SIMVASTATIN SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Simvastatin Sandoz 10 mg film-coated tablets EFG

Simvastatin Sandoz 20 mg film-coated tablets EFG

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

1. Contents of the pack and further information

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

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

Additionally, simvastatin raises the levels of "good" cholesterol (HDL cholesterol). Simvastatin belongs to a group of medicines called 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 can lead to a narrowing of the arteries, which can slow down or block the flow of blood to vital organs such as the heart and brain. This interruption 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 the arteries and protects against heart disease.

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

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

Simvastatin is used, along 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 disease (homozygous familial hypercholesterolemia), which increases the level of cholesterol in the 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 diseases). Simvastatin may 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 Sandoz

Do not take Simvastatin Sandoz

• 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 pregnant or breastfeeding,
• if you are also 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 (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 patients with organ transplants),
• 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, in the last 7 days, have taken or been given a medicine called 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 a rare and severe genetic cholesterol disorder).

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 Sandoz:

• about all your medical problems, 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 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).
• if you are Asian, as you may need a different dose.

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 simvastatin.

While taking this medicine, your doctor will carefully monitor you if you have diabetes or are at risk of developing diabetes. You may develop diabetes if you have high levels of sugar and fat 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.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and medication may be needed to diagnose and treat this problem.

The risk of muscle failure is higher with high doses of simvastatin, 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 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.

Children and adolescents

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

Taking Simvastatin Sandoz with other medicines

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

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

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will tell you when you can restart treatment with simvastatin. The use of simvastatin with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4,
• cyclosporine (a medicine used in patients with organ transplants),
• 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 such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates with an active substance such as gemfibrozil and bezafibrate (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 HIV infections),
• antiviral medicines 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 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 diseases),
• lomitapide (used to treat a rare and severe genetic cholesterol disorder),
• 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. Your doctor may decide that you should stop taking simvastatin for a while,
• 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 well as the medicines mentioned above, tell 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 substances:

• medicines with an active substance 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).

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 uses some medicines, including simvastatin. You should avoid consuming grapefruit juice.

Tell 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

Simvastatin 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 simvastatin.

Simvastatin Sandoz 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 Sandoz

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

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

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

The recommended dose isone tablet once a day by mouth.

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

For children (10-17 years), the recommended initial dose is 10 mg per day in the evening. The maximum recommended dose is 40 mg per day.

Method and duration of administration:

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

The tablet can be divided into equal doses.

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 Sandoz than you should

Consult your doctor immediately. In case of overdose, your doctor will take symptomatic and supportive measures.

If you have taken more Simvastatin Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Simvastatin Sandoz

Do not take a double dose to make up for forgotten doses, continue treatment with the prescribed dose.

If you stop taking Simvastatin Sandoz

Talk to your doctor or pharmacist because your cholesterol may rise again.

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

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

The following adverse effects have been reported:

• Muscle pain, sensitivity, weakness, or cramps. In rare cases, these muscle problems can be serious, including muscle failure that causes kidney damage; and in very rare cases, deaths have occurred,
• Hypersensitivity reactions (allergic) that include:
• Swelling of the face, tongue, and throat that can cause difficulty breathing (angioedema),
• Severe muscle pain, usually in the shoulders and hips,
• Skin rash accompanied by weakness in the limbs and neck muscles,
• Pain or inflammation of the joints (polymyalgia rheumatica),
• Inflammation of blood vessels (vasculitis),
• Bruises, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, redness,
• Difficulty breathing (dyspnea) and feeling unwell,
• Lupus-like changes (including skin rash, joint disorders, and effects on blood cells),
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite, and very rarely, liver failure,
• Pancreas inflammation, often with severe abdominal pain.

The following serious adverse effects have been reported, although very rarely:

• A serious allergic reaction that causes difficulty breathing or dizziness (anaphylaxis),
• Gynecomastia (enlargement of breast tissue in men),
• A rash that can occur on the skin or sores in the mouth (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 (anemia),
• Numbness or weakness in the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision, vision problems,
• Digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Increased levels in some 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):

• Sleeping problems,
• Memory loss.

Frequency Not Known(cannot be estimated from available data):

• Erectile dysfunction,
• Depression,
• Lung inflammation causing respiratory problems, including persistent cough and shortness of breath or fever,
• Tendon problems, sometimes complicated by ruptures,
• Constant muscle weakness,
• Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia of the eyes (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in the arms or legs that worsens 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 can occur if you have high levels of sugar and fat in your blood, if you are overweight, and if you have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting 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: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the blister pack and on the outer packaging after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

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

Keep in the original packaging to protect it from light.

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. If in doubt, 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 Sandoz 10 mg

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

Tablet core: pregelatinized corn starch, lactose monohydrate, microcrystalline cellulose, butylhydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (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 ingredient is simvastatin. One film-coated tablet contains 20 mg of simvastatin.
• The other ingredients are:

Tablet core: pregelatinized corn starch, lactose monohydrate, microcrystalline cellulose, butylhydroxyanisole (E320), citric acid monohydrate (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 ingredient is simvastatin. One film-coated tablet contains 40 mg of simvastatin.
• The other ingredients are:

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

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

Appearance of the Product and Package Contents

Simvastatin Sandoz 10 mg is presented in the form of film-coated tablets, light pink in color, oval, scored, convex, marked with "SIM 10" on one face, which are available in the following formats:

Blister pack (Aluminum/PVC):

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

Polyethylene bottle with screw cap:

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

Simvastatin Sandoz 20 mg is presented in the form of film-coated tablets, orange in color, oval, biconvex, scored on both faces, marked with "20" on one face, which are available in the following formats:

Blister pack (Aluminum/PVC):

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

Polyethylene bottle with screw cap:

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

Simvastatin Sandoz 40 mg is presented in the form of film-coated tablets, reddish-brown in color, oval, scored, biconvex, marked with "40" on one face, which are available in the following formats:

Blister pack (Aluminum/PVC):

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

Polyethylene bottle with screw cap:

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

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 TarguMures, 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 medicine 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 Last Revision of this Leaflet: April 2023

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