Ezen

Package Leaflet: Information for the Patient

Ezen, 10 mg, tablets

Ezetimibe

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 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 high cholesterol levels.
Ezen lowers the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, Ezen increases the level of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezen, reduces the absorption of cholesterol in the gut.
Ezen enhances the action of statins, a group of medicines that lower cholesterol levels produced in the body.
Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of arteries in the form of plaques. The accumulation of these plaques can eventually lead to narrowing of the arteries, restricting blood flow or even causing blockage of blood flow to vital organs such as the heart and brain. Blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat found in the blood that can contribute to an increased risk of heart disease.
The medicine is used in patients for whom a cholesterol-lowering diet is not sufficient to control their cholesterol levels. 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:

• high levels of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial or non-familial])
• in combination with a statin, if cholesterol levels are not adequately controlled with statin therapy alone
• as monotherapy, if statin therapy is not appropriate or is not tolerated
• a genetic disorder (homozygous familial hypercholesterolemia) that causes high levels of cholesterol in the blood. The patient will be treated with a statin and may be treated with other therapies.
• a genetic disorder (homozygous sitosterolemia, also known as phytosterolemia) that causes high levels of plant sterols in the blood.

If the patient has heart disease, taking Ezen with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgical procedures to increase 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, read the package leaflet for that medicine.

When not to take Ezen:

• if you are 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,
• in case of pregnancy or breastfeeding.

Warnings and precautions

Before taking Ezen, discuss it with your doctor or pharmacist.

• Tell your doctor about all your symptoms, including allergies.
• Before taking 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 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 in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
Do not use this medicine in children and adolescents aged 6 to 17 years unless prescribed by a specialist, due to a lack of data on safety and efficacy.
Do not use this medicine in children under 6 years of age due to a lack of data in this age group.

Ezen and other medicines

Tell your doctor or pharmacist about all medicines you are 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 (often used in patients who have had an organ transplant),
• medicines containing substances that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindion (anticoagulants),
• colestyramine (also used to lower cholesterol levels), as it affects the action of Ezen,
• fibrates (also used to lower cholesterol levels).

Pregnancy and breastfeeding

Do not take Ezen in combination with a statin if you are pregnant, plan 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, ask your doctor for advice before taking this medicine.
Do not take Ezen in combination with a statin during breastfeeding, as it is not known whether the medicine passes into breast milk. Ezen alone should not be used in breastfeeding women. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Ezen is unlikely to affect your ability to drive or use machines.
However, consider that some people may experience dizziness after taking Ezen.
Ezen contains lactose and sodium.
If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Ezen

Always take this medicine exactly as your doctor has told you. Unless your doctor has told you otherwise, continue to take any other cholesterol-lowering medicines you have been taking. If you are unsure, ask your doctor or pharmacist.

• Before starting Ezen, follow a cholesterol-lowering diet.
• While taking Ezen, continue to follow a cholesterol-lowering diet.

The recommended dose is one 10 mg Ezen tablet, taken orally once a day.
Ezen can be taken at any time of day, with or without food.
If your doctor has prescribed Ezen and a statin, you can take both medicines at the same time. In this case, read the information on dosing in the package leaflet for that medicine.
If your doctor has prescribed Ezen and another cholesterol-lowering medicine that contains the active substance colestyramine or any other medicine containing a bile acid sequestrant, take Ezen at least 2 hours before or 4 hours after taking the bile acid sequestrant.

What to do if you take more Ezen than you should

Contact your doctor or pharmacist.

What to do if you forget to take Ezen

Do not take a double dose to make up for a forgotten tablet. Take your usual dose of Ezen the next day at the usual time.

What to do if you stop taking Ezen

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

Seek medical help immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle symptoms can be severe and potentially life-threatening.

This can be a life-threatening condition.
During normal use, allergic reactions, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment), have been reported.
The following side effects have been reported in patients taking Ezen alone or in combination with a statin:
Common (may affect up to 1 in 10 people)

• abdominal pain, diarrhea, bloating;
• feeling tired;
• headache;
• increased levels of some liver enzymes (transaminases) in the blood.

Uncommon (may affect up to 1 in 100 people)

• increased muscle enzyme levels (creatine kinase);
• cough;
• indigestion, heartburn, nausea, dry mouth, gastritis;
• joint pain, muscle cramps, neck pain, back pain, pain in the arms and legs;
• decreased appetite;
• pain; chest pain; unexplained tiredness or weakness; swelling, particularly of the hands and feet;
• itching, rash, urticaria;
• tingling sensation.

The following side effects have also been reported with an unknown frequency (frequency cannot be estimated from the available data):

• dizziness;
• red, raised rash, sometimes target-shaped (erythema multiforme);
• liver inflammation, 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/bleeding (thrombocytopenia);
• depression;
• shortness of breath.

The following side effect has been reported in patients taking Ezen in combination with fenofibrate: abdominal pain.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ezen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
Store in a temperature below 30°C. Store in the original package to protect from moisture.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. 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 Ezen contains

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

What Ezen looks like and contents of the pack

Ezen 10 mg is a white, elongated tablet, approximately 8 mm long and 4 mm wide, smooth on both sides.
Blister packs of PVC/Aclar/PVC/Aluminum or PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum.
Pack sizes: 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 nr.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 authorized 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, Slovakia
Ezen
Portugal
Ezetimiba Zentiva
Hungary
Ezetimib-Zentiva
United Kingdom
Ezetimibe
Romania
Cexado

For more information on this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. (22) 375 92 00
Date of last revision of the package leaflet:September 2022