EZETIMIBE/SIMVASTATIN Aurovitas 10 mg/20 mg Tablets

Introduction

Package Leaflet: Information for the User

Ezetimibe/Simvastatin Aurovitas10 mg/20 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Ezetimibe/Simvastatin Aurovitas and what is it used for
2. What you need to know before you take Ezetimibe/Simvastatin Aurovitas
3. How to take Ezetimibe/Simvastatin Aurovitas
4. Possible side effects
5. Storage of Ezetimibe/Simvastatin Aurovitas

1. Contents of the pack and other information

1. What is Ezetimibe/Simvastatin Aurovitas and what is it used for

Ezetimibe/Simvastatin Aurovitas contains the active substances ezetimibe and simvastatin. Ezetimibe/Simvastatin Aurovitas is a medicine used to lower the levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. It also raises the levels of “good” cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways. The active substance ezetimibe reduces the amount of cholesterol absorbed from the gut. The active substance simvastatin, which belongs to a group of medicines known as “statins”, inhibits the production of cholesterol made by the body.

Cholesterol is one of the fatty substances that can be found in the blood. 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 can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of the blood flow can lead to 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 against heart disease.

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

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a cholesterol-lowering diet.

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

• High levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fatty substances in the blood (mixed hyperlipidaemia):
• that are not well controlled with a statin alone,
• for which you have taken a statin and ezetimibe as separate tablets.
• A hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You may also receive other treatments.
• Heart disease, ezetimibe/simvastatin reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe/simvastatin does not help you lose weight.

2. What you need to know before you take Ezetimibe/Simvastatin Aurovitas

Do not takeEzetimibe/Simvastatin Aurovitasif:

• 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 breast-feeding.
• You are taking medicines with 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 disease in which the inner lining of the uterus grows outside the uterus).
• You are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and ezetimibe/simvastatin can 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 and severe genetic cholesterol disorders).

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking Ezetimibe/Simvastatin Aurovitas:

Tell your doctor:

• About all your medical problems, including allergies.
• If you drink large amounts of alcohol or if you have ever had liver disease. Ezetimibe/simvastatin may not be suitable for you.
• If you are going to have an operation. You may need to stop taking the ezetimibe/simvastatin tablets for a short time.
• If you are Asian, 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 ezetimibe/simvastatin. 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 ezetimibe/simvastatin.

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 sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

The combined use of ezetimibe/simvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the combined use of ezetimibe/simvastatin and fibrates has not been studied.

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

The risk of muscle breakdown is greater 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. Tell your doctor if any of the following applies to you:

• 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 during treatment with cholesterol-lowering medicines called “statins” (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrato).
• You or your close relatives have a hereditary muscle problem.

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

If you have or have had myasthenia (a disease that causes general muscle weakness that can affect the muscles used for breathing) or myasthenic syndrome (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or trigger the onset of myasthenia (see section 4).

Children and adolescents

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

Other medicines andEzetimibe/Simvastatin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking ezetimibe/simvastatin with some of the following medicines may increase the risk of muscle problems (some of these are already included in the section above “Do not take Ezetimibe/Simvastatin Aurovitas if”).

• If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can restart treatment with ezetimibe/simvastatin. The use of ezetimibe/simvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Cyclosporine (used in organ transplant patients).
• Danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).
• Medicines with an active substance used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole.
• Fibrates with an active substance such as gemfibrozil and bezafibrato (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).
• Antivirals for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection).
• Neefazodone (used to treat depression).
• Medicines with the active substance cobicistat.
• Amiodarone (used to treat irregular heartbeat).
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases).
• Lomitapide (used to treat rare and severe genetic cholesterol disorders).
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The risk of side effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (such as ezetimibe/simvastatin). Your doctor may decide that you should stop taking ezetimibe/simvastatin for a while.
• High doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol).
• Colchicine (used to treat gout).

As well as the medicines mentioned above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking any of the following:

• Medicines with an active substance used to prevent blood clots, such as warfarin, fludione, phenprocoumon, or acenocoumarol (anticoagulants).
• Colestyramine (also used to lower cholesterol), as it affects how ezetimibe/simvastatin works.
• Fenofibrate (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (antiplatelet agent).

