EULITOP RETARD 400 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Eulitop Retard 400 mg Prolonged-Release Tablets

Bezafibrate

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 Package Leaflet

1. What Eulitop Retard 400 mg tablets are and what they are used for
2. What you need to know before you take Eulitop Retard 400 mg tablets
3. How to take Eulitop Retard 400 mg tablets
4. Possible side effects
5. Storage of Eulitop Retard 400 mg tablets
6. Contents of the pack and other information

1. What Eulitop Retard 400 mg tablets are and what they are used for

Eulitop Retard belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood (e.g. triglycerides).

Eulitop Retard is used, along with a low-fat diet and other non-drug treatments such as exercise and weight loss, to lower blood fat levels.

2. What you need to know before you take Eulitop Retard 400 mg tablets

Do not take Eulitop Retard

• If you are allergic to bezafibrate, clofibric acid derivatives, fibrates in general, or any of the other ingredients of this medicine (listed in section 6).
• If fibrates (the type of medicine that bezafibrate belongs to) cause you allergic reactions when exposed to the sun (phototoxicity).
• If you are pregnant or breastfeeding.
• If you have severe or chronic kidney disease. Its use is contraindicated in patients undergoing dialysis.
• If you have liver disease (except fatty liver) or bile duct disorders with or without stones (cholestasis).
• If you are being treated with MAOI medicines (for depression) or with HMG CoA reductase inhibitors (statins, to lower cholesterol) in patients at risk of myopathy.

Do not take Eulitop Retard if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eulitop Retard if:

• You are taking oral contraceptives that contain estrogen in their composition.
• You are taking cholesterol-lowering medicines called statins or ion exchange resins.
• You are being treated with anticoagulant medicines.
• You have muscle weakness or mild kidney disease. The presence of muscle damage increases in patients with a history of hypoalbuminemia (high concentration of a protein called albumin in the blood) and kidney disease.

It is very important to follow the diet and other dietary measures that your doctor has prescribed for you.

If you experience any symptoms indicating gallstones such as severe abdominal pain, interrupt treatment and consult your doctor.

If you experience symptoms such as muscle weakness, muscle pain, and muscle cramps, consult your doctor, as in isolated cases, severe muscle damage (rhabdomyolysis) may occur. In case of rhabdomyolysis, treatment with this medicine should be discontinued immediately.

As with other fibrates, pancreatitis has been reported with bezafibrate.

Your doctor will perform blood tests to check your response to the medicine and more frequently if you receive prolonged treatment with Eulitop Retard.

Children

The use of Eulitop Retard is not recommended in children.

Other medicines and Eulitop Retard

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may interact with Eulitop Retard. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medicines.

It is important that you inform your doctor if you are taking any of the following medicines:

• Anticoagulants:Eulitop Retard enhances the effect of anticoagulant medicines, so your doctor will reduce the dose of the anticoagulant at the start of treatment with Eulitop Retard and frequently monitor blood coagulation.

• Medicines for treating diabetes:Eulitop Retard enhances the effect of diabetes medicines (medicines to lower blood sugar). If you are using or taking these medicines, your doctor will likely reduce the dose of these medicines.

• Colchicine (for the treatment of gout):the risk of myopathy and rhabdomyolysis increases with the concomitant administration of Eulitop Retard and colchicine.

• Cyclosporin:if you have undergone a transplant and are taking medicines to prevent rejection, your doctor may recommend discontinuing treatment with Eulitop Retard.

• Other medicines to control blood fat levels:the concomitant administration of medicines used to lower cholesterol and Eulitop Retard may produce an increase in muscle disorders. If you are taking medicines with ion exchange resins (cholestyramine) to lower blood cholesterol levels, you should leave at least 2 hours between the administration of both medicines.

• Certain antidepressants:you should not take Eulitop Retard if you are taking MAOI inhibitor medicines (a type of medicine for depression).

• Contraceptives:there is a possible increase in fat levels caused by the oral administration of estrogens.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Eulitop Retard is contraindicated during pregnancy and breastfeeding.

Driving and using machines

Patients should be warned that bezafibrate may reduce their ability to respond and their ability to drive and use machines. This is due to possible side effects such as dizziness, fatigue, and muscle weakness.

Eulitop Retard contains lactose

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

Eulitop Retard contains sodium

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

3. How to take Eulitop Retard 400 mg tablets

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Eulitop Retard should be taken orally. The recommended dose is one tablet per day.

The tablet should be swallowed whole and not chewed, preferably after dinner. Take the tablets with a sufficient amount of liquid (a glass of water).

