Package Insert: Information for the User

Ezetimiba Aristo 10 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Ezetimibe Aristo is a medication to reduce elevated levels of cholesterol.

Ezetimibe reduces total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides that circulate in the blood. Additionally, ezetimibe increases concentrations of "good" cholesterol (high-density lipoprotein, HDL).

Ezetimibe, the active ingredient of Ezetimibe Aristo, acts by reducing the cholesterol absorbed in the digestive tract.

Ezetimibe Aristo adds to the effect of lowering cholesterol of statins, a group of medications that reduce cholesterol produced by the body itself.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to prevent the accumulation of bad cholesterol in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of heart disease.

It is used in patients who cannot control their cholesterol levels solely with a cholesterol-lowering diet. While taking this medication, you must follow a cholesterol-lowering diet.

Ezetimibe Aristo is used in combination with a cholesterol-lowering diet if you have:

• Elevated cholesterol levels in the blood (primary hypercholesterolemia [familial heterozygous and non-familial])

• junto with a statin, when your cholesterol level is not well controlled with a statin alone.
• solo, when statin treatment is inappropriate or not tolerated.

• A hereditary disease (familial homozygous hypercholesterolemia), which increases the level of cholesterol in the blood. You will also be prescribed a statin and may also be prescribed other treatments.
• A hereditary disease (familial sitosterolemia, also known as phytosterolemia), which increases the levels of plant sterols in the blood.

If you have cardiovascular disease, ezetimibe combined with medications to lower cholesterol called statins, reduces the risk of myocardial infarction, stroke, coronary artery bypass surgery, or hospitalization for chest pain.

Ezetimibe Aristo does not help you lose weight.

If you take Ezetimiba Aristo with a statin, please read the leaflet for that medicine.

Do not take Ezetimiba Aristo if:

• You are allergic to ezetimiba or any of the other ingredients in this medicine (listed in section 6).

Do not take Ezetimiba Aristo with a statin if:

• You currently have liver problems.
• You are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ezetimiba Aristo.

• Inform your doctor of all your medical conditions, including allergies.
• Your doctor will make a blood test before you start taking ezetimiba with a statin. This is to check that your liver is in good condition.
• Your doctor may also want to make blood tests to check your liver again after you start taking ezetimiba with a statin.

If you have moderate or severe liver problems, Ezetimiba Aristo is not recommended.

The safety and efficacy of using ezetimiba with certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not administer this medicine to children and adolescents (6 to 17 years old) unless prescribed by a specialist, as the safety and efficacy data are limited.

Do not administer this medicine to children under 6 years old as there is no information available for this age group.

Taking Ezetimiba Aristo with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

• Ciclosporin (often used in organ transplant patients).
• Medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• Colestiramine (also used to lower cholesterol), as it affects how it works.
• Ezetimiba.
• Fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ezetimiba with a statin if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking ezetimiba with a statin, stop taking both medicines immediately and inform your doctor.

The use of ezetimiba with a statin during pregnancy has not been studied. Consult your doctor before using Ezetimiba Aristo if you are pregnant.

Do not take Ezetimiba Aristo with a statin if you are breastfeeding, as it is unknown whether the medicines pass into breast milk. If you are breastfeeding, do not take ezetimiba, even without taking a statin. Consult your doctor.

Driving and operating machines

Ezetimiba is not expected to interfere with your ability to drive or operate machines. However, some people may experience dizziness after taking Ezetimiba Aristo.

Ezetimiba Aristo contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Follow exactly the administration instructions for this medication as indicated by your doctor. Continue taking your other medications to lower cholesterol unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

• Before starting to take Ezetimiba Aristo, you must follow a diet to reduce cholesterol.
• You must continue with this cholesterol-reducing diet while taking Ezetimiba Aristo.

The recommended dose is one Ezetimiba Aristo 10 mg tablet once a day taken orally. Take Ezetimiba Aristo at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimiba along with a statin, both medications can be taken at the same time. In this case, please read the dosage instructions on the medication package.

If your doctor has prescribed ezetimiba along with another cholesterol-lowering medication that contains the active ingredient cholestyramine or any other medication that contains a bile acid sequestrant, You must take Ezetimiba Aristo at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Ezetimiba Aristo than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package and the medication package to the healthcare professional.

If you forget to take Ezetimiba Aristo

Do not take a double dose to compensate for the missed doses, simply take your usual amount of Ezetimiba Aristo at the usual time the next day.

If you interrupt treatment with Ezetimiba Aristo

Speak with your doctor or pharmacist as your cholesterol levels may increase again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems, including muscle degeneration that can cause kidney damage, can be serious and potentially life-threatening.

In general use, allergic reactions have been reported, including swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (requiring immediate treatment).

When used alone, the following side effects have been reported:

Frequent(may affect up to 1 in 10 patients):

• abdominal pain;
• diarrhea;
• gas;
• fatigue.

Rare(may affect up to 1 in 100 patients):

• elevation of results from some liver function tests (transaminases) or muscle function tests (CK);
• cough;
• indigestion;
• heartburn;
• nausea;
• joint pain;
• muscle spasms;
• neck pain;
• loss of appetite;
• pain;
• chest pain;
• flushing;
• high blood pressure.

Additionally, when used with a statin, the following side effects have been reported:

Frequent(may affect up to 1 in 10 patients):

• elevation of results from some liver function tests (transaminases);
• headache;
• muscle pain;
• sensitivity to pressure or weakness.

Rare(may affect up to 1 in 100 patients):

• tingling sensation;
• dry mouth;
• itching;
• eruption;
• hives;
• back pain;
• muscle weakness;
• pain in arms and legs;
• unusual fatigue or weakness;
• swelling, especially in hands and feet.

When used with fenofibrate, the following frequent side effect has been reported: abdominal pain.

Additionally, in general use, the following side effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised, red, and sometimes blistered patches (erythema multiforme); muscle pain, sensitivity to pressure, or muscle weakness; muscle degeneration; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in blood cell count, which may cause bruising or bleeding (thrombocytopenia); tingling sensation; depression; unusual fatigue or weakness; shortness of breath.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Keep the medication in the original packaging to protect it from moisture. Do not store at a temperature above 25°C.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Ezetimiba Aristo

• The active ingredient is ezetimiba. Each tablet contains 10 mg of ezetimiba.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, povidone, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the package

Ezetimiba Aristo 10 mg tablets are round white to off-white tablets.

They are available in blister packs of 14, 28, 30, 50, 98, and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10
13435 Berlin

Germany

Manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10
13435 Berlin

Germany

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana 26

28850, Torrejón de Ardoz

Madrid. Spain

Local representative

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Ezetimib Aristo 10 mg Tabletten

Finland:Ezetimib Aristo 10 mg tabletti

Germany:Ezetimib Aristo 10 mg Tabletten

Italy:Ezetimibe Aristo

Netherlands:Ezetimibe Aristo 10 mg tabletten

Norway:Ezetimib Aristo

Poland:Ezetymib Aristo

Portugal:Ezetimiba Aristo 10 mg comprimidos

Spain:Ezetimiba Aristo 10 mg comprimidos EFG

Sweden:Ezetimib Aristo 10 mg tabletter

United Kingdom:Ezetimibe Aristo 10 mg tablets

Last review date of this leaflet: May 2018

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)