EZETIMIBE ARISTO

Package leaflet: Information for the patient

Ezetimibe Aristo 10 mg tablets

Ezetimibe
Generic medicine
Please read this entire 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ezetimibe Aristo is a medicine used to reduce elevated cholesterol levels.
Ezetimibe Aristo lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. Ezetimibe Aristo also increases levels of "good" cholesterol (HDL cholesterol).
Ezetimibe, the active substance in Ezetimibe Aristo, works by reducing the absorption of cholesterol by the digestive system.
The cholesterol-lowering effect of Ezetimibe Aristo adds to that provided by statins, a group of medicines that work by reducing the body's own cholesterol production.
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 form of fat in the blood that may increase the risk of heart disease.
It is used for 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 Aristo 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 cholesterol is not adequately controlled with a statin alone;
• alone, when treatment with statins is not appropriate or not tolerated. Page 1 of 6
• an inherited disease (homozygous familial hypercholesterolaemia) that increases cholesterol levels in the blood. You will also be prescribed a statin, and you may receive additional treatments.
• an inherited disease (homozygous sitosterolaemia, also known as phytosterolaemia) that increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Aristo, when used in combination with statins (cholesterol-lowering medicines), reduces the risk of heart attack, stroke, surgical procedures to improve blood flow to the heart, or hospitalisation due to chest pain.
Ezetimibe Aristo does not help with weight loss.

2. What you need to know before taking Ezetimibe Aristo

If Ezetimibe Aristo is taken together with a statin, please read the package leaflet of that specific medicine.

Do not take Ezetimibe Aristo

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

Do not take Ezetimibe Aristo 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 Aristo.

• Inform your doctor about all medical conditions you have, including allergies.
• Your doctor should order a blood test before you start treatment with Ezetimibe Aristo together 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 during treatment with Ezetimibe Aristo in combination with a statin. If you have moderate or severe liver problems, the use of Ezetimibe Aristo is not recommended. The safety and efficacy of combining Ezetimibe Aristo with fibrates, medicines that reduce cholesterol, have not been established.

Children and adolescents
Do not give this medicine to children and adolescents (between 6 and 17 years of age) unless specifically advised 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 available data in this age group.

Other medicines and Ezetimibe Aristo
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:

• cyclosporine (often used in organ transplant patients)
• medicines containing an active ingredient that prevents blood clotting, such as warfarin, fenprocumone, acenocoumarol, or fluindione (anticoagulants)
• colestyramine (also used to lower cholesterol), as it may alter the effect of Ezetimibe Aristo
• fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding
Do not take Ezetimibe Aristo together with a statin if you are pregnant, planning a pregnancy, or suspect you may be pregnant. If you become pregnant while taking Ezetimibe Aristo together with a statin, stop both treatments immediately and contact your doctor.
There is no experience with the use of Ezetimibe Aristo without a statin during pregnancy. If you are pregnant, consult your doctor for advice before taking Ezetimibe Aristo.
Do not take Ezetimibe Aristo together with a statin while breastfeeding, as it is not known whether these medicines are excreted in breast milk.
Ezetimibe Aristo, even when taken alone without a statin, should not be used during breastfeeding. Consult your doctor for advice.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ezetimibe Aristo 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 Aristo.

Ezetimibe Aristo contains lactose
Ezetimibe Aristo tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Ezetimibe Aristo

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 unsure, consult your doctor or pharmacist.

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

The recommended dose is one 10 mg tablet of Ezetimibe Aristo taken once daily by mouth. You may take Ezetimibe Aristo at any time of day. The tablet may be taken with or without food.
If your doctor has prescribed Ezetimibe Aristo together with a statin, the two medicines may be taken at the same time. In this case, refer to the dosing instructions provided in the package leaflet of that specific medicine.
If your doctor has prescribed Ezetimibe Aristo together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take Ezetimibe Aristo at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Ezetimibe Aristo than you should
Contact your doctor or pharmacist.
If you forget to take Ezetimibe Aristo
Do not take a double dose to make up for the missed tablet. Take your usual dose of Ezetimibe Aristo at the usual time on the following day.
If you stop taking Ezetimibe Aristo
Consult 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 everyone gets them.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or muscle weakness.
This is because, in rare cases, muscle problems, including damage to muscle tissue leading to kidney damage,
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can be serious and potentially life-threatening.
Allergic reactions have been reported with the common use of this medicine, including swelling of the face,
lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate treatment).

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 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 this medicine has been used together with a statin, the following side effects have been reported:
Common: may affect up to 1 in 10 people

• increases in blood test values indicating liver function (transaminases)
• headache
• muscle pain, tenderness or muscle 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 of the hands and feet

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

• abdominal pain

Additionally, with the usual use of this medicine, the following side effects have been reported:
dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised red rash, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness or muscle weakness; muscle tissue damage; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); inflammation of the
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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/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 Aristo

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 carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Do not store above 25°C.
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 Aristo contains
The active substance is ezetimibe.
The other components are:

• monohydrate lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, colloidal anhydrous silica, magnesium stearate

Description of the appearance of Ezetimibe Aristo and package contents
Ezetimibe Aristo 10 mg tablets are white to off-white, round in shape.
Ezetimibe Aristo 10 mg is available in packs containing 14, 28, 30, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Ezetimib Aristo 10 mg Tabletten
Finland Ezetimib Aristo 10 mg tabletti
Germany Ezetimib Aristo 10 mg Tabletten
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Italy Ezetimibe Aristo Aristo
Netherlands Ezetimibe Aristo 10 mg tabletten
Norway Ezetimib Aristo
Poland Ezetymib Aristo
Portugal Ezetimiba Aristo
Spain Ezetimiba Aristo 10 mg comprimidos EFG
Sweden Ezetimib Aristo 10 mg tabletter
United Kingdom Ezetimibe Aristo 10 mg tablets
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