Inegi

PATIENT INFORMATION LEAFLET

Enclosed patient information leaflet

INEGY, 10 mg + 10 mg, tablets

INEGY, 10 mg + 20 mg, tablets

INEGY, 10 mg + 40 mg, tablets

INEGY, 10 mg + 80 mg, tablets

Ezetimibe + Simvastatin

Read all of this leaflet carefully before 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.

Contents of the pack

• 1. What INEGY is and what it is used for
• 2. Important information before taking INEGY
• 3. How to take INEGY
• 4. Possible side effects
• 5. How to store INEGY
• 6. Contents of the pack and other information

1. What INEGY is and what it is used for

INEGY contains the active substances ezetimibe and simvastatin. INEGY is used to lower the levels of cholesterol and other fats in the blood. It works by reducing the absorption of cholesterol in the gut and by reducing the production of cholesterol in the body. Cholesterol is one of several fatty substances found in the blood. The main types of fatty substances in the blood are LDL (low-density lipoprotein) cholesterol, HDL (high-density lipoprotein) cholesterol and triglycerides. LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of the arteries, forming plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. Reduced blood flow to the heart can cause a heart attack, and reduced blood flow to the brain can cause a stroke. HDL cholesterol is often referred to as "good" cholesterol because it helps to remove "bad" cholesterol from the arteries, thereby protecting against heart disease. Triglycerides are another type of fat found in the blood, which can also contribute to the risk of heart disease. INEGY is used in patients who are at risk of heart disease or who have already been diagnosed with heart disease. INEGY is used in addition to a low-cholesterol diet to reduce the levels of "bad" cholesterol and triglycerides, and to increase the levels of "good" cholesterol. INEGY is not intended to reduce weight.

2. Important information before taking INEGY

When not to take INEGY:

• if you are allergic to ezetimibe, simvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you currently have liver problems,
• if you are pregnant or breast-feeding,
• if you are taking any of the following medicines:
• 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 (used to treat HIV infection),
• boceprevir or telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporine (often used in patients who have had an organ transplant),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the womb grows outside the womb).
• if you are currently taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. Taking fusidic acid with INEGY can cause serious muscle problems (rhabdomyolysis). Do not take INEGY with lomitapide (used to treat a rare and serious genetic cholesterol disorder) at a dose greater than 10 mg + 40 mg.

If you are unsure if you are taking any of the above medicines, consult your doctor.

Warnings and precautions

Tell your doctor:

• about any medical conditions you have, including allergies,
• if you drink large amounts of alcohol or have ever had liver disease. INEGY may not be suitable for you,
• if you are due to have an operation. You may need to stop taking INEGY for a short time,
• if you are of Asian origin, as a different dose may be more suitable for you,
• if you have or have had muscle problems (including muscle weakness) or if you have or have had a disease that affects the muscles (myopathy), as statins can sometimes make these conditions worse (see section 4).

Your doctor will do a blood test before you start taking INEGY and while you are taking it if you have any liver problems. The test will check how well your liver is working. Your doctor may also do 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 at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight or have high blood pressure. Tell your doctor if you have severe lung disease. Do not take INEGY with fibrates (a type of medicine used to lower cholesterol), as no studies have been done to show that INEGY and fibrates can be taken safely together.

Must contact doctor immediately in case of:

Unexplained muscle pain, tenderness or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.
The risk of muscle damage is greater when taking higher doses of INEGY, especially the 10 mg + 80 mg dose. The risk of muscle breakdown is also greater in some patients. You should discuss this with your doctor:

• if you have kidney problems,
• if you have thyroid problems,
• if you are 65 years or older,
• if you are a girl or woman,
• if 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),
• if you or a close family member have a muscle disorder (myopathy).

Tell your doctor or pharmacist if muscle weakness persists. Additional tests and medicines may be needed to diagnose and treat this condition.

Children and adolescents

• INEGY should not be used in children under the age of 10.

INEGY and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take, including those obtained without a prescription. Taking INEGY with the following medicines may increase the risk of muscle problems (some of these are listed in the "When not to take INEGY" section above):

• If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking INEGY for the duration of the fusidic acid treatment. Your doctor will tell you when it is safe to restart INEGY.

Taking INEGY with fusidic acid may, in rare cases, lead to muscle weakness, tenderness or pain (rhabdomyolysis).

Additional information on rhabdomyolysis can be found in section 4.

• cyclosporine (often used in patients who have had an organ transplant),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the womb grows outside the womb),
• medicines containing the active substances itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates containing the active substances 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),
• antiviral medicines used to treat hepatitis C virus infection, such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat irregular heartbeats),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, angina or other heart conditions),
• lomitapide (used to treat a rare and serious genetic cholesterol disorder),
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle side effects may be greater when this medicine is taken with simvastatin (e.g. INEGY). Your doctor may decide to stop INEGY for a while.
• high doses (1 g or more per day) of niacin or nicotinic acid (also used to lower cholesterol),
• colchicine (used to treat gout).

Also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking:

• medicines that prevent blood clots, such as warfarin, flindione, phenprocoumon or acenocoumarol (anticoagulants),
• colestyramine (also used to lower cholesterol), as it can affect the way INEGY works,
• fenofibrate (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis),
• tikagrelor (an antiplatelet medicine).

Also tell any doctor who prescribes you another medicine that you are taking INEGY.

INEGY with food and drink

Grapefruit juice contains one or more ingredients that can increase the metabolism of some medicines, including INEGY. You should avoid drinking grapefruit juice as it may increase the risk of muscle problems.

