Ezetimibe Combix 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ezetimibe Combix 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 other people, 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.

Contents of the leaflet

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

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

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

Ezetimiba Combix lowers total cholesterol, "bad" cholesterol (LDL cholesterol), and a type of fat in the blood called triglycerides. In addition, Ezetimiba Combix increases levels of "good" cholesterol (HDL cholesterol).

Ezetimibe, the active substance in this medicine, works by reducing the amount of cholesterol absorbed in the digestive tract. Ezetimibe 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. Such blockage 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 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.

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

• high levels of cholesterol 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
• a hereditary condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You will also be prescribed a statin, and you may also be given other treatments.

Ezetimibe does not help you to lose weight.

2. What you need to know before taking Ezetimiba Combix

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

Do not take Ezetimiba Combix

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

Do not take Ezetimiba Combix together with a statin

• if you currently have liver problems,
• if you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Ezetimiba Combix.

• 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 whether your liver is functioning properly.
• Your doctor may also want to carry out blood tests to monitor your liver function after you start taking ezetimibe with a statin.

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

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

Children and adolescents

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

Taking Ezetimiba Combix 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 active substances used to prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or fluindione (anticoagulants),
  • colestyramine (also used to lower cholesterol), because 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 together with a statin during pregnancy. Consult your doctor before using ezetimibe if you are pregnant.

Do not take ezetimibe with a statin while breastfeeding, as it is unknown whether these medicines pass into breast milk. If you are breastfeeding, you should not take ezetimibe, even without a statin. Consult your doctor.

Driving and using machines

Ezetimibe is not expected to affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking ezetimibe.

Ezetimiba Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ezetimiba Combix

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, ask your doctor or pharmacist.

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

• Before starting ezetimiba, you should already be on a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimiba.

Adults, adolescents and children (aged 10 to 17 years): The dose is one 10 mg ezetimiba tablet once daily by mouth.

Take ezetimiba at any time of day. You may take it with or without food. If your doctor has prescribed ezetimiba 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 ezetimiba together with another cholesterol-lowering medicine containing the active substance colestyramine or any other medicine containing a bile acid sequestrant, you must take ezetimiba at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more EzetimibaCombix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 EzetimibaCombix

Do not take a double dose to make up for missed doses. Simply take your usual dose of ezetimiba at the regular time the next day.

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 can cause adverse 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 breakdown leading 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; diarrhoea; flatulence; and feeling tired.

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 adverse effects have been reported:

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

• 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 lead to bruising/bleeding (thrombocytopenia); tingling sensation; depression; unusual tiredness or weakness; shortness of breath.

Reporting of adverse effects

If you experience any adverse effect, consult 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 System of Pharmacovigilance 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 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and containers should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of EzetimibaCombix

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

Appearance of the product and contents of the pack

White to off-white, capsule-shaped, flat tablets with bevelled edges, smooth on both sides.

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

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

Packs containing 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 the most recent revision of this leaflet: February 2014

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