Product Information for the Patient

Ezetimiba Viatris 10 mg Tablets EFG

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

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

Ezetimiba Viatris contains the active ingredient ezetimiba. Ezetimiba Viatris is a medication to reduce elevated levels of cholesterol. Ezetimiba Viatris reduces total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba Viatris increases concentrations of "good" cholesterol (high-density lipoprotein, HDL).

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from heart disease.

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

Ezetimiba Viatris acts by reducing cholesterol absorbed in the digestive tract. Ezetimiba Viatris does not help you lose weight.

Ezetimiba Viatris adds to the effect of lowering cholesterol of statins, a group of medications that reduce cholesterol produced by the body itself.

Ezetimiba Viatris is used in patients who cannot control their cholesterol levels solely with a cholesterol-lowering diet. While taking this medication, you must continue with your cholesterol-lowering diet.

Ezetimiba Viatris is used along with a cholesterol-lowering diet if you have:

• Elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial]).
• • Along with a statin, when your cholesterol level is not well controlled with a statin alone.
  • Alone, when statin treatment is inappropriate or not tolerated.

A genetic disorder (familial homozygous hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may receive other treatments.

• A genetic disorder (sitosterolemia homozygous, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, Ezetimiba Viatris combined with medications to lower cholesterol called statins, reduce the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba does not help you lose weight.

If you take Ezetimiba Viatris with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Viatris:

• If you are allergic to ezetimiba or any of the other ingredients in this medicine (including those listed in section 6).

Do not take Ezetimiba Viatris with a statin if:

• You currently have liver problems.
• You are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Viatris.

Inform your doctor of all your medical conditions, including allergies.

Your doctor should do a blood test before you start taking Ezetimiba Viatris with a statin. This is to check if your liver is working properly.

Your doctor may also want to do blood tests to check if your liver is working properly after you start taking Ezetimiba Viatris with a statin.

If you have moderate or severe liver problems, Ezetimiba Viatris is not recommended.

The safety and efficacy of the combined use of ezetimiba and certain cholesterol-lowering medicines, such as fibrates, have not been studied.

If you experience muscle pain, tenderness or weakness without a clear cause while taking these tablets, especially if accompanied by fever, inform your doctor.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist, as the safety and efficacy data are limited.

Do not administer this medicine to children under 6 years of age as there is no information available for this age group.

Taking Ezetimiba Viatris with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take other medicines, including those purchased without a prescription. In particular, inform your doctor or pharmacist if you are taking medicines with any of the following active ingredients:

• Ciclosporin (often used in organ transplant patients).
• Medicines with an active ingredient to prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants).
• Colestiramine (also used to lower cholesterol), as it affects how Ezetimiba Viatris works.
• Fibrates (used to lower cholesterol).

Pregnancy and breastfeeding

Do not take Ezetimiba Viatris with a statin if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while taking Ezetimiba Viatris with a statin, stop taking both medicines immediately and inform your doctor.

There is no experience with the use of Ezetimiba Viatris with a statin during pregnancy.

Do not take Ezetimiba Viatris with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, do not take Ezetimiba Viatris, even without taking a statin.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Ezetimiba Viatris is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Ezetimiba Viatris; if this happens, do not drive or operate machines.

Ezetimiba Viatris contains lactose and sodium

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".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. Continue taking your other medications to lower cholesterol unless your doctor tells you to stop. In case of doubt, consult your doctor or pharmacist again.

Before starting to take Ezetimiba Viatris, you must be following a diet to reduce cholesterol. You must continue with this cholesterol-lowering diet while taking Ezetimiba Viatris.

Adults and adolescents (10 to 17 years old)

The recommended dose is one Ezetimiba Viatris 10 mg tablet once a day by mouth.

Take Ezetimiba Viatris at any time of the day. You can take it with or without food.

Instructions for opening the blister pack:

1. Do not press the blister pack to open it.

2. For the perforated blister pack; remove any side of the perforated area as indicated in the image.

3. Hold the blister pack by the edges and separate one blister compartment from the rest of the strip by gently tearing along the perforation that surrounds it.