Pregnancy and breast-feeding

Do not take INEGY if you are pregnant, planning to become pregnant or think you may be pregnant. If you become pregnant while taking INEGY, stop taking it immediately and consult your doctor. Do not take INEGY if you are breast-feeding as it is not known if the medicine passes into breast milk. Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

INEGY is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness when 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 medicine.

INEGY contains sodium

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

3. How to take INEGY

Your doctor will decide on the dose of INEGY that is best for you, based on your current treatment and your individual risk. The tablets are not scored and should not be divided. Always take INEGY exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

• Before starting INEGY, you should be on a cholesterol-lowering diet.
• While taking INEGY, you should continue to follow a cholesterol-lowering diet. Adults: the recommended dose is 1 tabletof INEGY once a day.

Use in children and adolescents(aged 10 to 17 years): the recommended dose is 1 tabletof INEGY once a day (do not exceed the maximum dose of 10 mg + 40 mg once a day). The 10 mg + 80 mg dose of INEGY is only recommended for adult patients with very high cholesterol and a high risk of heart disease who have not reached their cholesterol goal on lower doses. INEGY should be taken in the evening. You can take it with or without food. If your doctor has prescribed INEGY and another cholesterol-lowering medicine containing the active substance colestyramine or another bile acid sequestrant, you should take INEGY at least 2 hours before or 4 hours after taking the bile acid sequestrant.

What to do if you take more INEGY than you should:

• Contact your doctor or pharmacist.

What to do if you forget to take INEGY:

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

What to do if you stop taking INEGY:

• Consult your doctor or pharmacist, as your cholesterol levels 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, INEGY can cause side effects, although not everybody gets them (see section 2: Important information before taking INEGY). The following side effects have been reported in patients taking INEGY:

• muscle pain,
• increased liver enzymes in the blood (transaminases) and/or muscle enzymes (creatine kinase) in the blood.

The following side effects have been reported in patients taking INEGY:

• increased liver enzymes in the blood; increased uric acid in the blood; prolonged blood clotting time; protein in the urine; weight loss,
• dizziness; headache; tingling sensation,
• abdominal pain; nausea; bloating; nausea; vomiting; abdominal distension; diarrhea; dry mouth; heartburn,
• rash; itching; hives,
• joint pain; muscle pain, tenderness, weakness or cramps; neck pain; pain in the arms and legs; back pain,
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• sleep disturbances; sleep problems.

The following side effects have been reported with INEGY but the frequency cannot be estimated from the available data:

• myasthenia gravis (a condition that causes muscle weakness, including muscles used for breathing),
• myasthenic syndrome (a condition that causes muscle weakness, especially in the eyes).

Contact your doctor if you experience unexplained muscle weakness, tenderness or pain, especially if you have difficulty walking or trouble swallowing. Additional side effects have been reported in patients taking INEGY or medicines containing the active substances ezetimibe or simvastatin:

• reduced red blood cell count (anaemia); reduced platelet count, which may increase the risk of bruising or bleeding (thrombocytopenia),
• numbness or weakness in the hands and feet; memory loss, forgetfulness, confusion,
• breathing difficulties, including persistent coughing and/or shortness of breath or fever,
• constipation,
• pancreatitis, often with severe abdominal pain,
• liver inflammation with the following symptoms: yellowing of the skin and eyes; itching; dark urine or pale stools; tiredness or weakness; loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting),
• hair loss; red, raised rash, sometimes with circular, indurated lesions (erythema multiforme),
• blurred vision and other vision problems (each of these may affect up to 1 in 1,000 people),
• rash that may appear on the skin or mucous membranes (drug-induced lupus) (each of these may affect up to 1 in 10,000 people),
• allergic reactions, including anaphylaxis (a severe allergic reaction that requires immediate medical attention), angioedema (swelling of the face, lips, tongue and/or throat), Stevens-Johnson syndrome (a severe skin and mucous membrane disorder), toxic epidermal necrolysis (a severe skin condition), and/or Dress syndrome (drug reaction with eosinophilia and systemic symptoms),
• muscle pain, tenderness or weakness; muscle breakdown; muscle damage (which may affect up to 1 in 10,000 people); tendon disorders, sometimes complicated by tendon rupture,
• gynaecomastia (breast enlargement in men) (which may affect up to 1 in 10,000 people),
• decreased appetite,
• hot flushes with flushing of the face; high blood pressure,
• pain,
• erectile dysfunction,
• depression,
• changes in the results of some laboratory tests used to check how the liver is working.

Additional possible side effects that have been reported in patients taking some statins:

• sleep disturbances, including nightmares,
• sexual dysfunction,
• diabetes. The risk of developing diabetes is greater if you have high levels of sugar 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 may not go away after stopping INEGY (frequency not known).

Must contact doctor immediately in case of:

Unexplained muscle pain, tenderness or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.

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 national reporting system listed in the "Further information" section below. By reporting side effects, you can help provide more information on the safety of this medicine.

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 blister after EXP.
• Do not store INEGY above 30°C.

Blister packs: store in the original package to protect from moisture and light. Bottles: store in a tightly closed container to protect from moisture and light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What INEGY contains

The active substances are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of simvastatin. The other ingredients are butylhydroxyanisole, 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 or almost white, capsule-shaped, marked with "311", "312", "313" or "315" on one side. The tablets are not scored and should not be divided. Packs of 14, 28, or a multipack containing 98 (2 packs of 49) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warszawa
Tel.: + 48 22 105 50 01
organonpolska@organon.com

Manufacturer

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

INEGY in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, the Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom.
Vytorin in Germany, Italy, Portugal and Spain.
Goltor in Germany and Italy.

Date of last revision of the leaflet: 07/2023