Ezoleta

Package Leaflet: Information for the Patient

Ezoleta, 10 mg, Tablets

Ezetimibe

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

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 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 lower increased cholesterol levels.
Ezoleta reduces the amount of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition, Ezoleta increases the level of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezoleta, reduces the absorption of cholesterol in the gut.
Ezoleta enhances the action of statins, a group of medicines that lower cholesterol produced by 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 called "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 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 found in the blood that can increase the risk of heart disease.
The medicine is used in patients for whom diet alone is not enough to control their 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:

• 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,
• alone, if statin therapy is not suitable or not tolerated;
• a genetic disorder (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels. The patient will be treated with a statin and may be treated with other lipid-lowering therapies;
• a genetic disorder (homozygous sitosterolemia, also known as phytosterolemia) characterized by high levels of plant sterols in the blood.

If you have heart disease, taking Ezoleta 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.
Ezoleta does not help you lose weight.

2. Important information before taking Ezoleta

If you are taking Ezoleta in combination with a statin, read the package leaflet for that statin.

When not to take Ezoleta:

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

When not to take Ezoleta in combination with a statin:

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

Warnings and precautions

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

• Tell your doctor about all your illnesses, including allergies.
• Before starting Ezoleta 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 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 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.

Ezoleta and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might 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 active substances that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulant medicines),
• colestyramine (also used to lower cholesterol levels), as it affects the action of Ezoleta,
• fibrates (also used to lower cholesterol levels).

Ezoleta with food and drink

Ezoleta can be taken with or without food.

Pregnancy and breastfeeding

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

Driving and using machines

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

Ezoleta contains sodium

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

3. How to take Ezoleta

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 tells you otherwise, continue to take any other cholesterol-lowering medicines you are currently taking. If you are in doubt, consult your doctor or pharmacist.

• Before starting Ezoleta, follow a cholesterol-lowering diet.
• While taking Ezoleta, follow a cholesterol-lowering diet.

The recommended dose is one Ezoleta tablet, once a day, 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 and a statin, you can take both medicines at the same time. In this case, read the dosing instructions in the package leaflet for the statin.
If your doctor has prescribed Ezoleta and another cholesterol-lowering medicine containing colestyramine or any other bile acid sequestrant, take Ezoleta at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezoleta than you should

Contact your doctor or pharmacist.

If you forget to take Ezoleta

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

If you stop taking Ezoleta

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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and life-threatening.

This is 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 ezetimibe alone:
Common (may affect up to 1 in 10 people):abdominal pain; diarrhea; bloating with gas; feeling tired.
Uncommon (may affect up to 1 in 100 people):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, the following side effects have been reported in patients taking ezetimibe in combination with a statin:
Common (may affect up to 1 in 10 people):increased levels of some liver enzymes in the blood; headache; muscle pain, tenderness, or weakness.
Uncommon (may affect up to 1 in 100 people):tingling sensation; dry mouth; itching; rash; hives; back pain; muscle weakness; pain in the arms and legs; unexplained tiredness or weakness; swelling, especially of the hands and feet.
The following side effect has been reported in patients taking ezetimibe in combination with fenofibrate:
Common (may affect up to 1 in 10 people):abdominal pain.
In addition, the following side effects have been reported during normal use (frequency not known):
dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; a red, raised rash, sometimes in a butterfly shape (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; decreased platelet count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unexplained tiredness or weakness; shortness of breath.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Contact" section below.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezoleta

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 packaging after "EXP". The expiry date refers to the last day of that month.
The batch number is stated on the packaging after "Lot".
Store in the original package to protect from moisture.
Medicines should 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 Ezoleta contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: sodium lauryl sulfate, povidone K30, mannitol, croscarmellose sodium, 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 beveled edges. Tablet dimensions: 8 mm x 4 mm.

Packaging:

• 14, 28, 30, 50, 56, 60, 90, 98, and 100 tablets in blisters in 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 tablet in single-dose blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, contact your local representative of the Marketing Authorization Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
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 medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the package leaflet: 23.11.2023