4. Carefully remove the paper cover from the unsaled area.

5. Remove the tablet from the opened blister pack.

If your doctor has prescribed Ezetimiba Viatris along with a statin, both medications can be taken at the same time. In this case, please read the administration instructions in the package insert for that specific medication.

If your doctor has prescribed Ezetimiba Viatris along with cholestyramine or any other medication that contains a bile acid sequestrant (cholesterol-lowering medications), you must take Ezetimiba Viatris at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Viatris than you should

If you take more Ezetimiba tablets than you should, consult your doctor or pharmacist immediately.

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

If you forget to take Ezetimiba Viatris

Do not take a double dose to make up for the missed dose, simply take your usual amount of Ezetimiba at the usual time the next day.

If you interrupt treatment with Ezetimiba Viatris

Speak with your doctor or pharmacist before stopping this medication, as your cholesterol levels may increase again.

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

Like all medicines, this medicine may 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, sensitivity to pressure, or unexplained muscle weakness. This is because, in rare cases, muscle problems, including muscle degradation that causes kidney damage, can be severe and potentially life-threatening.
• Allergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate treatment).
• Pancreatitis, often with intense abdominal pain.
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting).
• Swollen and red rashes, sometimes with target-shaped lesions.
• Hepatitis (which may cause fatigue, fever, nausea, vomiting, general discomfort, yellowing of the skin and eyes, light-colored stools, and dark-colored urine).

When used alone, the following side effects have been reported:

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

• Abdominal pain.
• Diarrhea.
• Gas (flatulence).
• Feeling tired.

Less frequent (may affect up to 1 in 100 people):

• Elevation of some liver and muscle enzymes in blood tests.
• Cough.
• Indigestion.
• Heartburn.
• Nausea.
• Joint pain.
• Muscle spasms.
• Neck pain.
• Loss of appetite.
• Pain.
• Chest pain.
• Heat.
• High blood pressure.

In addition, when used with a statin, the following side effects have been reported:

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

• Elevation of some liver enzymes in blood tests.
• Headache.
• Muscle pain.

Less frequent (may affect up to 1 in 100 people):

• Tingling sensation.
• Dry mouth.
• Stomach pain, nausea, vomiting with blood, blood in stools, itching.
• Rash.
• Hives.
• Back pain.
• Muscle weakness.
• Pain in arms and legs.
• Unusual fatigue or weakness.
• Swelling, especially in hands and feet.

When used with or without a statin, the following side effects may occur:

Unknown frequency (cannot be estimated from available data):

• Dizziness.
• Allergic reactions, including skin rash and hives.
• Constipation.
• Reduction in the number of blood cells, which may cause bruising/bleeding (thrombocytopenia).
• Tingling sensation.
• Depression.
• Unusual fatigue or weakness.
• Difficulty breathing.

When used with fenofibrate, the following side effect may occur:

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

• Abdominal pain.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report any side effects directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use athttps://www.notificaram.es..

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication 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 medication does not require special conservation conditions.

Bottles: Use within 100 days of opening.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Ezetimibe Viatris Composition

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other components are: lactose monohydrate (see section 2 "Ezetimibe Viatris contains lactose monohydrate"); sodium laurilsulfate (E-487); croscarmellose sodium; hypromellose (E-464); crospovidone (type B); microcrystalline cellulose; magnesium stearate.

Appearance of the product and contents of the pack

Ezetimibe Viatris 10 mg tablets are white to off-white capsule-shaped tablets with beveled edges, marked with "M" on one face and "EE1" on the other.

Ezetimibe Viatris 10 mg tablets are available in blister packs or detachable blister packs of 14, 28, 30, 56, 84, 90, 98, and 100 tablets; perforated unit dose blisters of 14 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1, and 98 x 1 tablets; calendar blisters of 28 and 30 tablets and plastic bottles of 14, 28, 50, 56, 84, and 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person

Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Or

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Last update of this leaflet: November 2021.

For further information about this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/