Ezetimiba sun 10 mg comprimidos efg

Package Insert: Information for the User

EzetimibaSUN10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, 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 should 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 package insert. See section 4.

Ezetimiba SUN is a medication to reduce elevated levels of cholesterol.elevatedcholesterol levels.Ezetimiba SUNreduces total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba SUN increases concentrations of "good" cholesterol (HDL cholesterol).

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

Ezetimiba SUN 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 heart disease.

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

• elevated levels of cholesterol 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 genetic disorder (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may receive other treatments.
• a genetic disorder (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.
• If you have heart disease, Ezetimiba SUN combined with cholesterol-lowering medications called statins, reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

This medication does not help you lose weight.

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

Do not take Ezetimiba SUN

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

Do not take Ezetimiba SUN with a statin

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

Warnings and precautions

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

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

If you have moderate to severe liver problems, Ezetimiba SUN is not recommended.

If you feel muscle pain or weakness,contact your doctor immediately. This may be a sign of a muscle disease called rhabdomyolysis.

The safety and efficacy of using Ezetimiba SUNtogether with fibrates (medicines to reduce cholesterol) have not been established.

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.

Other medicines and Ezetimiba SUN

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 organ transplant patients)
• medicines with an active ingredient to prevent blood clotting, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to reduce cholesterol), as it affects how Ezetimiba SUN works)
• fibrates (also used to reduce 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 ezetimiba if you are pregnant.

Do not take ezetimiba with a statin if you are breastfeeding, as it is unknown if the medicines pass into breast milk. If you are breastfeeding, do not take ezetimiba, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Ezetimiba SUN is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Ezetimiba SUN.In these cases, do not drive or operate machinery until you feel better.

Ezetimiba SUN contains lactose and sodium.

This medicine containslactose. If your doctor has told you that you have an intolerance to certain 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"

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 SUN, you must be following a diet to reduce cholesterol.
• You should continue with this cholesterol-lowering diet while taking Ezetimiba SUN.

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

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

Taking Ezetimiba SUN with a statin

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 dosage instructions on the medication package.

Taking Ezetimiba SUNwith a bile acid sequestrant (for example, colestiramine)

If your doctor has prescribed Ezetimiba SUN along with another cholesterol-lowering medication that contains the active ingredient colestiramine or any other medication that contains a bile acid sequestrant, you should 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication package insert to the healthcare professional.

If you forget to take Ezetimiba SUN

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

If you interrupt treatment with Ezetimiba SUN

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 can cause side effects, although not everyone will experience them.

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

• if you experience pain, sensitivity to pressure, or muscle weakness that is unexplained. This is because, in rare cases, muscle problems, including muscle degradation that causes 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 (which requires immediate treatment) (hypersensitivity, anaphylaxis, and angioedema).
• raised, red, and swollen eruptions, sometimes with target-shaped lesions (erythema multiforme)

Other side effects

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

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

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

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

• elevation of results from 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 with a statin, the following side effects have been reported:

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

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

Infrequent (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 fatigue or weakness;
• swelling, especially in hands and feet.
• pain, nausea, vomiting, vomiting blood, gastrointestinal motility disorders (gastritis)

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

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

• abdominal pain.

In addition, in general use, the following side effects have been reported:

• dizziness;
• muscle pain;
• liver problems;
• allergic reactions, including rash and urticaria;
• muscle pain, sensitivity to pressure, or muscle weakness; muscle degradation,(rhabdomyolysis)
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting);
• pancreatitis, often with severe abdominal pain;
• constipation;
• reduction in blood cell count, which can cause bruising or bleeding (thrombocytopenia);
• tingling sensation;
• depression;
• unusual fatigue or weakness;
• shortness of breath.

In addition, the following side effects have been reported in people taking ezetimiba/simvastatin or medications containing the active ingredients ezetimiba or simvastatin:

• hair loss; red, swollen, and blistered rash, sometimes with target-shaped lesions (erythema multiforme),
• blurred vision and deterioration of vision (may affect up to 1 in 1,000 people)
• rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions) (may affect up to 1 in 10,000 people)
• muscle pain, sensitivity to pressure, weakness, or muscle cramps; muscle failure;

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

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

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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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 medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ezetimibe SUN Composition

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

Appearance of the product and contents of the package

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

This medication is available in the following package sizes:

• Alu-Alu Blister: 28, 30, 50, 90, and 100 tablets in blisters in a carton box.
• Freeze-dried blisters: 28, 30, 50, 90, and 100 tablets in blisters in a carton box.
• HDPE Bottles: a bottle containing 100 tablets.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing

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 medication is authorized in the member states of the European Economic Area with the following names:

Germany: EZETIMIB BASICS 10 mg Tablets

Spain: Ezetimiba SUN 10mg tablets SUN

France: EZETIMIBE SUN 10mg, tablet

Poland Etibax

Last review date of this leaflet:April 2022.

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