Ezetimibe Sun 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

EzetimibaSUN 10 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Ezetimiba SUN is a medicine used to reduce elevated cholesterol levels. Ezetimiba SUN lowers blood concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol), and a group of fatty substances called triglycerides. In addition, Ezetimiba SUN increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba SUN, works by reducing the amount of cholesterol absorbed in the gastrointestinal tract.

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

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists 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 plaque buildup can lead to 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 medicine, you must continue to follow a cholesterol-lowering diet.

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

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial])

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

• as monotherapy, 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 may receive other treatments

• a hereditary condition (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood

• If you have heart disease, Ezetimiba SUN in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

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

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

Do not take Ezetimiba SUN

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

Do not take Ezetimiba SUN together with a statin

• if you currently have liver problems.
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Ezetimiba SUN.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimiba SUN with a statin. This is to check whether your liver is functioning properly.
• Your doctor may also want to carry out blood tests to monitor your liver function after you start taking Ezetimiba SUN with a statin.

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

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

The safety and efficacy of combining Ezetimiba SUN with fibrates (medicines used to lower cholesterol) have not been established.

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.

Other medicines and Ezetimiba SUN

Inform 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:

• ciclosporin (often used in organ transplant patients)
• medicines containing an active substance used to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (also used to lower cholesterol), as it affects how Ezetimiba SUN works
• fibrates (also used to lower cholesterol)

Pregnancy, breastfeeding and fertility

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

Ezetimiba SUN 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 SUN. In such cases, you should not drive or operate machinery until you feel better.

Ezetimiba SUN contains lactose and sodium.

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

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 SUN, you should already be following a cholesterol-lowering diet.
• You should continue this cholesterol-lowering diet while taking Ezetimiba SUN.

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

Take ezetimiba at any time of day. It may be taken with or without food.

Taking Ezetimiba SUN with a statin

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

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

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

If you take more Ezetimiba SUN than you should

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

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

If you stop taking Ezetimiba SUN

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 may cause adverse effects, although not everyone will experience them.

In the following cases, stop treatment with Ezetimiba SUN and contact your doctor immediately:

• if you experience unexplained muscle pain, tenderness or weakness. This is because, rarely, muscle problems including muscle breakdown leading to kidney damage may be serious and potentially life-threatening.
• allergic reactions have been reported during general use, including swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (requiring immediate treatment) (hypersensitivity, anaphylaxis and angioedema).
• raised and red skin rashes, sometimes with target-like lesions (erythema multiforme).

Other adverse effects

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

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

• abdominal pain;
• diarrhoea;
• gas;
• feeling of tiredness.

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

• increased results in certain liver function tests (transaminases) or muscle function tests (CK);
• cough;
• indigestion;
• heartburn; nausea;
• joint pain;
• muscle spasm;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• flushing;
• high blood pressure.

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

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

• increased results in certain liver function tests (transaminases);
• headache; muscle pain;

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

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

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

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

• abdominal pain.

In addition, during general use, the following adverse effects have been reported:

• dizziness;
• muscle pain;
• liver problems;
• allergic reactions including rash and urticaria;
• muscle pain, tenderness, or muscle weakness; muscle breakdown (rhabdomyolysis);
• 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.

Additionally, the following adverse effects have been reported in patients taking ezetimibe/simvastatin or medicines containing the active substances ezetimibe or simvastatin:

• hair loss; red, raised rash, sometimes with target-like lesions (erythema multiforme);
• blurred vision and visual impairment (may affect up to 1 in 1,000 people);
• skin rash or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people);
• muscle pain, tenderness, weakness or cramps; muscle failure;
• muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture;
• gynaecomastia (enlargement of the breast in men) (may affect up to 1 in 10,000 people).

Reporting of adverse effects

If you experience any type of adverse effect, consult 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. Conservation of Ezetimiba SUN

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimiba SUN

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

Appearance of the product and contents of the pack

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

This medicine is available in the following pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany: EZETIMIB BASICS 10 mg Tabletten

Spain: Ezetimiba SUN 10mg comprimidos SUN

France: EZETIMIBE SUN 10mg, comprime

Poland: Etibax

Date of the most recent review of this leaflet: April 2022.

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