Leaflet:information for the user

Ezetimiba Aurovitas 10 mg tablets EFG

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

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

1. What isEzetimiba Aurovitasand what is it used for

2. What you need to know before you start takingEzetimiba Aurovitas

3. How to takeEzetimiba Aurovitas

4. Possible side effects

5. Storage ofEzetimiba Aurovitas

6. Contents of the pack and additional information

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

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

Ezetimiba, the active ingredient of Ezetimiba Aurovitas, acts by reducing the cholesterol absorbed in the digestive tract.

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

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed 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 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 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 cardiovascular diseases.

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 solely with a cholesterol-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

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

• Elevated cholesterol levels 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 hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have cardiovascular disease, ezetimiba combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimiba Aurovitas does not help you lose weight.

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

Do not take Ezetimiba Aurovitas if:

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

Do not take Ezetimiba 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 Ezetimiba Aurovitas.

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

If you have moderate to severe liver problems, Ezetimiba Aurovitas 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.

Children and adolescents

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

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

Taking Ezetimiba Aurovitas with other medicines

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

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

Pregnancy and breastfeeding

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

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

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

Do not take Ezetimiba Aurovitas 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, even without a statin. Consult your doctor.

Driving and operating machinery

Ezetimiba is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Ezetimiba Aurovitas.

Ezetimiba Aurovitas contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Ezetimiba Aurovitas contains sodium

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

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

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

The recommended dose is one Ezetimiba Aurovitas 10 mg tablet once a day taken orally.

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

If your doctor has prescribed ezetimiba along with a statin, both medications can be taken at the same time. In this case, please read the dosing instructions on the medication package.

If your doctor has prescribed ezetimiba along with another cholesterol-lowering medication that contains the active ingredient cholestyramine or any other medication that contains 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication package insert to the healthcare professional.

If you forget to take Ezetimiba Aurovitas

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

If you interrupt treatment with Ezetimiba Aurovitas

Speak with 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems, including muscle degradation that can cause kidney damage, can be severe and potentially life-threatening.

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

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

Common:Abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon:Elevation of results from some 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 flashes; high blood pressure.

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

Common:Elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity to pressure or weakness.

Uncommon:Tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; arm and leg pain; unusual fatigue or weakness; swelling, especially in hands and feet.

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

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised, red, sometimes blistered patches (erythema multiforme); muscle pain, sensitivity to pressure or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising or bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofEzetimiba Aurovitas

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

Appearance of the product and contents of the package

Tablet.

Uncoated tablets of white to off-white color, capsule-shaped with a beveled edge, engraved with ‘E Z’ on one face and ‘10’ on the other. The size is 8.1 mm x 4.1 mm.

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

Package sizes:

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Arrow Génériques

26 avenue Tony Garnier

69007 Lyon

France

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: February 2021

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