Package Insert: Information for the Patient

EzetimibaCombix10 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

EzetimibaCombixis a medication to reduce elevated levels of cholesterol.

EzetimibaCombixreduces total cholesterol, "bad" cholesterol (LDL cholesterol) and certain fatty substances called triglycerides that circulate in the blood. Additionally, EzetimibaCombixincreases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active ingredient of this medication, acts by reducing the cholesterol absorbed in the digestive tract. Ezetimiba 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 that are 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 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-reducing diet. While taking this medication, you must follow a cholesterol-reducing diet.

Ezetimiba is used in combination with a cholesterol-reducing diet if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial])
• • 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 hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may also be prescribed other treatments,

Ezetimiba does not help you lose weight.

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

Do not take EzetimibaCombix

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

Do not take EzetimibaCombixwith 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 EzetimibaCombix.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking ezetimiba with a statin. This is to checkif 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 ezetimiba with a statin.

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

The safety and efficacy of using ezetimiba with certain cholesterol-lowering medications, such as fibrates, have not been studied.

Children and adolescents

Ezetimiba is not recommended for children under 10 years old.

Taking EzetimibaCombixwith other medicines

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

• ciclosporin (often used in organ transplant patients),
• blood-thinning medicines, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants),
• • colestiramine (also used to lower cholesterol), because it affects the way ezetimiba works),
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ezetimiba with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ezetimiba with a statin, stop taking both medicines immediately and inform your doctor. There is no experience of using ezetimiba 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 whether the medicines pass into breast milk. If you are breastfeeding, do not take ezetimiba, even without taking a statin. Consult your doctor.

Driving and operating machinery

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

EzetimibaCombixcontains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Continue taking your other medications to lower cholesterol unless your doctor tells you to stop.

• Before starting to take ezetimiba, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking ezetimiba.

Adults, adolescents, and children (10 to 17 years old): The dose is one 10 mg ezetimiba tablet once a day by mouth.

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

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

If You Take More Ezetimiba Combix Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication packaging to the healthcare professional.

If You Forget to Take Ezetimiba Combix

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

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.

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 can cause difficulty breathing or swallowing (requiring immediate treatment).

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

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

• abdominal pain; diarrhea; gas and feeling of fatigue.

Rare (can 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; decreased appetite; pain; chest pain, warmth; high blood pressure.

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

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

• elevation of results from some liver function tests (transaminases); headache; muscle pain; sensitivity to pressure or weakness.

Rare (can affect up to 1 in 100 people):

• tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; arm and leg pain; unusual fatigue or weakness; swelling, especially in hands and feet.

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

Frequent (can 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; raised, red, and sometimes blistered patches, sometimes with target lesions (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with intense abdominal pain; constipation; reduced blood cell count, which can cause bruising or bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

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 leaflet. You can also report them directly through the Spanish System for the 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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Ezetimibe CompositionCombix

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other components (excipients) are: lactose monohydrate, pregelatinized cornstarch, crospovidone (Type B), povidone K30, sodium lauryl sulfate, microcrystalline cellulose (E460i), sodium stearate fumarate, and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

White to off-white colored tablets, in capsule shape, flat, and with beveled edges, and smooth on both faces.

OPA/Al/PVC-Aluminum (standard or perforated) blisters.

PVC/ACLAR-Aluminum (standard or perforated) blisters.

Packaging of 28 tablets.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Responsible for Manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Last review date of this leaflet: February 2014

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es.