Ezetrol

Patient Information Leaflet

EZETROL 10 mg tablets

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What EZETROL is and what it is used for
2. What you need to know 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 reduce elevated levels of cholesterol.
EZETROL lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. EZETROL also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient in EZETROL, works by reducing the absorption of cholesterol in the gastrointestinal tract.
The cholesterol-lowering effect of EZETROL adds to that provided by statins, a group of medicines that work by reducing the body's own production of cholesterol.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Such blockage of blood flow may cause a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
It is used for patients who cannot control their cholesterol levels by reducing cholesterol through diet alone. You must follow a cholesterol-lowering diet while taking this medicine.
EZETROL is used in addition to your cholesterol-lowering diet if you have:

• elevated cholesterol levels in the blood (primary hypercholesterolemia [heterozygous familial and non-familial])
• in combination with a statin, when your cholesterol level is not adequately controlled with a statin alone
• alone, when treatment with statins is not appropriate or not tolerated
• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and possibly another treatment
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you have heart disease, EZETROL in combination with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalization due to chest pain.
EZETROL does not help with weight loss.

2. What you need to know before taking EZETROL

If EZETROL has been prescribed together with a statin, please read the package leaflet of that specific prescribed medicine.

Do not take EZETROL if:

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

Do not take EZETROL together with a statin if:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking EZETROL.

• Inform your doctor about all medical conditions you have, including allergies.
• Your doctor should prescribe a blood test before starting treatment with EZETROL together with a statin, to check how your liver is functioning.
• Your doctor may also ask you to have blood tests to monitor liver function after you start taking EZETROL together with a statin.

If you have moderate or severe liver problems, use of EZETROL is not recommended.
The safety and efficacy of EZETROL when administered 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 prescribed by a specialist, as there is limited data on safety and efficacy.
Do not give this medicine to children under 6 years of age, as there is no information available for this age group.

Other medicines and EZETROL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor if you are taking a medicine containing any of the following active substances:

• cyclosporine (often used in patients who have had an organ transplant)
• medicines containing an active ingredient that prevents blood clotting, such as warfarin, fenprocumone, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (also used to reduce cholesterol), as it alters the effectiveness of EZETROL
• fibrates (also used to reduce cholesterol).

Pregnancy and breastfeeding
Do not take EZETROL together with a statin if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. If you become pregnant while taking EZETROL together with a statin, stop both treatments immediately and contact your doctor.
There is no experience with the use of EZETROL without a statin during pregnancy. If you are pregnant, consult your doctor for appropriate advice before using EZETROL.
Do not take EZETROL together with a statin if you are breastfeeding, as it is unknown whether these medicines are excreted in human milk. EZETROL, even when taken alone without a statin, must not be used during breastfeeding. Consult your doctor for appropriate advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
EZETROL is not expected to affect the ability to drive or use machines. However, you should be aware that some people may experience dizziness after taking EZETROL.

EZETROL contains lactose
EZETROL tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

EZETROL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take EZETROL

Take this medicine exactly as your doctor has told you. Continue taking your other cholesterol-lowering medicines unless your doctor tells you otherwise. If you are unsure, consult your doctor or pharmacist.

• Before starting to take EZETROL, you must follow a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking EZETROL.

The recommended dose is one 10 mg EZETROL tablet once daily, taken by mouth.
You can take EZETROL at any time of day, with or without food.
If your doctor has prescribed EZETROL together with a statin, the two medicines may be taken at the same time. In this case, refer to the specific dosing instructions provided in the

Patient Information Leaflet of the Other Prescribed Medication

If your doctor has prescribed EZETROL together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing bile acid sequestrants, you must 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 the missed tablet. Simply resume your usual dose of EZETROL at the regular time the next day.
If you stop taking EZETROL
Consult your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe how often the side effects have been reported:

• 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.
This is because, in rare cases, muscle problems, including muscle tissue damage, may lead to
kidney damage, which can be serious and potentially life-threatening.
With regular use of the medicine, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment).

When used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of tiredness.
Uncommon: increases in values of certain liver laboratory tests (transaminases) or muscle function (CK); cough; indigestion; heartburn; nausea; joint pain; muscle spasms; neck pain; decreased appetite; pain; chest pain; hot flushes; high blood pressure.

Additionally, when the medicine is used together with a statin, the following side effects have been reported:
Common: increases in values of certain liver function laboratory tests (transaminases); headache; muscle pain, tenderness or weakness.
Uncommon: tingling sensation; dry mouth; itching; rash; urticaria; back pain; muscle weakness; pain in arms and legs; unusual tiredness or weakness; swelling, especially of the hands and feet.

When used together with fenofibrate, the following common side effect has been reported:
abdominal pain.

Furthermore, with general use of the medicine, the following side effects have been reported: dizziness; muscle aches; liver problems; allergic reactions including rash and urticaria; raised red rash, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or weakness; muscle tissue damage; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the pancreas often accompanied by severe abdominal pain; constipation; reduction in blood cell count, which may cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 container 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 container.
Bottles: keep bottles tightly closed. These measures will help protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EZETROL contains

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

Description of the appearance of EZETROL and contents of the pack
EZETROL tablets are white/white-tinged, capsule-shaped, with "414" engraved on one side.
Pack sizes:
7, 10, 14, 20, 28, 30, 50, 98, 100 or 300 tablets in press-through blisters or unit-dose blisters with peelable lid;
84 or 90 tablets in press-through blisters;
50, 100 or 300 tablets in unit-dose press-through blisters;
100 tablets in bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy

Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorized under the name EZETROL in 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.