Ezetimibe Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe Aurovitas 10 mg tablets EFG

Read the entire 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 effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Ezetimiba Aurovitas is a medication used to reduce elevated cholesterol levels.

Ezetimiba reduces blood concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, ezetimiba increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba Aurovitas, works by reducing the cholesterol absorbed in the digestive tract.

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

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

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this plaque buildup can cause narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such interruption in blood flow may lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from accumulating 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.

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

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

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

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

• alone, when treatment with a statin is inappropriate or not tolerated.

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

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

Ezetimiba Aurovitas does not help you lose weight.

2. What you need to know before starting to take Ezetimiba Aurovitas

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

Do not take Ezetimiba Aurovitas if:

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

Do not take Ezetimiba Aurovitas 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 you start taking Ezetimiba Aurovitas.

• Inform your doctor about all your medical conditions, 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 functioning properly.
• Your doctor may also want to carry out further blood tests to monitor your liver function after you start taking ezetimibe with a statin.

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

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

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 Aurovitas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• Cyclosporine (often used in organ transplant patients).
• Medicines containing an active ingredient used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestiramine (also used to lower cholesterol), as it affects how ezetimibe works.
• Fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

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

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

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

Do not take Ezetimiba Aurovitas with a statin while breastfeeding, as it is unknown whether these medicines pass into breast milk. If you are breastfeeding, you should not take ezetimibe, even without taking a statin. Consult your doctor.

Driving and using machines

Ezetimibe is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Ezetimiba Aurovitas.

Ezetimiba Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Ezetimiba Aurovitas contains sodium

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

3. How to take Ezetimiba Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. 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 Aurovitas, you should follow a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking Ezetimiba Aurovitas.

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

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

If your doctor has prescribed ezetimibe together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the package leaflet of the statin medicine.

If your doctor has prescribed ezetimibe together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimiba Aurovitas at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Aurovitas than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ezetimiba Aurovitas

Do not take a double dose to make up for missed doses. Simply take your normal dose of Ezetimiba Aurovitas at the usual time the next day.

If you stop taking Ezetimiba Aurovitas

Talk to your doctor or pharmacist, 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.

The following terms are used to describe how frequently the adverse 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 unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and potentially life-threatening.

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

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

Common: abdominal pain; diarrhoea; flatulence; and feeling of tiredness.

Uncommon: increased results in certain liver function tests (transaminases) or muscle function tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.

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

Common: increased results in certain liver function tests (transaminases); headache; muscle pain; tenderness to pressure 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 together with fenofibrate, the following common adverse effect has been reported: abdominal pain.

Furthermore, in general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised and red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness to pressure, or muscle weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas, often with severe abdominal pain; constipation; reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Aurovitas

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

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

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. 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 Aurovitas

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

Nature of the product and pack contents

Tablet.

Uncoated tablets, white to off-white, capsule-shaped with bevelled edges, engraved with 'E Z' on one side and '10' on the other. Size: 8.1 mm x 4.1 mm.

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

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area (EEA) 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 most recent revision of this leaflet: February 2021

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