EZETIMIBE/SIMVASTATIN VIATRIS 10 mg/20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe/Simvastatin Viatris 10 mg/20 mg Tablets EFG

ezetimibe / simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ezetimibe/Simvastatin Viatris and what is it used for
2. What you need to know before you take Ezetimibe/Simvastatin Viatris
3. How to take Ezetimibe/Simvastatin Viatris
4. Possible side effects
   1. Storage of Ezetimibe/Simvastatin Viatris

1. Contents of the pack and further information

1. What is Ezetimibe/Simvastatin Viatris and what is it used for

Ezetimibe/Simvastatin Viatris contains two active substances, ezetimibe and simvastatin.

Ezetimibe/simvastatin is used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat in the blood called triglycerides. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe/simvastatin works by reducing cholesterol in two ways. The active substance ezetimibe reduces the amount of cholesterol absorbed from the gut. The active substance simvastatin, which belongs to a group of medicines known as statins, inhibits the production of cholesterol in the body.

Cholesterol is one of the fatty substances found in the blood. Total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of the arteries and form plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block blood flow to important organs such as the heart and brain. Blockage of blood flow to the heart can lead to a heart attack, and blockage of blood flow to the brain can lead to a 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 found in the blood that can increase the risk of heart disease.

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

Ezetimibe/simvastatin is used, along with a low-cholesterol diet, if you have:

• High levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fat in the blood (mixed hyperlipidaemia):

• That are not well controlled with a statin alone.
• For which you have used a statin and ezetimibe as separate tablets.

• A rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia) that causes very high levels of cholesterol in the blood. You may also receive other treatments.
• Heart disease, ezetimibe/simvastatin reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.

Ezetimibe/simvastatin does not help you lose weight.

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 that contain 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 and serious genetic cholesterol disorder).

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

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) or muscle weakness (myasthenic syndrome), as statins can sometimes make these conditions worse (see section 4).
• 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 the tablets 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 a blood test if you have any symptoms of liver problems while taking ezetimibe/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 Ezetimibe/Simvastatin Viatris.

While you are taking this medicine, your doctor will closely monitor you 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, and 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 and fibrates together has not been studied.

Immediately contact your doctor if you experience unexplained muscle pain, tenderness or weakness. This is because, on rare occasions, muscle problems can be serious, such as muscle breakdown causing kidney damage, and very rarely, deaths have occurred.

The risk of muscle breakdown is greater with higher doses of ezetimibe/simvastatin, especially the 10 mg/80 mg dose. The risk of muscle breakdown is also greater 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 while taking medicines to lower cholesterol, such as statins (e.g., simvastatin, atorvastatin, and rosuvastatin) or fibrates (e.g., gemfibrozil and bezafibrate).
• If you or a close family member have a hereditary muscle disorder.
• If you are of Asian origin.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. You may need further tests and additional medicines for your diagnosis and treatment.

Paediatric population

Ezetimibe/simvastatin is not recommended in 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. Taking ezetimibe/simvastatin with some of the following medicines may increase the risk of muscle problems.

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 restart the treatment with ezetimibe/simvastatin. 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, a condition in which the lining of the uterus grows outside the uterus).
• medicines with an active ingredient used to treat fungal infections, such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole.
• fibrates with active ingredients 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 that contain 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 rare and serious genetic cholesterol disorders).
  • 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 while you are being treated with simvastatin (e.g., ezetimibe/simvastatin). Your doctor may decide that you should 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).

In addition to 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 any of the following:

• medicines with an active ingredient used to prevent blood clots, such as warfarin, fluvastatin, phenprocoumon, or acenocoumarol (anticoagulants).
• cholestyramine (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).

You should 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.

You should also inform 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 affect 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

Follow exactly the instructions given to you by your doctor or pharmacist. Your doctor will determine the appropriate dose of the medicine for you, depending on your current treatment and your personal risk status.

If you are in doubt, consult your doctor or pharmacist again.

• Before starting to take 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 tablet once a day, taken orally in the evening.

The dose of ezetimibe/simvastatin 10 mg/80 mg 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 adolescents (10 to 17 years)

The recommended dose is one ezetimibe/simvastatin tablet once a day, taken orally in the evening (do not exceed a maximum dose of 10 mg/40 mg once a day).

• 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 that contains the active ingredient 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 tablets than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately 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 forgotten doses, 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 the treatment with this medicine, because 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 the 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 are taking this medicine.
• Gynecomastia (enlargement of the mammary glands 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.

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

• Increased blood levels indicative of 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; pain, sensitivity, weakness, or muscle spasms; neck pain; pain in the arms and legs; back pain.
• Unusual fatigue or weakness; fatigue; chest pain; swelling, especially of the 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 the available data):

• Low red blood cell count (anemia); reduced blood cell count, which can cause bruising/hemorrhage (thrombocytopenia).
• Numbness or weakness of the 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 the 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 pack, carton, 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 away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your 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 20 mg of simvastatin.
• The other ingredients 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 Viatris tablets are white to off-white, oval, biconvex, marked with M on one side and ES2 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.

Not all pack 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/20 mg Tabletten

Belgium Ezetimibe/Simvastatine Viatris 10 mg/20 mg tabletten

Cyprus Ezetimibe/Simvastatin Mylan 10 mg/20 mg Tablets

Spain Ezetimiba/Simvastatina Viatris 10 mg/20 mg comprimidos EFG

France EZETIMIBE/SIMVASTATINE VIATRIS 10/20 mg comprimé

Greece Ezetimibe/Simvastatin Mylan 10 mg/20 mg Tablets

Ireland Ezetimibe/Simvastatin 10 mg/20 mg Tablets

Italy Ezetimibe e Simvastatina Mylan

Luxembourg Ezetimibe/Simvastatine Viatris 10 mg/20 mg comprimés

Netherlands Ezetimibe/Simvastatine Mylan 10 mg/20 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/