Prospect: Information for the User

Simvastatina Aurovitas 40 mg Film-Coated Tablets

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine 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 prospect. See section 4.

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

2.What you need to know before starting to take Simvastatina Aurovitas

3.How to take Simvastatina Aurovitas

4.Possible adverse effects

5.Storage of Simvastatina Aurovitas

6.Contents of the pack and additional information

Simvastatina is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, this medication increases the levels of "good" cholesterol (HDL cholesterol). This medication is a member of a class of medications called statins.

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 your 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 heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

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

While taking this medication, you must follow a cholesterol-reducing diet.

This medication is used, along with a cholesterol-reducing diet, if you have:

•Elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia).

•A hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.

•Coronary heart disease (CHD) or if you have a high risk of coronary heart disease (because you have diabetes, a history of stroke or other vascular disease). This medication can prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in the blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor may measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

Do not take Simvastatina Aurovitas

•If you are allergic to simvastatin or any of the other ingredients of this medication (listed in section 6).

•If you currently have liver problems.

•If you are taking medications 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 with organ transplants).

-Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

•If you are taking, or have taken in the last 7 days, a medication that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure if your medication is on this list.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina Aurovitas:

•All of your medical problems, including allergies.

•If you consume large amounts of alcohol.

•If you have ever had liver disease. This medication may not be suitable for you.

•If you are scheduled for surgery. You may need to stop taking this medication for a short period of time.

•If you are Asian, as you may need a different dose.

•If you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections), by mouth or injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).

Your doctor will do a blood test before you start taking simvastatin and also if you have any symptoms of liver problems while taking simvastatin. 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 treatment with this medication.

While taking this medication, your doctor will closely monitor you 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, being overweight, and high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness, 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.

The risk of muscle failure is higher with high doses of this medication, especially with the 80 mg dose. The risk of muscle failure is also higher in certain patients.

Talk to your doctor if any of the following situations affect you:

•You consume large amounts of alcohol.

•You have kidney problems.

•You have thyroid problems.

•You are 65 years or older.

•You are a woman.

•You have ever had muscle problems during treatment with cholesterol-lowering medications called "statins" or fibrates.

•You or a close relative have a hereditary muscle problem.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

If you have or have had myasthenia (a condition that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (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

The efficacy and safety of simvastatin treatment were studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year earlier (see section 3 "How to take Simvastatina Aurovitas"). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medications and Simvastatina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any medication, including those obtained without a prescription.

Taking simvastatin with any of the following medications may increase the risk of muscle problems (some of which are already included in the section above "Do not take Simvastatina Aurovitas"):

•If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily interrupt the use of this medication. Your doctor will indicate when you can restart the treatment with simvastatin. The use of simvastatin with fusidic acid may cause, in rare cases, 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 inner lining of the uterus grows outside the uterus).

•Medications 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, telithromycin, or fusidic acid (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).

•Medications with an active ingredient such as 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).

•Colchicine (used to treat gout).

•Daptomycin (a medication used to treat skin and skin structure infections and bacteremia). It is possible that muscle side effects may be greater when this medication is taken during treatment with simvastatin. Your doctor may decide that you stop taking simvastatin for a time.

As with the medications mentioned above, inform your doctor or pharmacist if you are taking or have taken recently other medications, even those obtained without a prescription. In particular, inform your doctor if you are taking medications with any of the following active ingredients:

•Medications with an active ingredient to prevent blood clot formation, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).

•Fenofibrate (also used to reduce cholesterol).

•Niacin (also used to reduce cholesterol).

•Rifampicin (used to treat tuberculosis).

•Ticagrelor (antiplatelet medication).

You should also inform any doctor who prescribes a new medication that you are taking simvastatin.

Taking Simvastatina Aurovitas with food and drinks

Orange juice contains one or more components that alter how the body uses some medications, including simvastatin. You should avoid consuming orange juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Do not take this medication if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Driving and operating machinery

This medication is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking this medication.

Simvastatina Aurovitas contains lactose

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

Your doctor will determine the appropriate dose for you, based on your condition, current treatment, and personal risk factors.

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

You must maintain a low-cholesterol diet while taking this medication.

Dosage

The recommended dose is 1 tablet of 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin once a day, orally.