Remember that, in addition to taking Eulitop Retard, it is also important to exercise regularly and follow a low-fat diet.

During treatment with this medicine, your doctor will regularly perform blood tests to check your blood lipid levels.

Use in children

The use of this medicine is not recommended in children.

If you take more Eulitop Retard than you should

If you have taken more Eulitop Retard tablets than you should, consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service immediately, telephone 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Eulitop Retard

Do not take a double dose to make up for forgotten doses.

If you stop taking Eulitop Retard

Your doctor will indicate the duration of your treatment with Eulitop Retard. Do not stop treatment prematurely, as it is usually a long-term treatment.

If you have any other questions about 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.

According to clinical data and post-marketing experience, the following side effects may appear:

Frequent (may affect up to 1 in 10 patients)

• Gastrointestinal disorders, decreased appetite.

Uncommon (may affect up to 1 in 100 patients)

• Abdominal pain, constipation, diarrhea, stomach heaviness, vomiting, nausea, which usually disappear without the need to discontinue treatment, after 1 or 2 weeks.
• Increased transaminases (values that indicate liver function), bile congestion (cholestasis), and increased liver size (hepatomegaly).
• Itching, hives, allergy to sunlight, hair loss (alopecia), and rash.
• Allergic reactions.

• Muscle weakness, muscle pain, and muscle cramps.

• Dizziness, headache.
• Somnolence.
• Impotence, changes in libido.
• Kidney problems (acute renal failure), painful urination (dysuria), decreased urine production (oliguria), blood in the urine (hematuria), or excessive protein in the urine (proteinuria).
• Increased blood creatinine, creatine phosphokinase, and urea.
• Increased or decreased alkaline phosphatase in blood (values that indicate kidney function).
• Increased platelets and decreased hematocrit (part of the blood composed of red blood cells) and white blood cells.
• Decreased gamma-glutamyl transferase (an enzyme that is mainly present in the liver).

Rare (may affect up to 1 in 1,000 patients)

• Pancreatitis.
• Peripheral nerve disorders (those that are not in the brain or spinal cord), tingling or numbness of certain areas of the skin.
• Depression, insomnia (difficulty sleeping).
• Anemia (your blood is not carrying enough oxygen to the rest of your body), eosinophilia (increase in eosinophils, a type of white blood cell), agranulocytosis (severe decrease in the number of white blood cells).

Very rare (may affect up to 1 in 10,000 patients)

• Appearance of bile stones (gallstones). If you experience any symptoms indicating gallstones such as severe abdominal pain, interrupt treatment and consult your doctor.

• Severe skin disorders.
• Pancytopenia (decrease, below normal, of the concentration of the three main types of blood cells: red blood cells, white blood cells, and platelets), leucopenia (decrease in white blood cells), thrombocytopenia (decrease in platelets).
• Changes in heart rhythm.
• Acute muscle damage (rhabdomyolysis). In case of acute muscle pain, without known cause, the medication should be discontinued.
• Interstitial lung disease (inflammation or scarring of the lungs).
• Decrease in hemoglobin levels, increase in platelet count in blood, decrease in white blood cell count, increase in gamma-glutamyl transferase (an enzyme that is mainly present in the liver), increase in transaminase levels (enzymes that are found in the liver).
• Lyell's syndrome (skin disease with blisters and lesions on the skin and mucous membranes).
• Increased gamma-glutamyl transferase (an enzyme that is mainly present in the liver).

• Generalized hypersensitivity reactions (exaggerated immune response) with chest tightness, dyspnea (difficulty breathing), tachycardia, skin symptoms, hypotension, edema (excess fluid in an organ or tissue), circulatory collapse (inability of the circulatory system to supply oxygenated blood to the body's tissues), chills, or syncope (sudden and temporary loss of consciousness and postural tone).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website (https://www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eulitop Retard 400 mg tablets

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

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

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eulitop Retard 400 mg tablets

• The active ingredient is bezafibrate. Each tablet contains 400 mg of bezafibrate.
• The other ingredients are: lactose, povidone, sodium lauryl sulfate, hypromellose, colloidal silicon dioxide, magnesium stearate, Eudragit NE3OD, polyethylene glycol, talc, titanium dioxide, polysorbate 80, sodium citrate, and purified water.

Appearance of the product and pack contents

Prolonged-release tablets are white, round, and have a marking D9 on one side. Eulitop Retard is available in cartons containing blister packs of 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer

CENEXI SAS.

Rue Marcel et Jacques Gaucher, 52 (Fontenay-sous-Bois)

F-94120 France

Date of last revision of this leaflet: April 2023

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