Simvastatin Aurovitas 20 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Simvastatina Aurovitas 20 mg film-coated 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 must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol). This medicine belongs to a class of medicines known as statins.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL cholesterol 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. This interruption in blood flow may result in 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 your blood that may increase the risk of heart disease.

While taking this medicine, you must continue to follow a cholesterol-lowering diet.

This medicine is used, together with a cholesterol-lowering diet, if you have:

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

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol levels, and discuss your target goals with your doctor.

2. What you need to know before taking Simvastatina Aurovitas

Do not take Simvastatina Aurovitas

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

• If you currently have liver problems.

• If 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 reduce 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).

• If you are taking, or have taken within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) taken orally or by injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medicine is included in the list above.

Warnings and precautions

Talk to your doctor or pharmacist before starting Simvastatina Aurovitas:

• About all your medical conditions, 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 this medicine temporarily.
• If you are of Asian origin, as you may require a different dose.
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection), taken orally or by injection. The combination of fusidic acid and simvastatin may cause serious muscle problems (rhabdomyolysis).

Your doctor will perform a blood test before you start taking simvastatin and may also do so if you develop any symptoms of liver problems while taking 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 this medicine.

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

Inform your doctor if you have a severe lung disease.

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 (rhabdomyolysis), which can lead to kidney damage; and very rarely, deaths have occurred.

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

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

• You consume large amounts of alcohol.
• You have kidney problems.
• You have thyroid problems.
• You are 65 years of age or older.
• You are female.
• You have ever had muscle problems while taking cholesterol-lowering medicines called "statins" or fibrates.
• You or a close family member 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 gravis (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition 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

The efficacy and safety of simvastatin treatment has been studied in boys aged 10 to 17 years and in girls who have had their first menstrual period (menstruation) at least one year prior (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 medicines and Simvastatina Aurovitas

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

Taking 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 Simvastatina Aurovitas”):

• 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 simvastatin treatment. Using simvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about 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 reduce 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 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, severe genetic cholesterol disorders).
• Colchicine (used to treat gout).
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Adverse effects affecting the muscles may be increased when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should temporarily stop taking simvastatin.
• Ribociclib (used to treat breast cancer).
• Palbociclib (used to treat breast cancer).

As with 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 medicines containing any of the following active substances:

• Medicines with active substances used to prevent blood clots, 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 (an antiplatelet medicine).

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

Taking Simvastatina Aurovitas with food and drink

Grapefruit juice contains one or more components that interfere with how the body processes certain medicines, including simvastatin. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine if you are pregnant, planning 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, as it is unknown whether this medicine passes into breast milk.

Driving and using machines

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

Simvastatina Aurovitas contains lactose

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.

3. How to take Simvastatin Aurovitas

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

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You must maintain a cholesterol-lowering 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 daily, taken orally.

Adults:

The usual starting dose is 10 mg, 20 mg, 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 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 disease-related problems who have not reached their cholesterol target with lower doses.

Use in children and adolescents

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

Method of administration

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

If your doctor has prescribed simvastatin together with another cholesterol-lowering medicine containing 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 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatin Aurovitas

• Do not take a double dose; the next day, take your usual amount of simvastatin at the regular time. Do not take a double dose to make up for a missed dose.

If you stop taking 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 terms are used to describe how frequently 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 immediately and contact your doctor or go to the nearest hospital emergency department:

• Muscle pain, tenderness to pressure, weakness, muscle breakdown, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure, which may lead to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity (allergic) reactions including:
  • Swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema).
  • Severe muscle pain, usually in the shoulders and hips.
  • Skin rash accompanied by weakness of the limb and neck muscles.
  • Rash that may appear on the skin or cause mouth ulcers (drug-induced lichenoid eruptions).
  • Joint pain or inflammation (polymyalgia rheumatica).
  • Inflammation of blood vessels (vasculitis).
  • Unusual bruising, skin rashes, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes.
  • 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 urine or pale 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 (anaemia).
• Numbness or weakness in arms and legs.
• Headache, tingling sensation, dizziness.
• Blurred vision, deterioration of vision.
• Gastrointestinal disorders (abdominal pain, constipation, gas, indigestion, diarrhoea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Sleep problems (very rare).
• Poor memory (very rare), memory loss, confusion.

The following very rare serious adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction).
• Gynaecomastia (enlargement of breast tissue in men).

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

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

Ocular myasthenia (a condition causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs 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. This is more likely if you have high levels of blood sugar and fats, are overweight, and 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 this medicine (frequency not known).

Additional tests

In some blood tests, elevations in liver function and in 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in the pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Aurovitas

• The active substance is simvastatin. Each film-coated tablet contains 20 mg of simvastatin.
• The other components are:

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

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

Appearance of the product and contents of the pack

Film-coated tablets, light pink in colour, round (8.1 mm in diameter), biconvex, marked with “SI” on one side and “20” on the other.

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

Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Simvastatin PUREN 20 mg Filmtabletten

Spain: Simvastatina Aurovitas 20 mg comprimidos recubiertos con película EFG

France: SIMVASTATINE ARROW LAB 20 mg, comprimés pelliculés

Italy: Simvastatina Aurobindo 20 mg compresse rivestite con film

Netherlands: Simvastatine Aurobindo 20 mg filmomhulde tabletten

Poland: Simvastatin Aurovitas

Portugal: Simvastatina Aurobindo

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

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