EZETIMIBE 10 mg Tablets

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1. Ezetimibe Aristo 10 mg tablets
   1. What is Ezetimibe Aristo and what is it 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. Package Contents and Other Information

Ezetimibe Aristo 10 mg tablets

Ezetimibe

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 Aristo is and what it is used for
• 2. What you need to know before you take 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 is Ezetimibe Aristo and what is it used for

Ezetimibe Aristo is a medicine to reduce increased cholesterol levels.
Ezetimibe Aristo decreases the levels of total cholesterol, “bad” cholesterol (LDL cholesterol) and fats, called triglycerides, in the blood. Ezetimibe Aristo also increases the levels of “good” cholesterol (HDL cholesterol).
Ezetimibe, the active ingredient of Ezetimibe Aristo, works by decreasing the absorption of cholesterol by the digestive system.
The decrease in cholesterol levels due to Ezetimibe Aristo is added to that due to statins, a group of medicines that work by reducing the production of cholesterol by the body itself.
Cholesterol is one of the various fatty substances found in the bloodstream. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can accumulate in the walls of the arteries forming plaques. Over time, this accumulation in the form of plaque 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. 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 accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat present in the blood that can increase the risk of heart disease.
It is used for patients who cannot control cholesterol levels by reducing cholesterol levels with diet alone.
You must follow a diet to reduce cholesterol during therapy with this medicine.
Ezetimibe Aristo is used in addition to a cholesterol-lowering diet in cases where you have:

• an increased level of cholesterol in the blood (primary hypercholesterolemia [heterozygous familial and non-familial]);
• together with a statin, when cholesterol is not adequately controlled with a statin alone;
• alone, when treatment with statins is not appropriate or is not tolerated. Page 1of 6
• an inherited disease (homozygous familial hypercholesterolemia) that increases cholesterol levels in the blood. You will also be prescribed a statin and you may be given other treatments.
• an inherited disease (homozygous sitosterolemia, also known as phytosterolemia) that increases levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Aristo in combination with statins, medicines that lower cholesterol, reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.
Ezetimibe Aristo does not help with weight loss.

2. What you need to know before taking Ezetimibe Aristo

medicinal product.

Do not take Ezetimibe Aristo

• if you are allergic (hypersensitive) to ezetimibe or to any of the other ingredients of this medicinal product (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.

• Tell your doctor about all medical conditions you have, including allergies.
• Your doctor may prescribe a blood test before starting therapy with Ezetimibe Aristo together with a statin. This is to check the function of your liver.
• Your doctor may ask you to have blood tests to check how your liver is functioning even after starting therapy with Ezetimibe Aristo together with a statin. If you have moderate or severe liver problems, the use of Ezetimibe Aristo is not recommended. The safety and efficacy of the combined use of 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) unless directed by a
specialist as there are limited data on safety and efficacy. Do not give this medicine to
children under 6 years of age as no data are available in this age group.

Other medicines and Ezetimibe Aristo
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 medicines containing one of the following
active substances:

• cyclosporine (often used in patients undergoing organ transplantation)
• medicines based on an active substance that prevents blood clotting, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants)
• cholestyramine (also used to reduce cholesterol), as it alters the action of Ezetimibe Aristo
• fibrates (also used to reduce cholesterol).

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

Driving and using machines
No effects of Ezetimibe Aristo on the ability to drive or operate machinery are expected. However,
you should take into account that some people may experience dizziness after taking
Ezetimibe Aristo.

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

3. How to take Ezetimibe Aristo

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

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

The recommended dose is one 10 mg tablet of Ezetimibe Aristo once a day to be taken by mouth. Take Ezetimibe Aristo at any time of the day. You can take the tablet independently of meals.

If your doctor has prescribed Ezetimibe Aristo together with a statin, the two medicines can be taken at different times of the day, as directed by your doctor for that specific medicine.

If your doctor has prescribed Ezetimibe Aristo together with another medicine to reduce cholesterolcontaining the active ingredient 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 a missed tablet, but take the usual dose of Ezetimibe Aristo at the usual time the next day.

If you stop taking Ezetimibe Aristo
Contact your doctor or pharmacist because your cholesterol may increase again.
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 everybody gets them.
manifest them.

Contact your doctor immediately in case of unexplained muscle pain, tenderness or muscle weakness.
This is because, in rare cases, muscle problems, including muscle tissue injury
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muscle tissue that results in 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 (which requires
immediate treatment) have been reported with common use of the medicine.
When used alone, the following side effects have been reported:

Common: may affect up to 1 in 10 people

• abdominal pain
• diarrhea
• flatulence
• feeling tired

Uncommon: may affect up to 1 in 100 people

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

In addition, the following side effects have been reported when the medicine has been used together with a statin:

Common: may affect up to 1 in 10 people

• increases in the values of some liver function (transaminases) laboratory tests
• headache
• muscle pain, tenderness or muscle weakness

Uncommon: may affect up to 1 in 100 people

• feeling of pins and needles
• dry mouth
• itching
• skin rash
• hives
• back pain
• muscle weakness
• pain in arms and legs
• unusual tiredness or weakness
• swelling, especially of the hands and feet.

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

• abdominal pain

In addition, with the usual use of the medicine, the following side effects have been reported:
dizziness; muscle pain; liver problems; allergic reactions including skin rash and
hives; raised, red skin lesions, sometimes with target-like lesions (erythema multiforme);
muscle pain, tenderness or muscle weakness; muscle tissue injury; gallstones or
inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); inflammation of the
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pancreas often accompanied by severe abdominal pain; constipation; reduced number of blood
cells, which can cause bruising/bleeding (thrombocytopenia); feeling of pins and needles; depression;
unusual tiredness or weakness; shortness of breath.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 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 package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture. Do not store at
a temperature above 25°C
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 Aristo Contains
The active ingredient is ezetimibe
The other ingredients are:

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

Description of the Appearance of Ezetimibe Aristo and Package Contents
Ezetimibe Aristo 10 mg tablets are white to off-white, round.
Ezetimibe Aristo 10 mg is available in packs of 14, 28, 30, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria Ezetimib Aristo 10 mg Tablets
Finland Ezetimib Aristo 10 mg tablets
Germany Ezetimib Aristo 10 mg Tablets
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Italy Ezetimibe Aristo Aristo
Netherlands Ezetimibe Aristo 10 mg tablets
Norway Ezetimib Aristo
Poland Ezetymib Aristo
Portugal Ezetimiba Aristo
Spain Ezetimiba Aristo 10 mg comprimidos EFG
Sweden Ezetimib Aristo 10 mg tablets
United Kingdom Ezetimibe Aristo 10 mg tablets
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