AZIBE 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Azibe 10 mg Tablets EFG

Ezetimibe

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 pack

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

1. What is Azibe and what is it used for

Azibe is a medicine to lower high levels of cholesterol.

Azibe reduces the concentrations of total cholesterol, "bad" cholesterol (LDL cholesterol) and substances called triglycerides that circulate in the blood. Additionally, Azibe increases the concentrations of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in Azibe, works by reducing the cholesterol absorbed in the gut.

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

Cholesterol is one of the fatty substances that are 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. This narrowing can slow down or block the blood flow to vital organs such as the heart and brain. This blockage 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 them from heart disease.

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 by diet alone. While taking this medicine, you should follow a cholesterol-lowering diet.

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

• high blood levels of cholesterol (primary hypercholesterolaemia [heterozygous and non-familial])
• in combination with a statin, when your cholesterol level is not well controlled with a statin alone
• alone, when treatment with a statin is not appropriate or not tolerated
• a hereditary disease (homozygous familial hypercholesterolaemia) that increases the level of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

If you have heart disease, Azibe 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 due to chest pain.

Azibe does not help you lose weight.

2. What you need to know before you take Azibe

If you take Azibe with a statin, please read the package leaflet of that medicine.

Do not take Azibe

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

Do not take Azibe with a statin

• If you currently have liver problems.
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Azibe.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Azibe 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 Azibe with a statin.

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

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

Children and adolescents

Do not give this medicine to children and adolescents (6 to 17 years old) 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 old as there is no information in this age group.

Other medicines and Azibe

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 substances:

• cyclosporin (often used in patients with transplanted organs)
• medicines with an active substance to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants)
• cholestyramine (also used to lower cholesterol), as it affects how Azibe 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

There is no experience with the use of ezetimibe with a statin during pregnancy. Ask your doctor for advice before taking Azibe if you are pregnant.

Do not take Azibe 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 Azibe, even without taking a statin. Ask your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Azibe is not expected to affect your ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking ezetimibe.

Azibe contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Azibe

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 Azibe, you should be following a cholesterol-lowering diet.
• You should continue with this cholesterol-lowering diet while taking Azibe.

The recommended dose is one 10 mg ezetimibe tablet once a day by mouth.

Take this medicine at any time of day. You can take it with or without food.

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

If your doctor has prescribed Azibe with another cholesterol-lowering medicine that contains the active substance cholestyramine or any other medicine that contains a bile acid sequestrant, you should take Azibe at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Azibe than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you forget to take Azibe

Do not take a double dose to make up for forgotten doses, simply take your usual dose the next day.

If you stop taking Azibe

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

The following terms are used to describe how often side effects are reported:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people, including isolated cases)

Contact your doctor immediately if you experience pain, tenderness, or weakness of the muscles that cannot be explained. This is because, in rare cases, muscle problems, including muscle breakdown that causes kidney damage, can be serious and potentially life-threatening.

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

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

Common: abdominal pain; diarrhea; gas and feeling tired.

Uncommon: 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, flushing; high blood pressure.

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

Common: elevated results of some liver function tests (transaminases); headache; muscle pain, tenderness, or weakness.

Uncommon: 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 reddened skin, sometimes with target-shaped 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; reduced 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azibe

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Azibe

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) (from potato), povidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and pack size

White or almost white, round, biconvex, smooth tablets on both sides.

Pack sizes:

PVC/PCTFE (polychlorotrifluoroethylene)-Aluminum blisters in packs of 28 tablets

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet:January 2017

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