Package Leaflet: Information for the Patient

Ezetimiba pensa 10 mg tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 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 leaflet. See section 4.

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

2. What you need to know before taking Ezetimiba Pensa

3. How to take Ezetimiba Pensa

4. Possible side effects

5. Storage of Ezetimiba Pensa

6. Contents of the pack and additional informationadditional information

Ezetimiba Pensa is a medication to reduce elevated levels of cholesterol. Ezetimiba Pensa reduces total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, Ezetimiba Pensa increases concentrations of "good" cholesterol (high-density lipoprotein, HDL).

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

Ezetimiba complements the effect of lowering cholesterol of statins, a group of medications that reduce cholesterol produced by the body itself.fabricated 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.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of 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 myocardial infarction or a 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 the blood that can increase the risk of heart disease.

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Ezetimiba Pensa 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 in combination with a cholesterol-lowering diet if you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [familial heterozygous and non-familial])
• • in combination 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 receive other treatments.

If you have cardiovascular disease, Ezetimiba Pensa combined with medications to lower cholesterol called statins, reduce the risk of myocardial infarction, stroke, coronary artery bypass surgery, and hospitalization for chest pain.

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

Do not take Ezetimiba Pensa:

-if you are allergic (hypersensitive) to ezetimiba or to any of the other ingredients of this medicine (see section 6: Contents of the pack and additional information).

Do not take Ezetimiba Pensa together 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 Pensa.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking Ezetimiba Pensa with a statin. This is to check if 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 Pensa with a statin.

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

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

Children and adolescents

Do not administer this medicine to children and adolescents between 6 and 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.

Taking Ezetimiba Pensa with other medicines

Inform your doctor or pharmacist if you are taking,have takenrecentlyor 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)
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how Ezetimiba Pensa works)
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Ezetimiba Pensa containslactose

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 Ezetimiba Pensa, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-reducing diet while taking Ezetimiba Pensa.

The recommended dose is one Ezetimiba Pensa 10 mg tablet once a day taken orally. Take Ezetimiba Pensa at any time of the day. You can take it with or without food.

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

If you take more Ezetimiba Pensa 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 packaging and the medication packaging to the healthcare professional.

If you forget to take Ezetimiba Pensa

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

If you interrupt treatment with Ezetimiba Pensa

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 patients)
• Common (may affect up to 1 in 10 patients)
• Uncommon (may affect up to 1 in 100 patients)
• Rare (may affect up to 1 in 1,000 patients)
• Very rare (may affect up to 1 in 10,000 patients, including isolated cases)

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 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 (which requires immediate treatment).

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

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

Uncommon:elevation of liver function test results (transaminases) or muscle function test results (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; heat; high blood pressure.

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

Common:elevation of liver function test results (transaminases); headache; muscle pain; sensitivity to pressure or 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 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; reduced blood cell count, which may cause hematoma/hemorrhage (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 Pharmacovigilance of Medicines for Human Use: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 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. By doing so, you will help protect the environment.

Composition of Ezetimiba Pensa

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose pH101, povidone, croscarmellose sodium, sodium lauryl sulfate, and sodium stearate fumarate.

Appearance of the product and contents of the packaging

Ezetimiba Pensa are oblong, non-coated white tablets, without a notch, with the logo “EZ1” and dimensions of 8.2 x 4.1 ± 0.5 mm.

The tablets are presented in aluminum/aluminum blisters with 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Industrial Area Areta

31620 Huarte (Pamplona),

Spain

or

Laboratorios Cinfa, S.A.

Roncesvalles Avenue s/n

31699 Olloki (Navarra)

Spain

Last review date of this leaflet:June 2016

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