Package Insert: Information for the Patient

Ezetimiba Tarbis 10 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 read it again.

- If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Ezetimiba Tarbis

3. How to take Ezetimiba Tarbis

4. Possible adverse effects

5. Storage of Ezetimiba Tarbis

6. Contents of the package and additional information

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

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

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

Ezetimiba Tarbis 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 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 against heart disease.

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 Tarbis is used in combination 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. You will also be prescribed a statin and may also be prescribed other treatments.

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

Ezetimiba Tarbis does not help you lose weight.

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

Do not take Ezetimiba Tarbis if:

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

Do not take Ezetimiba Tarbis with a statin if:

• you currently have liver problems.

• you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Tarbis.

• Inform your doctor of all your medical conditions, including allergies.

• Your doctor will do a blood test before you start taking Ezetimiba Tarbis with a statin to check if 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 Tarbis with a statin.

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

The safety and efficacy of using Ezetimiba Tarbis with certain cholesterol-lowering medicines, 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 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 Tarbis with 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), as it affects how Ezetimiba Tarbis works

• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

Do not take Ezetimiba Tarbis with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimiba Tarbis with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of Ezetimiba Tarbis without a statin during pregnancy. Consult your doctor before using Ezetimiba Tarbis if you are pregnant.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

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.

• You must be following a diet to reduce cholesterol before starting to take Ezetimiba Tarbis.

• You should continue with this cholesterol-reducing diet while taking Ezetimiba Tarbis.

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

You can take Ezetimiba Tarbis at any time of the day. You can take it with or without food.

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

If you take more Ezetimiba Tarbis 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 Ezetimiba Tarbis

Do not take a double dose, simply take your usual amount of Ezetimiba Tarbis at the usual time the next day.

If you interrupt treatment with Ezetimiba Tarbis

Speak with your doctor or pharmacist as your cholesterol levels may increase again.

If you have any other questions about the use of this product, 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)

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 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 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 intense abdominal pain; constipation; reduction in blood cell count, which may cause bruising/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 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.

•Do not use this medication after the expiration date that appears on the packaging or on the container after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect the product from moisture. Do not remove the tablet from the blister pack until it is to be taken.

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

Ezetimiba Tarbis Composition

- The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.

- The other components are: lactose monohydrate, sodium croscarmellose (E468), povidone K30 (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572).

Product appearance and packaging contents

Ezetimiba Tarbis tablets are capsule-shaped, white or off-white in color, engraved with “E 10” on one face and nothing on the other face. The tablet dimensions are 8.1 x 4.1 mm.

Packaging sizes:

Ezetimiba Tarbis 10 mg is provided in 28, 30, 56, 98, or 100 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 (Barcelona) - Spain

Manufacturer:

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-Solità i Plegamans

(Barcelona) – Spain

Last review date of this leaflet: June 2017

The 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