Package leaflet: Information for the user

Ezetimibe Teva 10 mg tablets

ezetimibe
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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Ezetimibe Teva is and what it is used for
What you need to know before taking Ezetimibe Teva
How to take Ezetimibe Teva
Possible side effects
How to store Ezetimibe Teva
Contents of the pack and other information

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

Ezetimibe Teva is a medicine used to reduce elevated cholesterol levels.
Ezetimibe Teva lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and blood fats known as triglycerides. In addition, Ezetimibe Teva increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Teva, works by reducing the absorption of cholesterol by the digestive system.
The cholesterol-lowering effect of Ezetimibe Teva adds to that provided by statins, a group of medicines that reduce 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. This blockage of blood flow can 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 type of fat in the blood that may increase the risk of heart disease.
This medicine is used for patients who cannot control their cholesterol levels with a cholesterol-lowering diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.
Ezetimibe Teva is used in addition to a cholesterol-lowering diet if you have:

elevated cholesterol levels in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial])
in combination with a statin, when your cholesterol level is not adequately controlled by a statin alone
as monotherapy, when treatment with a statin is not appropriate or not tolerated
an inherited disease (homozygous familial hypercholesterolaemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and other treatments may be administered
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, when used in combination with cholesterol-lowering medicines known as statins, reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisation due to chest pain.
Ezetimibe Teva does not help with weight loss.

2. What you need to know before taking Ezetimibe Teva

If you are taking Ezetimibe Teva together with a statin, read the package leaflet of that specific statin.
DO NOT take Ezetimibe Teva

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

DO NOT take Ezetimibe Teva 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.

Inform your doctor about all your medical conditions, including allergies.
Your doctor must arrange a blood test before starting your treatment with Ezetimibe Teva together with a statin, to check your liver function.
Your doctor may also ask you to have blood tests to monitor your liver function after you have started taking Ezetimibe Teva together with a statin.

If you have moderate or severe liver problems, the use of Ezetimibe Teva is not recommended.
The safety and efficacy of Ezetimibe Teva administered in combination with certain cholesterol-lowering medicines, fibrates, have not been established.
Children and adolescents
This medicine should not be given to children and adolescents aged 6 to 17 years unless prescribed by a specialist, as data on safety and efficacy are limited.
This medicine should not be given to children under 6 years of age, as there is no data available for this age group.
Other medicines and Ezetimibe Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. In particular, inform your doctor if you are taking medicines containing any of the following active substances:

cyclosporine (a medicine often used in organ transplant patients)
medicines containing an active substance that prevents blood clots, such as warfarin, fenprocoumon, acenocoumarol, or fluindione (anticoagulants)
colestyramine (also used to lower cholesterol), as it alters the way Ezetimibe Teva works
fibrates (also used to lower cholesterol)

Ezetimibe Teva with food
Ezetimibe Teva can be taken with or without food.
Pregnancy and breastfeeding
Do not take Ezetimibe Teva 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 together with a statin, you must stop both treatments immediately and contact your doctor.
There is no experience with the use of Ezetimibe Teva without a statin during pregnancy. If you are pregnant, ask your doctor for advice before using Ezetimibe Teva.
Do not take Ezetimibe Teva together with a statin while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Ezetimibe Teva without a statin should not be used during breastfeeding. Ask your doctor for advice.
Ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
Ezetimibe Teva is not expected to affect the ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking Ezetimibe Teva.
Ezetimibe Teva contains lactose
Ezetimibe Teva tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ezetimibe Teva

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 not sure, ask your doctor or pharmacist.

Before starting Ezetimibe Teva, you must follow a cholesterol-lowering diet.
You must continue this cholesterol-lowering diet while taking Ezetimibe Teva.

The recommended dose is one 10 mg Ezetimibe Teva tablet taken once daily by mouth. You may take Ezetimibe Teva at any time of day. You may take the tablets with or without food.
If your doctor has prescribed Ezetimibe Teva together with a statin, both medicines may be taken at the same time. In this case, also refer to the dosing instructions provided in the package leaflet of the specific statin.
If your doctor has prescribed Ezetimibe Teva 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 at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

If you forget to take Ezetimibe Teva:
Do not take a double dose to make up for the forgotten dose. Simply take your usual dose of Ezetimibe Teva at the regular time on the following day.

If you stop taking Ezetimibe Teva:
Contact 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 everyone gets them.
The following terms are used to describe how frequently 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)

If you experience unexplained muscle pain, tenderness or weakness, contact your doctor immediately. This is
because, in rare cases, muscle problems, including damage to muscle tissue leading to kidney damage, can be
serious and potentially life-threatening.
Contact your doctor immediately if you experience allergic reactions, including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing. These effects have been reported with common use of the medicine.

When used alone, the following side effects have been reported:
Common: abdominal pain; diarrhoea; flatulence; feeling of fatigue.
Uncommon: increases in the values of certain laboratory tests indicating liver function (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 used in combination with a statin, the following side effects have been reported:
Common: increases in the values of certain laboratory tests indicating liver function (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 in combination with fenofibrate, the following common side effect has been reported: abdominal pain.

Furthermore, with the usual use of this medicine, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including skin rash and urticaria; raised skin rash with redness, 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 www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Teva contains

The active substance is ezetimibe.
Each tablet contains 10 mg of ezetimibe.
The other components are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, sodium croscarmellose, povidone K 30, sodium lauryl sulfate, anhydrous colloidal silica, stearic acid, poloxamer 407.

Description of the appearance of Ezetimibe Teva and package contents
Ezetimibe Teva tablets are white, biconvex, capsule-shaped, with '10' engraved on one side.
Pack sizes:
Ezetimibe Teva tablets are packaged in blisters made of PVC/ACLAR/PVC-Al or
PVC/PVC/PVDC/PVC/PVC-Al containing 14, 28, 28x1, 30, 30x1, 50, 90, 90x1, 98, 98x1, 100, 105 and 120
tablets, or in HDPE containers with child-resistant PP closure and induction seal, with a silica gel desiccant pack, containing 100 and 105 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, 89143, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb 10000 Croatia