Patient Information Leaflet

Simvastatina Viatris10 mg Film-Coated Tablets

Simvastatina Viatris 20 mg Film-Coated Tablets

Simvastatina Viatris 40 mg Film-Coated Tablets

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 doubts, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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.

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

2.What you need to know before you start taking Simvastatina Viatris

3.How to take Simvastatina Viatris

4.Possible side effects

5Storage of Simvastatina Viatris

6.Contents of the pack and additional information

This medicationcontains the active ingredient simvastatina, which is a member of a class of medications called statins. 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).

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 heart 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 may 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 takeSimvastatin Viatris

• if you are allergic (hypersensitive) 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 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),
  • protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (protease inhibitors for HIV are 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 who have undergone organ transplantation),
  • 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 that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and simvastatin may cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor if you are not sure if your medicine is on the above list.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• about all your medical conditions, including allergies,
• if you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4),
• 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 for a short period of time,
• if you are of Asian origin, 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.

Your doctor will also monitor you for diabetes or the risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fat 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 muscle failure that causes kidney damage; and very rarely, deaths have occurred.

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.

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.

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 Viatris"). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medicines and Simvastatin Viatris

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

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when you can start taking simvastatin again. Taking simvastatin with fusidic acid rarely may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• ciclosporin (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 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),
• protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections),
• antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient 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 rare and severe cholesterol disorders),
• 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 simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a time,
• colchicine (used to treat gout).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even 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 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 a new medicine that you are taking simvastatin.

Simvastatin Viatris with food and drinks

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

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Simvastatin is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking simvastatin.

Simvastatin Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor again.

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

Before starting to take simvastatin, you must be following a diet to reduce cholesterol.

The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin once a day, at night, orally. The 20 mg tablets can be divided into equal doses.

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

Adults:

The usual starting dose is 10, 20, or in some cases, 40 mg per day, at night, with or without food.

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 problems who have not achieved their cholesterol goal with lower doses.

Use in children and adolescentsandyoung adults

In children and adolescents (between 10 and 17 years) the recommended daily dose for starting treatment is 10 mg at night, with or without food. The maximum recommended daily dose is 40 mg.

If you take more Simvastatin Viatris than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20, or consult with your doctor or pharmacist.

If you forgot to take Simvastatin Viatris

Do not take a double dose to compensate for the missed doses.The next day, take your usual amount of simvastatin at the usual time.

If you interrupt the treatment with Simvastatin Viatris

Talk to your doctor or pharmacist because your cholesterol may rise again. Do not stop treatment until your doctor tells you to.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

If any of the serious side effects mentioned below occur, stop taking the medicine and inform your doctor immediately or go to the nearest hospital emergency department.

Very rare serious side effects (may affect up to 1 in 1,000 people):

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Allergic reactions that include:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
  • Intense muscle pain, usually in the shoulders and hips,
  • Skin rash with weakness of the muscles of the limbs and neck,
  • Joint pain or inflammation (polymyalgia rheumatica),
  • Inflammation of blood vessels (vasculitis),
  • Atypical hematomas, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes,
  • Difficulty breathing (dyspnea) and general discomfort,
  • Pseudolupus syndrome (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; liver insufficiency (very rare),
• Pancreatitis, often with severe abdominal pain,
• Rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions).

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

• Severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction),
• Gynecomastia (enlargement of breast tissue in men).

Other side effects

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

• Anemia (low red blood cell count),
• Numbness or weakness of the arms and legs,
• Headache, tingling sensation, dizziness,
• Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Blurred vision and visual disturbances,
• Weakness.

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

• Sleep problems (very rare),
• Poor memory (very rare), memory loss, confusion.

Unknown frequency (may affect an unknown number of people):

• Erectile dysfunction,
• Depression,
• Pneumonitis, which causes breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture,
• Sleep disorders, including nightmares,
• Sexual dysfunction,
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine,
• Constant muscle pain, sensitivity, or weakness, which may not disappear after stopping simvastatin treatment,
• In some blood tests, elevations in liver function (transaminases) and a muscle enzyme (creatine kinase) were observed,
• Myasthenia gravis (a disease that causes generalized muscle weakness, which 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 your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging after CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Simvastatina Viatris

The active ingredient is simvastatina. Each film-coated tablet contains 10 mg, 20 mg or 40 mg of simvastatina.

The other components are:

Tablet core:lactose monohydrate, microcrystalline cellulose (E460), pregelatinized cornstarch, ascorbic acid (E300), citric acid monohydrate (E330), butylhydroxyanisole (E320), sodium lauryl sulfate, hypromellose (E464), talc (E553b) and magnesium stearate (E470B).

Film coating:hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), macrogol, talc (E553b) and iron oxide red (E172). Additionally, the 20 mg and 40 mg tablets contain iron oxide yellow (E172).

See section 2 “Simvastatina Viatris contains lactose and sodium”.

Appearance of the product and contents of the package

Simvastatina Viatris 10 mg film-coated tablets are presented as pink to brick-red, round, biconvex, beveled-edge tablets, engraved with S2 on one face and unengraved on the other.

Simvastatina Viatris 20 mg film-coated tablets are presented as dark, oval, biconvex, beveled-edge tablets, engraved with SV3 on one face and a groove on the other. The tablet can be divided into equal doses.

Simvastatina Viatris 40 mg film-coated tablets are presented as pink, oval, biconvex, beveled-edge tablets, engraved with SV4 on one face and an M on the other.

This medicinal product is available in packs containing 28, 30, 60, 84 and 90 film-coated tablets, or calendar packs containing 28 film-coated tablets, or bottles containing 28, 30, 100 or 250 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road,

Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1.

H-2900, Komárom

Hungary

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

DenmarkSimvastatin Mylan

SpainSimvastatina Viatris 10 mg film-coated tablets EFG

Simvastatina Viatris 20 mg film-coated tablets EFG

Simvastatina Viatris 40 mg film-coated tablets EFG

FinlandSimvastatin Mylan

FranceSimvastatine Mylan Pharma 10 mg coated tablet

Simvastatine Mylan Pharma 20 mg coated tablet

Simvastatine Mylan Pharma 40 mg coated tablet

IcelandSimvastatin Mylan

NorwaySimvastatin Mylan

PortugalSimvastatin Mylan Pharma

SwedenSimvastatin Mylan

Last revision date of thisleaflet:April2023

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