Product Information for the Patient

Ezetimiba Sandoz 10 mg Tablets EFG

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

-Keep this product information, as you may need to read it again.

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

-This medicine has been prescribed only for you, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this product information.Seesection4.

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

2.What you need to knowbeforestarting totake Ezetimiba Sandoz

3.How to take Ezetimiba Sandoz

4.Possible side effects

5.Storage of Ezetimiba Sandoz

6.Contents of the package and additional information

Ezetimibe Sandoz is a medication to decrease elevated levels of cholesterol.

Ezetimibe is a medication used to reduce total cholesterol, "bad" cholesterol (LDL cholesterol), and certain types of fat called triglycerides that circulate in the blood. Additionally, this medication increases concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance of Ezetimibe Sandoz, acts by reducing the cholesterol absorbed in the digestive tract.

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

Cholesterol is one of several fatty substances thatare found in the bloodstream. 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 its 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 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-reducing diet. While taking this medication, you must follow a cholesterol-reducing diet.

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

• elevated levels of cholesterol in the blood (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 genetic disorder (familial hypercholesterolemia), which 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 combined with medications to lower cholesterol called statins, reduces the risk of heart attack, stroke, coronary artery bypass grafting, or hospitalization for chest pain.

Ezetimibe does not help you lose weight.

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

Do not take Ezetimiba Sandoz

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

Do not take Ezetimiba Sandoz with a statin if:

• you currently haveliver problems,
• you arepregnantor inlactation.

Warnings and precautions

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

• Informyour doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking this medicine with a statin. This is to check how your liver is working.
• Your doctor may also want to make blood tests to check how your liver is working after you start taking this medicine with a statin.

If you havemoderate or severe liver problems,Ezetimiba Sandoz is not recommended.

The combined use of ezetimiba andfibrates(cholesterol-lowering medicines) is not recommended as their safety and efficacy have not been studied.

Contact your doctor immediately if you have:

• unexplained muscle pain, sensitivity, or weakness.

This is because in rare cases, muscle problems, including muscle degradation that causes kidney damage,can be severe and potentially life-threatening.

The risk of muscle degradation is higher in some patients taking ezetimiba with cholesterol-lowering medicines, such as statins.

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 Sandoz with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.Especially, inform your doctor if you are taking any of the following medicines:

• ciclosporin (a medicine often used in patients with organ transplants),
• blood-thinning medicines, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• colestiramine (a cholesterol-lowering medicine), because it affects how ezetimiba works,
• fibrates (cholesterol-lowering medicines) (see also section 2: Warnings and precautions).

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Lactation

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

Driving and operating machines

Ezetimiba is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking ezetimiba. If this happens, do not drive or operate machines until you feel better.

Ezetimiba Sandoz contains sodium and lactose

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

If your doctor has told you that you have an intolerance to certain sugars, 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 reduce cholesterol unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take ezetimiba, you must follow a diet to reduce cholesterol.
• You must continue with this cholesterol-reducing diet while taking this medication.

The dose is one tablet once a day taken orally.

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

If your doctor has prescribed ezetimiba along with a statin, both medications can be taken at the same time. In this case, read the instructions on how to take the medication in the prospectus for that particular medication.

If your doctor has prescribed ezetimiba along with cholestyramine or any other bile acid sequestrant (medications to reduce cholesterol), you must take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Sandoz than you should

If you have taken more Ezetimiba Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Ezetimiba Sandoz

Do not take a double dose to make up for the missed doses. Simply take your normal amount of Ezetimiba Sandoz the next day.

If you interrupt treatment with Ezetimiba Sandoz

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.

Contact your doctor immediately if you experience:

• muscle pain or weakness,
• unexplained muscle pain.

This is because, in rare cases, muscle problems, including muscle degeneration, which can cause kidney damage, can be serious and potentially life-threatening.

Allergic reactions, including:, including:

• swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing,
• dizziness or fainting and irregular or rapid heartbeat,

that require immediate treatment.

Other reported side effects in clinical trials

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

Common side effects (may affect up to 1 in 10 patients):

• abdominal pain,
• diarrhea,
• flatulence (gas),
• fatigue.

