Simvastatin Sandoz 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Simvastatina Sandoz 10 mg film-coated tablets EFG

Simvastatina Sandoz 20 mg film-coated tablets EFG

Simvastatina Sandoz 40 mg film-coated tablets EFG

Simvastatin

Read all of this 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 others, even if they have the same symptoms as you, because it could 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.

Contents of the leaflet

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

2. What you need to know before taking Simvastatina Sandoz

3. How to take Simvastatina Sandoz

4. Possible adverse effects

5. How to store Simvastatina Sandoz

6. Contents of the pack and other information

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

Simvastatina Sandoz contains the active substance simvastatin. Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.

In addition, simvastatin increases levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a class of medicines known as statins.

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 disruption in blood flow may 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 your blood that may increase the risk of heart disease.

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

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

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fatty substances in the blood (mixed hyperlipidemia),
• a hereditary condition (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You may also receive other treatments,
• coronary heart disease (CHD) or are at high risk of coronary heart disease (due to diabetes, history of stroke, or other blood vessel disease). Simvastatin 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 treatment goals with your doctor.

2. What you need to know before starting to take Simvastatin Sandoz

Do not take Simvastatin Sandoz

• 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 pregnant or breastfeeding,

• if you are also 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 (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 or been given, within the last 7 days, an oral or injectable medicine called fusidic acid (used to treat bacterial infections). 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 a rare, serious genetic cholesterol disorder).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Simvastatin Sandoz:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. Simvastatin may not be suitable for you,
• if you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period of time,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• if you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking simvastatin and also 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 simvastatin.

While taking this medicine, your doctor will carefully monitor you for diabetes or risk factors for developing diabetes. You may develop diabetes if you have high levels of sugar and fats in the blood, are overweight, and 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, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.

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.

The risk of muscle breakdown is higher with higher doses of simvastatin, especially the 80 mg dose. The risk of muscle breakdown is also greater 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 previously experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates,
• you or a close family member have a hereditary muscle disorder.

Children and adolescents

The safety and efficacy of simvastatin have been studied in children aged 10–17 years and in girls who have had their first menstrual period (menstruation) at least one year prior (see section 3: "How to take Simvastatin Sandoz"). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Taking Simvastatin Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking simvastatin with any of these medicines may increase the risk of muscle problems (some of these are already listed in the section above "Do not take Simvastatin Sandoz").

• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart simvastatin treatment. Using simvastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4,
• cyclosporine (a medicine often 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),
• 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 or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat HIV infections),
• hepatitis C antiviral medicines 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 a serious genetic cholesterol disorder),
• 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 simvastatin treatment. Your doctor may decide that you should temporarily stop taking simvastatin,
• colchicine (used to treat gout),
• ticagrelor (used in patients who have had a heart attack or angina or chest pain that is not well controlled). Do not take more than 40 mg of simvastatin per day if you are taking ticagrelor.

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 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).

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

Taking Simvastatin Sandoz with food, drinks and alcohol

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

Inform your doctor if you consume large amounts of alcohol.

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.

If you become pregnant while taking simvastatin, you must stop taking the tablets immediately and contact your doctor.

Do not take simvastatin while breastfeeding, as it is unknown whether this medicine passes into breast milk.

Driving and using machines

Simvastatin is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking simvastatin.

Simvastatin Sandoz contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Simvastatin Sandoz

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

Always follow exactly the instructions for use of this medicine provided by your doctor. If you are unsure, consult your doctor or pharmacist again.

You must follow a cholesterol-lowering diet while taking simvastatin.

The recommended dose is one tablet once daily by mouth.

Adults:

The usual starting dose is 10, 20, or in some cases, 40 mg once daily. After at least 4 weeks, your doctor may adjust your dose up to a maximum of 80 mg daily. 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 complications who have not achieved their cholesterol goal with lower doses.

Use in children and adolescents

For children (10–17 years of age), the recommended initial dose is 10 mg taken at night. The recommended maximum dose is 40 mg per day.

Method and duration of administration:

Take this medicine at night. You may take it with or without food. Continue taking simvastatin as long as your doctor advises you to do so.

The tablet may be divided into equal doses.

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 Sandoz than you should

Contact your doctor immediately. In case of overdose, your doctor should implement symptomatic and supportive measures.

If you have taken more Simvastatin Sandoz than you should, contact your doctor, pharmacist, or call the Poison Information Service at telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Simvastatin Sandoz

Do not take a double dose to make up for missed doses. Continue your treatment with the prescribed dose.

If you stop taking Simvastatin Sandoz

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

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

4. Possible adverse effects

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

If you experience any of the following serious adverse effects, stop taking this medicine immediately and consult your doctor or go to the nearest hospital emergency department:

The following adverse effects have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and in very rare cases, death has occurred,
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue, and throat which may cause difficulty breathing (angioedema),
• severe muscle pain, usually in shoulders and hips,
• skin rash accompanied by weakness in the limbs and neck muscles,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, redness,
• difficulty breathing (dyspnea) and feeling unwell,
• lupus-like disorders (including skin rash, joint disorders, and effects on blood cells),
• liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark urine or pale stools, feeling tired or weak, loss of appetite, and very rarely, liver failure,
• inflammation of the pancreas, often with severe abdominal pain.

