EZETIMIBE COMBIX 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

EzetimibeCombix10 mg film-coated 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 pack

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

1. What Ezetimibe Combix is and what it is used for

Ezetimibe Combix is a medicine to lower high levels of cholesterol.

Ezetimibe Combix lowers the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat in the blood called triglycerides. It also raises the levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active ingredient in this medicine, works by reducing the amount of cholesterol absorbed in the gut. Ezetimibe adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol made by the body.

Cholesterol is one of the fats 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 "bad" cholesterol from building up 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 Combix 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 is used in combination with a low-cholesterol diet if you have:

• high levels of cholesterol in the blood (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 is not tolerated.
• a rare inherited cholesterol condition (homozygous familial hypercholesterolaemia) that can lead to high levels of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.

Ezetimibe does not help you lose weight.

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

If you are taking ezetimibe with a statin, please read the package leaflet that comes with that medicine.

Do not take Ezetimibe Combix

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

Do not take Ezetimibe Combix with a statin

• if you currently have liver problems,
• if you are pregnant or breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ezetimibe Combix.

• Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking ezetimibe with a statin to make sure your liver is working properly.
• Your doctor may also want to do blood tests to check that your liver is working properly after you start taking ezetimibe with a statin.

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

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

Children and adolescents

Ezetimibe is not recommended for children under 10 years of age.

Taking Ezetimibe Combix 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 transplanted organs),
• medicines with an active ingredient to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol or fluindione (anticoagulants),
• • cholestyramine (also used to lower cholesterol), because it affects how ezetimibe works,
• fibrates (also used to lower cholesterol).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 tell your doctor. There is no experience of the use of ezetimibe with a statin during pregnancy. Ask your doctor for advice before taking ezetimibe if you are pregnant.

Do not take ezetimibe with a statin if you are breast-feeding because it is not known if the medicines pass into breast milk. If you are breast-feeding, do not take ezetimibe, even if you are not taking a statin. Ask your doctor for advice.

Driving and using machines

Ezetimibe 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.

Ezetimibe Combix 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 Ezetimibe Combix

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Continue to take your other cholesterol-lowering medicines unless your doctor tells you to stop.

• Before starting to take ezetimibe, you should be on a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking ezetimibe.

Adults, adolescents and children (10 to 17 years old): The dose is one 10 mg ezetimibe tablet per day, taken by mouth.

Take ezetimibe at any time of day. You can take it with or without food. If your doctor has prescribed ezetimibe with a statin, you can take both medicines at the same time. In this case, please read the dosing instructions in the package leaflet of the other medicine.

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

If you take more Ezetimibe Combix than you should

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

If you forget to take Ezetimibe Combix

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

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 muscle pain, tenderness or weakness.

Allergic reactions, including swelling of the face, lips, tongue and/or throat which may cause difficulty in 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 and feeling tired.

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

• increased 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 (may affect up to 1 in 10 people):

• increased 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 side effects have been reported:

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

• abdominal pain.

In addition, the following side effects have been reported:

izziness; muscle pain; liver problems; allergic reactions including rash and hives; blistering and peeling skin, sometimes with mouth sores (Stevens-Johnson syndrome); 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; low blood cell counts, which can cause bruising/bleeding (thrombocytopenia); tingling sensation; 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 possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ezetimibe Combix

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

No special storage conditions are required.

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.

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 to protect the environment.

6. Contents of the pack and other information

Composition of Ezetimibe Combix

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients (excipients) are: lactose monohydrate, pregelatinized maize starch, crospovidone (Type B), povidone K30, sodium lauryl sulfate, microcrystalline cellulose (E460i), sodium stearyl fumarate and magnesium stearate (E470b).

Appearance and packaging

White to off-white, capsule-shaped, flat, beveled-edged tablets, smooth on both sides.

OPA/Al/PVC-Aluminum (standard or perforated) blisters.

PVC/ACLAR-Aluminum (standard or perforated) blisters.

Packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C / Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of last revision of this leaflet: February 2014

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