycin, clarithromycin, or telithromycin (used to treat infections)

•    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections)

•    boceprevir or telaprevir (used to treat hepatitis C virus infections)

•    nefazodone (used to treat depression)

•    cobicistat

•    gemfibrozil (used to lower cholesterol)

•    ciclosporin (often used in organ transplant patients)

•    danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

•    you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infection).

Do not take more than 10/40 mg INEGY if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).

Tell your doctor:

•    about all your medical conditions including allergies.

• if you drink large amounts of alcohol or have ever had liver disease. INEGY may not be right for you.

• if you are due to have an operation. You may need to stop taking INEGY tablets for a short time.

• if you are Asian, because a different dose may be applicable to you.

Your doctor should do a blood test before you start taking INEGY and if you have any symptoms of liver problems while you take INEGY. 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 INEGY.

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 if you have severe lung disease.

The combined use of INEGY and fibrates (certain medicines for lowering cholesterol) should be avoided since the combined use of INEGY and fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of INEGY, particularly the 10/80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

•    you have kidney problems

•    you have thyroid problems

•    you are 65 years or older

•    you are female

•    you have ever had muscle problems during treatment with cholesterol lowering medicines called "statins” (like simvastatin, atorvastatin, and rosuvastatin) or fibrates (like gemfibrozil and bezafibrate)

•    you or close family members have a hereditary muscle disorder

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.

Children and adolescents

•    INEGY is not recommended for children under age 10.

Other medicines and INEGY

Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking INEGY with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section "Do not take INEGY if”).

•    ciclosporin (often used in organ transplant patients)

•    danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

•    medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)

•    fibrates with active ingredients like gemfibrozil and bezafibrate (used to lower cholesterol)

•    erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 4 of this leaflet.

•    HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)

•    boceprevir or telaprevir (used to treat hepatitis C virus infections)

•    nefazodone (used to treat depression)

•    medicines with the active ingredient cobicistat

•    amiodarone (used to treat an irregular heartbeat)

•    verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)

•    lomitapide (used to treat a serious and rare genetic cholesterol condition)

•    large amounts (1 gram or more each day) of niacin or nicotinic acid (also used to lower cholesterol)

•    colchicine (used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription. In particular, tell your doctor if you are taking any of the following:

•    medicines with an active ingredient to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants)

•    colestyramine (also used to lower cholesterol), because it affects the way INEGY works

•    fenofibrate (also used to lower cholesterol)

•    rifampicin (used to treat tuberculosis).

You should also tell any doctor who is prescribing a new medicine for you that you are taking INEGY.

INEGY with food and drink

Grapefruit juice contains one or more components that alter the metabolism of some medications, including INEGY. Consuming grapefruit juice should be avoided as it may increase your risk of muscle problems.

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XXXXXXX/XX-X

Pregnancy and breast-feeding

Do not take INEGY if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking INEGY, stop taking it immediately and tell your doctor. Do not take INEGY if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

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

Driving and using machines

INEGY is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking INEGY.

INEGY contains lactose

INEGY 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 INEGY

Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk status.

The tablets are not scored and should not be divided.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Before starting INEGY, you should be on a diet to lower your cholesterol.

•    You should keep on this cholesterol-lowering diet while taking INEGY.

Adults: The dose is 1 tablet INEGY by mouth once a day.

Use in adolescents (10 to 17 years of age): The dose is 1 tablet INEGY by mouth once a day (a maximum dose of 10 mg/40 mg once daily must not be exceeded).

The INEGY 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Take INEGY in the evening. You can take it with or without food.

If your doctor has prescribed INEGY along with another medicine for lowering cholesterol containing the active ingredient colestyramine or any other bile acid sequestrant, you should take INEGY at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more INEGY than you should:

•    please contact your doctor or pharmacist If you forget to take INEGY:

•    Do not take a double dose to make up for a forgotten tablet, just take your normal amount of INEGY at the usual time the next day

If you stop taking INEGY:

•    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.

4. Possible side effects

Like all medicines, INEGY can cause side effects, although not everybody gets them (see Section 2 What you need to know before you take INEGY).

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

•    muscle aches

•    elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function The following uncommon side effects were reported (may affect up to 1 in 100 people):

•    elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; weight decreased

•    dizziness; headache; tingling sensation

•    abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn

•    rash; itching; hives

•    joint pain; muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain

•    unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in the hands and feet

•    sleep disorder; trouble sleeping

Additionally, the following side effects have been reported in people taking either INEGY or medicines containing the active ingredients ezetimibe or simvastatin:

•    low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia)

•    numbness or weakness of the arms and legs; poor memory, memory loss, confusion

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

•    constipation

•    inflammation of the pancreas often with severe abdominal pain

•    inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)

•    hair loss; raised red rash, sometimes with target-shaped lesions (erythema multiforme)

•    a hypersensitivity reaction including some of the following: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately, pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells))

•    muscle pain, tenderness, weakness or cramps; muscle breakdown; tendon problems, sometimes complicated by rupture of the tendon

•    decreased appetite

•    hot flush; high blood pressure

•    pain

•    erectile dysfunction

•    depression

•    alterations in some laboratory blood tests for liver function Additional possible side effects reported with some statins:

•    sleep disturbances, including nightmares

•    sexual difficulties

•    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 that may not go away after stopping INEGY (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

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: medsafety@hpra.ie

Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

5. How to store INEGY

•    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 container after [EXP].

•    Do not store INEGY Tablets above 30°C.

Blisters: Store in the original package in order to protect from moisture and light.

Bottles: Keep bottles tightly closed in order to protect from moisture and light.

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.

6. Contents of the pack and other information

O MSD PROFILE

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What INEGY contains

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg ezetimibe and 20 mg,

40 mg, or 80 mg simvastatin.

The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate.

What INEGY looks like and contents of the pack

INEGY Tablets are white to off-white, capsule-shaped tablets with code "312”, "313”, or "315” on one side. The tablets are not scored and should not be divided.

Pack sizes:

7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multi-pack containing 98 (2 cartons of 49), 100, or 300 tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road

Hoddesdon, Hertfordshire EN11 9BU United Kingdom Manufacturer:

The manufacturer of the 10 mg/20 mg tablets is Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland, NE23 3JU, UK.

The manufacturer of the 10 mg/40 mg and 10 mg/80 mg tablets is Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem, The Netherlands.

This medicinal product is authorised in the Member States of the EEA under the following name: INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,

Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.

The leaflet was last revised in February 2016

^ MSD

© Merck Sharp & Dohme Limited, 2016. All rights reserved.

PIL.VYT.15.UK.4551-WS-262

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