EZETIMIBE SANDOZ 10 mg TABLETS

Introduction

Patient Information Leaflet

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

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

Ezetimibe Sandoz is a medicine to lower high levels of cholesterol.

Ezetimibe is a medicine used to lower total cholesterol, "bad" cholesterol (LDL cholesterol), and substances called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Ezetimibe Sandoz, works by reducing the absorption of cholesterol in the gut.

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

Cholesterol is one of several fats found in the bloodstream. Total cholesterol is mainly made up 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 a narrowing of the arteries, which can reduce 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.

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

Ezetimibe Sandoz is used together with a low-cholesterol diet if you have:

• high blood levels of cholesterol (primary hypercholesterolaemia [heterozygous 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 suitable or not tolerated.

• a hereditary disease (homozygous familial hypercholesterolaemia) 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 in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase heart blood flow, or hospitalization for chest pain.

Ezetimibe does not help you lose weight.

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

If you take Ezetimibe Sandoz with a statin, read the patient information leaflet for that medicine.

Do not take Ezetimibe Sandoz

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

DO NOT take Ezetimibe Sandoz with a statin if:

• you currently have liver problems,
• you are pregnantor breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Sandoz.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do 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 do blood tests to check how your liver is working after you start taking this medicine with a statin.

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

The combined use of ezetimibe and fibrates(medicines to lower cholesterol) is not recommended as the safety and efficacy have not been studied.

Contact your doctor immediately if you have:

• unexplained muscle pain, tenderness, or weakness.

This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

The risk of muscle breakdown is higher in some patients taking ezetimibe with cholesterol-lowering medicines such as statins.

Children and adolescents

Do not give this medicine to children and adolescents (6 to 17 years of age) unless it has been prescribed by a specialist, as the safety and efficacy 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 Sandoz 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 any of the following medicines:

• cyclosporine (a medicine often used in patients with transplanted organs),
• medicines to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
• cholestyramine (a medicine to lower cholesterol), as it affects how ezetimibe works,
• fibrates (medicines to lower cholesterol) (see also section 2: Warnings and precautions).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take ezetimibe with a statin if you are pregnant, if you are trying to become pregnant, or if you think you may be pregnant. If you become pregnant while taking ezetimibe with a statin, stop taking both medicines immediately and tell your doctor. There is no experience with the use of ezetimibe alone during pregnancy.

Breast-feeding

Do not take ezetimibe with a statin if you are breast-feeding as it is not known whether these medicines pass into breast milk. If you are breast-feeding, do not take ezetimibe, even without taking a statin. Ask your doctor.

Driving and using machines

Ezetimibe 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. If this happens, do not drive or use machines until you feel better.

Ezetimibe 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 some sugars, consult with them before taking this medicine.

3. How to take Ezetimibe Sandoz

Follow exactly the instructions of your doctor for taking this medicine.

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 ezetimibe, you should follow a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking this medicine.

The dose is one tablet once a day by mouth.

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

If your doctor has prescribed ezetimibe with a statin, you can take both medicines at the same time. In this case, read the instructions on how to take the medicine in the patient information leaflet for that particular medicine.

If your doctor has prescribed ezetimibe with cholestyramine or any other bile acid sequestrant (medicines to lower cholesterol), you should take ezetimibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Sandoz than you should

If you have taken more Ezetimibe Sandoz than you should, talk to a doctor, pharmacist, or call the Toxicology Information Service (tel. 91 562 04 20), indicating the medicine and the amount used.

If you forget to take Ezetimibe Sandoz

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

If you stop taking Ezetimibe Sandoz

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

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

4. Possible side effects

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

Contact your doctor immediately if you have:

• muscle pain or weakness,
• unexplained muscle pain.

This is because muscle problems, including muscle breakdown that can cause kidney damage, can be serious and potentially life-threatening.

Allergic reactions, including:

• swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing,
• dizziness or fainting and unusually fast or irregular heartbeats,

that require immediate treatment.

Other side effects reported in clinical trials

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

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

• abdominal pain,
• diarrhea,
• flatulence (gas),
• feeling tired.

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

• increased results of some liver function tests (transaminases) or muscle function tests (CK),
• cough,
• indigestion,
• heartburn,
• nausea,
• joint pain,
• muscle cramp,
• neck pain,
• decreased appetite,
• pain,
• chest pain,
• hot flushes,
• high blood pressure.

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

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

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

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

• tingling sensation (pins and needles),
• dry mouth,
• inflammation of the stomach lining,
• itching,
• rash,
• hives,
• back pain,
• muscle weakness,
• pain in arms and legs,
• unusual tiredness or weakness,
• swelling, especially in the hands and feet.

When used with fenofibrate(a medicine for high cholesterol), the following side effect has been reported:

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

• abdominal pain.

In addition, the following side effects have been reported in general use (after the medicine has been marketed):

Side effects of unknown frequency(cannot be estimated from the 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 ring-shaped lesions, a red ring around a pale center,
• muscle pain or sensitivity,
• muscle weakness: cramps, stiffness, or spasms,
• severe muscle pain or weakness and reddish-brown urine due to muscle breakdown,
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting),
• inflammation of the pancreas, often with severe abdominal pain,
• constipation,
• reduced blood cell count, which may cause bruising or bleeding (thrombocytopenia),
• tingling sensation,
• depression,
• unusual tiredness or weakness,
• shortness of breath.

Reporting of side effects

If you get 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 via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimibe Sandoz

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 blister, packaging, or bottle after EXP. The expiry date refers to the last day of the month shown.

Blister packs: Store in the original package to protect from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ezetimibe Sandoz contains

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

Appearance and packaging

Ezetimibe Sandoz 10 mg tablets are white or almost white, oval (7.4 mm x 4.0 mm), with the imprint "10" on one side and "EZT" on the other.

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

HDPE bottles with child-resistant polypropylene closure: 100 and 250 tablets (clinical pack).

HDPE bottles of white to off-white color with polypropylene closure with induction-sealed liner and separate addition of silica gel desiccant: 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

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 under the following names:

Germany: Ezetimib – 1 A Pharma 10 mg Tabletten

Austria Ezetimib Sandoz 10 mg - Tabletten S

Belgium: Ezetimibe Sandoz 10 mg tabletten

Cyprus: Ezetimibe Sandoz 10 mg

Croatia: Elanix 10 mg tablete

Slovenia Elanix 10 mg tablete

Denmark Ezetimib Sandoz

Estonia Kolxip

Finland Ezetimib Sandoz 10 mg tabletti

France: EZETIMIBE SANDOZ 10 mg, comprimé

Greece: Ezetimibe/Sandoz

Hungary Ezetimibe Sandoz 10 mg tabletta

Italy: EZETIMIBE SANDOZ

Luxembourg: Ezetimib Sandoz 10 mg comprimés

Malta: Ezetimibe 10mg Tablets

Norway Ezetimib Sandoz 10 mg tabletter

Netherlands: Ezetimibe Sandoz 10 mg, tabletten

Portugal Ezetimiba Sandoz

United Kingdom: Ezetimibe 10mg Tablets

Czech Republic Tezzimi 10mg

Slovak Republic Ezetimibe Sandoz 10 mg

Romania: EZETIMIB SANDOZ 10 mg comprimate

Sweden: Ezetimib Sandoz, 10 mg tablett

Date of last revision of this leaflet: June 2020

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

Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente.