Ezoleta

Package leaflet: Information for the patient

Ezoleta, 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Ezoleta is and what it is used for

Ezoleta is a medicine used to reduce elevated cholesterol levels.
Ezoleta lowers blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides. In addition, Ezoleta increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezoleta, reduces cholesterol absorption in the gastrointestinal tract.
Ezoleta 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 is often called "bad" cholesterol because it 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 result in heart attack or stroke.
HDL cholesterol is often called "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 in the blood that may contribute to 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. While taking this medicine, you should continue to follow a cholesterol-lowering diet.
Ezoleta is used as an addition 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 with a statin alone;
• as monotherapy when statin therapy is not appropriate or poorly tolerated;
• a hereditary disorder (homozygous familial hypercholesterolemia) causing elevated blood cholesterol levels. A statin will be used, and other treatment methods may also be applied;
• a hereditary disorder (homozygous sitosterolemia, also known as phytosterolemia), in which blood levels of plant sterols are elevated.

If you have heart disease, taking Ezoleta together with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.
Ezoleta does not help reduce body weight.

2. Important information before using Ezoleta

When using Ezoleta in combination with a statin, please read the package leaflet for that specific statin.
When not to use Ezoleta:

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

When not to use Ezoleta in combination with a statin:

• if the patient currently has liver function disorders,
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Ezoleta, discuss this with your doctor or pharmacist.

• Inform your doctor about all medical conditions, including allergies.
• Before starting Ezoleta 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 Ezoleta in combination with a statin.
• Ezoleta is not recommended for patients with moderate or severe liver impairment.
• The safety and efficacy of Ezoleta 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 lack of data on safety and efficacy.
Do not use this medicine in children under 6 years of age due to lack of data in this age group.
Ezoleta and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

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

Ezoleta with food and drink
Ezoleta can be taken independently of meals.
Pregnancy and breastfeeding
Do not take Ezoleta 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 Ezoleta in combination with a statin, stop taking both medicines immediately and contact your doctor.
There are no clinical data on the use of ezetimibe without a statin during pregnancy.
If you are pregnant, consult your doctor before using Ezoleta.
Do not take Ezoleta in combination with a statin during breastfeeding, as it is unknown whether the medicine passes into breast milk.
Ezoleta, even when not combined with a statin, should not be used in breastfeeding women. Consult your doctor for advice.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
Ezoleta is not expected to affect the ability to drive or operate machinery. However, bear in mind that dizziness may occur in some individuals after taking Ezoleta.
Ezoleta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Ezoleta

Always take this medicine exactly as directed by your doctor. Unless otherwise advised by your doctor,
continue taking any cholesterol-lowering medicines previously prescribed. If in doubt, consult your doctor
or pharmacist.

• Before starting treatment with Ezoleta, a cholesterol-lowering diet should be initiated.
• While taking Ezoleta, maintain a cholesterol-lowering diet.

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

Taking more Ezoleta than recommended
Contact your doctor or pharmacist immediately.

If you forget to take Ezoleta
Do not take a double dose to make up for the missed dose. Take your usual dose of Ezoleta at the next
scheduled time.

Stopping Ezoleta
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. In rare cases, muscle-related problems, including
rhabdomyolysis leading to kidney damage, may be severe and progress to a potentially life-threatening condition.
Allergic reactions have been reported during regular use, including swelling of the face, lips, tongue and (or)
throat, which may cause difficulty in breathing or swallowing (requiring immediate treatment).
The following adverse effects have been reported during use of ezetimibe alone:
Common (may occur in up to 1 in 10 patients): abdominal pain; diarrhoea; bloating with passing wind; feeling of fatigue.
Uncommon (may occur in up to 1 in 100 patients): 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 reported when used in combination with a statin:
Common (may occur in up to 1 in 10 patients): increased parameters in certain liver function tests (aminotransferases); headache; muscle pain, tenderness or weakness.
Uncommon (may occur in up to 1 in 100 patients): tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unexplained tiredness or weakness; oedema, particularly in hands and feet.
When used in combination with fenofibrate, the following adverse effect has been commonly reported: abdominal pain.
Additionally, during regular use, the following adverse effects have been reported (frequency unknown): dizziness; muscle pain; liver function disorders; allergic reactions, including rash and urticaria; red, raised rash, sometimes with lesions in the shape of a disc (erythema multiforme); muscle pain, tenderness or weakness; rhabdomyolysis; gallstones or cholecystitis (may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in blood cell counts, which may lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects 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 can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ezoleta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the mentioned month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Store in the original packaging to protect 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 packaging and other information

What Ezoleta contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: sodium lauryl sulfate, povidone K30, mannitol, sodium croscarmellose, microcrystalline cellulose type 102, and sodium stearyl fumarate. See section 2, "Ezoleta contains sodium".

What Ezoleta looks like and contents of the pack
White to almost white capsule-shaped tablets with bevelled edges. Tablet dimensions:
8 mm x 4 mm.
Pack sizes:

• 14, 28, 30, 50, 56, 60, 90, 98 and 100 tablets in blister packs within a cardboard box;
• 14 x 1, 28 x 1, 30 x 1, 50 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1 and 100 x 1 tablets in unit dose blisters within a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw, Poland
Tel. 22 57 37 500
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
This medicinal product is authorised in the European Economic Area and in Great Britain (Northern Ireland) under the following names: