Label: information for the user

VYTORIN 10mg/20mg tablets

VYTORIN 10mg/40mg tablets

Ezetimibe and simvastatin

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

• Keep this label, as you may need to read 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 even if they 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 label. See section 4.

6. Contents of the pack and additional information

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

VYTORINacts by reducing cholesterol in two ways.The active principle ezetimibareduces the cholesterol absorbed in the digestive tract.The active principle simvastatina, which belongs to the group of "statins", inhibits the production ofcholesterol manufactured by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is composed mainly 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 myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to 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.

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

VYTORIN is used, along with a cholesterol-lowering diet,if you have:

• elevated blood levels of cholesterol (primary hypercholesterolemia, both 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 in separate tablets have been used.

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

VYTORINdoes not help you lose weight.

Do not take VYTORIN if

• You are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients in this medicine (listed in section 6. Contents of the pack and other information for healthcare professionals),
• 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 have taken or are taking a medicine that contains fusidic acid in the past 7 days (used to treat bacterial infections). Taking VYTORIN with fusidic acid can cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure if your medicine is mentioned above.

Warnings and precautions

Inform your doctor:

• About all your medical conditions, including allergies,
• If you consume large amounts of alcohol or have ever had liver disease. VYTORIN may not be suitable for you,
• If you are due to have an operation. You may need to stop taking VYTORIN 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 disease (a condition that causes weakness of the eye muscles), as statins like VYTORIN can sometimes worsen the condition or cause it to develop (see section 4).

Your doctor will do a blood test before you start taking VYTORIN and also if you have any symptoms of liver problems while taking VYTORIN. 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 VYTORIN.

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 VYTORIN with fibrates (certain medicines to reduce cholesterol), as the combination has not been studied.

See your doctor immediately if you experience:

Pain, tenderness or weakness of the muscles that is not explained. 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 VYTORIN, 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 ever had muscle problems during treatment with medicines that lower cholesterol called statins (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate),
• If you or a close relative 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

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

Taking VYTORIN 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 VYTORIN 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 VYTORIN if”).

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking VYTORIN. Your doctor will tell you when you can start taking VYTORIN again. Taking VYTORIN with fusidic acid rarely can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on 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 muscle problems may be more severe when this medicine is taken during treatment with simvastatin (such as VYTORIN). Your doctor may decide that you should stop taking VYTORIN 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),
• Colestiramine (also used to reduce cholesterol), because it affects how VYTORIN 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 VYTORIN.

Taking VYTORIN with food and drink

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

VYTORIN is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness after taking VYTORIN.

VYTORIN 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.

VYTORIN contains sodium

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

Your doctor will determine the appropriate dose for you, based on your current treatment and your individual 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 VYTORIN, you must be following a diet to reduce cholesterol.
• You will need to continue this cholesterol-lowering diet while taking VYTORIN.

Adults: the dose is1 tabletofVYTORINonce a day by mouth.

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

The VYTORIN 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 VYTORIN at night. You can take it with or without food.

If your doctor has prescribed VYTORIN along withanother cholesterol-lowering medication that contains the active ingredientcolestiramine or any other bile acid sequestrant, you must take VYTORIN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more VYTORIN than you should

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

If you forget to take VYTORIN

• Do not take a double dose to make up for the missed dose, take your usual dose of VYTORIN at the usual time

If you interrupt treatment with VYTORIN

• Talk to 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 you start taking VYTORIN).

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

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

The following side effects were reported infrequently (may affect up to 1 in 100 people):

• Liver function elevations in blood tests; uric acid elevations in the blood; blood clotting time elevations; proteinuria; 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 were reported with unknown frequency (the frequency cannot be estimated from the available data):

• 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 eyelid drooping, difficulty swallowing, or difficulty breathing.

In addition, the following side effects were reported in people taking VYTORIN or medications containing the active ingredients ezetimibe or simvastatin:

• Low red blood cell count (anemia), reduction of blood cell count, which may 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 may cause abdominal pain, nausea, vomiting),
• Hair loss; red, swollen, and sometimes blistering rash (erythema multiforme),
• Blurred vision and vision deterioration (may affect up to 1 in 1,000 people),
• Rash that may occur on the skin or ulcers in the mouth (medication-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 may cause difficulty breathing or swallowing and require 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 may 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.

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

• 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 may not disappear after stopping VYTORIN 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 causes 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 VYTORIN 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 SIGREpoint of 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 ofVYTORIN

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

VYTORIN tablets are capsule-shaped, white to bone-colored, with the code “312”in the VYTORIN10mg/20mg tablet or “313” in the VYTORIN10mg/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,multiple pack containing 98tablets (2boxes of 49),100, or 300tablets.

Only some package sizes may be commercially available.

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

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.

Last review 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/)