EZETIMIBE 10 mg Tabletka Powlekana

Treść ulotki

1. Ezetimibe Sandoz 10 mg tablets
   1. What is Ezetimibe Sandoz and what is it used for
   2. What you need to know before taking Ezetimibe Sandoz
   3. How to take Ezetimibe Sandoz
   4. Possible side effects
   5. How to store Ezetimibe Sandoz
   6. Package contents and other information

Ezetimibe Sandoz 10 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Ezetimibe Sandoz is a medicine used to reduce increased cholesterol levels.
Ezetimibe Sandoz decreases the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fats called triglycerides in the blood. This medicine also increases the levels of
"good" cholesterol (HDL cholesterol).
Ezetimibe is the active substance of Ezetimibe Sandoz and works by decreasing the absorption of
cholesterol from the intestine.
The effect of Ezetimibe Sandoz is added to the decrease in cholesterol levels due to
statins, a group of medicines that reduce the production of cholesterol by the
body itself.
Cholesterol is one of the various fatty substances present in the blood. Total cholesterol is
mainly composed of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the
walls of the arteries forming plaques. The formation of these plaques can lead to
a narrowing of the arteries. This narrowing can slow down or block the flow of
blood to vital organs such as the heart and brain. Blocking the blood flow can cause
a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the accumulation of
"bad" cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart
disease.
This medicine is used for patients who cannot control cholesterol levels by reducing them with diet alone. You must maintain a low-fat diet
while taking this medicine.
Ezetimibe Sandoz is used in addition to a cholesterol-lowering diet in the case you have:

• an elevated blood cholesterol level (primary hypercholesterolemia [heterozygous familial and non-familial]).
• together with a statin, when your cholesterol level is not adequately controlled with a statin alone
• alone, when treatment with statins is not appropriate or is 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 be prescribed other medicines
• an inherited disease (homozygous sitosterolemia also known as phytosterolemia) that increases phytosterol levels in the blood.

If you have heart disease, this medicine in combination with drugs that lower
cholesterol called statins, reduces the risk of heart attack, stroke, surgery to
increase blood flow to the heart, or hospitalization for chest pain.
Ezetimibe Sandoz does not help you lose weight.

2. What you need to know before taking Ezetimibe Sandoz

specific medicinal product.

DO NOT takeEzetimibe Sandoz

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

DO NOT takeEzetimibe Sandoz together with a statinif:

• you currently have liver problems
• you are pregnantor breastfeeding.

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

• tell your doctor about all medical conditions you have, including allergies;
• your doctor will prescribe a blood test before you start taking this medicine together with a statin. This is to check how well your liver is working;
• your doctor may also ask you to have blood tests to check how your liver is working after you have started taking this medicine together with a statin.

If you have moderate or severe liver problems, the use of Ezetimibe Sandoz is not recommended.
The administration of Ezetimibe Sandoz in combination with fibrates(medicines that
reduce cholesterol) should be avoided because the safety and efficacy of the
combination of Ezetimibe Sandoz with fibrates have not been established.

Contact your doctor immediately if you experience

• unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems, including muscle tissue injury leading to kidney damage, can be serious and potentially life-threatening.

The risk of muscle tissue injury is greater in some patients who take
Ezetimibe Sandoz with medicines that lower cholesterol, such as statins.

Children and adolescents
Do not give this medicine to children and adolescents (aged 6 to 17 years) unless
on the advice of a specialist, because there is limited data on safety and efficacy. Do
not give this medicine to children under 6 years of age, because there is no
information in this age group.

Other medicines and Ezetimibe Sandoz
Tell 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 any of the following medicines:

• cyclosporine (a medicine often used in patients with organ transplant)
• medicines that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (a medicine used to lower cholesterol), as it alters the action of Ezetimibe Sandoz (see section 3)
• fibrates (medicines to reduce cholesterol) (see also section 2: Warnings and precautions).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are trying to become pregnant, or are
breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
Do not take Ezetimibe Sandoz together with a statin if you are pregnant, are trying to
become pregnant, or think you may be pregnant. If you become pregnant while taking Ezetimibe Sandoz together with a statin, you should
stop taking both medicines immediately and contact your doctor.
There is no experience with the use of Ezetimibe Sandoz without a statin in pregnancy.
.
Breastfeeding
Do not take Ezetimibe Sandoz together with a statin while breastfeeding, as it is
not known whether the two medicines are excreted in human milk.
Ezetimibe Sandoz, even if taken without a statin, should not be used during
breastfeeding.
Ask your doctor for advice.

Driving and using machines
Ezetimibe Sandoz is not expected to affect your ability to drive or operate
machinery. However, some people may experience dizziness after taking
Ezetimibe Sandoz. If this happens, do not drive or operate machinery until you feel
better.

Ezetimibe Sandoz contains sodium and lactose
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e.
it is essentially “sodium-free”. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Ezetimibe Sandoz

Take this medicine following the instructions of your doctor exactly. Continue to
take other medicines to reduce cholesterol, unless your doctor tells you to
stop taking them. If you have any doubts, consult your doctor or pharmacist.

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

The recommended dose is one tablet once a day to be taken by mouth.
You can take this medicine at any time of the day and independently
of meals.
If your doctor has prescribed Ezetimibe Sandoz together with a statin, the two medicines
can be taken at the same time. In this case, also read the instructions of
If your doctor has prescribed Ezetimibe Sandoz together with cholestyramine or any other
bile acid sequestrant (medicines to reduce cholesterol), you must take
Ezetimibe Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.

