Ezehron

Package Leaflet: Information for the Patient

Ezehron, 10 mg, Tablets

Ezetimibe

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

1. What is Ezehron and what is it used for

Ezehron is a medicine used to lower high cholesterol levels. Ezehron lowers the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, Ezehron increases the level of "good" cholesterol (HDL cholesterol). Ezehron works by reducing the amount of cholesterol absorbed by the body. Ezehron complements the action of statins, a group of medicines that lower cholesterol produced by the body. 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 the narrowing of the arteries, which can cause a reduction in blood flow or 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 the development of heart disease. Triglycerides are another type of fat found in the blood, which can increase the risk of developing heart disease. The medicine is used in patients for whom a cholesterol-lowering diet is not enough to control their cholesterol levels. The medicine can be used alone or in combination with other medicines used to lower high cholesterol levels. While taking this medicine, patients should follow a cholesterol-lowering diet. Ezehron does not affect weight loss.

Ezehron may be prescribed by a doctor in the following cases:

• high cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial or non-familial])
• in combination with a statin, if it is not possible to achieve adequate cholesterol reduction with statin therapy alone
• as monotherapy, if statin therapy is not indicated or is poorly tolerated
• homozygous familial hypercholesterolemia, a genetic disorder that causes high cholesterol levels in the blood. The patient will be treated with a statin and may be treated with other therapies
• homozygous sitosterolemia, a genetic disorder that causes high levels of plant sterols in the blood

If the patient has heart disease, Ezehron, when used in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, and hospitalization due to chest pain.

2. Important information before taking Ezehron

When not to take Ezehron:

• if the patient is allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6. Contents of the pack and other information).

When not to take Ezehron in combination with a statin:

• if there are current liver problems
• if the patient is pregnant or breastfeeding

Women of childbearing age are advised to use effective methods of contraception to prevent pregnancy while taking Ezehron in combination with statins (see section: Pregnancy and breastfeeding).

Warnings and precautions

• The patient should inform their doctor about all their ailments, including allergies.
• Before starting Ezehron in combination with a statin, the doctor should perform blood tests to assess liver function.
• The doctor may also perform blood tests to assess liver function after starting Ezehron in combination with a statin.

Ezehron is not recommended for use in patients with moderate or severe liver impairment. The safety and efficacy of Ezehron in combination with fibrates, medicines that lower cholesterol levels, have not been established. If the patient experiences pain of unknown origin, tenderness, or weakness while taking this medicine, especially if it is associated with a high temperature, they should consult their doctor. If the patient is hospitalized or undergoing treatment for other reasons, they should inform the medical staff that they are taking Ezehron.

Children and adolescents

Due to the lack of data on the safety and efficacy of Ezehron in children and adolescents aged 6 to 17, this medicine should not be used in this age group unless prescribed by a specialist. This medicine should not be used in children under 6 years of age due to the lack of data in this age group.

Ezehron and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor if they are taking medicines containing any of the following active substances: cyclosporine (used, for example, after organ transplantation), warfarin, phenprocoumon, acenocoumarol, or fluindione, as well as other medicines that prevent blood clotting (anticoagulants), fibrates (used to lower cholesterol levels, such as gemfibrozil, fenofibrate), or cholestyramine (also used to lower cholesterol levels).

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Ezehron in combination with a statinif the patient is pregnant, plans to become pregnant, or thinks they may be pregnant. If the patient becomes pregnant while taking Ezehron in combination with a statin, they should stop taking both medicines immediatelyand consult their doctor. Women of childbearing age are advised to use effective methods of contraception to prevent pregnancy while taking Ezehron in combination with statins. There are no clinical data on the use of Ezehron without statins during pregnancy. The patient should consult their doctor for advice.

Breastfeeding

Do not take Ezehron in combination with a statinduring breastfeeding. Ezehron should not be used during breastfeeding. The patient should consult their doctor for advice.

Driving and using machines

Most people can drive and use machines after taking Ezehron – in most patients, the medicine does not affect the ability to drive and use machines. However, some people may experience dizziness after taking Ezehron. The patient should not drive or use machines if they experience dizziness.

