Ezetimibe/simvastatin Aurovitas 10 mg/40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe/Simvastatin Aurovitas 10 mg/40 mg tablets EFG

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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ezetimibe/Simvastatin Aurovitas is and what it is used for
2. What you need to know before taking Ezetimibe/Simvastatin Aurovitas
3. How to take Ezetimibe/Simvastatin Aurovitas
4. Possible side effects
5. How to store Ezetimibe/Simvastatin Aurovitas
6. Contents of the pack and other information

1. What Ezetimiba/Simvastatina Aurovitas is and what it is used for

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

This medicine works to reduce cholesterol in two ways. The active substance ezetimibe reduces the cholesterol absorbed in the gastrointestinal tract. The active substance simvastatin, which belongs to the group of drugs known as "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 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 lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such interruption of blood flow may 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 them from heart disease.

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

Ezetimibe/simvastatin 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.

Ezetimibe/simvastatin is used, together with a cholesterol-lowering diet, if you have:

• High cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidemia):
• that are not well controlled with a statin alone,
• for whom a statin and ezetimibe have previously been used as separate tablets.
• An inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.
• Heart disease; in such cases, ezetimibe/simvastatin reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe/simvastatin does not help you lose weight.

2. What you need to know before taking Ezetimiba/Simvastatina Aurovitas

Do not take Ezetimiba/Simvastatina Aurovitas if:

• You are allergic to ezetimibe, simvastatin, or any of the other ingredients of this medicine (listed in section 6).

• 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 lower 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) by oral or injectable route. The combination of fusidic acid and ezetimibe/simvastatin may cause serious muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Ezetimiba/Simvastatina Aurovitas:

Inform your doctor:

• About all your medical conditions, including allergies.
• If you consume large amounts of alcohol or have ever had liver disease. Ezetimibe/simvastatin may not be suitable for you.
• If you are scheduled for surgery. You may need to stop taking ezetimibe/simvastatin tablets for a short period.
• If you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking this medicine and may repeat it if you develop symptoms of liver problems while taking ezetimibe/simvastatin. This is to check how well your liver is functioning.

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

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

Inform your doctor if you have a severe lung disease.

The combined use of ezetimibe/simvastatin and fibrates (certain medicines to lower cholesterol) 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, rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

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

• You have kidney problems.
• You have thyroid problems.
• You are over 65 years old.
• You are female.
• 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 close family members 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.

If you have or have had myasthenia (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), inform your doctor, as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Children and adolescents

Ezetimibe/simvastatin is not recommended for children under 10 years of age.

Other medicines and Ezetimiba/Simvastatina Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Taking ezetimibe/simvastatin 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 Ezetimiba/Simvastatina Aurovitas 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 advise you when you can restart ezetimibe/simvastatin treatment. The use of ezetimibe/simvastatin with fusidic acid rarely may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further 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 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 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, serious genetic cholesterol disorders).
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., ezetimibe/simvastatin). Your doctor may decide that you should temporarily stop taking ezetimibe/simvastatin.
• High doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol).
• Colchicine (used to treat gout).
• Ribociclib (used to treat breast cancer).
• Palbociclib (used to treat breast cancer).

As well as 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 with active substances used to prevent blood clot formation, such as warfarin, fluindione, phenprocoumon, or acenocoumarol (anticoagulants).
• Colestipol (also used to lower cholesterol), as it may affect how ezetimibe/simvastatin works.
• Fenofibrate (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (antiplatelet agent).

You should also inform any doctor prescribing you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimiba/Simvastatina Aurovitas with food and drink

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including Ezetimiba/Simvastatina Aurovitas. Consumption of grapefruit juice should be avoided, as it may increase the risk of muscle problems.

Pregnancy and breastfeeding

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

Ezetimibe/simvastatin is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking ezetimibe/simvastatin.

Ezetimiba/Simvastatina Aurovitas contains lactose and sodium

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.

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

3. How to take Ezetimibe/Simvastatin Aurovitas

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

• Before starting this medicine, you must already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking this medicine.

Adults: the dose is 1 tablet of ezetimibe/simvastatin once daily by mouth.

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

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

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

Take this medicine in the evening. It may be taken with or without food.

If your doctor has prescribed ezetimibe/simvastatin together with another cholesterol-lowering medicine containing the active substance cholestyramine or any other bile acid sequestrant, you must take ezetimibe/simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe/Simvastatin Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimibe/Simvastatin Aurovitas

Do not take a double dose to make up for forgotten doses. Simply take your usual dose of ezetimibe/simvastatin at the regular time on the following day.

If you stop taking Ezetimibe/Simvastatin Aurovitas

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

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; abdominal bloating; diarrhea; dry mouth; heartburn.
• Rash; itching; hives.
• Joint pain; muscle pain, tenderness, weakness, or spasms; neck pain; pain in arms and legs; back pain.
• Unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in hands and feet.
• Sleep disorders; difficulty sleeping.

In addition, the following adverse effects have been reported in people taking ezetimibe/simvastatin or medicines containing the active substances ezetimibe or simvastatin:

• Low red blood cell count (anemia), reduced blood cell count which may cause bruising/bleeding (thrombocytopenia).
• Numbness or weakness in arms and legs; memory impairment, memory loss, confusion.
• Breathing 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-colored urine or pale stools, feeling tired or weak, loss of appetite; liver failure; gallstones or gallbladder inflammation (which may cause abdominal pain, nausea, vomiting).
• Hair loss; red, raised rash, sometimes with target-like lesions (erythema multiforme).
• Rash that may occur on the skin or mouth ulcers (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 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, blood vessel inflammation, atypical bruising, skin rashes and swelling, hives, skin sensitivity to sunlight, fever, hot flushes, breathing difficulties, and general malaise, lupus-like 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 rupture, muscle breakdown (may affect up to 1 in 10,000 people); tendon problems, which occasionally may lead to tendon rupture.
• Gynaecomastia (enlargement of breasts 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 indicating liver function.

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

• Sleep disorders, including nightmares.
• Sexual dysfunction.
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or 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 ezetimibe/simvastatin treatment (frequency not known).

If any of these serious adverse effects occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department: Muscle pain, tenderness, weakness, or cramps. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

Frequency not known (cannot be estimated from available data):

• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects 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.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Ezetimibe/Simvastatin Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

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

6. Contents of the pack and other information

Composition of Ezetimiba/Simvastatina Aurovitas

• The active substances are ezetimibe and simvastatin.

Each Ezetimiba/Simvastatina Aurovitas 10 mg/40 mg tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.

• 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 pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

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

Germany: Ezetimib/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

Date of the most recent revision of this leaflet: March 2026

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