Ezetimibe Aristo 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ezetimibe Aristo 10 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 Ezetimiba Aristo is and what it is used for

Ezetimiba Aristo is a medicine used to reduce elevated cholesterol levels.

Ezetimiba reduces levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides circulating in the blood. In addition, ezetimiba increases levels of "good" cholesterol (HDL cholesterol).

Ezetimiba, the active substance in Ezetimiba Aristo, works by reducing the cholesterol absorbed in the digestive tract.

Ezetimiba Aristo adds to the cholesterol-lowering effect of statins, a group of medicines that reduce cholesterol produced by the body itself.

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 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 interruption in 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 type of fat in your blood that may increase the risk of heart disease.

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

Ezetimiba Aristo is used together with a cholesterol-lowering diet if you have:

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

• together with a statin, when your cholesterol level is not well controlled with a statin alone.

• alone, when treatment with a statin is inappropriate or not tolerated.

• an inherited disease (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may additionally be prescribed other treatments.

• an inherited disease (familial sitosterolemia, also known as phytosterolemia), which increases levels of plant sterols in the blood.

If you have heart disease, ezetimiba combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to improve blood flow to the heart, or hospitalization due to chest pain.

Ezetimiba Aristo does not help you lose weight.

2. What you need to know before starting to take Ezetimiba Aristo

If you are taking Ezetimiba Aristo together with a statin, please read the package leaflet of that medicine.

Do not take Ezetimiba Aristo if:

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

Do not take Ezetimiba 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 starting to take Ezetimiba Aristo.

• Inform your doctor about all your medical conditions, including allergies.
• Your doctor will perform a blood test before you start taking ezetimibe with a statin. This is to check that your liver is functioning properly.
• Your doctor may also want to carry out further blood tests to monitor your liver function after you start taking ezetimibe with a statin.

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

The safety and efficacy of combining ezetimibe with certain cholesterol-lowering medicines called fibrates have not been studied.

Children and adolescents

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

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

Taking Ezetimiba Aristo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 substance used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants).
• cholestyramine (also used to lower cholesterol), as it affects how ezetimibe works.
• fibrates (also used to lower cholesterol).

Pregnancy and breastfeeding

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

Do not take ezetimibe with a statin if you are pregnant, trying to become pregnant, or think you could 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 with the use of ezetimibe with a statin during pregnancy. 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, you should not take ezetimibe, even without taking a statin. Consult your doctor.

Driving and using machines

Ezetimibe is not expected to affect your ability to drive or use machines. However, it should be noted that some people may experience dizziness after taking Ezetimiba Aristo.

Ezetimiba Aristo contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ezetimiba Aristo

Follow exactly the instructions for administration of this medicine as given by your doctor. Continue taking your other cholesterol-lowering medicines unless your doctor tells you to stop. If in doubt, consult your doctor or pharmacist again.

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

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

If your doctor has prescribed ezetimibe together with a statin, both medicines may be taken at the same time. In this case, please read the dosing instructions in the package leaflet of the medicine.

If your doctor has prescribed ezetimibe together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Ezetimiba Aristo

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

If you stop taking Ezetimiba Aristo

Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, in rare cases, muscle problems—including muscle breakdown that can lead to 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, which may cause difficulty breathing or swallowing (requiring immediate treatment).

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

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

• abdominal pain;
• diarrhea;
• gas;
• feeling of tiredness.

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

• increased results in certain liver function tests (transaminases) or muscle function tests (CK);
• cough;
• indigestion;
• heartburn;
• nausea;
• joint pain;
• muscle spasm;
• neck pain;
• decreased appetite;
• pain;
• chest pain;
• hot flushes;
• high blood pressure.

Additionally, when used in combination with a statin, the following adverse effects have been reported:

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

• increased results in certain 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 in combination with fenofibrate, the following common adverse effect has been reported: abdominal pain.

Additionally, in general use, the following adverse effects have been reported: dizziness; muscle pain; liver problems; allergic reactions including rash and hives; raised and red skin rashes, sometimes with target-like lesions (erythema multiforme); muscle pain, tenderness, or muscle weakness; muscle breakdown; 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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ezetimiba Aristo

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and additional information

Composition of Ezetimiba Aristo

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

Appearance of the medicinal product and content of the container

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

Available in blister packs containing 14, 28, 30, 50, 98 and 100 tablets.

Only certain 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 medicinal product is authorized in the European Economic Area (EEA) member states 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 the most recent review of this leaflet: May 2018

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