Leaflet: information for the user

Ezetimiba Teva 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 Ezetimiba Teva is and what it is used for

2. What you need to know before you start taking Ezetimiba Teva

3. How to take Ezetimiba Teva

4. Possible side effects

5. Storage of Ezetimiba Teva

6. Contents of the pack and additional information

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

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

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

Ezetimiba Teva 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 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 the 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 Tevais used in combination with a cholesterol-lowering diet if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia [familial heterozygous and non-familial])
• • 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
• a hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

If you have cardiovascular disease, Ezetimiba Teva combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, heart surgery to increase blood flow to the heart, or hospitalization for chest pain.

Ezetimiba Teva does not help you lose weight.

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

DO NOT takeEzetimiba Teva:

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

DO NOT takeEzetimiba Tevawith 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 Teva.

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

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

The safety and efficacy of the combined use of Ezetimiba Teva and 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.

TakingEzetimiba Tevawith 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 transplant patients)
• medicines with an active ingredient to prevent blood clots, such as warfarin, fenprocomon, acenocoumarol, or fluindione (anticoagulants)
• colestiramine (also used to lower cholesterol), as it affects how Ezetimiba Teva works
• fibrates (also used to lower cholesterol)

Ezetimiba Teva with food

Ezetimiba Teva can be taken with or without food.

Pregnancy and breastfeeding

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

The safety and efficacy of Ezetimiba Teva with a statin during pregnancy have not been studied. Consult your doctor before using Ezetimiba Teva if you are pregnant.

Do not take Ezetimiba Teva with a statin if you are breastfeeding, as it is unknown whether the medicine passes into breast milk.

If you are breastfeeding, do not take Ezetimiba Teva, even without taking a statin. Consult your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Ezetimiba Tevacontains lactose

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

Ezetimiba Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. Continue taking your other cholesterol-lowering medications unless your doctor tells you to stop..In case of doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba Teva, you must be following a diet to reduce cholesterol.
• You will need to continue with this cholesterol-lowering diet while taking Ezetimiba Teva.

The recommended dose is one Ezetimiba Teva 10 mg tablet once a day by mouth.

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

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

If you take moreEzetimiba Tevathan you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to takeEzetimiba Teva

Do not take a double dose to make up for the missed dose, simply take your usual amount of Ezetimiba Teva at the usual time the next day.

If you interrupt treatment withEzetimiba Teva

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 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)

Immediately contact your doctor if you experience pain, pressure sensitivity, 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.

Immediately contact your doctor if you experienceallergic reactions, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing. These reactions have been reported during general use.

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, heat; high blood pressure.

In addition, 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; pressure sensitivity or weakness.

Uncommon:tingling sensation; dry mouth; stomach inflammation;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 side effect has been reportedcommon:abdominal pain.

In addition, during general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and urticaria; raised, red, and sometimes blistered patches, sometimes with target lesions (erythema multiforme); muscle pain, pressure sensitivity, or muscle weakness; muscle degradation; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduced blood cell count, which may cause bruising or 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, blister pack, or bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ezetimiba Teva

• The active ingredient is ezetimiba.
• Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate, maize pregelatinized starch, microcrystalline cellulose, sodium croscarmellose, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, stearic acid, poloxamer 407.

Appearance of the product and contents of the package

Ezetimiba Teva tablets are white, biconvex, capsule-shaped tablets marked with “10” on one side.

Formats

Ezetimiba Teva is packaged in PVC/ACLAR/PVC-Al or PVC/AquaBA SW/PVC-Al blisters of 14, 28, 28x1, 30, 30x1, 50, 90, 90x1, 98, 98x1, 100, 105, and 120 tablets or HDPE bottles with a PP child-resistant closure and an internal seal to induce sealing with a silica gel desiccant container containing 100 and 105 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

Alcobendas 28108 (Madrid)

Spain

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3, Blaubeuren

89143 Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000 Croatia

This medicinal product is authorized in the EEA member states under the following names:

Germany:Ezetimib AbZ 10 mg Tabletten

Austria:Ezetimib ratiopharm 10 mg Tabletten

Belgium:Ezetimibe Teva 10 mg Tabletten

Croatia:Ezact 10 mg tablete

Czech Republic: Ezetimib Teva

Finland:Ezetimibe ratiopharm 10 mg tabletti

France:Ezetimibe Teva 10 mg comprimé

Ireland:Ezetimibe Teva 10 mg Tablets

Italy:Ezetimibe Teva 10 mg compresse

Netherlands:Ezetimibe Teva 10 mg, tabletten

Portugal:Ezetimiba Teva 10 mg, Comprimido

Slovakia:Ezetimib Teva 10 mg

Spain:Ezetimiba Teva 10 mg comprimidos EFG

United Kingdom (Northern Ireland): Ezetimibe 10 mg Tablets

Last review date of this leaflet:May 2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/