You should also tell any doctor who prescribes you a new medicine that you are taking ezetimibe/simvastatin.

TakingEzetimibe/Simvastatin Aurovitaswith food and drink

Grapefruit juice contains one or more components that alter the metabolism of some medicines, including Ezetimibe/Simvastatin Aurovitas. You should avoid drinking grapefruit juice, as it can increase the risk of muscle problems.

Pregnancy and breast-feeding

Do not take ezetimibe/simvastatin if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it immediately and tell your doctor. Do not take ezetimibe/simvastatin if you are breast-feeding, as it is not known whether this medicine passes into breast milk.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe/simvastatin is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking ezetimibe/simvastatin.

Ezetimibe/Simvastatin Aurovitas contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Ezetimibe/Simvastatin Aurovitas

Follow exactly the instructions of your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

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

• Before you start taking this medicine, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking this medicine.

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

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

The dose of ezetimibe/simvastatin 10 mg/80 mg is only recommended for adult patients with very high cholesterol levels and a high risk of heart problems who have not reached the treatment goal with lower doses.

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

Take this medicine in the evening. You can take it with or without food.

If your doctor has prescribed ezetimibe/simvastatin along with another cholesterol-lowering medicine that contains the active substance colestyramine or any other bile acid sequestrant, you should take ezetimibe/simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take moreEzetimibe/Simvastatin Aurovitasthan you should

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

If you forget to takeEzetimibe/Simvastatin Aurovitas

Do not take a double dose to make up for forgotten doses, simply take your normal dose of ezetimibe/simvastatin at the usual time the next day.

If you stop takingEzetimibe/Simvastatin Aurovitas

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

If you have any further questions on 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 all people suffer from them.

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

• Muscle pain.
• Increased blood test results for liver function (transaminases) and/or muscle (CK).

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

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

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

• Low red blood cell count (anemia), reduced blood cell count that can cause bruising/bleeding (thrombocytopenia).
• Numbness or weakness of 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.
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale-colored stools, feeling tired or weak, loss of appetite; liver failure; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting).
• Hair loss; red and swollen rash, sometimes with target-like lesions (erythema multiforme).
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid rash) (may affect up to 1 in 10,000 people).
• Blurred vision and visual disturbance (may affect up to 1 in 1,000 people).
• Hypersensitivity reactions that can 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), pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin rashes, and swelling, hives, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, 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) 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 can occasionally be complicated by tendon rupture.
• Gynecomastia (breast enlargement in men) (which may affect up to 1 in 10,000 people).
• Decreased appetite.
• Hot flashes; high blood pressure.
• Pain.
• Erectile dysfunction.
• Depression.
• Abnormalities in some blood tests for 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 sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Persistent muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with ezetimibe/simvastatin (frequency not known).

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

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

• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofEzetimibe/Simvastatin Aurovitas

• The active ingredients are ezetimibe and simvastatin.

Each Ezetimibe/Simvastatin Aurovitas 10 mg/20 mg tablet contains 10 mg of ezetimibe and 20 mg of simvastatin.

• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose 2910, red iron oxide (E172), and butylhydroxytoluene (E321). See section 2 "Ezetimibe/Simvastatin Aurovitas contains lactose and sodium".

Appearance of the Product and Package Contents

Pinkish-white, oval, and biconvex tablets. The tablet size is 11 mm x 5.5 mm.

Ezetimibe/Simvastatin Aurovitas 10 mg/20 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 Manufacturer

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Ezetimib/Simvastatin PUREN 10 mg/20 mg tablets

Belgium: Ezetimib/Simvastatin AB 10 mg/20 mg tablets

Spain: Ezetimiba/Simvastatina Aurovitas 10 mg/20 mg tablets EFG

France: EZETIMIBE/SIMVASTATINE ARROW 10 mg/20 mg, tablet

Italy: Ezetimibe and Simvastatina Aurobindo

Netherlands: Ezetimibe/Simvastatine Aurobindo 10/20 mg, tablets

Date of the Last Revision of this Leaflet:June 2023

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