EZETIMIBE TARBIS 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ezetimibe Tarbis 10 mg Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Ezetimibe Tarbis and what is it used for
2. What you need to know before you take Ezetimibe Tarbis
3. How to take Ezetimibe Tarbis
4. Possible side effects
5. Storing Ezetimibe Tarbis
6. Contents of the pack and other information

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

Ezetimibe Tarbis is a medicine used to lower high levels of cholesterol.

Ezetimibe Tarbis reduces the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat called triglycerides in the blood. It also increases the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in Ezetimibe Tarbis, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe Tarbis adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by the body.

Cholesterol is one of the fats found in the bloodstream. Your total cholesterol level is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up 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.

Ezetimibe Tarbis is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a cholesterol-lowering diet.

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

• high levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])
• in combination with a statin, when your cholesterol level is not well controlled with a statin alone
• alone, when treatment with a statin is not appropriate or is not tolerated
• a hereditary disease (homozygous familial hypercholesterolemia) that increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have heart disease, Ezetimibe Tarbis, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimibe Tarbis does not help you lose weight.

2. What you need to know before you take Ezetimibe Tarbis

If you are taking Ezetimibe Tarbis with a statin, please read the package leaflet for that medicine.

Do not take Ezetimibe Tarbis if:

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

Do not take Ezetimibe Tarbis with a statin if:

• you currently have liver problems.
• you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Tarbis.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Tarbis with a statin. This is 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 Ezetimibe Tarbis with a statin.

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

The safety and efficacy of the combined use of Ezetimibe Tarbis and certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy data are limited.

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

Taking Ezetimibe Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking medicines with any of the following active ingredients:

• cyclosporin (often used in patients with transplanted organs)
• medicines with an active ingredient to prevent blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it affects how Ezetimibe Tarbis works
• fibrates (also used to lower cholesterol)

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe Tarbis is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Ezetimibe Tarbis.

This medicine contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Ezetimibe Tarbis

Follow exactly the instructions for administration of this medicine given by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If you are in doubt, consult your doctor or pharmacist again.

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

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

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

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

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

If you take more Ezetimibe Tarbis than you should

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

It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe Tarbis

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

If you stop taking Ezetimibe Tarbis

Talk to your doctor or pharmacist, as your cholesterol levels may increase again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects are 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)

Contact your doctor immediately if you experience pain, tenderness, or weakness of the muscles. This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious 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 tired.

Uncommon: elevated results of 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; flushing; high blood pressure.

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

Common: elevated results of some liver function tests (transaminases); headache; muscle pain; tenderness or weakness.

Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially in hands and feet.

When used in combination 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 hives; blistering and reddened skin, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (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 tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ezetimibe Tarbis

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect the product from moisture. Do not remove the tablet from the blister until you are ready to take it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Tarbis

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, croscarmellose sodium (E468), povidone K30 (E1201), sodium lauryl sulfate (E487), magnesium stearate (E572).

Appearance of the product and pack size

Ezetimibe Tarbis tablets are capsule-shaped, white or almost white, engraved with "E 10" on one side and nothing on the other side. The dimensions of the tablets are 8.1 x 4.1 mm.

Pack sizes:

Ezetimibe Tarbis 10 mg is available in packs of 28, 30, 56, 98, or 100 tablets.

Not all pack sizes may be marketed.

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

Date of last revision of this leaflet: June 2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es