Ezetrol

Package leaflet: Information for the patient

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

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

Contents of the leaflet

1. What Ezetrol is and what it is 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 Ezetrol is and what it is used for

Ezetrol is a medicine used to lower elevated cholesterol levels.
Ezetrol reduces blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fat substances called triglycerides. In addition, Ezetrol increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetrol, reduces cholesterol absorption in the gastrointestinal tract.
Ezetrol 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 consists mainly of LDL and HDL cholesterol fractions.
LDL cholesterol, often called "bad" cholesterol, can deposit in the walls of arteries as atherosclerotic plaques. Accumulation of these plaques may eventually lead to narrowing of the arteries, slowing blood flow or blocking blood supply to vital organs such as the heart and brain. Interruption of blood flow may cause 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.
Ezetrol is used as an adjunct to a cholesterol-lowering diet in the following conditions:

• elevated blood cholesterol levels (primary hypercholesterolaemia [heterozygous familial or non-familial])
• in combination with a statin when cholesterol levels are not adequately controlled on statin therapy alone
• as monotherapy when statin therapy is not appropriate or poorly tolerated
• a hereditary disorder (homozygous familial hypercholesterolaemia) causing increased blood cholesterol levels. A statin will be used in the patient, and other treatment methods may also be applied
• a hereditary disorder (homozygous sitosterolaemia, also known as phytosterolaemia) causing increased levels of plant sterols in the blood

If you have heart disease, Ezetrol taken with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalisation 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, please read the package leaflet
for that specific medicine.
When not to take Ezetrol:

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

When not to take Ezetrol in combination with a statin:

• if the patient currently has liver problems.
• during pregnancy or breastfeeding.

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

• Inform your doctor about all medical conditions, including allergies.
• Before starting Ezetrol in combination with a statin, your doctor should perform blood tests to assess liver function.
• Your doctor may also perform blood tests to monitor liver function after starting 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 called fibrates have not been established.
Children and adolescents
This medicine should not be used in children and adolescents (aged 6 to 17 years) unless specifically 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.
Ezetrol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. In particular, inform your doctor if the patient is taking medicines containing any of the following active substances:

• cyclosporine (commonly used in patients who have had an organ transplant)
• 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 Ezetrol
• fibrates (also used to reduce cholesterol levels)

Pregnancy and breastfeeding
Do not take Ezetrol 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 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 without a statin during pregnancy.
If you are pregnant, consult your doctor before taking Ezetrol.
Do not take Ezetrol in combination with a statin during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Ezetrol, even without combination with a statin, should not be used by breastfeeding women.
Consult your doctor for advice.
Consult your doctor or pharmacist before taking any medicine.
Driving and operating machinery
Ezetrol is not expected to affect the ability to drive or operate machinery.
However, consider that dizziness may occur in some individuals after taking Ezetrol.
Ezetrol contains lactose
The Ezetrol tablet contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Ezetrol contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ezetrol

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

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

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

Taking more Ezetrol than prescribed
Contact your doctor or pharmacist immediately.

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

Stopping Ezetrol
Discuss this with your doctor or pharmacist, as your 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is classified as follows:

• Very common (may occur in more than 1 in 10 patients);
• Common (may occur in up to 1 in 10 patients);
• Uncommon (may occur in up to 1 in 100 patients);
• Rare (may occur in up to 1 in 1000 patients);
• Very rare (may occur in up to 1 in 10,000 patients, including single cases).

You should contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle-related symptoms,
including rhabdomyolysis leading to kidney damage, may be severe and potentially
life-threatening.
During routine use, hypersensitivity reactions have been reported, including facial, lip, tongue
and (or) throat swelling, which may cause difficulty in breathing or swallowing (requiring
immediate treatment).
The following adverse effects have been observed during monotherapy with this medicine:
Common: abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon: increased parameters in certain liver function tests (aminotransferases) or muscle tests (CK); cough; indigestion; heartburn; nausea; joint pain; muscle cramps; neck pain; decreased appetite; pain; chest pain; sudden flushing of the face; high blood pressure.
Additionally, the following adverse effects have been observed when used in combination with a statin:
Common: increased parameters in certain liver function tests (aminotransferases); headache; muscle pain, tenderness or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unexplained fatigue or weakness; swelling, particularly in hands and feet.
When used in combination with fenofibrate, the following adverse effect was commonly reported: abdominal pain.
Additionally, during routine use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; hypersensitivity reactions including rash and urticaria; red, raised rash, sometimes with lesions in a target-like shape (erythema multiforme); muscle pain, tenderness or weakness; rhabdomyolysis; gallstones or cholecystitis (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased blood cell counts, which may lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained fatigue or weakness; shortness of breath.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to 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 stated on the carton or container under "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
• Do not store Ezetrol above 30°C.

Blister packs: store in the original packaging.
Bottles: keep tightly closed. Storing as recommended will protect the product from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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: monohydrate lactose, microcrystalline cellulose, povidone, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.

What Ezetrol looks like and contents of the pack
Ezetrol tablets are white or almost white, capsule-shaped, marked with the number "414" on one side.
Pack sizes:
14, 28, 30 tablets in press-through blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]
Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium
This medicinal product is authorised in the following countries under the name EZETROL: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.