Ezetimibe Viatris 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimibe Viatris 10 mg tablets EFG

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

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

Leaflet contents

1. What Ezetimibe Viatris is and what it is used for.
2. What you need to know before taking Ezetimibe Viatris.
3. How to take Ezetimibe Viatris.
4. Possible side effects.
5. How to store Ezetimibe Viatris.
6. Contents of the pack and other information

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

Ezetimiba Viatris contains the active substance ezetimibe. Ezetimiba Viatris is a medicine used to reduce elevated cholesterol levels. Ezetimiba Viatris lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat known as triglycerides circulating in the blood. In addition, Ezetimiba Viatris increases levels of "good" cholesterol (HDL cholesterol).

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can narrow the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Disruption of blood flow may lead to a heart attack or 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 in your blood that may increase the risk of heart disease.

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

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

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

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

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

A hereditary disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may receive other treatments as well.

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

If you have heart disease, Ezetimiba Viatris in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimibe does not help you lose weight.

2. What you need to know before taking Ezetimiba Viatris

If you are taking Ezetimiba Viatris together with a statin, please read the package leaflet of that medicine.

Do not take Ezetimiba Viatris:

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

Do not take Ezetimiba Viatris together with a statin if:

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

Warnings and precautions

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

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

Your doctor should perform a blood test before you start taking Ezetimiba Viatris with a statin. This is to check whether your liver is functioning properly.

Your doctor may also want to carry out blood tests to monitor liver function after you start taking Ezetimiba Viatris with a statin.

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

The safety and efficacy of combining ezetimibe with certain cholesterol-lowering medicines, fibrates, have not been studied.

If you experience unexplained muscle pain, tenderness, or weakness while taking these tablets, especially if accompanied by fever, inform your doctor.

Children and adolescents

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

Do not give 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking medicines containing any of the following active substances:

• Cyclosporine (often used in organ transplant patients).
• Medicines containing active substances used to prevent blood clots, 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, you should not take Ezetimiba Viatris, even without taking a statin.

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

Driving and using machines

Ezetimiba Viatris is not expected to affect your ability to drive or use machines. However, some people may experience dizziness after taking Ezetimiba Viatris; if this occurs, do not drive or operate machinery.

Ezetimiba Viatris contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him 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 Ezetimiba Viatris

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

Before starting to take Ezetimiba Viatris, you should already be on a cholesterol-lowering diet. You must continue this cholesterol-lowering diet while taking Ezetimiba Viatris.

Adults and adolescents (aged 10 to 17 years)

The recommended dose is one Ezetimiba Viatris 10 mg tablet taken once daily by mouth.

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

Instructions for peeling the blister pack:

1. Do not press the blister cavity to open it.
2. For perforated blister packs: peel back any side of the perforated area as shown in the image.
3. Hold the blister strip at the edges and separate one blister cavity from the rest of the strip by gently tearing along the surrounding perforation.
4. Carefully peel back the paper lid material from the unsealed area.
5. Remove the tablet from the opened blister cavity.

(Single-dose peelable blister packs only)

If your doctor has prescribed Ezetimiba Viatris together with a statin, both medicines may be taken at the same time. In this case, please read the instructions for use provided in the leaflet of that specific medicine.

If your doctor has prescribed Ezetimiba Viatris together with colestyramine or any other medicine containing a bile acid sequestrant (cholesterol-lowering medicines), 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, contact your doctor or pharmacist immediately.

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

If you forget to take Ezetimiba Viatris

Do not take a double dose to make up for missed doses. Simply take your usual dose of ezetimiba at the usual time on the following day.

If you stop taking Ezetimiba Viatris

Talk to your doctor or pharmacist before stopping this medicine, as your cholesterol levels may rise again.

If you have any further questions about 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 everyone experiences them.

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

• Unexplained muscle pain, tenderness to pressure, or muscle weakness. This is because, rarely, muscle problems—including muscle breakdown leading to kidney damage—can be severe and potentially life-threatening.
• Allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment).
• Inflammation of the pancreas, often accompanied by severe abdominal pain.
• Gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting).
• Raised and red skin rashes, sometimes with target-like lesions.
• Inflammation of the liver (which may cause fatigue, fever, nausea or vomiting, general malaise, yellowing of the skin and eyes, pale stools, and dark urine).

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

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

• Abdominal pain.
• Diarrhea.
• Gas (flatulence).
• Feeling of tiredness.

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

• Increased levels of certain liver and muscle enzymes in blood tests.
• Cough.
• Indigestion.
• Heartburn.
• Nausea.
• Joint pain.
• Muscle spasms.
• Neck pain.
• Loss of appetite.
• Pain.
• Chest pain.
• Flushing.
• High blood pressure.

Additionally, when used in combination with a statin, the following adverse effects have been reported:

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

• Increased levels of certain liver enzymes in blood tests.
• Headache.
• Muscle pain.

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

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

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

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

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

When used in combination with fenofibrate, the following adverse effect may occur:

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

• Abdominal pain.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report any adverse effects directly via the Spanish Pharmacovigilance System for Human Medicines at https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Viatris

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container, after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Bottles: Use within 100 days of opening.

Medicines must not be disposed of via wastewater drains or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba Viatris

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

Appearance of the product and contents of the pack

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

Ezetimiba Viatris 10 mg tablets are available in blister packs or peelable blisters of 14, 28, 30, 56, 84, 90, 98 and 100 tablets; single-dose perforated blisters of 14 x 1, 28 x 1, 30 x 1, 50 x 1, 90 x 1 and 98 x 1 tablets; calendar blister packs 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

Manufacturer

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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: November 2021.

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