Uncommon side effects (may affect up to 1 in 100 patients):

• elevation of some liver function test results (transaminases) or muscle function test results (CK),
• cough,
• indigestion,
• heartburn,
• nausea,
• joint pain,
• muscle cramps,
• neck pain,
• loss of appetite,
• pain,
• chest pain,
• palpitations,
• high blood pressure.

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

Common side effects (may affect up to 1 in 10 patients):

• elevation of some liver function test results (transaminases),
• headache,
• muscle pain or weakness.

Uncommon side effects (may affect up to 1 in 100 patients):

• tingling sensation,
• dry mouth,
• inflammation of the stomach lining,
• itching,
• eruption,
• hives,
• back pain,
• muscle weakness,
• pain in arms and legs,
• unusual fatigue or weakness,
• swelling, especially in hands and feet.

When used with fenofibrate (cholesterol-lowering medication), the following side effect has been reported:

Common side effects (may affect up to 1 in 10 patients):

• abdominal pain.

Additionally, in general use, the following side effects have been reported (since the medication has been marketed):

Side effects of unknown frequency (cannot be estimated from available data):

• dizziness,
• liver problems,
• allergic reactions such as skin rash, hives, swelling of the face, tongue, or throat, and fainting,
• red rash, sometimes with lesions in the shape of a ring of red color around a pale center,
• muscle pain or sensitivity,
• muscle weakness: cramps, stiffness, or spasms,
• severe muscle pain or weakness and brownish-red urine due to muscle degeneration,
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting),
• pancreatitis, often with intense abdominal pain,
• constipation,
• reduction in blood cell count, which can 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 blister, the container, or the bottle after CAD. The expiration date is the last day of the month indicated.

Blisters: Store in the original packaging to protect it from moisture.

Bottles: Keep the container perfectly closed to protect it from moisture. Shelf life after first opening: 9 months. Store below 25°C.

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

Composition of Ezetimiba Sandoz

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are lactose monohydrate (for more information, see the end of section 2), hypromellose, croscarmellose sodium, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.

Appearance of the product and contents of the package

Ezetimiba Sandoz 10 mg tablets are white or off-white, oval-shaped (7.4 mm x 4.0 mm) tablets with the imprint “10” on one side and “EZT” on the other.

Alu/Alu blisters: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, and 100 (clinical pack) tablets.

HDPE bottles with a safety closure of polypropylene: 100 and 250 tablets (clinical pack).

HDPE bottles of white to off-white color with a polypropylene closure with a thermoset induction coating and silica gel desiccant added separately in the bottle: 250 tablets.

Authorized marketing title and responsible manufacturer

Authorized marketing title

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana,

Slovenia

or

LEK, S.A.

u.l. Domaniewska 50 C

02-672 Warsazwa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures,

Romania

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Ezetimib – 1 A Pharma 10 mg Tabletten

AustriaEzetimib Sandoz 10 mg - Tabletten S

Belgium:Ezetimibe Sandoz 10 mg tabletten

Cyprus:Ezetimibe Sandoz 10 mg

Croatia:Elanix 10 mg tablete

SloveniaElanix 10 mg tablete

DenmarkEzetimib Sandoz

EstoniaKolxip

Finland:Ezetimib Sandoz 10 mg tabletti

France:EZETIMIBE SANDOZ 10 mg, comprimé

Greece:Ezetimibe/Sandoz

HungaryEzetimibe Sandoz 10 mg tabletta

Italy:EZETIMIBE SANDOZ

Luxembourg:Ezetimib Sandoz 10 mg comprimés

Malta:Ezetimibe 10mg Tablets

NorwayEzetimib Sandoz 10 mg tabletter

Netherlands:Ezetimibe Sandoz 10 mg, tabletten

PortugalEzetimiba Sandoz

United Kingdom:Ezetimibe 10mg Tablets

Czech RepublicTezzimi 10mg

Slovak RepublicEzetimibe Sandoz 10 mg

Romania:EZETIMIB SANDOZ 10 mg comprimate

Sweden:Ezetimib Sandoz, 10 mg tablett

Last review date of this leaflet: June 2020

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