Ezetimibe Teva Italia

Package leaflet: Information for the patient

Ezetimibe Teva Italia 10 mg tablets

Generic medicine
Please read this leaflet carefully before taking 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Ezetimibe Teva Italia is and what it is used for

Ezetimibe Teva Italia is a medicine used to reduce elevated cholesterol levels.
Ezetimibe Teva Italia lowers levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fats called triglycerides in the blood. In addition, Ezetimibe Teva Italia increases levels of “good” cholesterol (HDL cholesterol).
Ezetimibe Teva Italia works by reducing the absorption of cholesterol in the digestive tract.
The cholesterol-lowering effect of Ezetimibe Teva Italia adds to that provided by statins, a group of medicines that reduce cholesterol produced by the body.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of arteries, forming plaques. Over time, this plaque 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. This blockage of blood flow may 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 in the blood that may increase the risk of heart disease.
It is used in patients who cannot control their cholesterol levels through diet alone. Follow a cholesterol-lowering diet while taking this medicine.
Ezetimibe Teva Italia is used in addition to diet if you have:

• elevated blood cholesterol levels (primary hypercholesterolaemia [heterozygous familial and non-familial]) together with a statin, when your cholesterol level is not adequately controlled by a statin alone, or Ezetimibe Teva Italia is used alone when treatment with a statin is inappropriate or not tolerated.
• an inherited disease (homozygous familial hypercholesterolaemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and may receive additional therapy.
• an inherited disease (homozygous sitosterolaemia, also known as phytosterolaemia) that increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Teva Italia, in combination 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.
Ezetimibe Teva Italia does not help with weight loss.

2. What you need to know before taking Ezetimibe Teva Italia

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

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

Do not take Ezetimibe Teva Italia 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 Ezetimibe Teva Italia.

• Inform your doctor about your medical condition, including any allergies
• Your doctor will perform blood tests before you start taking Ezetimibe Teva Italia with a statin. These tests are to check how well your liver is functioning
• Your doctor may also perform blood tests after you have started taking Ezetimibe Teva Italia with a statin to monitor your liver function

If you have moderate or severe liver problems, Ezetimibe Teva Italia is not recommended.
The safety and efficacy of combining Ezetimibe Teva Italia with fibrates, medicines that lower cholesterol, have not been established.
Children and adolescents
Do not give this medicine to children and adolescents aged between 6 and 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 Ezetimibe Teva Italia
Inform 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 medicines containing any of the following active substances:

• ciclosporin (often 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)
• colestyramine (also used to lower cholesterol), as it affects the mechanism of action of Ezetimibe Teva Italia
• fibrates (also used to lower cholesterol)

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ezetimibe Teva Italia together with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimibe Teva Italia with a statin, stop taking both medicines immediately and inform your doctor. There is no experience with the use of Ezetimibe Teva Italia without a statin during pregnancy. Consult your doctor before taking Ezetimibe Teva Italia without a statin during pregnancy. Ask your doctor for advice before taking Ezetimibe Teva Italia if you are pregnant.
Do not take Ezetimibe Teva Italia with a statin while breastfeeding, as it is not known whether the medicines pass into breast milk. Do not take Ezetimibe Teva Italia without a statin while breastfeeding. Ask your doctor for advice.
Driving and using machines
Ezetimibe Teva Italia is not expected to affect your ability to drive or use machines.
However, bear in mind that some people may experience dizziness after taking Ezetimibe Teva Italia.
Ezetimibe Teva Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Ezetimibe Teva Italia

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

• Before starting treatment with Ezetimibe Teva Italia, you must follow a cholesterol-lowering diet.
• Continue the diet while taking Ezetimibe Teva Italia.

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

If you take more Ezetimibe Teva Italia than you should:
Inform your doctor or pharmacist.

If you forget to take Ezetimibe Teva Italia:
Do not take a double dose to make up for the missed tablet. Take your next dose at the usual time the following day.

If you forget to take Ezetimibe Teva Italia:
Inform your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use 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.
Stop taking Ezetimibe Teva Italia and contact your doctor or go immediately to the nearest
emergency room if you experience any of the following symptoms:

• Unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems, including muscle breakdown leading to kidney damage, can be serious and potentially life-threatening.
• Allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing.

When used alone, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• abdominal pain, diarrhoea, flatulence
• feeling of fatigue

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

• increases in blood test values related to liver function (transaminases) and/or muscle function (CK)
• cough
• indigestion, heartburn
• nausea
• joint pain, muscle spasms, neck pain
• pain
• chest pain
• decreased appetite
• hot flushes
• high blood pressure

In addition, when used in combination with a statin, the following side effects have been reported:
Common (may affect up to 1 in 10 people):

• increases in blood test values of liver function (transaminases)
• 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 arms and legs
• unusual tiredness or weakness
• swelling, especially in hands and feet

When used in combination with fenofibrate, the following common side effects have been reported (may affect
up to 1 in 10 people):

• abdominal pain.

In addition, with general use of the medicine, the following side effects have been reported:

• dizziness
• muscle pain
• liver problems
• allergic reactions including rash and hives, red raised rash sometimes with target-like lesions (erythema multiforme)
• muscle pain, tenderness or weakness, muscle breakdown
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often with severe abdominal pain
• constipation
• reduction in blood cell counts, 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 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 Ezetimibe Teva Italia

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.
No special storage conditions required.
Do not dispose of medicines 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 Teva Italia contains
The active substance in Ezetimibe Teva Italia is ezetimibe. Each 10 mg tablet of Ezetimibe Teva Italia contains 10 mg of ezetimibe.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, hypromellose and crospovidone.

Description of the appearance of Ezetimibe Teva Italia and contents of the pack
Ezetimibe Teva Italia 10 mg tablets are capsule-shaped, white to off-white tablets measuring 8 mm x 4 mm, marked "713" on one side and flat on the other.
Ezetimibe Teva Italia is available in blisters with push-through packaging.
Pack size:
Blister pack: 30 tablets.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.,
Dupnitsa 2600
Bulgaria
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR)
Italy
Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This Patient Information Leaflet was last revised in: February 2026