EZETIMIBE ACCORD 10 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

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

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

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

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

Ezetimibe, the active ingredient in Ezetimibe Accord, works by reducing the amount of cholesterol absorbed in the gut.

Ezetimibe Accord 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. This narrowing can reduce or block 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 against heart disease.

Triglycerides are another type of fat found in your blood. High levels of triglycerides can increase your risk of heart disease.

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

• High levels of cholesterol in your 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 statin treatment is not suitable or not tolerated
• A rare inherited cholesterol disorder (homozygous familial hypercholesterolaemia), which can cause very high levels of cholesterol in the blood. You will also be prescribed a statin and may be prescribed other treatments.
• A rare inherited disorder (familial sitosterolaemia, also known as phytosterolaemia), which can cause very high levels of plant sterols in the blood.

If you have heart disease, Ezetimibe Accord, in combination with cholesterol-lowering medicines called statins, reduces the risk of heart attack, stroke, the need for heart surgery, or hospitalization for chest pain.

Ezetimibe Accord does not help you lose weight.

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

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

Do not take Ezetimibe Accord if:

• You are allergic (hypersensitive) to ezetimibe or any of the other ingredients of this medicine (see section 6: Contents of the pack and other information).

Do not take Ezetimibe Accord with a statin if:

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

Warnings and precautions

• Talk to your doctor or pharmacist before you start taking Ezetimibe Accord. Tell your doctor about all your medical conditions, including allergies.
• Your doctor will do a blood test before you start taking Ezetimibe Accord with a statin. This is to make sure that your liver is working well.
• Your doctor may also want to do blood tests to check how well your liver is working after you start taking Ezetimibe Accord with a statin.

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

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

Children and adolescents

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

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

Taking Ezetimibe Accord 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, fenprocoumon, 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

Do not take Ezetimibe Accord 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 Ezetimibe Accord with a statin, stop taking both medicines immediately and tell your doctor.

There is no experience with the use of Ezetimibe Accord with a statin during pregnancy. Talk to your doctor before using Ezetimibe Accord if you are pregnant.

Do not take Ezetimibe Accord with a statin if you are breastfeeding because it is not known whether the medicines pass into breast milk.

If you are breastfeeding, do not take Ezetimibe Accord, with or without a statin. Talk to your doctor.

Talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

Ezetimibe Accord 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 Accord.

Ezetimibe Accord contains lactose

Ezetimibe Accord tablets contain a sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Ezetimibe Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

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3. How to take Ezetimibe Accord

Take this medicine exactly as your doctor has told you. Continue to take your other cholesterol-lowering medicines unless your doctor tells you to stop. If you are in doubt, talk to your doctor or pharmacist.

• Before you start taking this medicine, you should be on a low-cholesterol diet.
• You should continue with this low-cholesterol diet while taking this medicine.

The recommended dose is one Ezetimibe Accord 10 mg tablet a day, taken by mouth.

You can take Ezetimibe Accord at any time of the day. You can take it with or without food.

If your doctor has prescribed Ezetimibe Accord 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 statin medicine.

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

If you take more Ezetimibe Accord than you should

Talk to your doctor, pharmacist, or call the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

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

If you forget to take Ezetimibe Accord

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

If you stop taking Ezetimibe Accord

Talk to your doctor or pharmacist because 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.

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

• 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 muscle pain, tenderness, or weakness. This is because muscle problems, including muscle breakdown, which 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 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.

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; sensitivity 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 peeling of the skin, sometimes with mouth sores (erythema multiforme); muscle pain, sensitivity to pressure, or muscle 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 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 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. Storage of Ezetimibe Accord

• 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 that month.
• This medicine does not require any special storage conditions.

Blister packs: Store in the original package to protect from moisture.

Bottles: Keep the bottles tightly closed to protect from moisture.

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

What Ezetimibe Accord contains

• The active substance is ezetimibe. Each tablet contains 10 mg of ezetimibe.
• The other ingredients are: lactose monohydrate, sodium croscarmellose (E468), povidone K-30 (E1201), sodium lauryl sulfate, magnesium stearate (E470b), Polysorbate 80 (E433).

Appearance and packaging

Product description: white or almost white, capsule-shaped tablets, engraved with "10" on one side.

Package sizes:

7, 10, 14, 20, 28, 30, 50, 98, 100, or 300 tablets in aluminum-aluminum or aluminum-PVC/Aclar blister packs;

30 and 100 tablets in HDPE bottles with polypropylene caps.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer:

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

or

Laboratori FUNDACIO DAU

C/ De la letra C, 12-14, Poligono Industrial de la Zona,

Franca, 08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice,

Poland

or

Accord Healthcare Single Member S.A.,

64th Km National Road Athens Lamia,

Schimatari, 32009, Greece

This medicinal product is authorized in the Member States of the EEA under the following names:

Date of last revision of this leaflet:May 2021.

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.es/