SIMVASTATIN Aurovitas 40 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Simvastatin Aurovitas 40 mg film-coated 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

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

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

Simvastatin 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 is a member of a group of medicines called statins.

Cholesterol is one of the fatty substances that occur 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 buildup of plaque can cause your arteries to narrow, which can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in your arteries and protects you from heart disease.

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

While taking this medicine, you should follow a low-cholesterol diet.

This medicine is used, along with a low-cholesterol diet, if you have:

• High levels of cholesterol in your blood (primary hypercholesterolemia) or high levels of fatty substances in your blood (mixed hyperlipidemia).
• A hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in your blood. You may also receive other treatments.
• Coronary heart disease (CHD) or if you are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel disease). This medicine can prolong your life by reducing the risk of heart problems, regardless of the amount of cholesterol in your blood.

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

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

Do not take Simvastatin Aurovitas

• If you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems.
• If 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).
  • 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).
• If you are taking, or have taken in the last 7 days, a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).
• Do not take more than 40 mg of 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 on the list above.

Warnings and precautions

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

• About all your medical problems, including allergies.
• If you consume large amounts of alcohol.
• If you have ever had liver disease. This medicine may not be suitable for you.
• If you are scheduled for surgery. You may need to stop taking the tablets of this medicine for a short period.
• If you are Asian, as you may need a different dose.
• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections), orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).

Your doctor will perform 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 perform blood tests to check how well your liver is working after you start treatment with this medicine.

While taking this medicine, 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 sugars and fats in your blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

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

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

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

• You consume large amounts of alcohol.
• You have kidney problems.
• You have thyroid problems.
• You are 65 years or older.
• You are female.
• You have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates.
• You or a close relative have a hereditary muscle problem.

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

If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease 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 before (see section 3 "How to take Simvastatin Aurovitas"). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medicines and Simvastatin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Taking simvastatin with any of these medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Aurovitas" section):

• 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 simvastatin treatment. Taking simvastatin with fusidic acid can, in rare cases, 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 disease 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 lower cholesterol).
• Erythromycin, clarithromycin, telithromycin, or fusidic acid (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).
• Nefazodone (used to treat depression).
• Medicines with the active ingredient 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).
• Colchicine (used to treat gout).
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). It is possible that the adverse effects that affect the muscles may be greater when this medicine is taken during simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a while.

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

• Medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).
• Fenofibrate (also used to lower cholesterol).
• Niacin (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (an antiplatelet medicine).

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

Taking Simvastatin Aurovitas with food and drinks

Grapefruit juice contains one or more components that alter how the body uses some medicines, including simvastatin. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant, plan 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 medicine if you are breastfeeding because it is not known whether this medicine passes into breast milk.

Driving and using machines

This medicine is not expected to interfere with your ability to drive or use machines. However, you should be aware that some people experience dizziness after taking this medicine.

Simvastatin Aurovitas contains lactose

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.

3. How to take Simvastatin Aurovitas

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

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You should maintain a low-cholesterol diet while taking this medicine.

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 medicines mentioned above 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 problems who have not reached 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, in the evening. The maximum recommended daily dose is 40 mg.

Method of administration

Take this medicine in the evening. You can take it with or without food. Continue taking this medicine unless your doctor tells you to stop.

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

If you take more Simvastatin Aurovitas than you should

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

If you forget to take Simvastatin 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 make up for the forgotten dose.

If you stop taking Simvastatin Aurovitas

• Talk to your doctor or pharmacist because your cholesterol may rise 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 terms are used to describe how often adverse 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 the available data).

The following serious rare adverse effects have been reported.

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

• Muscle pain, sensitivity to pressure, weakness, muscle rupture, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure, which causes kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) including:
  • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema).
  • Severe muscle pain, usually in the shoulders and hips.
  • Skin rash with weakness of the limb and neck muscles.
  • Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).
  • Pain or inflammation of the joints (polymyalgia rheumatica).
  • Inflammation of the blood vessels (vasculitis).
  • Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes.
  • Difficulty breathing (dyspnea) and general malaise.
  • Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells).
• Inflammation of the liver 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 (very rare).
• Inflammation of the pancreas, often with severe abdominal pain.

Rarely, the following adverse 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 impairment.
• Digestive disorders (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 serious very rare adverse effects have been reported:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).
• Gynecomastia (enlargement of the breast in men).

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

• Erectile dysfunction.
• Depression.
• Inflammation of the lungs that causes breathing problems, including persistent cough and/or difficulty breathing, or fever.
• Tendon problems, sometimes complicated by tendon rupture.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Eye 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.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares.
• Sexual dysfunction.
• Diabetes. It is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Constant muscle pain, sensitivity, or weakness that may not disappear when you stop taking this medicine (frequency not known).

Complementary tests

In some blood tests, elevations of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatin Aurovitas

• The active ingredient is simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
• The other ingredients are:

Tablet core: butylhydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460a), pregelatinized corn starch, lactose monohydrate, magnesium stearate (E470B).

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

Appearance of the Product and Package Contents

Film-coated tablets are pink, round (10.1 mm in diameter), biconvex, with the mark "SI" on one side and "40" on the other.

Simvastatin Aurovitas 40 mg film-coated tablets EFG are available in PVC/PE/PVdC/aluminum blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.

Not all pack 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:

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 under the following names:

Germany: Simvastatin PUREN 40 mg Filmtabletten

Spain: Simvastatina Aurovitas 40 mg film-coated tablets EFG

France: SIMVASTATINE ARROW LAB 40 mg, film-coated tablets

Italy: Simvastatina Aurobindo 40 mg film-coated tablets

Netherlands: Simvastatine Aurobindo 40 mg film-coated tablets

Poland: Simvastatin Aurovitas

Portugal: Simvastatina Aurobindo

Date of the last revision of this leaflet:June 2023

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