EZETIMIBE SUN 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

EzetimibeSUN10 mg tablets EFG

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

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

Ezetimibe SUN is a medicine to lower high levels of cholesterol. Ezetimibe SUN lowers the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

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

Ezetimibe SUN adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by the body.

Cholesterol is one of the fatty substances that can be found in the blood. Your total cholesterol level 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.

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

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

• high levels of cholesterol in the blood (primary hypercholesterolaemia [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 suitable or not tolerated

• a hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You will also be prescribed a statin and may receive other treatments.
• a hereditary disease (familial sitosterolaemia, also known as phytosterolaemia) that increases the levels of plant sterols in the blood.
• If you have heart disease, Ezetimibe SUN 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.

This medicine does not help you lose weight.

2. What you need to know before you take Ezetimibe SUN

If you are taking Ezetimibe SUN with a statin, please read the package leaflet of that medicine.

Do not take Ezetimibe SUN

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

Do not take Ezetimibe SUN with a statin

• if you currently have liver problems.
• if you are pregnant or breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe SUN.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe SUN with a statin. This is to check if your liver is working properly.
• Your doctor may also want to do blood tests to check if your liver is working properly after you start taking Ezetimibe SUN with a statin.

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

If you experience muscle pain or weakness, contact your doctor immediately. These can be signs of a muscle disease called rhabdomyolysis.

The safety and efficacy of the combined use of Ezetimibe SUN with fibrates (medicines to lower cholesterol) have not been established.

Children and adolescents

Do not give this medicine to children and adolescents (6 to 17 years old) 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 old as there is no information in this age group.

Other medicines and Ezetimibe SUN

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:

• cyclosporin (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 Ezetimibe SUN works
• fibrates (also used to lower cholesterol)

Pregnancy, breast-feeding and fertility

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

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

Do not take ezetimibe with a statin if you are breast-feeding because it is not known whether the medicines pass into breast milk. If you are breast-feeding, do not take ezetimibe, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe SUN is not expected to interfere with your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Ezetimibe SUN. In these cases, do not drive or use machinery until you feel better.

Ezetimibe SUN contains lactose and sodium.

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

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

3. How to take Ezetimibe SUN

Follow the instructions for administration of this medicine exactly as indicated 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 Ezetimibe SUN, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Ezetimibe SUN.

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

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

Taking Ezetimibe SUN with a statin

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

Taking Ezetimibe SUN with a bile acid sequestrant (e.g. cholestyramine)

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

If you take more Ezetimibe SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating 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 Ezetimibe SUN

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of Ezetimibe SUN, at the usual dose, the next day.

If you stop taking Ezetimibe SUN

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

If you have any other questions about 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.

In the following cases, stop taking Ezetimibe SUN and contact your doctor immediately:

• if you experience pain, tenderness or weakness of the muscles that you cannot explain. 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) (hypersensitivity, anaphylaxis and angioedema), have been reported.
• blistering and peeling skin, sometimes with lesions in a target shape (erythema multiforme)

Other side effects

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

Common(may affect up to 1 in 10 people):

• abdominal pain;
• diarrhea;
• gas
• feeling tired.

Uncommon(may affect up to 1 in 100 people):

• increased results of some liver function tests (transaminases) or muscle function tests (CK);
• cough;
• indigestion;
• heartburn; nausea;
• joint pain;
• muscle spasms;
• neck pain;
• loss of 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(may affect up to 1 in 10 people):

• increased results of some liver function tests (transaminases);
• headache; muscle pain;

Uncommon(may affect up to 1 in 100 people):

• 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.
• pain, nausea, vomiting, vomiting blood, blood in the stool (gastritis)

When used in combination with fenofibrate, the following side effects have been reported:

Common(may affect up to 1 in 10 people):

• 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;
• muscle pain, tenderness or weakness; muscle breakdown (rhabdomyolysis)
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting);
• inflammation of the pancreas, 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.

Additionally, the following side effects have been reported in people taking ezetimibe/simvastatin or medicines containing the active ingredients ezetimibe or simvastatin:

• hair loss; blistering and peeling skin, sometimes with lesions in a target shape (erythema multiforme),
• blurred vision and vision loss (may affect up to 1 in 1,000 people)
• rash that may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• muscle pain, tenderness or weakness; muscle cramps; muscle failure;

Muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture,

• breast enlargement in men (gynaecomastia) (may affect up to 1 in 10,000 people)

Reporting of side effects

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

5. Storage of Ezetimibe SUN

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 after EXP. The expiry date refers to the last day of the month shown.

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If in doubt, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe SUN

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients (excipients) are: lactose monohydrate, povidone K-30, croscarmellose sodium, sodium lauryl sulfate, pregelatinized corn starch, magnesium stearate.

Appearance of the product and pack contents

Ezetimibe SUN are white to off-white, capsule-shaped tablets, 7.9 to 8.5 mm in length, marked with "E 10" on one side and smooth on the other side.

This medicine is available in the following pack sizes:

• Aclar blisters: 28, 30, 50, 90 and 100 tablets in blisters in a cardboard box.
• Cold-formed blisters: 28, 30, 50, 90 and 100 tablets in blisters in a cardboard box.
• HDPE bottles: a bottle containing 100 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia, S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona. Spain

Tel.:+34 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: EZETIMIB BASICS 10 mg tablets

Spain: Ezetimiba SUN 10mg tablets SUN

France: EZETIMIBE SUN 10mg, tablet

Poland: Etibax

Date of last revision of this leaflet:April 2022.

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