EULITOP 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Eulitop 200 mg Film-Coated Tablets

Bezafibrate

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Eulitop 200 mg film-coated tablets are and what they are used for
2. What you need to know before you take Eulitop 200 mg film-coated tablets
3. How to take Eulitop 200 mg film-coated tablets
4. Possible side effects
5. Storage of Eulitop 200 mg film-coated tablets
6. Contents of the pack and other information

1. What Eulitop 200 mg film-coated tablets are and what they are used for

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

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

2. What you need to know before you take Eulitop 200 mg film-coated tablets

Do not take Eulitop

• If you are allergic to bezafibrate, clofibrate 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 (photoallergy).
• If you are pregnant or breastfeeding.
• If you have severe or chronic kidney disease. Its use is contraindicated in patients on 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 if any of the above circumstances apply 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 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 coumarin anticoagulants.
• 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 indicated.

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 see the response to the medicine and more frequently if you receive prolonged treatments with Eulitop.

Children

The use of Eulitop is not recommended in children.

Other medicines and Eulitop

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

Some medicines may interact with Eulitop. 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 take any of the following medicines:

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

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

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

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

• Other medicines for controlling blood fat levels:the concomitant administration of medicines used to lower cholesterol and Eulitop may produce an increase in muscle disorders. If you are taking 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 if you are taking MAOI inhibitor medicines (a type of medicine for depression).

• Oral 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 is contraindicated during pregnancy and breastfeeding.

Driving and using machines

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

Eulitop contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., it is essentially "sodium-free".

3. How to take Eulitop 200 mg film-coated 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 should be taken orally. The recommended dose is one tablet three times a day.

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

Remember that, in addition to taking Eulitop, 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 monitor blood lipid levels.

Use in children

The use of this medicine is not recommended in children.

If you take more Eulitop than you should

If you have taken more Eulitop 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 medicine and the amount ingested.

If you forget to take Eulitop

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

If you stop taking Eulitop

Your doctor will indicate the duration of your treatment with Eulitop. Do not discontinue treatment prematurely; 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), biliary congestion (cholestasis), and increased liver size (hepatomegaly).
• Itching, hives, allergic reactions 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 (inflammation of the pancreas).
• Peripheral nerve disorders (those not located in the brain or spinal cord), tingling or numbness of certain skin areas.
• 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).
• Decreased hemoglobin levels, increased platelet count in blood, decreased white blood cell count, increased gamma-glutamyl transferase (an enzyme that is mainly present in the liver), increased transaminase levels (enzymes found in the liver).
• Lyell 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 body tissues), chills, or syncope (sudden and temporary loss of consciousness and postural tone).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (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 Eulitop 200 mg film-coated tablets

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

Do not use this medicine after the expiry date that appears on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

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

6. Contents of the pack and other information

Composition of Eulitop 200 mg film-coated tablets:

• The active substance is bezafibrate. Each tablet contains 200 mg of bezafibrate.
• The other ingredients are: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (derived from potato starch), colloidal silicon dioxide, magnesium stearate, titanium dioxide (E 171), talc, macrogol 3350, polyvinyl alcohol, and purified water.

Appearance of the product and contents of the pack

White, round, film-coated tablets with G6 engraved on one side. Eulitop is available in cartons containing blister packs of 60 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 the last revision of this package 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/)