INEGY 10 mg/20 mg TABLETS

Introduction

Package Leaflet: Information for the User

INEGY 10mg/20mg tablets

INEGY 10mg/40mg 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.

Contents of theleaflet

1. What is INEGY and what is it used for
2. What you need to know before you take INEGY
3. How to take INEGY
4. Possible side effects
5. Storage of INEGY

1. Contents of the pack and other information

1. What is INEGY and what is it used for

INEGY contains the active substances ezetimibe and simvastatin. INEGY is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that are circulating in the blood. INEGY also increases the levels of "good" cholesterol (HDL cholesterol).

INEGY works by reducing cholesterol in two ways. The active substance ezetimibe reduces the cholesterol that is absorbed in the gut. The active substance simvastatin, which belongs to a group of medicines known as "statins", inhibits the production of cholesterol made by the body itself.

Cholesterol is one of the fatty substances that are 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 plaques. Over time, this can lead to a narrowing of the arteries. This narrowing can slow down or block the blood flow to vital organs such as the heart and brain. This blocking of the blood flow can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease.

INEGY is used in patients who cannot control their cholesterol levels by diet alone. While you are taking this medicine, you should also follow a cholesterol-lowering diet.

INEGY is used, in addition to a cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidaemia):
• that are not well controlled with a statin alone,
• for which you have used a statin and ezetimibe in separate tablets.

• a hereditary disease (homozygous familial hypercholesterolaemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• heart disease, INEGY reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart or hospitalisation due to chest pain.

INEGY does not help you lose weight.

2. What you need to know before you take INEGY

Do not take INEGY if

• 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 medicines with one or more of the following active substances:

• 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 infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporin (used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).

• you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and INEGY can cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are not sure if your medicine is mentioned above.

Warnings and precautions

Tell your doctor:

• about all your medical problems, including allergies,
• if you drink large amounts of alcohol or if you have ever had liver disease. INEGY may not be suitable for you,
• if you are going to have an operation. You may need to stop taking INEGY tablets for a short time,
• if you are Asian, as you may need a different dose,
• if you have or have had myasthenia (a disease that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes make these conditions worse or trigger myasthenia (see section 4).

Your doctor will do a blood test before you start taking INEGY and also if you have any symptoms of liver problems while taking INEGY. This is to check how well your liver is working.

Your doctor may also want to do blood tests to check how well your liver is working after you start treatment with INEGY.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight and have high blood pressure.

Talk to your doctor if you have severe lung disease.

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

Consult your doctor immediately if you experience muscle pain, tenderness or weakness that you cannot explain. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown that can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is greater with higher doses of INEGY, especially the 10/80 mg dose. The risk of muscle breakdown is also greater in certain patients. Tell your doctor in the following situations:

• if you have kidney problems,
• if you have thyroid problems,
• if you are over 65 years old,
• if you are female,
• if you have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" (such as simvastatin, atorvastatin and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate),
• you or a close family member have a hereditary muscle disorder.

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

Children and adolescents

• INEGY is not recommended in children under 10 years of age.

Taking INEGY with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Taking INEGY with some of the following medicines may increase the risk of muscle problems (some of these are already included in the "Do not take INEGY" section above).

• if you have to take fusidic acid by mouth to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when you can restart INEGY treatment. The use of INEGY with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporin (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus),
• medicines with an active substance used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole,
• fibrates with an active substance such as 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 antivirals such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines with the active substance cobicistat,
• amiodarone (used to treat irregular heartbeat),
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease or other heart diseases),
• lomitapide (used to treat rare and serious genetic cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteraemia). The risk of side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g. INEGY). Your doctor may decide that you should stop taking INEGY for a while,
• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol),
• colchicine (used to treat gout).

As well as the medicines mentioned above, 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 any of the following:

• medicines with an active substance used to prevent blood clots, such as warfarin, acenocoumarol, acenoquinol or phenindione (anticoagulants),
• cholestyramine (also used to lower cholesterol), as it affects how INEGY works,
• fenofibrate (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis)
• ticagrelor (an antiplatelet medicine).

