Package Insert: Information for the Patient

Eulitop Retard 400 mg Extended-Release Tablets

Bezafibrate

Read this entire 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 refer to 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 Retard 400 mg Tabletsand what is it used for

2. What you need to know before starting to takeEulitop Retard 400 mg Tablets

3. How to takeEulitop Retard 400 mg Tablets

4. Possible adverse effects

5. Storage ofEulitop Retard 400 mg Tablets

6. Contents of the package and additional information

Eulitop Retard belongs to a group of medications commonly known as fibrates. These medications are used to reduce the level of fats (lipids) in the blood (for example, fats called triglycerides).

Eulitop Retard 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 Retard

• 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 severe or chronic kidney disease. Its use is contraindicated in patients undergoing dialysis.
• 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 Retard 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 Retard 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 hypoproteinemia (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 the 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 how you respond to the medication and more frequently if you receive prolonged treatments with Eulitop Retard.

Children

Eulitop Retard is not recommended for use in children.

Other medications and Eulitop Retard

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 Retard. 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 are taking some of the following medications:

• Anticoagulants:Eulitop Retard 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 Retard potentiates the action of medications for diabetes (medications to reduce blood sugar). If you are using or taking these medications, your doctor will likely reduce the dose of these medications.

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

• Ciclosporin:If you have undergone a transplant and are taking medications for rejection, your doctor may recommend interrupting treatment with Eulitop Retard.

• Other medications for controlling lipid levels:The concomitant administration of medications used to reduce cholesterol and Eulitop Retard 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 Retard if you are taking medications that inhibit MAO (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 or plan to become pregnant, consult your doctor or pharmacist before using this medication. Eulitop Retard is contraindicated during pregnancy and lactation.

Driving and operating machines

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

Eulitop Retard contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Eulitop Retard contains sodium

This medication contains less than 1mmol of sodium (23 mg) per prolonged-release 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 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 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 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, contact the Toxicological Information Service immediately, phone 91 562 04 20, indicating the name of the medication and the amount ingested.

If you forget to take Eulitop Retard

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

If you interrupt treatment with Eulitop Retard

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Frequent (can affect up to 1 in 10 patients)

-Gastrointestinal disturbances, decreased appetite.

Rare (can 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 allergy, 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 (can affect up to 1 in 1,000 patients)

-Pancreatitis (inflammation of the pancreas).

-Peripheral nerve disorders (those not found 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 (can affect up to 1 in 10,000 patients)

• Appearance of gallstones (stones in the gallbladder). If you experience any symptoms indicating 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), leukopenia (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, treatment 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).
• Lyell 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 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.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at theSIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Eulitop Retard 400 mg tablets

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

Appearance of the product and contents of the packaging

Prolonged-release white tablets, round, with an engraving of D9 on one of their faces. Eulitop Retard is presented in boxes containing blister packs with 30 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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)