Package Insert: Information for the Patient

Azibe 10 mg Tablets EFG

Ezetimiba

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.

Azibe is a medication to reduce elevated levels of cholesterol.

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

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

Ezetimiba adds to the effect of lowering cholesterol from 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 artery narrowing. This narrowing can slow down or interrupt blood flow to vital organs such as the heart and brain. 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 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.

Azibe is used with a cholesterol-reducing 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 hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have cardiovascular disease, Azibe combined with medications to lower cholesterol called statins, reduce the risk of heart attack, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Azibe does not help you lose weight.

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

Do not take Azibe

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

Do not take Azibe 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 Azibe.

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

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

The safety and efficacy of using Azibe and certain cholesterol-lowering medicines, such as fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years old) unless prescribed by a specialist, as the data on safety and efficacy 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 Azibe

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 transplant patients)
• blood-thinning medicines, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how Azibe 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 Azibe with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Azibe with a statin, stop taking both medicines immediately and inform your doctor.

Ezetimibe with a statin has not been studied during pregnancy. Consult your doctor before using Azibe if you are pregnant.

Do not take Azibe 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 Azibe, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

Azibe is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking ezetimibe.

Azibe contains lactose

This medicine contains 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. 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 Azibe, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking Azibe.

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

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

If your doctor has prescribed Azibe 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.

If your doctor has prescribed Azibe 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 Azibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Azibe than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication package insert to the healthcare professional.

If you forget to take Azibe

Do not take a double dose to make up for the missed doses, simply take your usual dose the next day.

If you interrupt treatment with Azibe

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

The following terms are used to describe how often side effects have been reported:

• 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)

Immediately contact your doctor 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 severe and potentially life-threatening.

In general use, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate treatment).

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

Common:abdominal pain; diarrhea; gas and feeling of fatigue.

Uncommon: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.

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

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

Uncommon: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.

When used with fenofibrate, the following common side effect has been reported:

abdominal pain.

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; swollen and inflamed patches, sometimes with target lesions (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which may cause bruising or bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of 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 Medicinal Products for Human Usehttps://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.

This medication does not require special storage conditions.

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

Composition of Azibe

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium (Type A) (from potato), povidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and contents of the packaging

White or off-white, round, biconvex, smooth tablets on both sides.

Packaging sizes:

PVC/PCTFE (polychlorotrifluoroethylene)-aluminum blister packs containing 28 tablets.

Marketing authorization holder and manufacturer responsible

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet:January 2017

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/.