Adults:

The usual starting dose is 10, 20, or in some cases, 40 mg per day. After at least 4 weeks, your doctor may adjust your dose, up to a maximum of 80 mg per day. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medications indicated earlier or if you have certain kidney disorders.

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

Use in children and adolescents

In children and adolescents aged 10 to 17 years, the recommended daily starting dose is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Administration form

Take this medication at night. You can take it with or without food. Continue taking this medication unless your doctor tells you to stop.

If your doctor has prescribed simvastatin along with another cholesterol-lowering medication that contains a bile acid sequestrant, you must take simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatina Aurovitas than 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 take Simvastatina Aurovitas

•Do not take an extra dose; the next day, take your normal amount of simvastatin at the usual time.Do not take a double dose to compensate for the missed dose.

If you interrupt the treatment with Simvastatina Aurovitas

•Talk to your doctor or pharmacist because your cholesterol may rise 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 terms are used to describe how often side effects have been reported:

•Rare (may affect up to 1 in 1,000 people).

•Very rare (may affect up to 1 in 10,000 people).

•Frequency not known (cannot be estimated from available data).

The following serious rare side effects have been reported.

If any of these rare side effects occur, stop taking the medicine and inform your doctor immediately or go to the nearest hospital emergency department:

•Muscle pain, pressure sensitivity, weakness, muscle rupture, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure, which causes kidney damage; and very rarely, deaths have occurred.

•Allergic reactions, including:

-Swelling of the face, tongue, and throat, which can cause breathing difficulties (angioedema).

-Intense muscle pain, usually in the shoulders and hips.

-Skin rash with weakness of the arm and neck muscles.

-Rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions).

-Joint pain or inflammation (polymyalgia rheumatica).

-Inflammation of blood vessels (vasculitis).

-Unusual bruises, skin rash, and swelling (dermatomyositis), urticaria, sun sensitivity, fever, hot flashes.

-Difficulty breathing (dyspnea) and general discomfort.

-Pseudo-lupus syndrome (including skin rash, joint disorders, and blood cell effects).

•Liver inflammation 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 (very rare).

•Pancreatitis, often with intense abdominal pain.

Rarely, the following side effects have also been reported:

•Low red blood cell count (anemia).

•Numbness or weakness of the arms and legs.

•Headache, tingling sensation, dizziness.

•Blurred vision, vision deterioration.

•Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting).

•Skin rash, itching, hair loss.

•Weakness.

•Sleep problems (very rare).

•Poor memory (very rare), memory loss, confusion.

The following very rare serious side effects have been reported:

•A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).

•Gynecomastia (breast enlargement in men).

Also, the following side effects have been reported, but the frequency cannot be estimated from the available information (frequency not known):

•Erectile dysfunction.

•Depression.

•Pneumonia that causes breathing problems, including persistent cough and/or difficulty breathing, or fever.

•Tendon problems, sometimes complicated by tendon rupture.

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

Myasthenic eye (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.

Possible additional side effects 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 medicine.

•Constant muscle pain, sensitivity, or weakness that may not disappear when stopping this medicine (frequency not known).

Additional tests

In some blood tests, elevated liver function and a muscle enzyme (creatine kinase) were observed.

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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

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

Composition of Simvastatina Aurovitas

-The active ingredient is simvastatina. Each film-coated tablet contains 40 mg of simvastatina.

-The other components are:

Core tablet: butylhydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460a), pregelatinized cornstarch, lactose monohydrate,magnesium stearate (E470B).

Coating:hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553b), iron oxide red (E172).

Appearance of the product and contents of the package

Film-coated tablets of pink color, round (10.1 mm in diameter), biconvex, with the mark “SI” on one face and “40” on the other.

Simvastatina Aurovitas 40 mg film-coated tablets EFG are available inblister packs of PVC/PE/PVdC/aluminum with 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated 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:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Germany:Simvastatin PUREN 40 mg Filmtabletten

Spain:Simvastatina Aurovitas 40 mg film-coated tablets EFG

France:SIMVASTATINE ARROW LAB 40 mg, coated tablets

Italy:Simvastatina Aurobindo 40 mg film-coated tablets

Netherlands:Simvastatine Aurobindo 40 mg film-coated tablets

Poland:Simvastatin Aurovitas

Portugal:Simvastatina Aurobindo

Last review date of this leaflet:June 2023

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