EZETIMIBE AUROVITAS 10 mg TABLETS

Introduction

Leaflet:information for the user

Ezetimibe Aurovitas 10 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the leaflet

1. What is Ezetimibe Aurovitas and what is it used for
2. What you need to know before taking Ezetimibe Aurovitas
3. How to take Ezetimibe Aurovitas
4. Possible side effects
5. Storage of Ezetimibe Aurovitas
6. Package contents and additional information

1. What is Ezetimibe Aurovitas and what is it used for

Ezetimibe Aurovitas is a medication to reduce high cholesterol levels.

Ezetimibe reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe increases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Aurovitas, works by reducing the amount of cholesterol absorbed in the digestive tract.

Ezetimibe Aurovitas adds to the cholesterol-lowering effect of statins, a group of medications that reduce cholesterol produced by the body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists mainly of LDL and HDL cholesterol.

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 narrowing of the arteries. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. This 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 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.

It is used in patients who cannot control their cholesterol levels with diet alone. While taking this medication, you should follow a cholesterol-reducing diet.

Ezetimibe Aurovitas is used in combination with a cholesterol-reducing diet if you have:

• High blood cholesterol levels (primary hypercholesterolemia [heterozygous and non-familial])

• in combination with a statin, when your cholesterol level is not well controlled with a statin alone.
• alone, when statin treatment is not appropriate or not tolerated.

• A hereditary disease (homozygous familial hypercholesterolemia), which increases blood cholesterol levels. You will also be prescribed a statin and may be prescribed other treatments.

If you have heart disease, ezetimibe combined with cholesterol-lowering medications called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe Aurovitas does not help you lose weight.

2. What you need to know before taking Ezetimibe Aurovitas

If you are taking Ezetimibe Aurovitas with a statin, please read the leaflet of that medication.

Do not take Ezetimibe Aurovitas if:

• You are allergic to ezetimibe or any of the other components of this medication (listed in section 6).

Do not take Ezetimibe Aurovitas 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 Ezetimibe Aurovitas.

• Inform your doctor of all your medical problems, including allergies.
• Your doctor will perform a blood test before you start taking ezetimibe with a statin. This is to check that your liver is in good condition.
• Your doctor may also want to perform blood tests to check your liver function again after you start taking ezetimibe with a statin.

If you have moderate or severe liver problems, Ezetimibe Aurovitas is not recommended.

The safety and efficacy of the combined use of ezetimibe and certain cholesterol-reducing medications, fibrates, have not been studied.

Children and adolescents

Do not administer this medication to children and adolescents (6 to 17 years old) unless it has been prescribed by a specialist, as the data on safety and efficacy are limited.

Do not administer this medication to children under 6 years old, as there is no information available for this age group.

Taking Ezetimibe Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, inform your doctor if you are taking medications with any of the following active ingredients:

• Cyclosporine (often used in patients with organ transplants).
• Medications with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestyramine (also used to reduce cholesterol), as it affects how ezetimibe works.
• Fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding

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

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

There is no experience with the use of ezetimibe with a statin during pregnancy. Consult your doctor before using Ezetimibe Aurovitas if you are pregnant.

Do not take Ezetimibe Aurovitas with a statin if you are breastfeeding, as it is unknown whether the medications pass into breast milk. If you are breastfeeding, do not take ezetimibe, even without taking a statin. Consult your doctor.

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Ezetimibe Aurovitas.

Ezetimibe Aurovitascontains lactose

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

Ezetimibe Aurovitascontains sodium

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

3. How to take Ezetimibe Aurovitas

Follow the administration instructions of this medication indicated by your doctor exactly. Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimibe Aurovitas, you should follow a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking Ezetimibe Aurovitas.

The recommended dose is one 10 mg Ezetimibe Aurovitas tablet per day, orally.

Take Ezetimibe Aurovitas at any time of day. You can take it with or without food.

If your doctor has prescribed ezetimibe with a statin, both medications can be taken at the same time. In this case, please read the dosing instructions in the leaflet of the medication.

If your doctor has prescribed ezetimibe with another cholesterol-reducing medication containing the active ingredient colestyramine or any other medication containing a bile acid sequestrant, you should take Ezetimibe Aurovitas at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take moreEzetimibe Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the packaging and the leaflet of the medication to the healthcare professional.

If you forget to takeEzetimibe Aurovitas

Do not take a double dose to make up for forgotten doses; simply take your normal dose of Ezetimibe Aurovitas at the usual time the next day.

If you interrupt treatment with Ezetimibe Aurovitas

Talk to your doctor or pharmacist, as your cholesterol levels may increase again.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The following terms are used to describe how often side effects have been reported:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)

Contact your doctor immediately if you experience muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be serious and potentially life-threatening.

In general use, allergic reactions, including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (requiring immediate treatment), have been reported.

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

Common: abdominal pain; diarrhea; gas and feeling of tiredness.

Uncommon: elevation of some liver function test results (transaminases) or muscle function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain, hot flashes; high blood pressure.

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

Common: elevation of some liver function test results (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in hands and feet.

When used with fenofibrate, the following common side effect has been reported: abdominal pain.

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; bulging and reddened rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ezetimibe Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition ofEzetimibe Aurovitas

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, hypromellose [Type 2910 (3cp)], croscarmellose sodium, laurilsulfate sodium, crospovidone (Type B), microcrystalline cellulose (Grade 102), and magnesium stearate.

Appearance and packaging of the product

Tablet.

White to off-white, capsule-shaped, beveled-edge tablets, engraved with 'E Z' on one side and '10' on the other. The size is 8.1 mm x 4.1 mm.

Ezetimibe Aurovitas is available in blister packs and high-density polyethylene (HDPE) bottles.

Package sizes:

Blister pack: 10, 14, 15, 28, 30, 50, 56, 90, 98, 100, and 300 tablets.

HDPE bottle: 28, 98, 100, and 500 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon

France

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Ezetimib PUREN 10 mg Tabletten

Belgium: Ezetimib AB 10 mg tabletten

Spain: Ezetimiba Aurovitas 10 mg comprimidos EFG

France: Ezétimibe Arrow 10 mg comprimé

Netherlands: Ezetimibe Aurobindo 10 mg, tabletten

Poland: Ezetimibe Aurovitas

Portugal: Ezetimiba Aurovitas

Czech Republic: Ezetimib Aurovitas

Date of the last revision of this leaflet: February 2021

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