Prospect: information for the patient

EZETROL 10 mg Tablets

ezetimiba

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they 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 prospect. See section 4.

1.What is EZETROL and what it is used for

2.What you need to know before starting to take EZETROL

3.How to take EZETROL

4.Possible adverse effects

5.Storage of EZETROL

6.Contents of the package and additional information

Ezetimibe is a medication to reduce elevated levels of cholesterol.

Ezetimibe reduces total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimibe increases concentrations of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe, the active ingredient in Ezetimibe, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimibe is added 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 that are found in the bloodstream. Its total cholesterol is composed 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 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.

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

• elevated levels of cholesterol in the blood (primary hypercholesterolemia, both familial 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 inappropriate or not tolerated
• a genetic disorder (familial hypercholesterolemia, homozygous), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.
• a genetic disorder (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

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

Ezetimibe does not help you lose weight.

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

Do not take EZETROL if:

• You are allergic (hypersensitive) to ezetimibe or to any of the other ingredients in this medicine (see section 6: Contents of the pack and additional information).

Do not take EZETROL 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 EZETROL.

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

• Your doctor will make a blood test before you start taking EZETROL 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 EZETROL with a statin.

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

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

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 EZETROL with other medicines

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

• Ciclosporin (often used in patients with organ transplants)

• Medicines with an active ingredient to prevent blood clots, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)

• Colestiramine (also used to lower cholesterol), as it affects how EZETROL works

• Fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

Do not take EZETROL with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant.If you become pregnant while taking EZETROL with a statin, stop taking both medicines immediately and inform your doctor.There is no experience with the use of EZETROL with a statin during pregnancy.Consult your doctor before using EZETROL if you are pregnant.

Do not take EZETROL 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 EZETROL, even without taking a statin.Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

EZETROL contains lactose

EZETROL tablets contain a sugar called lactose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

EZETROL contains sodium

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

Follow the exact administration instructionsfor this medicationgiven by your doctor.Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. If you are unsure, consult your doctor or pharmacist again.

• Before starting EZETROL, you must be following a diet to reduce cholesterol.
• You will need to continue this cholesterol-lowering dietwhile taking EZETROL.

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

You can take EZETROL at any time of the day. You can take it with or without food.

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

If your doctor has prescribed EZETROL along withanother cholesterol-lowering medication that contains the active ingredientcolestiramine or any othermedication that contains abile acid sequestrant, you must take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETROLthan you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take EZETROL

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

If you interrupt treatment with EZETROL

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 patients)
• Common (may affect up to 1 in 10 patients)
• Uncommon (may affect up to 1 in 100 patients)
• Rare (may affect up to 1 in 1,000 patients)
• Very rare (may affect up to 1 in 10,000 patients, including isolated cases)

Contact your doctor immediately if you experience 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 serious and potentially life-threatening.

In general use, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat that may 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, warmth; 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; pain in arms and legs; 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; swollen and inflamed patches, sometimes with target lesions(erythema multiforme); muscle pain, sensitivity to pressure, ormuscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with intense abdominal pain; constipation; reduction in blood cell count, which may cause hematoma/hemorrhage (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of 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 Pharmacovigilance of Medicines 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 medicationafter the expiration date that appears on the packaging or on the container after CAD. The expiration date is the last day of the month indicated.
• Do not store EZETROL at a temperature above 30?°C.

Blister packs: Store in the original packaging. Bottles: Keep the bottles perfectly closed. These measures will protect the product from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of EZETROL

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are:monohydrate lactose, microcrystalline cellulose, povidone, sodium croscarmellose, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the packaging

EZETROL tablets are capsule-shaped, white or off-white in color, and have “414” engraved on one side.

Packaging sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100, or 300tablets in push-through blisters or single-dose blisters;

84 or 90 tablets in push-through blisters;

50, 100, or 300 tablets in single-dose push-through blisters;

100 tablets in a bottle.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicine is authorized under the name EZETROL in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

Last review date of this leaflet:08/2020.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/