• 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).

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

• 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 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 INEGY can lead to serious muscle problems (rhabdomyolysis).

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

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

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.

• INEGY is not recommended for children under age 10.

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").

• 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 INEGY. Taking INEGY with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
• 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, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS),
• Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• 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),
• daptomycin (a drug used to treat complicated skin and skin structure infections and bacteraemia). It is possible that side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin (e.g. INEGY). Your doctor may decide that you stop taking INEGY for a while,
• 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),
• cholestyramine (also used to lower cholesterol), because it affects the way INEGY works,
• fenofibrate (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (antiplatelet medicine).

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

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.

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.

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 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.

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

• Please contact your doctor or pharmacist.

• 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.

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

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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.

The manufacturer of the 10 mg/20 mg tablets is

The manufacturer of the 10 mg/40 mg and 10 mg/80 mg tablets is

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, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom.

VYTORIN in Germany, Italy, Portugal and Spain.

GOLTOR in Germany and Italy.