Vytorin 10 mg/20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VYTORIN 10mg/20mg tablets

VYTORIN 10mg/40mg tablets

Ezetimibe and simvastatin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What VYTORIN is and what it is used for

2. What you need to know before taking VYTORIN

3. How to take VYTORIN

4. Possible side effects

5. How to store VYTORIN

6. Contents of the pack and other information

1. What VYTORIN is and what it is used for

VYTORIN contains the active substances ezetimibe and simvastatin. VYTORIN is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, VYTORIN increases levels of "good" cholesterol (HDL cholesterol).

VYTORIN works to reduce cholesterol in two ways. The active substance ezetimibe reduces the cholesterol absorbed through the digestive tract. The active substance simvastatin, which belongs to a group of medicines called "statins," inhibits the production of cholesterol made by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL cholesterol 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 plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Disruption of blood flow may lead to a heart attack or stroke.

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

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

VYTORIN is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

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

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia):

• that are not well controlled by a statin alone,

• for whom a statin and ezetimibe have previously been used as separate tablets.

• a hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

• heart disease, in which case VYTORIN reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

VYTORIN does not help you to lose weight.

2. What you need to know before taking VYTORIN

Do not take VYTORIN if

• you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other components of this medicine (listed in section 6. Contents of the pack and other information),

• you currently have liver problems,

• you are pregnant or breastfeeding,

• you are taking medicines containing 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 reduce cholesterol),
  • cyclosporine (used in organ transplant patients),
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and VYTORIN may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medicine is listed above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, including allergies,
• if you drink large amounts of alcohol or have ever had liver disease. VYTORIN may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking VYTORIN tablets for a short period,
• if you are of Asian descent, as you may require a different dose,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking VYTORIN and may repeat it if you develop symptoms of liver problems while taking VYTORIN. This is to monitor how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with VYTORIN.

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. The risk of diabetes increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Talk to your doctor if you have severe lung disease.

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

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of VYTORIN, especially the 10/80 mg dose. The risk of muscle breakdown is also greater 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 female,
• if you have ever had muscle problems while being treated with cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate),
• if you or your close relatives have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

• VYTORIN is not recommended for children under 10 years of age.

Taking VYTORIN with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicine containing any of the following active substances. Taking VYTORIN with any of the following medicines may increase the risk of muscle problems (some of these are already listed in the section above “Do not take VYTORIN if”).

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can restart VYTORIN treatment. Using VYTORIN with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus),
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing active substances such as gemfibrozil and bezafibrate (used to reduce 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 containing the active substance 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),
• lomitapide (used to treat rare, inherited cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of muscle-related adverse effects may be increased when this medicine is taken during treatment with simvastatin (e.g., VYTORIN). Your doctor may decide that you should temporarily stop taking VYTORIN,
• high 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 listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are taking any of the following:

• medicines containing active substances to prevent blood clots, such as warfarin, phenindione, phenprocoumon, or acenocoumarol (anticoagulants),
• colestyramine (also used to reduce cholesterol), as it may affect how VYTORIN works,
• fenofibrate (also used to reduce cholesterol),
• rifampicin (used to treat tuberculosis),
• ticagrelor (an antiplatelet medicine).

You should also inform any doctor prescribing a new medicine that you are taking VYTORIN.

Taking VYTORIN with food and drink

Grapefruit juice contains one or more components that interfere with the metabolism of certain medicines, including VYTORIN. Consumption of grapefruit juice should be avoided, 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 while breastfeeding, as it is unknown whether this medicine passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

VYTORIN is not expected to affect your ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking VYTORIN.

VYTORIN contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance 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; essentially “sodium-free.”

3. How to take VYTORIN

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

The tablets do not have a score line and must not be divided.

Always follow exactly the instructions for use given by your doctor. If in doubt, consult your doctor or pharmacist again.

• Before starting VYTORIN, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking VYTORIN.

Adults: The dose is 1 tablet of VYTORIN once daily by mouth.

Use in adolescents (10 to 17 years of age): The dose is 1 tablet of VYTORIN once daily by mouth (the maximum dose should not exceed 10 mg/40 mg once daily).

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

Take VYTORIN in the evening. You may take it with or without food.

If your doctor has prescribed VYTORIN together with another cholesterol-lowering medicine containing the active substance colestyramine 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, contact the Toxicology Information Service at telephone number: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take VYTORIN

• Do not take a double dose to make up for missed doses. Take your usual dose of VYTORIN at your regular time.

If you stop taking VYTORIN

• Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about 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 everyone experiences them (see section 2. What you need to know before you start taking VYTORIN).

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

• muscle pain,
• increased liver function tests in blood laboratory analyses (transaminases) and/or muscle (CK).

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

• increased liver function in blood tests; increased blood uric acid levels; prolonged blood clotting time; protein in urine; weight loss,
• dizziness; headache; tingling sensation,
• abdominal pain; indigestion; flatulence; nausea; vomiting; bloating; diarrhoea; dry mouth; heartburn,
• rash; itching; urticaria,
• joint pain; pain, hypersensitivity, weakness, or muscle spasms; neck pain; pain in arms and legs; back pain,
• unusual tiredness or weakness; feeling tired; chest pain; swelling, especially of the hands and feet,
• sleep disorders; difficulty sleeping.

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

• myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in arms or legs 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 VYTORIN or medicines containing the active substances ezetimibe or simvastatin:

• low red blood cell count (anaemia), reduced blood cell count, which may cause bruising/bleeding (thrombocytopenia),
• numbness or weakness in arms and legs; memory impairment, memory loss, confusion,
• respiratory problems including persistent cough and/or difficulty breathing or fever,
• constipation,
• inflammation of the pancreas, often with severe abdominal pain,
• liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-coloured 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, raised rash, sometimes with target-like skin lesions (erythema multiforme),
• blurred vision and worsening of vision (may affect up to 1 in 1,000 people),
• skin rash or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people),
• hypersensitivity reactions which may include: allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing and require immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, atypical bruising, skin rashes and swelling, urticaria, skin sensitivity to sunlight, fever, hot flushes, breathing difficulty and general malaise, 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) may occur, causing difficulty breathing or dizziness, requiring immediate treatment (anaphylaxis),
• muscle pain, tenderness, weakness or cramps; muscle breakdown; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture,
• gynaecomastia (enlargement of breast tissue in men) (may affect up to 1 in 10,000 people),
• decreased appetite,
• hot flushes; high blood pressure,
• pain,
• erectile dysfunction,
• depression,
• changes in certain blood tests of liver function.

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

• sleep disorders, including nightmares,
• sexual dysfunction,
• diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness or weakness, which may not resolve after stopping treatment with VYTORIN (frequency not known).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VYTORIN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or container following [EXP].
• Do not store VYTORIN tablets above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of VYTORIN

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

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

Appearance of the product and contents of the pack

VYTORIN tablets are capsule-shaped, white to off-white in colour, with the code “312” on one side for VYTORIN 10 mg/20 mg tablets or “313” for VYTORIN 10 mg/40 mg tablets. The tablets do not have a score line and should not be divided.

Pack sizes:

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

The Netherlands

or

Savio Industrial Srl.

Via Emilia, 21

27100 Pavia (PV)

Italy

This medicinal product is authorised in the European Economic Area member states under the following name:

VYTORIN in: Germany, Italy, Portugal and Spain.

Date of the most recent review of this leaflet: 04/2026.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)