SIMVASTATIN VIATRIS 40 mg FILM-COATED TABLETS

2. What you need to know before taking Simvastatin Viatris Pharmaceuticals

Do not takeSimvastatin Viatris

• if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicinal product (listed in section 6).
• if you currently have liver problems.
• if you are pregnant or breastfeeding.
• if you are 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 (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 reduce cholesterol),
  • cyclosporine (used in organ transplant patients),
  • 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 have taken, in the last 7 days, a medicine containing 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 rare and severe genetic cholesterol disorders).

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 this medicine:

• about all your medical problems, including allergies,
• if you have or have had myasthenia (a disease characterized by 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 consume significant 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 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 you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

Tell 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

The risk of muscle failure is greater with high doses of simvastatin, especially with the 80 mg dose. The risk of muscle failure is also greater 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 of age or older,
• you are a woman,
• you have ever had muscle problems during treatment with cholesterol-reducing medicines called "statins" or fibrates,
• you or a close relative have a hereditary muscle problem.

Also, tell your doctor or pharmacist if you experience constant muscle weakness. You may need additional tests and medicines to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of simvastatin treatment have been 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

Tell your doctor if you are taking, have recently taken, or might take any other medicines. Taking simvastatin with some of the following medicines can increase the risk of muscle problems (some of these are already included in the "Do not take Simvastatin Viatris" section).

• If you need to take oral fusidic acid to treat a bacterial infection, you will temporarily need to stop using this medicine. Your doctor will tell you when you can restart simvastatin treatment. Taking simvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in transplant patients),
• 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 used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole,
• fibrates with an active substance 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 AIDS),
• antivirals 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 heartbeat),
• 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 genetic cholesterol disorders),
• 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 simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a while,
• colchicine (used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicines with any of the following active substances:

• medicines with an active substance used to prevent blood clots, 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 tell any doctor who prescribes you a new medicine that you are taking simvastatin.

Taking Simvastatin Viatris with food and drinks

Grapefruit juice contains one or more components that alter how the body uses some medicines, including simvastatin. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

Do not take simvastatin if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking simvastatin, stop taking it immediately and tell your doctor. Do not take simvastatin if you are breastfeeding because it is not known 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, you should be aware that some people experience dizziness after taking simvastatin.

Simvastatin Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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 Simvastatin Viatris Pharmaceuticals

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in 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 should be following a cholesterol-reducing diet.

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

If your doctor has prescribed simvastatin along with another cholesterol-reducing 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.

Adults:

The usual starting dose is 10, 20, or, in some cases, 40 mg per day, in the evening, 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 medicines mentioned 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 reached their cholesterol goal with lower doses.

Use in children and adolescents

In children and adolescents (10 to 17 years old), the recommended daily starting dose is 10 mg in the evening, 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, contact the Toxicology Information Service. Phone: 91 562 04 20, or consult your doctor or pharmacist.

If you forget to take Simvastatin Viatris

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

If you stop taking Simvastatin Viatris

Talk to your doctor or pharmacist because your cholesterol may rise again. It is not recommended to stop treatment until your doctor tells you to do so.

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

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

Serious rare adverse 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 serious, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) that include:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
  • Severe muscle pain, usually in the shoulders and hips,
  • Skin rash with weakness of the muscles of the limbs and neck,
  • Pain or inflammation of the joints (polymyalgia rheumatica),
  • Inflammation of the blood vessels (vasculitis),
  • Unusual bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes,
  • Difficulty breathing (dyspnea) and general malaise,
  • Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells),
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale-colored stools, feeling tired or weak, loss of appetite; liver failure (very rare),
• Inflammation of the pancreas, often with severe abdominal pain,
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).

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

• A severe allergic reaction that causes 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 (anemia),
• Numbness or weakness of the arms and legs,
• Headache, tingling sensation, dizziness,
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, 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 problems (very rare),
• Poor memory (very rare), memory loss, confusion.

Frequency not known (may affect an unknown number of people):

• Erectile dysfunction,
• Depression,
• Inflammation of the lungs, which can cause 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 fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Persistent muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with simvastatin,
• In some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine kinase) were observed,
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• Myasthenic 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 or drooping eyelids, difficulty swallowing or difficulty breathing.

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 Viatris Pharmaceuticals

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

Do not use this medicine after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatin Viatris

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

The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, ascorbic acid (E300), citric acid monohydrate (E330), butylhydroxyanisole (E320), sodium lauryl sulfate, hypromellose (E464), talc (E553b), and magnesium stearate (E470B).

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

See section 2 "Simvastatin Viatris contains lactose and sodium".

Appearance of the Product and Package Contents

Simvastatin Viatris 10 mg film-coated tablets are presented in the form of tablets that are between pink and brick-red in color, round, biconvex, with a beveled edge, engraved with S2 on one side and without engraving on the other.

Simvastatin Viatris 20 mg film-coated tablets are presented in the form of dark-colored, oval, biconvex tablets, with a beveled edge, engraved 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 presented in the form of pink, oval, biconvex tablets, with a beveled edge, engraved with SV4 on one side and an M on the other.

This medicine is available in packages that contain blisters of 28, 30, 60, 84, and 90 tablets, or calendar blisters that contain 28 tablets, or bottles that contain 28, 30, 100, or 250 tablets.

Only some package 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

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Denmark Simvastatin Mylan

Spain Simvastatin Viatris 10 mg film-coated tablets EFG

Simvastatin Viatris 20 mg film-coated tablets EFG

Simvastatin Viatris 40 mg film-coated tablets EFG

Finland Simvastatin Mylan

France Simvastatine Mylan Pharma 10 mg film-coated tablet

Simvastatine Mylan Pharma 20 mg film-coated tablet, divisible

Simvastatine Mylan Pharma 40 mg film-coated tablet

Iceland Simvastatin Mylan

Norway Simvastatin Mylan

Portugal Simvastatin Mylan Pharma

Sweden Simvastatin Mylan

Date of the Last Revision of this Leaflet:April 2023

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