Leaflet: information for the user

Ezetimiba/Simvastatina Aurovitas10 mg/40 mg EFG tablets

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ezetimibe/Simvastatin Aurovitascontains the active principles ezetimibe and simvastatin.Ezetimibe/Simvastatin Aurovitasis a medication used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe/simvastatin increases the concentrations of "good" cholesterol (high-density lipoprotein, HDL).

This medication acts by reducing cholesterol in two ways. The active principle ezetimibe reduces the cholesterol absorbed in the digestive tract. The active principle simvastatin, 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 composed mainly of LDL and HDL.

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 cardiovascular disease.

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

Ezetimibe/simvastatinis used, along with a cholesterol-reducing diet, if you have:

• Elevated cholesterol levels in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated levels in the blood of fatty substances (mixed hyperlipidemia):
• that are not well controlled with a single statin,
• for which a statin and ezetimibe have been used in separate tablets.
• A hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• Cardiovascular disease,ezetimibe/simvastatinreduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimibe/simvastatin does not help you lose weight.

Do not takeEzetimiba/Simvastatina Aurovitasif:

• You are allergic to ezetimiba, simvastatina or any of the other ingredients of this medicine (listed in section 6).
• 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 (protease inhibitors for HIV are 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 inner lining of the uterus grows outside the uterus).
• You are taking or have taken within 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 ezetimiba/simvastatina may cause severe muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of ezetimiba/simvastatina 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

Consult your doctor or pharmacist before starting to takeEzetimiba/Simvastatina Aurovitas:

Inform your doctor:

• About all your medical problems, including allergies.
• If you consume large amounts of alcohol or if you have ever had liver disease.Ezetimiba/simvastatinamay not be suitable for you.
• If you are scheduled for an operation. You may need to stop taking the ezetimiba/simvastatina tablets for a short period of time.
• If you are of Asian origin, as you may need a different dose.

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

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

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.

Inform your doctor if you have a severe lung disease.

Avoid the combined use of ezetimiba/simvastatina and fibrates (certain medicines to reduce cholesterol), as the combined use of ezetimiba/simvastatina and fibrates has not been studied.

Consult your doctor immediately if you experience muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be severe, including muscle breakdown that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with high doses of ezetimiba/simvastatina, especially with the dose of 10 mg/80 mg. The risk of muscle breakdown is also higher in certain patients. Inform your doctor if any of the following situations apply to you:

• 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 cholesterol-lowering medicines called "statins" (such as simvastatina, atorvastatina and rosuvastatina) or fibrates (such as gemfibrozilo or bezafibrato).
• If you or your close relatives have a hereditary muscle problem.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. You may need further tests and additional medicines to diagnose and treat this problem.

If you have or have had myasthenia (a condition that causes generalised muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a condition that causes weakness of the eye muscles), as statins can sometimes worsen the condition or cause myasthenia (see section 4).

Children and adolescents

Ezetimiba/simvastatina is not recommended for children under 10 years old.

Other medicines andEzetimiba/Simvastatina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. Taking ezetimiba/simvastatina 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 takeEzetimiba/Simvastatina Aurovitasif").

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can restart treatment withezetimiba/simvastatina. The use ofezetimiba/simvastatinawith fusidic acid rarely may cause muscle weakness, tenderness 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 inner 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 the active ingredient 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 diseases).
• 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 simvastatina (for example ezetimiba/simvastatina). Your doctor may decide that you should stop taking ezetimiba/simvastatina 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 well 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), as it affects how ezetimiba/simvastatina works.
• Fenofibrate (also used to reduce cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (antiplatelet agent).

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

TakingEzetimiba/Simvastatina Aurovitaswith food and drinks

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

Pregnancy and breastfeeding

Do not take ezetimiba/simvastatina if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking ezetimiba/simvastatina, stop taking it immediately and inform your doctor. Do not take ezetimiba/simvastatina 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 operating machines

Ezetimiba/simvastatina is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking ezetimiba/simvastatina.

Ezetimiba/Simvastatina Aurovitas contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

Adults:The dose is1 tabletof ezetimiba/simvastatina once a day by oral route.