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

Taking INEGY with food and drink

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

Pregnancy and breast-feeding

Do not take INEGY if you are pregnant, if you are trying to become pregnant or if you think you may be pregnant. If you become pregnant while taking INEGY, stop taking it immediately and tell your doctor. Do not take INEGY if you are breast-feeding, as it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

INEGY is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking INEGY.

INEGY contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

INEGY contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take INEGY

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

The tablets are not scored and should not be divided.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are in doubt, consult your doctor or pharmacist again.

• Before you start taking INEGY, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking INEGY.

Adults: the dose is 1 tabletof INEGY once a day by mouth.

Use in adolescents(10 to 17 years of age): the dose is 1 tabletof INEGY once a day by mouth (do not exceed a maximum dose of 10 mg/40 mg once a day).

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

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

If your doctor has prescribed INEGY with another cholesterol-lowering medicine that contains the active substance 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

• In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, consult your doctor or pharmacist.

If you forget to take INEGY

• Do not take a double dose to make up for forgotten doses, take your normal dose of INEGY at the usual time.

If you stop taking INEGY

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them (see section 2. What you need to know before starting to take INEGY).

The following frequent adverse effects have been reported (may affect up to 1 in 10 people):

• Muscle pain,
• Increases in laboratory blood tests of liver function (transaminases) and/or muscle (CK).

The following infrequent adverse effects have been reported (may affect up to 1 in 100 people):

• Elevation of liver function in blood tests; elevation of uric acid in the blood; elevation in the time it takes for blood to clot; protein in urine; weight loss,
• Dizziness; headache; tingling sensation,
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn,
• Rash; itching; hives,
• Joint pain; pain, hypersensitivity, weakness, or muscle spasms; neck pain; pain in the arms and legs; back pain,
• Unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• Sleep disorder; difficulty sleeping.

The following adverse effects have been reported with an unknown frequency (frequency cannot be estimated from the available data):

• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

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

• Low red blood cell count (anemia), reduction in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• Numbness or weakness of the arms and legs; poor memory, memory loss, confusion,
• Respiratory problems including persistent cough and/or difficulty breathing or fever,
• Constipation,
• Pancreatitis, often with severe abdominal pain,
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine, or pale-colored stools, feeling tired or weak, loss of appetite; liver failure; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting),
• Hair loss; red and swollen rash, sometimes with target-shaped lesions (erythema multiforme),
• Blurred vision and vision impairment (may affect up to 1 in 1,000 people),
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• Hypersensitivity reactions that can include the following: allergic reactions including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing and requires immediate treatment (angioedema), joint pain or inflammation, blood vessel inflammation, atypical bruising, skin rash, and swelling, hives, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, pseudolupus syndrome (including skin rash, joint disorders, and effects on white blood cells). A very rare severe allergic reaction (may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis),
• Muscle pain, sensitivity to pressure, weakness, or muscle cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture,
• Gynecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people),
• Decreased appetite,
• Hot flashes; high blood pressure,
• Pain,
• Erectile dysfunction,
• Depression,
• Abnormalities in some blood tests of liver function.

With some statins, the following additional adverse events have been reported:

• Sleep disorders, including nightmares,
• Sexual dysfunction,
• Diabetes. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Persistent muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with INEGY (frequency not known).

Consult your doctor immediately if you experience unexplained muscle pain, sensitivity to pressure, or weakness. This is because, in rare cases, muscle problems can be serious, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines:

https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of INEGY

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the packaging or after [CAD].
• Do not store INEGY tablets at a temperature above 30°C.

Blister packs: Store in the original packaging to protect them from moisture and light. Bottles: Keep the bottles tightly closed to protect them from moisture and light.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

INEGY Composition

The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 mg or 40 mg of simvastatin.

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

Product Appearance and Packaging Contents

INEGY tablets are capsule-shaped, white to bone-colored, with the code "312" on the INEGY 10 mg/20 mg tablet or "313" on the INEGY 10 mg/40 mg tablet on one side. The tablets are not scored and should not be divided.

Package sizes:

7, 10, 14, 28, 30, 50, 56, 84, 90, 98, multiple packaging containing 98 tablets (2 packs of 49), 100, or 300 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Or

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

VYTORIN in: Germany, Italy, Portugal, and Spain.

GOLTOR in: Germany and Italy.

Date of the last revision of this leaflet:07/2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)