Ezehron contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Ezehron contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free". A detailed list of ingredients can be found in the section: Contents of the pack and other information.

3. How to take Ezehron

This medicine should always be taken as directed by the doctor. Unless the doctor advises otherwise, the patient should continue taking any other cholesterol-lowering medicines they have been taking. If in doubt, the patient should consult their doctor or pharmacist. Before starting Ezehron, the patient should follow a cholesterol-lowering diet. While taking Ezehron, the patient should follow a cholesterol-lowering diet. The recommended dose is one 10 mg Ezehron tablet, taken orally once a day. Ezehron can be taken at any time of day, with or without food. If the doctor has prescribed Ezehron and a statin, both medicines can be taken at the same time. In this case, the patient should read the information on dosing in the leaflet for the specific medicine. If the doctor has prescribed Ezehron and another cholesterol-lowering medicine containing the active substance cholestyramine or any other medicine containing a bile acid sequestrant, Ezehron should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Ezehron than recommended

The patient should consult their doctor or the nearest hospital for advice.

Missing a dose of Ezehron

The patient should not worry; they should take their usual dose of Ezehron the next day at the usual time. The patient should not take a double dose to make up for the missed tablet.

Stopping Ezehron

The patient should consult their doctor if they are considering stopping the medicine, as their cholesterol levels may rise again. If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ezehron can cause side effects, although not everybody gets them. It is important for the patient to be aware of the possible side effects that can occur when taking this medicine. They are usually mild and disappear on their own after a short time. The patient should contact their doctor immediatelyif they experience any of the following allergic reactions:

• difficulty breathing or swallowing, with or without swelling of the face, lips, tongue, or throat.

The patient should contact their doctor immediately if they experience unexplained

muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be severe and life-threatening. The frequency of side effects is classified as follows:

• Very common (may affect more than 1 in 10 people);
• Common (may affect up to 1 in 10 people);
• Uncommon (may affect up to 1 in 100 people);
• Rare (may affect up to 1 in 1,000 people);
• Very rare (may affect up to 1 in 10,000 people, including isolated cases).

Common side effects:

• abdominal pain;
• diarrhea;
• bloating;
• fatigue.

Uncommon side effects:

• increased levels of certain liver function tests (aminotransferases) or muscle (CK);
• cough;
• indigestion;
• heartburn;
• nausea;
• joint pain;
• muscle cramps;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• sudden flushing of the face;
• high blood pressure.

In addition, when used in combination with a statin, the following side effects may occur:

Common side effects:

• increased levels of certain liver function tests;
• headache;
• muscle pain;
• muscle tenderness or weakness.

Uncommon side effects:

tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained fatigue or weakness; swelling, especially of the hands and feet. In addition, when used in combination with a statin or without, the following side effects may occur:

Side effects of unknown frequency:

dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; difficulty breathing or swallowing, with or without swelling of the face, lips, tongue, or throat, red, raised rash, sometimes with changes in the shape of a target (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or gallbladder inflammation (may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained fatigue or weakness; shortness of breath. When used in combination with fenofibrate, the following side effects may occur:

Common side effects:

• abdominal pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22-49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ezehron

The medicine should be stored out of sight and reach of children. Store in the original packaging. There are no special storage temperature recommendations for the medicinal product. Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the given month. Do not use this medicine if visible signs of deterioration are observed. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ezehron contains

• The active substance of Ezehron is ezetimibe. Each Ezehron tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, type 101, E 460(i), sodium lauryl sulfate, sodium croscarmellose E 468, povidone (K30, E 1201), corn starch, colloidal anhydrous silica E 551, microcrystalline cellulose, type 102, E 460(i), stearyl fumarate E 570.

What Ezehron looks like and contents of the pack

Package sizes: 28, 30, 56, 60, 84, 90, or 100 tablets in blisters. Not all package sizes may be marketed. Ezehron 10 mg, tablets are white or almost white, capsule-shaped tablets, marked with "1>1" on one side.

Marketing authorization holder

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Genericon Pharma Gesellschaft m.b.H., Hafnerstrasse 211, 8054 Graz, Austria

Date of last revision of the leaflet:09.2023