The following very rare serious adverse effects have been reported:

• a serious allergic reaction causing difficulty breathing or dizziness (anaphylaxis),
• gynaecomastia (enlargement of breasts in men),
• skin rash or mouth ulcers (lichenoid drug eruption),
• muscle rupture.

The following adverse effects have been reported:

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

• low blood cell count (anaemia),
• numbness or weakness in arms and legs,
• headache, tingling sensation, dizziness,
• blurred vision, visual disturbances,
• gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• skin rash, itching, hair loss,
• weakness,
• increases in certain blood tests of liver function (transaminases) and in a muscle enzyme (creatine kinase),
• memory loss, confusion.

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

• sleep problems,
• memory loss.

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

• erectile dysfunction,
• depression,
• lung inflammation causing breathing problems including persistent cough, shortness of breath, or fever,
• tendon problems, occasionally leading to ruptures,
• persistent muscle weakness,
• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the 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.

Additional possible adverse effects have been reported with some statins:

• sleep disorders, including nightmares,
• sexual difficulties,
• diabetes. This may occur if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Simvastatin Sandoz

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

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

Do not store above 30°C.

Keep the blister in the outer packaging to protect it from light.

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Simvastatin Sandoz 10 mg

• The active substance is simvastatin. One film-coated tablet contains 10 mg of simvastatin.
• The other components are:

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

Coating: hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Composition of Simvastatin Sandoz 20 mg

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

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

Coating: hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

Composition of Simvastatin Sandoz 40 mg

• The active substance is simvastatin. One film-coated tablet contains 40 mg of simvastatin.
• The other components are:

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

Coating: hypromellose, talc, titanium dioxide (E171) and red iron oxide (E172).

Appearance of the product and contents of the container

Simvastatin Sandoz 10 mg is presented as light pink, oval, film-coated tablets, biconvex, scored, marked with “SIM 10” on one side, available in the following pack sizes:

Blister (Aluminum/PVC):

Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50x1, 60, 84, 90, 98 and 100 film-coated tablets.

Polyethylene bottle with screw cap:

Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.

Simvastatin Sandoz 20 mg is presented as orange, oval, biconvex, film-coated tablets, scored on both sides, marked with “20” on one side, available in the following pack sizes:

Blister (Aluminum/PVC):

Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50x1, 60, 84, 90, 98 and 100 film-coated tablets.

Polyethylene bottle with screw cap:

Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.

Simvastatin Sandoz 40 mg is presented as reddish-brown, oval, film-coated tablets, biconvex, scored, marked with “40” on one side, available in the following pack sizes:

Blister (Aluminum/PVC):

Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50x1, 60, 84, 90, 98 and 100 film-coated tablets.

Polyethylene bottle with screw cap:

Pack sizes: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Center

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Lek S.A.

50 C, Domaniewska Str.

02-672 Warsaw

Poland

or

Lek d.d.

Verovskova ulica 57

Lubljana, 1526

Slovenia

or

S.C. Sandoz S.R.L.

Str. Livezeni nr. 7A

540472 Targu Mures, Jud. Mures

Romania

or

LEK S.A.

16, Podlipie Str.

95-010 Strykow

Poland

or

LEK Pharmaceuticals d.d.

Trimlini 2d

Lendava

9220 Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Simvastatin Sandoz 10 mg Filmtabletten
Simvastatin Sandoz 20 mg Filmtabletten
Simvastatin Sandoz 40 mg Filmtabletten

Denmark: Simvastatin "Sandoz" filmovertrukne tabletter

Slovenia: Simvastatin Lek 10 mg filmsko obložene tablete
Simvastatina Lek 20 mg filmsko obložene tablete
Simvastatina Lek 40 mg filmsko obložene tablete

Netherlands: SIMVASTATINE SANDOZ 10 mg, filmomhulde tabletten
SIMVASTATINE SANDOZ 20 mg, filmomhulde tabletten
SIMVASTATINE SANDOZ 40 mg, filmomhulde tabletten

Italy: SIMVASTATINA SANDOZ 10 mg compresse rivestite con film
SIMVASTATINA SANDOZ 20 mg compresse rivestite con film
SIMVASTATINA SANDOZ 40 mg compresse rivestite con film

Norway: Simvastatin Sandoz 10 mg tabletter, filmdrasjerte
Simvastatin Sandoz 20 mg tabletter, filmdrasjerte
Simvastatin Sandoz 40 mg tabletter, filmdrasjerte

Poland: CORR 20, 20 MG, TABLETKI POWLEKANE
CORR 40, 40 MG, TABLETKI POWLEKANE

Portugal: SINVASTATINA SANDOZ

United Kingdom: Simvastatin 10 mg film-coated tablets
Simvastatin 20 mg film-coated tablets
Simvastatin 40 mg film-coated tablets

Date of the most recent review of this leaflet: April 2023

Detailed and up-to-date 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/