Ezetimibe Zentiva

Package leaflet: Information for the patient

Ezetimibe Zentiva 10 mg tablets

Generic medicine
Please read all of this leaflet carefully before you take this medicine because 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ezetimibe Zentiva is and what it is used for

Ezetimibe Zentiva is a medicine used to lower elevated cholesterol levels.
Ezetimibe Zentiva reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. Ezetimibe Zentiva also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Zentiva, works by reducing the absorption of cholesterol by the intestine.
The cholesterol-lowering effect of Ezetimibe Zentiva 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 present in the bloodstream. Total cholesterol consists 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 accumulating in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that may increase the risk of heart disease.
1/6
It is used in patients who cannot control their cholesterol levels by reducing cholesterol through diet alone. You must follow a cholesterol-lowering diet while taking this medicine.
Ezetimibe Zentiva is used in addition to your diet to lower cholesterol levels if you have:

• Elevated blood cholesterol levels (Primary hypercholesterolemia [heterozygous familial and non-familial]), either alone or in combination with a statin, when your cholesterol level is not adequately controlled with a statin alone, or 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 you may additionally be prescribed other medicines.
• An inherited disease (Homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

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

2. What you need to know before taking Ezetimibe Zentiva

If you are taking Ezetimibe Zentiva together with a statin, please read the package leaflet of that specific medicine.
Do not take Ezetimibe Zentiva:

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

Do not take Ezetimibe Zentiva together with a statin:

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

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

• Tell your doctor about all medical conditions you have, including allergies;
• Your doctor should prescribe a blood test before starting treatment with Ezetimibe Zentiva together with a statin. This is to monitor your liver function;
• Your doctor may also ask you to have blood tests to monitor your liver function after you start taking Ezetimibe Zentiva with a statin. Ezetimibe Zentiva is not recommended if you have moderate or severe liver problems.

The safety and efficacy of ezetimibe administered in combination with certain cholesterol-lowering medicines, the fibrates, have not been established.

Children and adolescents
2/6
Do not give this medicine to children and adolescents (6 to 17 years of age) 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 Ezetimibe Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform 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 substance that prevents blood clotting, such as warfarin, fenprocumone, acenocoumarol or fluindione (anticoagulants);
• Colestyramine (also used to lower cholesterol), as it affects how Ezetimibe Zentiva works;
• Fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding
Do not take Ezetimibe Zentiva together with a statin if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking Ezetimibe Zentiva with a statin, stop both treatments immediately and contact your doctor.
There is no experience with the use of ezetimibe without a statin during pregnancy.
Ask your doctor for advice before taking Ezetimibe Zentiva if you are pregnant.
Do not take Ezetimibe Zentiva together with a statin while breastfeeding, as it is not known whether these medicines pass into human milk.
Ezetimibe Zentiva, even when taken alone without a statin, should not be used during breastfeeding. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Ezetimibe Zentiva contains lactose and sodium
Ezetimibe Zentiva tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Ezetimibe Zentiva

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist.

• Before starting to take Ezetimibe Zentiva, you must follow a cholesterol-lowering diet.

3/6

• You must continue this cholesterol-lowering diet while taking Ezetimibe Zentiva.

The dose is one 10 mg tablet of Ezetimibe Zentiva once daily, taken by mouth.
You may take Ezetimibe Zentiva at any time of day. You may take it with or without food.
If your doctor has prescribed Ezetimibe Zentiva together with a statin, both medicines may be taken at the same time. In this case, also refer to the specific dosing instructions provided in the package leaflet of the other prescribed medicine.
If your doctor has prescribed Ezetimibe Zentiva together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing bile acid sequestrants, you must take Ezetimibe Zentiva at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimibe Zentiva than you should
Contact your doctor or pharmacist.

If you forget to take Ezetimibe Zentiva
Do not take a double dose to make up for the missed tablet. Take your usual dose of Ezetimibe Zentiva at your regular time the next day.

If you stop taking Ezetimibe Zentiva
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any further questions about 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.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems – including damage to muscle tissue leading to kidney damage – can be serious and potentially life-threatening.
Allergic reactions have been reported with the usual use of this medicine, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (this requires immediate treatment).

The following side effects have been reported when this medicine was used alone or in combination with a statin:

Common (may affect up to 1 in 10 people):

• Abdominal pain; diarrhoea; flatulence.
• Feeling of tiredness.
• Headache.
• Increase in certain laboratory tests for liver function (transaminases).

Uncommon (may affect up to 1 in 100 people):

• Increases in values of certain laboratory tests or muscle function (CK).
• Cough.
• Indigestion; heartburn; nausea; dry mouth; inflammation of the stomach.
• Joint pain; muscle spasms; neck pain; back pain; pain in arms and legs.
• Loss of appetite.
• Pain; chest pain; unusual tiredness or weakness; swelling, especially in the hands and feet.
• Hot flushes; high blood pressure.
• Itching, rash, hives.
• Tingling sensation.

In addition, the following side effects have been reported with unknown frequency (cannot be estimated from the available data):

• Dizziness.
• Red, raised rash, sometimes with target-like lesions (erythema multiforme).
• Inflammation of the liver, 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).
• Depression.
• Shortness of breath.

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

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 www.agenziafarmaco.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 Ezetimibe Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Do not use this medicine if you notice any visible signs of deterioration.
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 Ezetimibe Zentiva contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.

5/6

• The other ingredients are: Monohydrate lactose, Sodium lauryl sulfate, Povidone K-30 (E1201), Sodium croscarmellose (E468), Magnesium stearate.

Description of the appearance of Ezetimibe Zentiva and the contents of the pack
Ezetimibe Zentiva 10 mg are white, oblong tablets with an approximate width of 8 mm and an approximate thickness of 4 mm, flat on both sides.
PVC/Aclar/PVC – Al foil or PVC/PVDC – Al foil or PVC/PE/PVDC – Al foil blisters.
Pack sizes: 14, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l. Via P. Paleocapa, 7, 20121 Milano
Manufacturer
S.C. Zentiva S.A.
B-dul Theodor Pallady nr.50, sector 3
Bucurest
032266 – Romania
Zentiva, k.s.
U kabelovny 130, Dolní Měcholupy
102 37 Praha 10
Czech Republic

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic, Slovak Republic, Poland: Ezen
Bulgaria: Езен
France, Italy, Denmark, Sweden, Norway: Ezetimibe Zentiva
Germany, Austria: Ezetimib Zentiva
Hungary: Ezetimib-Zentiva
United Kingdom: Ezetimibe
Portugal: Ezetimiba Zentiva
Romania: Cexado
6/6