Package Insert: Information for the Patient

Eulitop 200 mg Film-Coated Tablets

Bezafibrate

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isEulitop 200 mg Film-Coated Tabletsand what is it used for

2. What you need to know before starting to takeEulitop 200 mg Film-Coated Tablets

3. How to takeEulitop 200 mg Film-Coated Tablets

4. Possible side effects

5. Storage ofEulitop 200 mg Film-Coated Tablets

6. Contents of the package and additional information

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, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce the levels of fats in the blood.

Do not take Eulitop

• If you are allergic to bezafibrate, to clofibrate derivatives, to fibrates in general, or to any of the other components of this medication (listed in section 6).
• If fibrates (a type of medication to which bezafibrate belongs) cause allergic reactions when you are exposed to the sun (photodermatitis).
• If you are pregnant or breastfeeding.
• If you have a serious or chronic kidney disease. Its use is contraindicated in dialyzed patients.
• If you have any liver disease (except for fatty liver) or alterations in the bile duct with or without stones (cholestasis).
• If you are being treated with medications from the IMAO group (for depression) or with HMG CoA reductase inhibitors (statins, to reduce cholesterol) in patients at risk of myopathy.

Do not take Eulitop if any of the above circumstances affect you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

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

• You are taking oral contraceptives that contain estrogens.
• You are taking medications to reduce cholesterol called statins or ion exchange resins.
• You are being treated with anticoagulant coumarins.
• You have muscle weakness or have any mild kidney disease. The presence of muscle damage increases in patients with a history of hypalbuminemia (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 marked.

If you experience any symptoms indicative of gallstones such as intense 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 it may cause severe muscle damage (rhabdomyolysis). In case of rhabdomyolysis, treatment with this medication should be interrupted immediately.

Like other fibrates, bezafibrate has been reported to cause pancreatitis.

Your doctor will make blood tests to see the response to the medication and more frequently if you receive prolonged treatments with Eulitop.

Children

Eulitop is not recommended for use in children.

Other medications and Eulitop

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

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

It is essential to inform your doctor if you take some of the following medications:

• Anticoagulants:Eulitop potentiates the action of anticoagulant coumarins, so your doctor will initially reduce the dose of the anticoagulant and frequently monitor blood coagulation.

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

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

• Ciclosporin: If you have been transplanted and are taking medications for rejection, your doctor may recommend interrupting treatment with Eulitop.

• Other medications for controlling lipid levels:The concomitant administration of medications used to reduce cholesterol and Eulitop may produce an increase in muscle alterations. If you are taking medications with ion exchange resins (cholestyramine) to reduce cholesterol levels in the blood, you should leave at least 2 hours between the administration of both medications.

• Certain antidepressants:You should not take Eulitop if you are taking medications that inhibitMAO(a type of medication for depression).

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Eulitop is contraindicated during pregnancy and lactation.

Driving and operating machinery

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

Eulitop contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as 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 medication, your doctor will regularly perform blood tests to monitor blood lipid levels.

Use in children

This medication is not recommended for use 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 Toxicological Information Service immediately, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Eulitop

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eulitop

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 disturbances, decreased appetite.

Rare (may affect up to 1 in 100 patients)

• Abdominal pain, constipation, diarrhea, feeling of fullness in the stomach, vomiting, nausea, which usually disappear without the need to interrupt treatment, within 1 or 2 weeks.
• Increased transaminases (values indicating liver function), bile congestion (cholestasis) and increased liver size (hepatomegaly).
• Itching, urticaria, light sensitivity, hair loss (alopecia) and rash.
• Allergic reactions.

• Muscle weakness, muscle pain and cramps.

-Dizziness, headache.

-Drowsiness.

-Impotence, changes in libido.

-Problems with kidney function (acute renal insufficiency), pain while urinating (dysuria), decreased urine production (oliguria), presence of blood in the urine (hematuria) or excessive protein in the urine (proteinuria).

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

-Increased or decreased alkaline phosphatase in the blood (values indicating 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 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 in certain areas of the skin.

-Depression, insomnia (difficulty sleeping).

-Anemia (blood not transporting enough oxygen to the rest of the 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 gallstones (stones in the gallbladder). If you experience any symptoms indicative of gallstones such as intense abdominal pain, interrupt treatment and consult your doctor.

-Severe skin alterations.

-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 the case of presenting acute muscle pain, without known cause, medication should be interrupted.

-Pulmonary interstitial 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 mainly present in the liver), increased levels of transaminases (enzymes found in the liver).

-Stevens-Johnson syndrome (skin disease with blisters and lesions on the skin and mucous membranes).

• Increased gamma-glutamyl transferase (an enzyme mainly present in the liver).

-Generalized hypersensitivity reactions (exaggerated immune reaction) with chest oppression, dyspnea (difficulty breathing), tachycardia, skin symptoms, hypotension, edema (excess fluid in an organ or tissue), circulatory collapse (inability of the circulatory system to provide 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREcollection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Eulitop 200 mg tablets:

• The active ingredient is bezafibrate. Each tablet contains 200 mg of bezafibrate.
• The other components are: cornstarch, microcrystalline cellulose, carboxymethylstarch sodium (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 content of the packaging

Coated tablets, white in color, round, with G6 engraved on one face. Eulitop is presented in boxes containing blister packs with 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing

CENEXI SAS.

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

F-94120 France

Last review date of this leaflet: April 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)