EZETIMIBE/SIMVASTATIN VIATRIS 10 mg/40 mg TABLETS

2. What you need to know before you take Ezetimibe/Simvastatin Viatris

Do not take Ezetimibe/Simvastatin Viatris:

• If you are allergic to ezetimibe, 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 breast-feeding.
• If you are taking any of the following medicines:
• 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) or medicines containing cobicistat (also used to treat HIV infections).
• boceprevir or telaprevir (used to treat hepatitis C virus infection).
• nefazodone (used to treat depression).
• gemfibrozil (used to lower cholesterol).
• cyclosporine (often used in patients who have had an organ transplant).
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the 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 by injection. The combination of fusidic acid and ezetimibe/simvastatin can cause muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of ezetimibe/simvastatin if you are taking lomitapide (used to treat a rare inherited cholesterol disorder).

Check with your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Tell your doctor or pharmacist before taking Ezetimibe/Simvastatin Viatris:

• About all your medical conditions, including allergies.
• If you have or have had muscle problems (myasthenia gravis) or muscle weakness (myasthenic syndrome), as statins can sometimes make these conditions worse.
• If you drink large amounts of alcohol or have ever had liver disease, as ezetimibe/simvastatin may not be suitable for you.
• If you are going to have an operation. You may need to stop taking Ezetimibe/Simvastatin Viatris for a short time.
• If you are Asian, as you may need a different dose.

Your doctor will do a blood test before you start taking ezetimibe/simvastatin and may also do tests after you start taking it to check how well your liver is working.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. Your risk of developing diabetes is higher if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure.

Tell your doctor if you have severe lung disease.

The combined use of ezetimibe/simvastatin and fibrates (certain medicines used to lower cholesterol) should be avoided, as the use of ezetimibe/simvastatin with fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, on rare occasions, muscle problems can be serious, including muscle breakdown, which can cause kidney damage, and, very rarely, deaths have occurred.

The risk of muscle breakdown is higher with higher doses of ezetimibe/simvastatin, especially the 10 mg/80 mg dose. The risk of muscle breakdown is also higher in certain patients.

Tell your doctor:

• If you have kidney problems.
• If you have thyroid problems.
• If you are 65 years or older.
• If you are female.
• If you have ever had muscle problems during treatment with cholesterol-lowering medicines called statins (such as simvastatin, atorvastatin, and rosuvastatin) or fibrates (such as gemfibrozil or bezafibrate).
• If you or a close family member have a muscle disorder (myopathy).
• If you are of Asian origin.

Also, tell your doctor or pharmacist if you have persistent muscle weakness.

Children and adolescents

Ezetimibe/simvastatin is not recommended for children under 10 years.

Other medicines and Ezetimibe/Simvastatin Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines can increase the risk of muscle problems when taken with ezetimibe/simvastatin.

Do not take Ezetimibe/Simvastatin Viatris with:

• fusidic acid. If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when you can start taking ezetimibe/simvastatin again. Taking ezetimibe/simvastatin with fusidic acid can, on rare occasions, cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in patients who have had an organ transplant).
• danazol (a synthetic hormone used to treat endometriosis).
• medicines with active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• fibrates with active substances 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).

• hepatitis C virus protease inhibitors such as boceprevir, telaprevir, elbasvir, grazoprevir, or glecaprevir/pibrentasvir (used to treat hepatitis C virus infection).
• nefazodone (used to treat depression).
• medicines containing cobicistat (also used to treat HIV infections).

• amiodarone (used to treat irregular heartbeats).
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).
• lomitapide (used to treat a rare inherited cholesterol disorder).
• daptomycin (a medicine used to treat bacteremia and complicated skin and skin structure infections). The risk of side effects that affect the muscles may be greater when this medicine is taken with simvastatin (such as ezetimibe/simvastatin). Your doctor may decide that you need to stop taking ezetimibe/simvastatin Viatris for a while.

• high doses (1 gram or more per day) of niacin or nicotinic acid (also used to lower cholesterol).
• colchicine (used to treat gout).