Use in adolescents(10 to 17 years old):The dose is1 tabletof ezetimiba/simvastatina once a day by oral route (do not exceed a maximum dose of 10 mg/40 mg once a day).

The 10 mg/80 mg ezetimiba/simvastatina 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.

Not all recommended doses are possible with these medications; however, other medications with different doses (10 mg/80 mg) are also available.

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

If your doctor has prescribed ezetimiba/simvastatina along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other bile acid sequestrant, you must take ezetimiba/simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take moreEzetimiba/Simvastatina Aurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeEzetimiba/Simvastatina Aurovitas

Do not take a double dose to compensate for the missed doses, simply take your usual amount of ezetimiba/simvastatina at the usual time the next day.

If you interrupt the treatment withEzetimiba/Simvastatina Aurovitas

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Muscle pain.
• Increased liver function in blood tests (transaminases) and/or muscle (CK).

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

• Increased liver function in blood tests; increased uric acid in the blood; increased 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 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.

In addition, the following side effects have been reported in people taking ezetimiba/simvastatina or medications containing the active ingredients ezetimiba or simvastatina:

• Low red blood cell count (anemia), reduction of blood cell count that 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 insufficiency; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting).
• Hair loss; red, swollen, and sometimes blistered rash (erythema multiforme).
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruption) (may affect up to 1 in 10,000 people).
• Blurred vision and visual disturbances(may affect up to 1 in 1,000 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 require immediate treatment (angioedema), joint pain or inflammation, inflammation of blood vessels, atypical hematomas, skin rash, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, lupus-like syndrome (including skin rash, joint problems, and effects on white blood cells). A severe allergic reaction can occur very rarely (may affect up to 1 in 10,000 people) that causes difficulty breathing or dizziness and requires immediate treatment (anaphylaxis).
• Muscle pain, sensitivity, weakness, or cramps; muscle rupture, muscle breakdown (which may affect up to 1 in 10,000 people); tendon problems, which occasionally lead to tendon rupture.
• Gynecomastia (breast enlargement in men) (which 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.

In addition to the side effects listed above, the following side effects 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, which may not disappear after stopping ezetimiba/simvastatina treatment (unknown frequency).

If any of these severe side effects occur, stop taking the medication and immediately inform your doctor or go to the nearest hospital emergency department:Muscle pain, sensitivity, weakness, or cramps. This is because, in rare cases, muscle problems can be severe, including muscle breakdown that causes kidney damage; and very rarely, deaths have occurred.

Unknown frequency (cannot be estimated from available data)

• Myasthenia gravis (a disease that causes generalized muscle weakness, which, 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 carton and blister packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light and humidity.

Medications should not be disposed of through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition ofEzetimiba/Simvastatina Aurovitas

• The active principles are ezetimiba and simvastatina.

Each Ezetimiba/Simvastatina Aurovitas 10 mg/40 mg tablet contains 10 mg of ezetimiba and 40 mg of simvastatina.

• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose 2910, and butylhydroxytoluene (E321). See section 2 “Ezetimiba/Simvastatina Aurovitas contains lactose and sodium”.

Appearance of the product and contents of the package

White or almost white, biconvex, capsule-shaped tablets. The tablet size is 14mm x 6 mm.

Ezetimiba/Simvastatina Aurovitas 10 mg/40 mg tablets EFG are available in boxes containing 28, 30, 50, 90, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

Krka, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

or

TAD Pharma GmbH

Heinz-Lohmann-Straße 5

27472 Cuxhaven

Germany

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

GermanyEzetimib/Simvastatin PUREN 10 mg/40 mg Tabletten

Belgium:Ezetimib/Simvastatin AB 10 mg/40 mg tabletten

Spain:Ezetimiba/Simvastatina Aurovitas 10 mg/40 mg comprimidos EFG

France:EZETIMIBE/SIMVASTATINE ARROW 10 mg/40 mg, comprimé

Italy:Ezetimibe e Simvastatina Aurobindo

Netherlands:Ezetimibe/Simvastatine Aurobindo 10/40 mg, tabletten

Last review date of this leaflet:June 2023

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