Prospect: information for the patient

Ezetimiba Alter 10 mg tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they 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 prospect. See section 4.

Ezetimiba Alter is a medication to reduce elevated levels of cholesterol.

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

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

Ezetimiba combines with the effect to lower 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 composed mainly 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 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-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

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

• elevated blood cholesterol levels (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. Your doctor will also prescribe a statin and may also prescribe other treatments.

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

Ezetimiba Alter does not help you lose weight.

If you are taking Ezetimiba Alter with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Alter

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

Do not take Ezetimiba Alter 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 Alter.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking Ezetimiba Alter with a statin to check that your liver is in good condition.
• Your doctor may also want to make blood tests to check your liver condition again after you start taking Ezetimiba Alter with a statin.

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

The safety and efficacy of the combined use of Ezetimiba Alter and certain cholesterol-lowering medications, fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years of age) unless prescribed by a specialist, as the safety and efficacy data are limited. Do not administer this medicine to children under 6 years of age as there is no information available for this age group.

Other medicines and Ezetimiba Alter

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Ezetimiba Alter 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. In case of doubt, consult your doctor or pharmacist again.

• You must be following a diet to reduce cholesterol before starting to take Ezetimiba Alter.
• You will need to continue with this cholesterol-reducing diet while taking Ezetimiba Alter.

The recommended dose is one 10 mg ezetimiba tablet once a day taken orally.

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

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

If you take more Ezetimiba Alter 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 leaflet to the healthcare professional.

If you forget to take Ezetimiba Alter

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

If you interrupt treatment with Ezetimiba Alter

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; arm and leg pain; 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 skin, sometimes with lesions in the form of a target (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 intense abdominal pain; constipation; reduction in blood cell count, which may cause hematoma/hemorrhage (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 of Pharmacovigilance of Medicines 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 conditions for conservation.

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

Ezetimibe Alter Composition

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) (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 blisters in packaging of 28, 30, 50, or 90 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

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

France Ezétimibe Alter 10 mg, tablet

Italy Ezetimibe Alter 10 mg compresse

Spain Ezetimiba Alter 10 mg tablets EFG

Last review date of this prospectus: 08/2016

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/ .