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, especially:

• medicines with active substances used to prevent blood clots, such as warfarin, fluvastatin, phenprocoumon, or acenocoumarol (anticoagulants).
• colestyramine (also used to lower cholesterol), as it affects how ezetimibe/simvastatin works.
• fenofibrate (also used to lower cholesterol).
• rifampicin (used to treat tuberculosis).
• ticagrelor (an antiplatelet medicine).

Also, tell your doctor if you are taking niacin (nicotinic acid) or a product that contains it, or a related product such as acipimox (used to lower cholesterol), and if you are of Asian origin.

Also, tell any doctor who prescribes you a new medicine that you are taking ezetimibe/simvastatin.

Taking Ezetimibe/Simvastatin Viatris with food and drink

Grapefruit juice contains one or more ingredients that can alter the metabolism of some medicines, including ezetimibe/simvastatin. You should avoid drinking grapefruit juice as it can increase the risk of muscle problems.

Pregnancy and breast-feeding

Do not take ezetimibe/simvastatin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it immediately and tell your doctor.

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

Driving and using machines

Ezetimibe/simvastatin is unlikely to affect your ability to drive or use machines. However, some people may feel dizzy after taking ezetimibe/simvastatin; if this happens to you, do not drive or use machines.

Ezetimibe/Simvastatin Viatris contains lactose monohydrate

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

3. How to take Ezetimibe/Simvastatin Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. Your doctor will decide the appropriate dose of Ezetimibe/Simvastatin Viatris for you, depending on your current treatment and personal risk status.

If you are unsure, ask your doctor or pharmacist.

• Before starting ezetimibe/simvastatin, you should be on a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking ezetimibe/simvastatin.

Adults

The recommended dose is one Ezetimibe/Simvastatin Viatris tablet per day, taken orally in the evening.

The 10 mg/80 mg dose of ezetimibe/simvastatin is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease who have not reached their cholesterol goal with lower doses.

Use in adolescents (10 to 17 years)

The recommended dose is one Ezetimibe/Simvastatin Viatris tablet per day, taken orally in the evening (do not exceed a maximum dose of 10 mg/40 mg once daily).

• Take ezetimibe/simvastatin in the evening.
• You can take it with or without food.
• The tablets are not scored and should not be divided.

If your doctor has prescribed ezetimibe/simvastatin with another cholesterol-lowering medicine called colestyramine or any other bile acid sequestrant, you should take Ezetimibe/Simvastatin Viatris at least 2 hours before or 4 hours after taking these medicines.

If you take more Ezetimibe/Simvastatin Viatris than you should

If you take more Ezetimibe/Simvastatin Viatris than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ezetimibe/Simvastatin Viatris

Do not take a double dose to make up for a forgotten dose. Simply take your next dose of ezetimibe/simvastatin at the usual time the next day.

If you stop taking Ezetimibe/Simvastatin Viatris

Talk to your doctor before stopping treatment with this medicine, as your cholesterol levels may increase 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.

Contact your doctor immediately or go to the emergency department of the nearest hospital if you experience any of the following serious adverse effects; these effects are unknown (cannot be estimated from available data) but may require medical attention:

• Muscle pain, sensitivity, or weakness, especially unexplained constant muscle weakness, muscle rupture (which can affect up to 1 in 10,000 people). The reason is that, in rare cases, muscle problems can be severe, such as muscle degradation that causes kidney damage, and can become potentially life-threatening conditions.
• Allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (and requires immediate treatment) (angioedema).
• Pancreatitis, often with severe abdominal pain.
• Gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting).
• Skin rashes with redness, sometimes with target-shaped lesions (erythema multiforme) rashes that can occur on the skin or oral ulcers (lichenoid drug eruptions), (which can affect up to 1 in 10,000 people).
• Liver inflammation (which can cause yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness and loss of appetite).
• Liver failure.
• Respiratory problems such as persistent cough and/or difficulty breathing or fever.
• A hypersensitivity reaction that may include the following: hypersensitivity (severe allergic reactions that cause difficulty breathing or dizziness and require immediate treatment (anaphylaxis, which can affect 1 in 10,000 people) joint pain or inflammation, blood vessel inflammation, atypical bruising, skin rashes, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general malaise, pseudolupus syndrome [skin rash, joint disorders, and effects on white blood cells]).

• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you take this medicine.
• Gynecomastia (enlargement of breast tissue in men), (which can affect up to 1 in 10,000 people).

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people):

• Muscle pain.
• Increased blood levels of clinical analysis values of liver (transaminases) and/or muscle function.

Uncommon (may affect up to 1 in 100 people):

• Increased blood levels indicating liver function; increased uric acid in the blood; increased blood coagulation time; presence of proteins in urine; weight loss.
• Dizziness; headache; tingling sensation.
• Abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal swelling; diarrhea; dry mouth; heartburn.
• Skin rash; itching; urticaria.
• Joint pain; muscle pain, sensitivity, weakness, or spasms; neck pain; pain in arms and legs; back pain.
• Unusual fatigue or weakness; fatigue; chest pain; swelling, especially of hands and feet.
• Sleep disorders; difficulty sleeping.

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

• Blurred vision; altered vision.

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

• Low red blood cell count (anemia); reduced blood cell count, which can cause bruising/hemorrhage (thrombocytopenia).
• Numbness or weakness of arms and legs; poor memory, memory loss, confusion.
• Constipation.
• Hair loss.
• Muscle cramps; muscle inflammation; tendon problems, sometimes complicated by tendon rupture.
• Decreased appetite.
• Hot flashes; high blood pressure.
• Pain.
• Erectile dysfunction.
• Depression.
• Alterations in some clinical analyses that measure the amount of sugars present in the blood.
• Gastric mucosa inflammation.
• Difficulty breathing.
• Cough.

Additional adverse effects reported with the use of some statins:

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

• Sleep disorders, including nightmares.
• Sexual dysfunction.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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, 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 prospectus. 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 Ezetimibe/Simvastatin Viatris

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, cardboard box, or bottle, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Bottles: Use within 100 days of opening.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 Ezetimibe/Simvastatin Viatris

• The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 40 mg of simvastatin.
• The other components are: lactose monohydrate (see section 2 "Ezetimibe/Simvastatin Viatris contains lactose monohydrate"); citric acid monohydrate, butylhydroxyanisole (E320), ascorbic acid (E300), sodium lauryl sulfate (E487), croscarmellose sodium, hypromellose (E464), cellulose, microcrystalline, magnesium stearate.

Appearance of the product and package contents

Ezetimibe/Simvastatin tablets are white to off-white, oval, biconvex, marked with M on one side and ES3 on the other.

They are available in:

Blister packs:

14, 28, 30, 98, and 100 tablets

Calendar blister packs:

28 tablets

Unit-dose blister packs:

14 x 1, 28 x 1, 30 x 1, and 90 x 1 tablets

Plastic bottle with screw cap and aluminum seal along with absorbent cotton that contains:

30, 100, 250, and 500 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.

H-2900 Komárom

Mylan utca 1

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

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:

Germany Ezetimib/Simvastatin Mylan 10 mg/40 mg Tabletten

Belgium Ezetimibe/Simvastatine Viatris 10 mg/40 mg tabletten

Cyprus Ezetimibe/Simvastatin Mylan 10 mg/40 mg Tablets

Spain Ezetimiba/Simvastatina Viatris 10 mg/40 mg comprimidos EFG

France EZETIMIBE/SIMVASTATINE VIATRIS 10/40 mg comprimé

Greece Ezetimibe/Simvastatin Mylan 10 mg/40 mg Tablets

Ireland Ezetimibe/Simvastatin 10 mg/40 mg Tablets

Italy Ezetimibe e Simvastatina Mylan

Luxembourg Ezetimibe/Simvastatine Viatris 10 mg/40 mg comprimés

Netherlands Ezetimibe/Simvastatine Mylan 10 mg/40 mg tabletten

Portugal Sinvastatina + Ezetimiba Mylan

Date of the last revision of this prospectus: June 2023

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