EZETROL 10 mg TABLETS

Introduction

Patient Information: Summary of Product Characteristics

EZETROL 10 mg Tablets

ezetimibe

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What EZETROL is and what it is used for

EZETROL is a medicine to lower high levels of cholesterol.

EZETROL reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and substances called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in EZETROL, works by reducing the amount of cholesterol absorbed in the gut.

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

Cholesterol is one of the fatty substances in the bloodstream. Your total cholesterol is made up mainly of LDL and 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 can lead to a narrowing of the arteries. This narrowing can reduce or completely block the flow of blood to vital organs such as the heart and brain. This blockage can cause 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 the blood that can increase the risk of heart disease.

It is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (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 the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.
• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

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

EZETROL does not help you lose weight.

2. What you need to know before you take EZETROL

If you are taking EZETROL with a statin, please read the package leaflet for that medicine.

Do not take EZETROL if:

• you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6: Contents of the pack and other 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 taking EZETROL.

• Tell your doctor about all your medical conditions, including allergies.

• Your doctor will do 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 do 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 give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy data are limited.

Do not give this medicine to children under 6 years of age, as there is no information in this age group.

Taking EZETROL with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking medicines with any of the following active ingredients:

• cyclosporine (often used in patients with organ transplants)

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

• cholestyramine (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 tell 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 not known 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 taking any medicine.

Driving and using machines

EZETROL is not expected to affect your ability to drive or use machines. However, it should be taken into account that 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 some 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".

3. How to take EZETROL

Follow the instructions for administration of this medicine exactly as prescribed 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 EZETROL, you should be on a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking EZETROL.

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

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

If your doctor has prescribed EZETROL with a statin, you can take both medicines at the same time. In this case, please read the dosage instructions in the package leaflet of the other medicine.

If your doctor has prescribed EZETROL with another cholesterol-lowering medicine that contains the active ingredient colestyramine or any other medicine that contains a bile acid sequestrant, you should take EZETROL at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EZETROL than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take EZETROL

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

If you stop taking EZETROL

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects are experienced:

• 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, including isolated cases)

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

In general use, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which 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 tired.

Uncommon: elevated results of 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, flushing; high blood pressure.

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

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

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

When used in combination 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 urticaria; blistering, reddened skin, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; 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/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of EZETROL

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
• Do not store EZETROL above 30°C.

Blisters: Store in the original package. Bottles: Keep the bottles tightly closed. These measures will protect the product from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of EZETROL

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

Appearance of the product and pack size

EZETROL tablets are capsule-shaped, white or almost white, and engraved with "414" on one side.

Pack sizes:

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

84 or 90 tablets in blisters;

50, 100, or 300 tablets in unit-dose blisters;

100 tablets in a bottle.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

This medicine is authorized with 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.

Date of last revision of this leaflet:08/2020.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/