Ezen

Patient Information Leaflet

Ezen, 10 mg, tablets
Ezetimibe
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents

1. What Ezen is and what it is used for
2. Important information before taking Ezen
3. How to take Ezen
4. Possible side effects
5. How to store Ezen
6. Contents of the pack and other information

1. What Ezen is and what it is used for

Ezen is a medicine used to lower elevated cholesterol levels.
Ezen reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides. In addition, Ezen increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezen, reduces cholesterol absorption in the gastrointestinal tract.
Ezen enhances the effect of statins, a group of medicines that reduce cholesterol produced in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol mainly consists of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries as atherosclerotic plaques. The accumulation of these plaques may eventually lead to narrowing of the arteries, restricting blood flow or even blocking blood supply to vital organs such as the heart and brain. Interruption of blood flow may result in heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the deposition of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that may contribute to an increased risk of heart disease.
This medicine is used in patients in whom a cholesterol-lowering diet alone is not sufficient to control cholesterol levels in the blood. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Ezen is used as an adjunct to a cholesterol-lowering diet in the following cases:

• Elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial or non-familial])
• In combination with a statin when cholesterol levels are not adequately controlled by statin therapy alone
• As monotherapy when statin therapy is inappropriate or poorly tolerated
• A hereditary disorder (homozygous familial hypercholesterolemia) causing elevated blood cholesterol levels. Patients will be treated with a statin and may also receive other treatments.
• A hereditary disorder (homozygous sitosterolemia, also known as phytosterolemia) causing elevated levels of plant sterols in the blood.

If you have heart disease, taking Ezen together with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.
Ezen has no effect on weight loss.

2. Important information before taking Ezen

When taking Ezen in combination with a statin, please read the patient information leaflet for that specific
medication.
When not to take Ezen:

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

When not to take Ezen in combination with a statin:

• in patients with liver disease,
• during pregnancy or breastfeeding.

Warnings and precautions
Before starting to take Ezen, discuss this with your doctor or pharmacist.

• Inform your doctor about all medical conditions, including allergies.
• Before starting Ezen in combination with a statin, your doctor should perform blood tests to assess liver function.
• Your doctor may also perform blood tests to assess liver function after starting treatment with Ezen in combination with a statin.

Ezen is not recommended for use in patients with moderate or severe liver impairment.
The safety and efficacy of ezetimibe used in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
This medicine should not be used in children and adolescents aged 6 to 17 years unless prescribed by a specialist due to lack of data on safety and efficacy.
This medicine should not be used in children under 6 years of age due to lack of data in this age group.
Ezen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

• cyclosporine (commonly used in patients after organ transplantation),
• medicines containing active substances that prevent blood clotting, such as: warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants),
• cholestyramine (also used to reduce cholesterol levels), as it affects the action of Ezen,
• fibrates (also used to reduce cholesterol levels).

Pregnancy and breastfeeding
Do not take Ezen in combination with a statin if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Ezen in combination with a statin, stop taking both medicines immediately and contact your doctor. There is no data on the use of ezetimibe without concomitant statin use during pregnancy. If you are pregnant, consult your doctor before using this medicine.
Do not take Ezen in combination with a statin during breastfeeding, as it is unknown whether the medicine passes into breast milk. Ezen, even without combination with a statin, should not be used in patients who are breastfeeding. Consult your doctor for advice.
Patients should consult their doctor or pharmacist before using any medicine.
Driving and using machines
Ezen is not expected to affect the ability to drive or operate machinery.
However, consider that dizziness may occur in some individuals after taking Ezen.
Ezen contains lactose and sodium.
If a patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use the medicine Ezen

This medicine should always be taken exactly as directed by your doctor. Unless otherwise advised by your doctor, continue taking any cholesterol-lowering medicines you were previously using. If in doubt, consult your doctor or pharmacist.

• Before starting treatment with Ezen, a cholesterol-lowering diet should be initiated.
• During treatment with Ezen, a cholesterol-lowering diet should be maintained.

The recommended dose is one 10 mg Ezen tablet taken orally once daily.
Ezen can be taken at any time of day, with or without food.
If your doctor has prescribed Ezen and a statin, both medicines may be taken at the same time. In this case, please refer to the dosing instructions provided in the package leaflet for the respective medicine.
If your doctor has prescribed Ezen and another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant resin, Ezen should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant resin.

Taking more Ezen than prescribed
Contact your doctor or pharmacist.

If you miss a dose of Ezen
Do not take a double dose to make up for the missed tablet. Take your usual dose of Ezen the next day at the regular time.

Stopping Ezen
Discuss this with your doctor or pharmacist, as cholesterol levels may rise again.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if you experience unexplained muscle pain,
tenderness or weakness. In rare cases, muscle-related problems, including muscle breakdown
leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
During regular use, allergic reactions have been reported, including swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing (these require immediate treatment).
The following adverse reactions have been observed during use as monotherapy or in combination with a statin:
Common (may affect up to 1 in 10 people)

• abdominal pain, diarrhoea, flatulence;
• feeling of fatigue;
• headache;
• increased levels in certain liver function tests (aminotransferases).

Uncommon (may affect up to 1 in 100 people)

• increased muscle function parameters (creatine kinase - CK);
• cough;
• dyspepsia, heartburn, nausea, dry mouth, gastric mucosal inflammation;
• joint pain, muscle cramps, neck pain, back pain, pain in arms and legs;
• decreased appetite;
• pain; chest pain; unexplained fatigue or weakness; oedema, particularly in hands and feet;
• sudden flushing of the face; high blood pressure;
• itching, rash, urticaria;
• tingling sensation.

Additionally, the following adverse reactions have been reported with unknown frequency (frequency cannot be estimated from the available data):

• dizziness;
• red, raised rash, sometimes with target-like lesions (erythema multiforme);
• hepatitis, gallstones or cholecystitis (may cause abdominal pain, nausea, vomiting);
• pancreatitis, often with severe abdominal pain; constipation;
• decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia);
• depression;
• shortness of breath.

When used in combination with fenofibrate, the following adverse reaction has been reported: abdominal pain.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Ezen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container following "EXP".
The expiry date refers to the last day of the stated month.
Store below 30 °C. Keep in the original packaging to protect from moisture.
Do not use this medicine if signs of deterioration are visible.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ezen contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: monohydrate lactose, sodium lauryl sulphate, povidone K-30, sodium croscarmellose, magnesium stearate.

What Ezen looks like and contents of the pack
Ezen 10 mg are white, elongated tablets approximately 8 mm in length and 4 mm in width, smooth on both sides.
Blister made of PVC/Aclar/PVC/Aluminium or blister made of PVC/PVDC/Aluminium or blister made of PVC/PE/PVDC/Aluminium.
Pack sizes: 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer
S.C. Zentiva S.A
B-dul Theodor Pallady no. 50, sector 3
cod 032266, Bucharest, Romania
Zentiva, k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Germany Ezetimib Zentiva
Bulgaria Езен
Denmark, France, Norway, Sweden, Italy Ezetimibe Zentiva
Poland, Czech Republic, Slovak Republic Ezen
Portugal Ezetimiba Zentiva
Hungary Ezetimib-Zentiva
United Kingdom Ezetimibe
Romania Cexado

For any further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00