Prospect: Patient Information

Ezetimiba/Simvastatina Viatris 10 mg/20 mg Tablets EFG

ezetimiba / simvastatina

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they do not appear in this prospect. See section 4.

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

2.What you need to know before starting to take Ezetimiba/Simvastatina Viatris

3.How to take Ezetimiba/Simvastatina Viatris

4.Possible adverse effects

1. Storage of Ezetimiba/Simvastatina Viatris

6.Contents of the package and additional information

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

Ezetimibe/simvastatin is used to reduce total cholesterol, "bad" cholesterol (low-density lipoprotein or LDL) and certain types of fat called triglycerides present in the blood. Additionally, Ezetimibe/Simvastatin Viatris increases the levels of "good" cholesterol (high-density lipoprotein or HDL).

Ezetimibe/simvastatin acts by reducing cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in the digestive tract. The active ingredient simvastatin, which belongs to the group of statins, inhibits the production of cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries and form plaques. Over time, this accumulation in plaques can cause a narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. 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 arteries and protects against heart disease.

Triglycerides are another type of fat present in the blood that can increase the risk of heart disease.

Ezetimibe/simvastatin is used in patients who cannot control their cholesterol levels solely with diet. While taking this medication, you must follow a cholesterol-lowering diet.

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

• Elevated cholesterol levels in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]) or elevated levels of fatty substances (mixed hyperlipidemia):

• That are not well controlled with a statin alone.
• For those who have used a statin and ezetimibe in separate tablets.

• Hereditary disease (familial hypercholesterolemia) that increases the level of cholesterol in the blood. You may also receive other treatments.
• Cardiac disease, ezetimibe/simvastatin reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimibe/simvastatin does not help with weight loss.

Do not take Ezetimiba/Simvastatina Viatris:

-If you are allergic to ezetimiba, simvastatina, or any of the other components of this medication (listed in section 6).

-If you have liver problems.

-If you are pregnant or breastfeeding.

-If you are taking medications with one or more of the following active ingredients:

• Itraconazol, ketoconazol, posaconazol, or voriconazol (used to treat fungal infections).

• Eritromicina, claritromicina, or telitromicina (used to treat infections).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections) or medications containing cobicistat (also used to treat HIV infections).

• Boceprevir or telaprevir (used to treat hepatitis C infection).

• Nefazodona (used to treat depression).

• Gemfibrozilo (used to reduce cholesterol).

• Ciclosporina (often used in patients with organ transplants).

• 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 medication containing fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and ezetimiba/simvastatina may cause severe muscle problems (rhabdomyolysis).

Do not take more than 10 mg/40 mg of ezetimiba/simvastatina if you are taking lomitapida (used to treat rare and severe cholesterol disorders).

Consult your doctor if you are unsure if your medication is listed above.

Warnings and precautions

Inform your doctor or pharmacist before taking Ezetimiba/Simvastatina Viatris:

• All of your medical problems, including allergies.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (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 significant amounts of alcohol or have ever had liver disease. Ezetimiba/simvastatina may not be suitable for you.
• If you are scheduled for surgery. You may need to stop taking Ezetimiba/Simvastatina Viatris for a short period of time.
• If you are Asian, as you may need a different dose.

Your doctor should perform a blood test before you start taking ezetimiba/simvastatina and also if you have any symptoms of liver problems while taking ezetimiba/simvastatina. The purpose is to check the liver function.

Your doctor may also want to perform blood tests to check the liver function after starting treatment with Ezetimiba/Simvastatina Viatris.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Talk to your doctor if you have a severe lung disease.

Avoid the combined use of ezetimiba/simvastatina and fibrates (certain medications to reduce cholesterol), as the combined use of ezetimiba/simvastatina and fibrates has not been studied.

Contact your doctor immediately if you experience unexplained muscle pain, sensitivity, or weakness. The reason is that, in rare cases, muscle problems can be severe, for example, muscle degradation that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle degradation is higher with high doses of ezetimiba/simvastatina, especially the 10 mg/80 mg dose. The risk of muscle degradation is also higher in certain patients.

Inform your doctor in the following situations:

• If you have kidney problems.

• If you have thyroid problems.

• If you are 65 years or older.

• If you are a woman.

• If you have ever had muscle problems during treatment with cholesterol-lowering medications called "statins" (such as simvastatina, atorvastatina, and rosuvastatina) or fibrates (such as gemfibrozilo or bezafibrato).

• If you or your close relatives have a hereditary muscle disorder.

• If you are of Asian origin.

Also inform your doctor or pharmacist if you have persistent muscle weakness. You may need additional tests and medications for your diagnosis and treatment.

Pediatric population

Ezetimiba/simvastatina is not recommended for children under 10 years.

Other medications and Ezetimiba/Simvastatina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including any of the following. Taking ezetimiba/simvastatina with any of the following medications may increase the risk of muscle problems.

Do not take Ezetimiba/Simvastatina Viatris with:

• Fusidic acid.If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medication. Your doctor will tell you when you can restart the treatment with ezetimiba/simvastatina . Taking ezetimiba/simvastatina Viatris with fusidic acid may cause, in rare cases, muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Ciclosporina (often used in patients with organ transplants).

• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• Medications with an active ingredient such as itraconazol, ketoconazol, fluconazol, posaconazol, or voriconazol (used to treat fungal infections).

• Fibrates with active ingredients such as gemfibrozilo and bezafibrato (used to reduce cholesterol).

• Eritromicina, claritromicina, or telitromicina (used to treat bacterial infections).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections).

• Antiviral agents for hepatitis C, such as boceprevir, telaprevir, elbasvir, grazoprevir, or glecaprevir/pibrentasvir (used to treat hepatitis C infection).

• Nefazodona (used to treat depression).

• Medications containing cobicistat (also used to treat HIV infections).

• Amiodarona (used to treat cardiac arrhythmias).

• Verapamilo, diltiazem, or amlodipino (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases).

• Lomitapida (used to treat rare and severe cholesterol disorders).

• Daptomicina (a medication used to treat bacteremia and skin and skin structure infections with complications). The muscle side effects may be greater when this medication is taken while on simvastatina (for example, ezetimiba/simvastatina) treatment. Your doctor may decide that you stop taking ezetimiba/simvastatina Viatris for a time.

• High doses (1 gram or more per day) of niacina or nicotinic acid (also used to reduce cholesterol).

• Colchicina (used to treat gout).

Additionally, inform your doctor or pharmacist if you are taking or have taken recently other medications, even those purchased without a prescription. In particular, inform your doctor if you are taking any of the following:

• Medications with an active ingredient to prevent blood clot formation, such as warfarina, fluindiona, fenprocumon, acenocumarol (anticoagulants).

• Colestiramina (also used to reduce cholesterol), as it affects how ezetimiba/simvastatina works.

• Fenofibratos (also used to reduce cholesterol).

• Rifampicina (used to treat tuberculosis).

• Ticagrelor (antiplatelet medication).

You should also talk to your doctor if you are taking niacina (nicotinic acid) or a product that contains it, or related, such as acipimox (used to reduce cholesterol) and if you are of Asian origin.

You should also inform any doctor who prescribes a new medication that you are taking ezetimiba/simvastatina.

Taking Ezetimiba/Simvastatina Viatris with food and drinks

The juice of the pomelo contains one or more components that alter the metabolism of some medications, including ezetimiba/simvastatina . You should avoid consuming pomelo juice, as it may increase the risk of muscle problems.

Pregnancy and lactation

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

Do not take ezetimiba/simvastatina if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Driving and operating machinery

Ezetimiba/simvastatina is not expected to interfere with your ability to drive or operate machinery. However, some people may feel dizzy after taking ezetimiba/simvastatina; if this happens to you, do not drive or operate machinery.

Ezetimiba/Simvastatina Viatris contains lactose monohydrate

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. Your doctor will determine the appropriate dose per tablet for you, depending on your current treatment and personal risk level.

In case of doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba/simvastatina, you must be following a diet to reduce cholesterol.

• You must continue with this cholesterol-reducing diet while taking ezetimiba/simvastatina.

Adults

The recommended dose is one tablet of ezetimiba/simvastatina once a day by oral route at night.

The ezetimiba/simvastatina 10 mg/80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease problems who have not achieved cholesterol goals with lower doses.

Use in adolescents (10 to 17 years)

The recommended dose is one tablet of ezetimiba/simvastatina once a day by oral route at night (do not exceed a maximum dose of 10 mg/40 mg once a day).

• Take ezetimiba/simvastatina at night.
• You can take it with or without food.
• The tablets are not scored and should not be divided.

If your doctor has prescribed ezetimiba/simvastatina along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other bile acid sequestrant, you should take Ezetimiba/Simvastatina Viatris at least 2 hours before or 4 hours after taking these medications.

