EZETIMIBE PENSA 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe Pensa 10 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ezetimibe Pensa and what is it used for
2. What you need to know before taking Ezetimibe Pensa
3. How to take Ezetimibe Pensa
4. Possible side effects
5. Storage of Ezetimibe Pensa
6. Package Contents and Additional Information

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

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

Ezetimibe, the active ingredient in Ezetimibe Pensa, works by reducing the amount of cholesterol absorbed in the digestive tract.

Ezetimibe adds to the cholesterol-lowering effect of statins, a group of medications that reduce cholesterol produced by the body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol consists 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 plaque buildup can cause narrowing of the arteries. 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 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.

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Ezetimibe Pensa is used in patients who cannot control their cholesterol levels with diet alone. While taking this medication, you should follow a cholesterol-reducing diet.

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

• high 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 (homozygous familial hypercholesterolemia) that increases blood cholesterol levels. You will also be prescribed a statin and may receive other treatments.

If you have heart disease, Ezetimibe Pensa combined with cholesterol-lowering medications called statins reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, and hospitalization for chest pain.

2. What you need to know before taking Ezetimibe Pensa

If you are taking Ezetimibe Pensa with a statin, please read the package leaflet of that medication.

Do not take Ezetimibe Pensa:

• if you are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medication (see section 6: Package Contents and Additional Information).

Do not take Ezetimibe Pensa 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 Ezetimibe Pensa.

• Tell your doctor about all your medical problems, including allergies.
• Your doctor will perform a blood test before you start taking Ezetimibe Pensa with a statin. This is to check if your liver is in good condition.
• Your doctor may also want to perform blood tests to check your liver condition again after you start taking Ezetimibe Pensa with a statin.

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

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

Children and Adolescents

Do not give this medication to children and adolescents between 6 and 17 years old unless it has been prescribed by a specialist, as the data on safety and efficacy are limited.

Do not give this medication to children under 6 years old, as there is no information in this age group.

Taking Ezetimibe Pensa with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, tell your doctor if you are taking medications with any of the following active ingredients:

• cyclosporine (often used in patients with organ transplants)
• medications with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it affects how Ezetimibe Pensa works
• fibrates (also used to reduce cholesterol)

Pregnancy and Breastfeeding

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

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

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

Consult your doctor or pharmacist before taking any medication.

Driving and Using Machines

Ezetimibe Pensa is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Ezetimibe Pensa.

Ezetimibe Pensa ContainsLactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Ezetimibe Pensa

Follow your doctor's instructions for taking this medication exactly.

Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimibe Pensa, you should be following a cholesterol-reducing diet.
• You should continue with this cholesterol-reducing diet while taking Ezetimibe Pensa.

The recommended dose is one 10 mg Ezetimibe Pensa tablet per day, taken orally. Take Ezetimibe Pensa at any time of day. You can take it with or without food.

If your doctor has prescribed Ezetimibe Pensa with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions in the package leaflet of the medication.

If your doctor has prescribed Ezetimibe Pensa with another cholesterol-reducing medication containing the active ingredient cholestyramine or any other medication containing a bile acid sequestrant, you should take Ezetimibe Pensa at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If You Take More Ezetimibe Pensa 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 take the package and package leaflet of the medication to the healthcare professional.

If You Forget to Take Ezetimibe Pensa

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of Ezetimibe Pensa at the usual time the next day.

If You Interrupt Treatment with Ezetimibe Pensa

Talk to 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.

4. Possible Side Effects

Like all medications, this medication can 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, tenderness, or unexplained muscle weakness. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be severe and potentially life-threatening.

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

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

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

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

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

Common: elevation of some liver function test results (transaminases); headache; muscle pain; tenderness 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.

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and urticaria; blistering and reddened skin eruptions, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ezetimibe Pensa

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 stated on the package after EXP. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Ezetimibe Pensa

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

Appearance of the Product and Package Contents

Ezetimibe Pensa are oblong, uncoated white tablets, without a score, 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10 - Polígono Industrial Areta

31620 Huarte (Pamplona),

Spain

or

Laboratorios Cinfa, S.A.

Avda. Roncesvalles s/n

31699 Olloki (Navarra)

Spain

Date of the Last Revision of this Package Leaflet:June 2016

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