Ezetimibe Sandoz

Package leaflet: Information for the user

Ezetimibe Sandoz 10 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including 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 taking 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 Ezetimibe Sandoz is and what it is used for

Ezetimibe Sandoz is a medicine used to reduce elevated cholesterol levels.
Ezetimibe Sandoz lowers total cholesterol levels, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. This medicine also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe is the active substance in Ezetimibe Sandoz and works by reducing the absorption of cholesterol from the intestine.
The effect of Ezetimibe Sandoz adds to the cholesterol-lowering effect provided by statins, a group of medicines that reduce cholesterol production in the body.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Plaque formation 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. Blockage of blood flow can cause a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the buildup of "bad" cholesterol 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.
This medicine is used for patients who cannot control their cholesterol levels by diet alone. You must continue to follow a low-fat diet while taking this medicine.
Ezetimibe Sandoz is used in addition to diet to lower cholesterol levels when you have:

• elevated blood cholesterol levels (primary hypercholesterolemia [heterozygous familial and non-familial]).
• in combination with a statin, when your cholesterol levels are 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 other medicines may be prescribed as well
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of phytosterols in the blood.

If you have heart disease, this medicine, in combination with cholesterol-lowering medicines 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 with weight loss.

2. What you need to know before taking Ezetimibe Sandoz

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

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

DO NOT take Ezetimibe Sandoz 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 Sandoz.

• Discuss with your doctor all medical conditions you have, including allergies;
• your doctor will order a blood test before you start taking this medicine with a statin, to check how well your liver is functioning;
• your doctor may also ask you to have blood tests to monitor liver function after you begin taking this medicine with a statin.

If you have moderate or severe liver problems, the use of Ezetimibe Sandoz is not recommended.
The concomitant use of Ezetimibe Sandoz with fibrates (medicines that reduce cholesterol) should be avoided, as the safety and efficacy of combining 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 damage to muscle tissue that may lead to kidney damage—can be serious and potentially life-threatening.

The risk of muscle tissue damage is higher in some patients taking Ezetimibe Sandoz together with cholesterol-lowering medicines such as statins.
Children and adolescents
Do not give this medicine to children and adolescents (aged 6 to 17 years) unless specifically 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 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 organ transplant patients)
• medicines that prevent blood clotting, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (a medicine used to lower cholesterol), as it may interfere with the action of Ezetimibe Sandoz (see section 3)
• fibrates (medicines to lower cholesterol) (see also section 2: Warnings and precautions).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ezetimibe Sandoz together with a statin if you are pregnant, trying to become pregnant, or think you could be pregnant. If you become pregnant while taking Ezetimibe Sandoz together with a statin, stop taking both medicines immediately and contact your doctor.
There is no experience with the use of Ezetimibe Sandoz without a statin during pregnancy.
Breastfeeding
Do not take Ezetimibe Sandoz together with a statin while breastfeeding, as it is not known whether both medicines pass into human milk.
Ezetimibe Sandoz, even when taken without a statin, should not be used during breastfeeding.
Consult your doctor for advice.
Driving and use of 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 occurs, 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 your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Ezetimibe Sandoz

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

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

The recommended dose is one tablet once daily, taken by mouth.
You may take this medicine at any time of day, with or without food.
If your doctor has prescribed Ezetimibe Sandoz together with a statin, both medicines may be taken at the same time. In this case, also read the dosing instructions provided in the package leaflet of the other medicine.
If your doctor has prescribed Ezetimibe Sandoz together with colestyramine or any other bile acid sequestrant (medicines used to lower 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 the missed tablet. Take your usual dose of Ezetimibe Sandoz at the usual time the next day.

If you stop taking Ezetimibe Sandoz
Talk to your doctor or pharmacist, as your cholesterol levels may rise again if you stop taking this medicine.

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.
Contact your doctor immediately if you experience:

• unexplained muscle pain
• muscle tenderness or weakness. This is because, in rare cases, muscle problems—including damage to muscle tissue that may lead 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
• dizziness or fainting and unusually fast or irregular heartbeat, which require immediate treatment, have been reported during normal use.

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

• abdominal pain
• diarrhoea
• flatulence
• feeling of tiredness.

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

• increases in blood test values indicating liver function (transaminases) or muscle function (CK)
• cough
• indigestion
• heartburn
• feeling unwell
• joint pain
• muscle spasms
• neck pain
• loss of appetite
• pain
• chest pain
• hot flushes
• high blood pressure.

Additionally, when these tablets were used together with a statin, the following side effects were reported:
Common side effects (may affect up to 1 in 10 people):

• increases in blood test values indicating liver function (transaminases)
• headache
• muscle pain/tenderness.

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

• tingling sensation
• dry mouth
• inflammation of the stomach lining
• itching
• rash
• hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual tiredness or weakness
• swelling, especially in hands and feet.

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

• abdominal pain.

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

• dizziness
• liver problems
• allergic reactions including rash, hives, swelling of the face, tongue or throat, and fainting
• raised red rash, sometimes with target-like lesions – for example, pink-red rings around a pale center
• muscle pain/tenderness
• muscle weakness: cramps, stiffness, or spasms
• severe muscle pain or weakness and red-brown coloured urine due to muscle tissue damage
• 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.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, on the carton, and on the bottle after "Exp". The expiry date refers to the last day of that month.
Blister: Store in the original packaging to protect the medicine from moisture.
Bottle: Keep the bottle tightly closed to protect the medicine from moisture.
After first opening: store below 25 °C. Use within 9 months.
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 Sandoz contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are monohydrate lactose (see the end of section 2 for 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-shaped (7.4 mm x 4.0 millimetres), with "10" engraved 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 tablets (hospital pack).
HDPE bottle with polypropylene screw cap: 100 tablets and 250 tablets (for hospital use only and pharmacy dispensing only).
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Austria Ezetimib Sandoz 10 mg - Tabletten
Belgium Ezetimibe Sandoz 10 mg tabletten
Croatia Ezetimibe Sandoz
Cyprus Ezetimibe Sandoz 10mg
Czech Republic Tezzimi 10mg
Denmark Ezetimib Sandoz
Estonia Kolxip
Finland Ezetimib Sandoz 10 mg tabletti
France EZETIMIBE SANDOZ 10 mg, comprimé
Germany Ezetimib – 1 A Pharma 10 mg Tabletten
Greece Ezetimibe/Sandoz Sandoz GmbH
Hungary Ezetimibe Sandoz 10 mg tabletta
Italy EZETIMIBE SANDOZ
Latvia Kolxip 10 mg tabletes
Lithuania Kolxip 10 mg tabletės
Luxembourg Ezetimib Sandoz 10 mg comprimés
Malta Ezetimibe 10mg Tablets
Netherlands Ezetimibe Sandoz 10 mg, tabletten
Norway Ezetimib Sandoz 10 mg tabletter
Poland Tactus
Portugal Ezetimiba Sandoz
Romania EZETIMIB SANDOZ 10 mg comprimate
Slovak Republic Ezetimibe Sandoz 10 mg
Slovenia Elanix 10 mg tablete
Spain Ezetimiba Sandoz 10 mg comprimidos EFG
Sweden Ezetimib Sandoz 10 mg tabletter
United Kingdom Ezetimibe 10mg Tablets