If you take more Ezetimiba/Simvastatina Viatris than you should

If you take more tablets of ezetimiba/simvastatina than you should, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ezetimiba/Simvastatina Viatris

Do not take a double dose to compensate for the missed doses, simply take your next dose of ezetimiba/simvastatina at the usual time the next day.

If you interrupt treatment with Ezetimiba/Simvastatina Viatris

Talk to your doctor before interrupting treatment with this medication because your cholesterol may increase again.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

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

• Muscle pain, numbness, or weakness, especially persistent 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 degeneration that causes kidney damage, and can be potentially life-threatening conditions.
• Allergic reactions, including swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing (and require immediate treatment) (angioedema).
• Pancreatitis, often with intense abdominal pain.
• Gallstones in the bile duct or inflammation of the gallbladder (which can cause abdominal pain, nausea, or vomiting).
• Skin eruptions with redness, sometimes with target-shaped lesions (erythema multiforme) skin eruptions that can occur on the skin or mouth ulcers (drug-induced lichenoid eruptions), (which can affect up to 1 in 10,000 people).
• Hepatitis, 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 can 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, inflammation of blood vessels, atypical hematomas, skin eruptions, and swelling, urticaria, skin sensitivity to sunlight, fever, hot flashes, difficulty breathing, and general discomfort, pseudolupus-like condition [skin rash, joint disorders, and effects on white blood cells].

• 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.
• Gynecomastia (breast enlargement in men), (which can affect up to 1 in 10,000 people).

Other possible side effects:

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

•Muscle pain.

•Increases in blood levels of liver function analysis (transaminases) and/or muscle function.

Rare (can affect up to 1 in 100 people):

• Increases in blood levels indicative of liver function; elevated uric acid levels in the blood; increased blood clotting 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 eruptions; itching; urticaria.
• Joint pain; muscle pain, numbness, weakness, or spasms; neck pain; arm and leg pain; back pain.
• Unusual fatigue or weakness; fatigue; chest pain; swelling, especially of the hands and feet.
• Sleep disturbances; difficulty sleeping.

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

• Blurred vision; altered vision.

Unknown frequency (the frequency cannot be estimated from the available data):

• Low red blood cell count (anemia); reduction in white blood cell count, which can cause hematomas/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.
• Loss of appetite.
• Hot flashes; high blood pressure.
• Pain.
• Erectile dysfunction.
• Depression.
• Alterations in some blood tests that measure the amount of sugar present in the blood.
• Stomach mucosa inflammation.
• Difficulty breathing.
• Cough.

Additional side effects reported with the use of some statins:

Unknown frequency (cannot be estimated from the available data):

• Sleep disturbances, including nightmares.
• Sexual dysfunction.
• 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 Pharmacovigilance 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.

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

Do not use this medication after the expiration date that appears on the blister pack, carton case, or bottle, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Bottles: Use within 100 days of opening.

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

Ezetimibe/Simvastatin Viatris Composition

• The active ingredients are ezetimibe and simvastatin. Each tablet contains 10 mg of ezetimibe and 20 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 contents of the package

Ezetimibe/Simvastatin Viatris tablets are white to off-white, oval, biconvex, marked with M on one face and ES2 on the other.

They are available in:

Blister packs:

14, 28, 30, 98, and 100 tablets

Calendar blister packs:

28 tablets

Perforated single-dose blisters:

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

Plastic bottle with screw cap and aluminum foil seal with hydrophilic cotton (absorbent) containing:

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

Responsible for manufacturing:

McDermott Laboratories t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

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

For more information about this medicine, please contact 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 with the following names:

GermanyEzetimib/Simvastatin Mylan 10 mg/20 mg Tabletten

BelgiumEzetimibe/Simvastatine Viatris 10 mg/20 mg tabletten

CyprusEzetimibe/Simvastatin Mylan 10 mg/20 mg Tablets

SpainEzetimiba/Simvastatina Viatris 10 mg/ 20 mg comprimidos EFG

FranceEZETIMIBE/SIMVASTATINEVIATRIS10/20 mg comprimé

GreeceEzetimibe/Simvastatin Mylan 10 mg/20 mg Tablets

IrelandEzetimibe/Simvastatin 10 mg/20 mg Tablets

ItalyEzetimibe e Simvastatina Mylan

LuxembourgEzetimibe/Simvastatine Viatris 10 mg/20 mg comprimés

NetherlandsEzetimibe/Simvastatine Mylan 10 mg/20 mg tabletten

PortugalSinvastatina + Ezetimiba Mylan

Last review date of this leaflet: June 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/