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

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

If you stop taking Ezetimibe Sandoz
Consult your doctor or pharmacist because cholesterol may increase again if you stop
taking this medicine.
If you have any further questions on 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 will experience them.

Contact your doctor immediately if you experience:

• unexplained muscle pain
• muscle tenderness or weakness. This is because, in rare cases, muscle problems, including muscle tissue injury leading to kidney damage, can be serious and potentially life-threatening.

Allergic reactions, including:

• swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• dizziness or fainting and an unusually fast or irregular heartbeat that require immediate medical attention, have been reported with normal use that require immediate medical attention, have been reported with normal use.

Other side effects reported in clinical studies
When these tablets are taken alone, the following side effects have been reported:
Side effects common(may affect up to 1 in 10 people):

• abdominal pain
• diarrhoea
• flatulence
• feeling tired.

Side effects uncommon(may affect up to 1 in 100 people):

• increases in the values of some liver laboratory tests (transaminases) or muscle function (CK)
• cough
• indigestion
• heartburn
• feeling unwell
• joint pain
• muscle spasms
• neck pain
• decreased appetite
• pain
• chest pain
• hot flushes
• high blood pressure.

In addition, when these tablets have been used together with a statin, the following side effects have been reported:
Side effects common(may affect up to 1 in 10 people):

• increases in the values of some liver function laboratory tests (transaminases)
• headache
• muscle pain/tenderness.

Side effects uncommon(may affect up to 1 in 100 people):

• feeling of pins and needles
• dry mouth
• inflammation of the stomach lining
• itching
• skin rash
• urticaria
• back pain
• muscle weakness
• pain in the arms and legs
• unusual fatigue or weakness
• swelling, especially in the hands and feet.

When it has been used together with fenofibrate(for the treatment of high cholesterol), the following side effect has been reported:
Side effect common(may affect up to 1 in 10 people):

• abdominal pain.

In addition, with the general use of the medicine, the following side effects have been reported
(reported after marketing):
Side effects of unknown frequency(frequency cannot be estimated on the basis of available data):

• dizziness
• liver problems
• allergic reactions including skin rash, urticaria, swelling of the face, tongue or throat and fainting
• raised, red skin rash, sometimes with target-like lesions - for example, pink-red ring-shaped lesions around a pale center
• muscle pain/tenderness
• muscle weakness: cramps, stiffness or spasms
• severe muscle pain or weakness and red-brown urine due to muscle tissue injury
• gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting)
• inflammation of the pancreas, often with severe abdominal pain
• constipation
• decreased blood cell count, which can cause bruising/bleeding (thrombocytopenia)
• feeling of pins and needles
• depression
• unusual fatigue or weakness
• shortness of breath.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ezetimibe Sandoz

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 blister, the carton and
the bottle after “Exp”. The expiry date refers to the last day of that month.
Blister: Store in the original package to protect the medicine from moisture.
Bottle: Keep the bottle tightly closed to protect the medicine from moisture.
After first opening: store at a temperature below 25 °C. Use within 9 months.
Do not dispose of any medicine in 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 Sandoz contains

• The active ingredient is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are lactose monohydrate ( see the end of paragraph 2for further information), hypromellose, sodium croscarmellose, microcrystalline cellulose, sodium lauryl sulfate and magnesium stearate.

Description of the appearance of Ezetimibe Sandoz and package contents
Ezetimibe Sandoz tablets are white to off-white, oval (7.4 mm x 4.0
millimeters) with "10" imprinted on one side and "EZT" on the other side.
Alu/Alu blisters:
7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.
HDPE bottle with a polypropylene screw cap: 100 tablets and 250 tablets (for
hospital use and dispensing by the pharmacy only).
Not all pack sizes may be marketed.

Marketing authorization holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
S.C. Sandoz, S.R.L.,Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Austria Ezetimib Sandoz 10 mg - Tablets
Belgium Ezetimibe Sandoz 10 mg tablets
Croatia Ezetimibe Sandoz
Cyprus Ezetimibe Sandoz 10mg
Czech Republic Tezzimi 10mg
Denmark Ezetimib Sandoz
Estonia Kolxip
Finland Ezetimib Sandoz 10 mg tablets
France EZETIMIBE SANDOZ 10 mg, coated tablet
Germany Ezetimib – 1 A Pharma 10 mg Tablets
Greece Ezetimibe/Sandoz Sandoz GmbH
Hungary Ezetimibe Sandoz 10 mg tablet
Italy EZETIMIBE SANDOZ
Latvia Kolxip 10 mg tablets
Lithuania Kolxip 10 mg tabletės
Luxembourg Ezetimib Sandoz 10 mg coated tablets
Malta Ezetimibe 10mg Tablets
Netherlands Ezetimibe Sandoz 10 mg, tablets
Norway Ezetimib Sandoz 10 mg tablets
Poland Tactus
Portugal Ezetimiba Sandoz
Romania EZETIMIB SANDOZ 10 mg coated tablets
Slovak Republic Ezetimibe Sandoz 10 mg
Slovenia Elanix 10 mg tablets
Spain Ezetimiba Sandoz 10 mg coated tablets EFG
Sweden Ezetimib Sandoz 10 mg tablets
United Kingdom Ezetimibe 10mg Tablets