Eulitop 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Eulitop 200 mg film-coated tablets

Bezafibrate

Read this 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Eulitop 200 mg 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 (for example, fats called triglycerides).

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

2. What you need to know before taking Eulitop 200 mg tablets

Do not take Eulitop

• If you are allergic to bezafibrate, to clofibric acid derivatives, to fibrates in general, or to any of the other components of this medicine (listed in section 6).
• If fibrates (the class of medicines to which bezafibrate belongs) cause you allergic reactions when exposed to sunlight (photoallergy).
• If you are pregnant or breastfeeding.
• If you have a severe or chronic kidney disease. Its use is contraindicated in dialyzed patients.
• If you have any liver disease (except fatty liver) or gallbladder disorders with or without gallstones (cholestasis).
• If you are being treated with medicines from the group of MAO inhibitors (for depression) or with HMG CoA reductase inhibitors (statins, for lowering cholesterol) in patients at risk of myopathy.

Do not take Eulitop if any of the above conditions apply to you. If you are unsure, 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 containing estrogens.
• 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 risk 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 prescribed by your doctor.

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

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

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

Your doctor will perform blood tests to monitor your response to the medicine and more frequently if you are on long-term treatment with Eulitop.

Children

The use of Eulitop is not recommended in children.

Other medicines and Eulitop

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

Some medicines may interact with Eulitop. In such cases, it may be necessary to adjust 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 drugs:

• Anticoagulants: Eulitop enhances the effect of coumarin anticoagulants; therefore, your doctor will initially reduce the dose of the anticoagulant and monitor blood coagulation frequently during the start of Eulitop treatment.

• Medicines for diabetes: Eulitop enhances the effect of antidiabetic medicines (medicines that lower blood sugar). If you are using or taking these medicines, your doctor may need to reduce their dose.

• Colchicine (for the treatment of gout): the risk of myopathy and rhabdomyolysis increases when Eulitop and colchicine are administered concomitantly.

• Cyclosporine: if you have undergone transplantation and are taking medicines to prevent rejection, your doctor may recommend discontinuing treatment with Eulitop.

• Other medicines to control blood lipid levels: concomitant administration of medicines used to lower cholesterol and Eulitop may increase the risk of muscle disorders. If you are taking ion-exchange resins (cholestyramine) to reduce blood cholesterol levels, you should wait at least 2 hours between administering the two medicines.

• Certain antidepressants: you should not take Eulitop if you are taking MAO inhibitors (a type of medicine for depression).

• Contraceptives: there may be an increase in lipid levels caused by oral administration of estrogens.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 advised that bezafibrate may reduce reaction ability and the ability to drive or operate machinery. This is due to possible adverse 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 tablets

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in 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 your 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, contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service immediately at telephone number 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 a missed dose.

If you stop taking Eulitop

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

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 experiences them.

According to clinical data and post-marketing experience, the following adverse effects may occur:

Common (may affect up to 1 in 10 patients)

• Gastrointestinal disturbances, decreased appetite.

Uncommon (may affect up to 1 in 100 patients)

• Abdominal pain, constipation, diarrhea, stomach heaviness, vomiting, nausea, which usually resolve without the need to discontinue treatment within 1 or 2 weeks.

• Increased transaminases (values indicating liver function), biliary congestion (cholestasis), and enlargement of the liver (hepatomegaly).

• Itching, urticaria, photosensitivity (allergy to sunlight), hair loss (alopecia), and rash.

• Allergic reactions.

• Muscle weakness, muscle pain, and cramps.

• Dizziness, headache.

• Drowsiness.

• Impotence, changes in libido.

• Kidney function problems (acute renal failure), painful urination (dysuria), reduced urine production (oliguria), presence of blood in urine (hematuria), or excessive protein in urine (proteinuria).

• Increased blood levels of creatinine, creatine phosphokinase, and urea.

• Increase or decrease in alkaline phosphatase in blood (values indicating kidney function).

• Increased platelet count and decreased hematocrit (the portion of blood composed of red blood cells) and white blood cells.

• Decreased gamma-glutamyl transferase (an enzyme primarily present in the liver).

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

• Inflammation of the pancreas (pancreatitis).
• Peripheral nerve disorders (nerves outside the brain and spinal cord), tingling or numbness in certain areas of the skin.
• Depression, insomnia (difficulty sleeping).
• Anemia (your blood is not carrying enough oxygen to the rest of your body), eosinophilia (increased eosinophils, a type of white blood cell), agranulocytosis (severe decrease in white blood cell count).

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

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

• Severe skin reactions.

• Pancytopenia (decrease below normal levels of all 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). If you experience sudden, unexplained muscle pain, stop taking the medication.

• Interstitial lung disease (inflammation or scarring of the lungs).

• Decreased hemoglobin levels, increased platelet count, decreased white blood cell count, increased gamma-glutamyl transferase (an enzyme primarily present in the liver), increased transaminase levels (enzymes found in the liver).

• Lyell's syndrome (severe skin disease with blisters and lesions affecting skin and mucous membranes).

  • Increased gamma-glutamyl transferase (an enzyme primarily 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 deliver oxygenated blood to body tissues), chills, or syncope (sudden, temporary loss of consciousness and postural tone).

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 may also report them directly through the Spanish Pharmacovigilance System 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 Eulitop 200 mg tablets

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

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Eulitop 200 mg tablets:

• The active substance is bezafibrate. Each tablet contains 200 mg of bezafibrate.
• The other components are: maize starch, microcrystalline cellulose, sodium carboxymethylstarch (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

Film-coated white, round tablets, with "G6" engraved on one side. Eulitop is presented in cardboard boxes containing blister packs with 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 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 most recent revision of this leaflet: April 2023

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