Ezetrol

Package Leaflet: Information for the Patient

Ezetrol, 10 mg, Tablets

Ezetimibe

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

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

Table of Contents of the Leaflet

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

1. What is Ezetrol and what is it used for

Ezetrol is a medicine used to lower high blood cholesterol levels. Ezetrol reduces the amount of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetrol increases the level of "good" cholesterol (HDL cholesterol). The active substance in Ezetrol, ezetimibe, reduces the absorption of cholesterol in the gut. Ezetrol enhances the action of statins, a group of medicines that lower cholesterol produced in the body. Cholesterol is one of several fatty substances found in the blood. Total cholesterol is mainly made up of LDL 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, 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 that can contribute to an increased risk of developing heart disease. The medicine is used in patients who do not have sufficient control of their cholesterol levels with diet alone. While taking this medicine, you should continue to follow a cholesterol-lowering diet. Ezetrol is used as an adjunct to a cholesterol-lowering diet in the following cases:

• high blood cholesterol levels (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
• homozygous familial hypercholesterolemia, a genetic disorder that causes high blood cholesterol levels. The patient will also be treated with a statin and may be treated with other cholesterol-lowering therapies.
• homozygous sitosterolemia, a genetic disorder that causes high levels of plant sterols in the blood.

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

2. Important information before taking Ezetrol

When taking Ezetrol in combination with a statin, read the package leaflet for that medicine.

When not to take Ezetrol:

• if you are 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 Ezetrol in combination with a statin:

• if you currently have liver problems.
• if you are pregnant or breastfeeding.

Warnings and precautions

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

• Tell your doctor about all your illnesses, including allergies.
• Before taking Ezetrol in combination with a statin, your doctor should do blood tests to check your liver function.
• Your doctor may also do blood tests to check your liver function after you start taking Ezetrol in combination with a statin.

Ezetrol is not recommended for use in patients with moderate or severe liver impairment. The safety and efficacy of Ezetrol in combination with certain cholesterol-lowering medicines, fibrates, have not been established.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist due to a lack of data on safety and efficacy. Do not give this medicine to children under 6 years of age due to a lack of data in this age group.

Ezetrol 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, tell 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 fluindione (anticoagulant medicines)
• cholestyramine (also used to lower cholesterol levels), as it affects the action of Ezetrol
• fibrates (also used to lower cholesterol levels)

Pregnancy and breastfeeding

Do not take Ezetrol in combination with a statin if you are pregnant, plan to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetrol in combination with a statin, stop taking both medicines immediately and contact your doctor. There are no clinical data on the use of Ezetrol alone during pregnancy. If you are pregnant, ask your doctor for advice before taking Ezetrol. Do not take Ezetrol in combination with a statin while breastfeeding, as it is not known whether the medicine passes into breast milk. Ezetrol 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

Ezetrol is unlikely to affect your ability to drive or use machines. However, consider that some people may experience dizziness after taking Ezetrol.

Ezetrol contains lactose

Ezetrol tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking Ezetrol.

Ezetrol contains sodium

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

3. How to take Ezetrol

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Unless your doctor has told you otherwise, continue to take any other cholesterol-lowering medicines you are taking. If you are in doubt, consult your doctor or pharmacist.

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

The recommended dose is one 10 mg Ezetrol tablet, taken once daily. You can take Ezetrol at any time of the day, with or without food. If your doctor has prescribed Ezetrol 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 Ezetrol and another cholesterol-lowering medicine that contains the active substance cholestyramine or any other medicine that contains a bile acid sequestrant, take Ezetrol at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetrol than you should

Contact your doctor or pharmacist.

If you forget to take Ezetrol

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

If you stop taking Ezetrol

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. 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).

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown, can be serious and 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 in breathing or swallowing (which require immediate treatment), have been reported. When taking Ezetrol alone, the following side effects have been reported: Common: abdominal pain; diarrhea; bloating with gas; feeling tired. Uncommon: increased levels of some liver or muscle enzymes in the blood; cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; flushing. In addition, when taking Ezetrol in combination with a statin, the following side effects have been reported: Common: increased levels of some liver enzymes in the blood; headache; muscle pain, tenderness, or weakness. Uncommon: tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, particularly of the hands and feet. When taking Ezetrol in combination with fenofibrate, abdominal pain has been commonly reported. In addition, during normal use, the following side effects have been reported: dizziness; muscle pain, liver problems; allergic reactions, including rash and hives; red, raised rash, sometimes target-shaped (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased blood cell count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, you can help provide more information on the safety of this medicine.

5. How to store Ezetrol

• 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 carton or blister after "EXP". The expiry date refers to the last day of that month.
• Do not store Ezetrol above 30°C.

Blister packs: store in the original package. Bottles: keep the bottle tightly closed to protect the tablets from moisture. 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 Ezetrol contains

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

What Ezetrol looks like and contents of the pack

Ezetrol tablets are white or almost white, capsule-shaped, and marked with the number "414" on one side. Pack sizes: 14, 28, 30 tablets in blister packs. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
organonpolska@organon.com

Manufacturer

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorized in the European Economic Area under the name EZETROL in Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

Date of last revision of the leaflet: 11/2022