Package Insert: Information for the User

INEGY 10mg/20mg tablets

INEGY 10mg/40mg tablets

Ezetimibe and Simvastatin

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Package Insert Content

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

6. Contents of the package and additional information

INEGYcontains the active principles ezetimiba and simvastatina.INEGYis a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally,INEGYincreases the concentrations of "good" cholesterol (HDL cholesterol).

INEGYacts by reducing cholesterol in two ways. The active principle ezetimiba reduces the cholesterol absorbed in the digestive tract. The active principle simvastatina, which belongs to the group of "statins", inhibits the production of cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of its arteries forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

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

INEGY is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-reducing diet.

INEGY is used, along with a cholesterol-reducing diet,if you have:

• elevated blood levels of cholesterol (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated blood levels of fatty substances (mixed hyperlipidemia):
• that are not well controlled with a single statin,
• for which a statin and ezetimiba have been used in separate tablets.

• a hereditary disease (familial homozygous hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• cardiovascular disease,INEGY reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

INEGYdoes not help you lose weight.

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 have liver problems,
• you are pregnant or breastfeeding,
• you are taking medicines with one or more of the following active ingredients:

• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin, or telithromycin (used to treat infections),
• protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• boceprevir or telaprevir (used to treat hepatitis C infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to reduce cholesterol),
• ciclosporin (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 uterus grows outside the uterus).

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

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

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

Warnings and precautions

Inform your doctor:

• of all your medical problems, including allergies,
• if you consume 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 tablets for a short time,
• if you are of Asian origin, as you may need a different dose,
• if you have or have had myasthenia (a condition that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause 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 taking 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 sugar and fat in your blood, are overweight, and have high blood pressure.

Talk to your doctor if you have a serious lung disease.

You should avoid taking INEGY and fibrates (certain medicines to reduce cholesterol) together, as they have not been studied together.

See your doctor immediately if you experience:

unexplained muscle pain, tenderness or weakness. This is because muscle problems can sometimes be severe, including kidney damage; and very rarely, deaths have occurred.

The risk of muscle damage is higher with high doses of INEGY, especially the 10/80 mg dose. The risk of muscle damage is also higher in certain patients. Inform 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 a woman,
• if you have or have had muscle problems during treatment with medicines called "statins" (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate),
• if you or your close relatives have a hereditary muscle disorder.

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

Children and adolescents

• INEGY is not recommended for children under 10 years old.

Taking INEGY with other medicines

Inform your doctor if you are taking, have taken recently, or may need to take any other medicine with any of the following active ingredients. Taking INEGY with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above "Do not take INEGY if").

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking INEGY. Your doctor will tell you when you can start taking INEGY again. Taking INEGY with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• ciclosporin (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection),
• nefazodone (used to treat depression),
• medicines with an active ingredient called cobicistat,
• amiodarone (used to treat irregular heart rhythm),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapida (used to treat rare and severe cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin (for example, INEGY). Your doctor may decide that you should stop taking INEGY for a time,
• large doses (1 gram or more per day) of niacin or nicotinic acid (also used to reduce cholesterol),
• colchicine (used to treat gout).

As with the medicines mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those bought without a prescription. In particular, inform your doctor if you are taking any of the following:

• medicines with an active ingredient to prevent blood clotting, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants),
• cholestyramine (also used to reduce cholesterol), because it affects how INEGY works,
• fenofibrate (also used to reduce cholesterol),
• rifampicin (used to treat tuberculosis)
• ticagrelor (antiplatelet medicine).

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

Taking INEGY with food and drinks

Orange juice contains one or more components that alter the metabolism of some medicines, including INEGY. You should avoid consuming orange juice, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

Do not take INEGY if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking INEGY, stop taking it immediately and inform your doctor. Do not take INEGY if you are breastfeeding, 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 unlikely to affect your ability to drive or use machines. However, some people may experience dizziness after taking INEGY.

INEGY contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

INEGY contains sodium

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

Your doctor will determine the appropriate dose for you, based on your current treatment and personal risk factors.

The tablets are not scored and should not be divided.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting to take INEGY, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking INEGY.

Adults: the dose is1 tabletof INEGY once a day by mouth.

Use in adolescents(10 to 17 years of age): the dose is1 tabletof INEGY once a day by mouth (do not exceed a maximum dose of 10mg/40mg once a day).

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

Take INEGY at night. You can take it with or without food.

If your doctor has prescribed INEGY along with another cholesterol-lowering medication that contains the active ingredient colestiramine 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 INEGYthan you should

• In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 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 the missed dose, take your usual amount of INEGY at the usual time.

If you interrupt treatment with INEGY

• Speak with your doctor or pharmacist because your cholesterol may increase again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them (see section 2. What you need to know before starting to take INEGY).Que you need to know before starting to take INEGY).

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

• Muscle pain,
• Laboratory blood test elevations in liver function (transaminases) and/or muscle (CK).

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

• Elevations in liver function in blood tests; elevations in blood uric acid; elevations in blood clotting time; protein in urine; weight loss,
• Dizziness; headache; tingling sensation,
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn,
• Rash; itching; urticaria,
• Joint pain; muscle pain, hypersensitivity, weakness, or muscle spasms; neck pain; arm and leg pain; back pain,
• Unusual fatigue or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• Sleep disorder; difficulty sleeping.

The following side effects of unknown frequency (frequency cannot be estimated from available data) have been reported:

• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Myasthenia ocular (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.

In addition, the following side effects have been reported in people taking INEGY or medications containing the active ingredients ezetimibe or simvastatin:

• Low red blood cell count (anemia), reduction in blood cell count, which can cause hematoma/hemorrhage (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,
• Hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine, or pale stools, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting),
• Hair loss; red, swollen, and sometimes blistering rash (erythema multiforme),
• Blurred vision and deterioration of vision (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 may 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), muscle or joint pain, inflammation of blood vessels, atypical hematomas, skin eruptions, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, lupus-like syndrome (including skin rash, joint disorders, and effects on white blood cells).A severe allergic reaction, which can cause 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 (breast enlargement in men) (may affect up to 1 in 10,000 people),
• Loss of appetite,
• Hot flashes; high blood pressure,
• Pain,
• Erectile dysfunction,
• Depression,
• Alterations in some liver function blood tests.

The following additional adverse events have been reported with some statins:

• Sleep disorders, including nightmares,
• Sexual dysfunction,
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication,
• Constant muscle pain, sensitivity, or weakness that maynot disappear after discontinuing INEGY treatment (unknown frequency).

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 severe, including muscle failure, which can cause kidney damage; and very rarely, deaths have occurred.

Reporting of side effects:

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

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

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging or on the container 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 perfectly closed to protect them from moisture and light.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of INEGY

The active principles are ezetimiba and simvastatina. Each tablet contains 10mg of ezetimiba and 20mg or 40mg of simvastatina.

The other components are: butyl hydroxyanisole, citric acid monohydrate, croscarmelose sodium, hypromelose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.

Appearance of the product and contents of the package

INEGY tablets are capsule-shaped, white to bone-colored, with the code “312” on the INEGY 10mg/20mg tablet or “313” on the INEGY 10mg/40mg tablet on one side. The tablets have no groove and should not be divided.

Package sizes:

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible manufacturer

Organon Heist bv

Industriepark30

2220 Heist‑op‑den‑Berg

Belgium

O

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following name:

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 United Kingdom.

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

GOLTOR in: Germany and Italy.

Revision date of this leaflet:07/2023.

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