EZETIMIBE ARISTO 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Ezetimibe Aristo 10 mg Tablets EFG

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ezetimibe Aristo and what is it used for
2. What you need to know before you take Ezetimibe Aristo
3. How to take Ezetimibe Aristo
4. Possible side effects
5. Storage of 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 used to lower high levels of cholesterol.

Ezetimibe reduces the amounts of total cholesterol, "bad" cholesterol (low-density lipoprotein cholesterol or LDL), and a type of fat called triglycerides in the blood. It also increases the levels of "good" cholesterol (high-density lipoprotein cholesterol or HDL).

Ezetimibe, the active ingredient in Ezetimibe Aristo, works by reducing the amount of cholesterol absorbed by the body.

Ezetimibe Aristo is used in addition to the cholesterol-lowering effects of statins, a group of medicines that reduce the cholesterol produced by the body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can lead to a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the arteries and protects against heart disease.

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

Ezetimibe Aristo is used in patients who cannot control their cholesterol levels by diet alone. While taking this medicine, you should also follow a low-cholesterol diet.

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

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

• In combination with a statin, when your cholesterol levels are not well controlled with a statin alone.
• Alone, when statin treatment is not appropriate or is not tolerated.

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

If you have heart disease, ezetimibe 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 Aristo does not help you lose weight.

2. What you need to know before you take Ezetimibe Aristo

If you are taking Ezetimibe Aristo with a statin, please read the package leaflet for that medicine.

Do not take Ezetimibe Aristo if:

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

Do not take Ezetimibe Aristo with a statin if:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Aristo.

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

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

The safety and efficacy of the combined use of ezetimibe and certain cholesterol-lowering medicines, fibrates, have not been studied.

Children and adolescents

Do not give this medicine to children and adolescents (aged 6 to 17 years) unless it has been prescribed by a specialist, as the safety and efficacy data are limited.

Do not give this medicine to children under 6 years of age as there is no information in this age group.

Taking Ezetimibe Aristo with other medicines

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 with any of the following active ingredients:

• cyclosporine (often used in patients with organ transplants).
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• cholestyramine (also used to lower cholesterol), as it affects how ezetimibe works.
• ezetimibe.
• fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

There is no experience of the use of ezetimibe with a statin during pregnancy. Consult your doctor before taking Ezetimibe Aristo if you are pregnant.

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

Driving and using machines

Ezetimibe is not expected to interfere with your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Ezetimibe Aristo.

Ezetimibe Aristo contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them 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 to stop. If you are in doubt, consult your doctor or pharmacist again.

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

The recommended dose is one Ezetimibe Aristo 10 mg tablet once a day by mouth. You can take Ezetimibe Aristo at any time of the day. You can take it with or without food.

If your doctor has prescribed ezetimibe with a statin,both medicines can be taken at the same time. In this case, please read the dosage instructions in the package leaflet for the statin.

If your doctor has prescribed ezetimibe with another cholesterol-lowering medicinethat contains the active ingredient cholestyramine or any other medicine that contains a bile acid sequestrant, you should 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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to take Ezetimibe Aristo

Do not take a double dose to make up for forgotten doses. Simply take your normal dose of Ezetimibe Aristo at the usual time the next day.

If you stop taking Ezetimibe Aristo

Talk to your doctor or pharmacist, as your cholesterol levels 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.

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

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

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

Common(may affect up to 1 in 10 people):

• abdominal pain;
• diarrhea;
• gas
• feeling tired.

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

• elevated results of some liver function tests (transaminases) or muscle function tests (CK);
• cough;
• indigestion;
• heartburn;
• nausea;
• joint pain;
• muscle spasms;
• neck pain;
• decreased appetite;
• pain;
• chest pain,
• hot flushes;
• high blood pressure.

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

Common(may affect up to 1 in 10 people):

• elevated results of some liver function tests (transaminases);
• headache;
• muscle pain;
• tenderness or 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 in hands and feet.

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

In addition, the following side effects have been reported in general use: dizziness; muscle pain; liver problems; allergic reactions, including rash and hives; blistering and reddening skin eruptions, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or weakness; muscle breakdown; gallstones or inflammation of the gallbladder (which can cause abdominal pain, nausea, vomiting); pancreatitis, often with severe abdominal pain; constipation; reduction in blood cell count, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via the website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 after EXP. The expiry date refers to the last day of the month shown.

Store the medicine in the original package to protect it from moisture. Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Aristo

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

Appearance and packaging of the product

Ezetimibe Aristo 10 mg tablets are white to off-white, round tablets.

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

Not all pack 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 under 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

Date of last revision of this leaflet: May 2018

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