Patient Information Leaflet: Product Information

Simvastatina Sandoz 10 mg Film-Coated Tablets

Simvastatina Sandoz 20 mg Film-Coated Tablets

Simvastatina Sandoz 40 mg Film-Coated Tablets

Simvastatina

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

6.Contents of the pack and additional information

Simvastatina Sandoz contains the active ingredient simvastatina.Simvastatina is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood.

In addition, simvastatina increases the levels of "good" cholesterol (HDL cholesterol). Simvastatina 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 cardiovascular disease.

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

Simvastatina 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). Simvastatina can prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood.

Most people do not have 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 Sandoz

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have liver problems currently,
• if you are pregnant or breastfeeding,
• if you are also 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 (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 medicine called fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin can cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure if your medicine is on the above list.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatina 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 due to have an operation. You may need to stop taking the simvastatin tablets for a short time,
• if you have or have had myasthenia (a condition that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenic eye (a condition that causes weakness of the eye muscles), as statins sometimes worsen the condition or cause myasthenia (see section 4).
• if you are Asian, as you may need a different dose.

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 taking simvastatin.

While taking this medicine, your doctor will carefully monitor if you have diabetes or are at risk of developing diabetes. You may develop diabetes if you have high levels of sugar and fats in your blood, are overweight and have 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 kidney damage; and very rarely, deaths have occurred.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines 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 a woman,

•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 disorder.

Children and adolescents

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

Taking Simvastatina Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

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

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will tell you when you can start taking simvastatin again. The use of simvastatin with fusidic acid can cause muscle weakness, sensitivity or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4,
• ciclosporin (a medicine often 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),
• 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 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 infection),
• nefazodone (used to treat depression),
• medicines 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 conditions),
• lomitapida (used to treat a rare and severe genetic cholesterol disorder),
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide that you should stop taking simvastatin for a time,
• 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 taken recently other medicines, even those bought without a prescription. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

•blood-thinning medicines 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 a new medicine that you are taking simvastatin.

Taking Simvastatina Sandoz with food, drinks and alcohol

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

Inform your doctor if you consume large amounts of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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, stop taking the tablets immediately and contact your doctor.

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

Driving and using machines

Simvastatin is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness after taking simvastatin.

Simvastatina Sandoz contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

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

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

You should follow a low-cholesterol diet while taking simvastatina.

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 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 adolescentsand

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

Method and duration of administration:

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

The tablet can be split into equal doses.

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

If you take moreSimvastatina Sandozthan youshould

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

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

If you forgot to takeSimvastatinaSandoz

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

If you interrupt treatment withSimvastatinaSandoz

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

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

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

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

The following serious side effects have been reported:

• Muscle pain, sensitivity, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle failure that causes kidney damage; and in very rare cases, deaths have occurred,
• Allergic reactions that include:
• Swelling of the face, tongue, and throat that can cause difficulty breathing (angioedema),
• Intense muscle pain, usually in the 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),
• Brusing, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity to the sun, fever, redness,
• Difficulty breathing (dyspnea) and feeling unwell,
• Conditions similar to lupus (including skin rash, joint disorders, and effects on blood cells),
• 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, and very rarely liver failure,
• Pancreatitis, often with severe abdominal pain.

The following very rare serious side effects have been reported:

• A serious allergic reaction that causes difficulty breathing or dizziness (anaphylaxis),
• Gynecomastia (enlargement of breasts in men),
• Rash that can occur on the skin or sores in the mouth (erythema multiforme),
• Muscle rupture.

The following side effects have been reported:

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

• Low red blood cell count (anemia),
• Numbness or weakness in the arms and legs,
• Headache, tingling sensation, dizziness,
• Blurred vision, vision problems,
• Digestive problems (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Elevations in some blood tests of liver function (transaminases) and in an enzyme of muscle (creatine kinase),
• Memory loss, confusion.

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

• Difficulty sleeping,
• Memory loss.

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

• Erectile dysfunction,
• Depression,
• Pulmonary inflammation causing respiratory problems, including persistent cough and shortness of breath or fever,
• Tendon problems, sometimes complicated by rupture,
• Constant muscle weakness,
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

The following possible side effects have been reported with some statins:

• Sleep disorders, including nightmares,
• Sexual difficulties,
• Diabetes. This can occur if you have high blood sugar and fat levels, if you are overweight, and if you have high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting of 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 theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://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 blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store the blister pack 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 through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.By doing so, you will help protect the environment.

Composition of Simvastatina Sandoz 10 mg

• The active ingredient is simvastatina. A film-coated tablet contains 10 mg of simvastatina.
• The other components are:

Core of the tablet: pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose, butylated hydroxyanisole (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 Simvastatina Sandoz 20 mg

• The active ingredient is simvastatina. A film-coated tablet contains 20 mg of simvastatina.
• The other components are:

Core of the tablet: pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose, butylated hydroxyanisole (E320), citric acid monohydrate (E330), magnesium stearate.

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

Composition of Simvastatina Sandoz 40 mg

• The active ingredient is simvastatina. A film-coated tablet contains 40 mg of simvastatina.
• The other components are:

Core of the tablet: pregelatinized cornstarch, lactose monohydrate, microcrystalline cellulose, butylated hydroxyanisole (E320), citric acid monohydrate (E330), magnesium stearate.

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

Appearance of the product and packaging content

Simvastatina Sandoz 10 mg is presented in the form of film-coated tablets of light pink color, oval, scored, convex, marked with “SIM 10” on one of its faces, which are available in the following formats:

Blister (Aluminum/PVC):

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

Polyethylene container with screw cap:

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

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

Blister (Aluminum/PVC):

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

Polyethylene container with screw cap:

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

Simvastatina Sandoz 40 mg is presented in the form of film-coated tablets of reddish-brown color, oval, scored, biconvex, marked with “40” on one of its faces, which are available in the following formats:

Blister (Aluminum/PVC):

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

Polyethylene container with screw cap:

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

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 with 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 last review of this leaflet: April 2023

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