Simvastatin Viatris 40 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Simvastatina Viatris 10 mg film-coated tablets EFG

Simvastatina Viatris 20 mg film-coated tablets EFG

Simvastatina Viatris 40 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 you should not give it to other people, even if they have the same symptoms as you, because 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 Viatris is and what it is used for
2. What you need to know before taking Simvastatina Viatris
3. How to take Simvastatina Viatris
4. Possible adverse effects
5. Storage of Simvastatina Viatris
6. Contents of the pack and other information

1. What Simvastatin Viatris Pharmaceuticals is and what it is used for

This medicine contains the active substance simvastatin, which belongs to a class of medicines called statins. Simvastatin is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat called triglycerides circulating in the blood. In addition, simvastatin increases levels of "good" cholesterol (HDL cholesterol).

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up 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 cause 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 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 must 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 blood levels of fatty substances (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 has no 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 you start taking Simvastatina Viatris Pharmaceuticals

Do not take Simvastatina Viatris

• If you are allergic (hypersensitive) 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 taking medicines containing any 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 lower 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) by mouth 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, serious 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 this medicine:

• about all your medical conditions, including allergies,
• 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 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. It may be necessary to stop taking simvastatin tablets for a short period of time,
• 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 Simvastatina.

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, 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 which can lead to kidney damage; and very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of simvastatin, especially with 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 during treatment with 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.

Children and adolescents

The efficacy and safety of simvastatin treatment have 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 Viatris”). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medicines and Simvastatina Viatris

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. 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 Viatris”).

• 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. Taking simvastatin with fusidic acid rarely may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.
• ribociclib (used to treat breast cancer),
• palbociclib (used to treat breast cancer),
• 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 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 AIDS),
• hepatitis C antivirals 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, serious genetic cholesterol disorders),
• 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 treatment with simvastatin. Your doctor may decide that you should stop taking simvastatin temporarily,
• colchicine (used to treat gout).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription. In particular, inform your doctor if you are taking medicines containing 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 prescribing you a new medicine that you are taking simvastatin.

Taking Simvastatina Viatris with food and drink

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

Pregnancy and breastfeeding

Do not take simvastatin if you are pregnant, trying to become pregnant, or think you might 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 using machines

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

Simvastatina Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Simvastatina Viatris Pharmaceuticals

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again.

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

Before starting simvastatin, you should already be on a cholesterol-lowering diet.

The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin once daily at night, taken orally. The 20 mg tablets 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.

Adults:

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

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 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 disease complications who have not achieved their cholesterol target with lower doses.

Use in children and adolescents

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

If you take more Simvastatina Viatris than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take Simvastatina Viatris

Do not take a double dose to make up for forgotten doses. The next day, take your normal dose of simvastatin at the usual time.

If you stop taking Simvastatina Viatris

Talk to your doctor or pharmacist, as your cholesterol levels may rise again. Stopping treatment is not recommended unless your doctor advises you to do so.

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 will experience them.

If any of the following serious adverse effects occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department without delay.

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

• muscle pain, tenderness to pressure, muscle weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle breakdown (rhabdomyolysis) leading 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 with weakness of limb and neck muscles,
  • joint pain or inflammation (polymyalgia rheumatica),
  • inflammation of blood vessels (vasculitis),
  • atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, 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),
• liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark-colored urine, pale stools, feeling tired or weak, loss of appetite; liver failure (very rare),
• inflammation of the pancreas, often with severe abdominal pain,
• skin rash or mouth ulcers (drug-induced lichenoid eruptions).

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

• a severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction),
• gynecomastia (enlargement of breast tissue in men).

Other adverse effects

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

• low red blood cell count (anaemia),
• numbness or weakness in arms and legs,
• headache, tingling sensation, dizziness,
• gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• skin rash, itching, hair loss,
• blurred vision and visual disturbances,
• weakness.

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

• sleep disorders (very rare),
• reduced memory (very rare), memory loss, confusion.

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

• erectile dysfunction,
• depression,
• lung inflammation causing 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. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or 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 simvastatin treatment,
• in some blood tests, elevated liver function (transaminases) and increased levels of a muscle enzyme (creatine kinase),
• myasthenia gravis (a condition causing generalized muscle weakness, which in some cases affects 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.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Viatris Pharmaceuticals

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Viatris

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

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized maize starch, ascorbic acid (E-300), citric acid monohydrate (E-330), butylhydroxyanisole (E-320), sodium lauryl sulfate, hypromellose (E-464), talc (E-553b) and magnesium stearate (E-470B).

Tablet coating: hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171), macrogol, talc (E-553b) and iron oxide red (E-172). Additionally, the 20 mg and 40 mg tablets contain iron oxide yellow (E-172).

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

Appearance of the product and pack contents

Simvastatin Viatris 10 mg film-coated tablets are pink to brick-red, round, biconvex tablets with bevelled edges, marked with "S2" on one side and unmarked on the other.

Simvastatin Viatris 20 mg film-coated tablets are dark, oval, biconvex tablets with bevelled edges, marked with "SV3" on one side and a score line on the other. The tablet can be divided into equal doses.

Simvastatin Viatris 40 mg film-coated tablets are pink, oval, biconvex tablets with bevelled edges, marked with "SV4" on one side and "M" on the other.

This medicinal product is available in packs containing blisters of 28, 30, 60, 84 and 90 tablets, calendar blister packs containing 28 tablets, or bottles containing 28, 30, 100 or 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Mylan Hungary Kft.
Mylan utca 1.
H-2900, Komárom
Hungary

For further information about this medicinal product, contact 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 European Economic Area (EEA) Member States under the following names:

Denmark: Simvastatin Mylan
Spain: Simvastatina Viatris 10 mg comprimidos recubiertos con película EFG
Simvastatina Viatris 20 mg comprimidos recubiertos con película EFG
Simvastatina Viatris 40 mg comprimidos recubiertos con película EFG
Finland: Simvastatin Mylan
France: SIMVASTATINE VIATRIS 10 mg comprimé pelliculé
SIMVASTATINE VIATRIS 20 mg comprimé pelliculé sécable
SIMVASTATINE VIATRIS 40 mg comprimé pelliculé
Iceland: Simvastatin Mylan
Norway: Simvastatin Mylan
Portugal: Simvastatin Mylan
Sweden: Simvastatin Mylan

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

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