Leaflet: information for the user

Fenofibrate pensa pharma 145 mg film-coated tablets

Read this 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, pharmacist or nurse.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Fenofibrate pensa pharma is and what it is used for

2. What you need to know before you start taking Fenofibrate pensa pharma

3. How to take Fenofibrate pensa pharma

4. Possible side effects

5. Storage of Fenofibrate pensa pharma

6. Contents of the pack and additional information

Fenofibrate 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 known as triglycerides.

Fenofibrate 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.

Fenofibrate may be used along with other medications (statins), in certain circumstances, when a statin alone does not control the levels of fat in the blood.

Do not take Fenofibrato pensa pharma if:

Do not take fenofibrato 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 fenofibrato if:

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking fenofibrato.

Muscle effects

Stop taking fenofibrato and see your doctor immediately if you experience:

This is because this medication can cause muscle problems that can be serious. These problems occur in rare cases but include inflammation and muscle destruction. This can cause kidney damage or even death.

Your doctor may do a blood test to check your muscles before and after starting treatment.

The risk of muscle problem is higher in some patients. In particular, consult your doctor if:

• You are over 70 years old
• You have kidney problems
• You have thyroid problems
• You or a close relative have a hereditary muscle problem
• You drink large amounts of alcohol
• You are taking medications called “statins” to lower cholesterol (such as simvastatina, atorvastatina, pravastatina, rosuvastatina, or fluvastatina).
• You have had muscle problems during treatment with statins or fibrates (such as fenofibrato, bezafibrato, or gemfibrozilo).

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking this medication.

Other medications and Fenofibrato pensa pharma

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication. In particular, inform your doctor or pharmacist if you are taking any of the following medications:

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking fenofibrato.

Pregnancy and breastfeeding

•Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. As there is not enough evidence on the use of fenofibrato during pregnancy, only use this medication if your doctor considers it absolutely necessary.

•The passage of fenofibrato into breast milk is unknown. Therefore, do not use this medication if you are breastfeeding or planning to breastfeed your baby.

Driving and operating machinery

This medication does not affect your ability to drive or use tools or machines.

Fenofibrato pensa pharma contains saccharose

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fenofibrato pensa pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this 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.

Your doctor will determine the appropriate dose for you, depending on your condition, current treatment, and personal risk factors.

Medication intake

The film-coated tablet can be taken with or without food at any time of the day.

• Swallow the tablet with a glass of water.
• Do not crush or chew the tablet.

Remember that, in addition to taking fenofibrate, it is also important that:

• You have a low-fat diet.
• You exercise regularly.

How much to take

The recommended dose is one film-coated tablet per day.

Patients with kidney problems

If you have kidney problems, your doctor may recommend a lower dose. Consult your doctor or pharmacist about this.

Use in children and adolescents

Fenofibrate is not recommended for use in children and adolescents under 18 years old.

If you take more Fenofibrate pensa pharma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Fenofibrate pensa pharma

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Fenofibrate pensa pharma

Do not stop taking this medication unless your doctor tells you to or if the tablets make you feel unwell. This is because abnormal levels of fat in the blood require long-term treatment.

If your doctor stops the medication, do not store the remaining tablets unless your doctor tells you to.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking fenofibrate and see your doctor immediately if you notice any of the following severe side effects – you may need urgent medical treatment:

Rare:may affect up to 1 in 100 people

• Muscle cramps or pain, sensitivity or weakness – these may be signs of inflammation or muscle rupture, which can cause kidney damage or even death
• Abdominal pain – this may be a sign that the pancreas is inflamed (pancreatitis)
• Chest pain and shortness of breath – these may be signs of a blood clot in the lungs (pulmonary embolism)
• Pain, redness or swelling in the legs – these may be signs of a blood clot in the leg (deep vein thrombosis)

Rare:may affect up to 1 in 1,000 people

• Allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing
• Yellowing of the skin and white of the eyes (jaundice), or an increase in liver enzymes – these may be signs of liver inflammation (hepatitis)

Unknown:cannot be estimated from available data

• Severe skin eruption that reddens, peels and swells the skin and resembles a severe burn
• Long-term lung problems

Stop taking fenofibrate and see your doctor immediately if you notice any of the side effects listed above.

Other side effects:

See your doctor or pharmacist if you experience any of the following side effects:

Common:may affect up to 1 in 10 people

• Diarrhea
• Abdominal pain
• Gas (flatulence)
• Unpleasant feeling (nausea)
• Unpleasantness (vomiting)
• Elevated liver enzymes in the blood – seen in blood tests
• Increased homocysteine (excess of this amino acid in the blood has been associated with a higher risk of coronary disease, stroke and peripheral vascular disease, although no causal relationship has been established)

Rare:may affect up to 1 in 100 people

• Headache
• Bile stones
• Decreased libido
• Reactions such as skin rash, itching, hives on the skin
• Increased creatinine (substance excreted by the kidneys) – seen in blood tests

Rare:may affect up to 1 in 1,000 people

• Hair loss
• Increased urea (produced by the kidneys) – seen in blood tests
• Skin more sensitive to sunlight, sunlamps and sunbeds
• Decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes – seen in blood tests

Unknown:cannot be estimated from available data

• Muscle rupture
• Complications of bile stones
• Feeling of exhaustion (fatigue)

See your doctor or pharmacist if you experience any of the side effects listed above.

Reporting side effects

If you experience any type of side effect, see your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fenofibrate

• The active ingredient is fenofibrate. Each Fenofibrate pensa pharma 145 mg film-coated tablet contains 145 milligrams (mg) of fenofibrate.
• The other components are

In the core: sodium lauryl sulfate, hypromellose, sucrose, pregelatinized cornstarch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, stearate fumarate, and sodium.

In the film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol/polietilenglycol (E1521), talc.

Appearance of the product and contents of the package

Fenofibrate pensa pharma 145 mg film-coated tablets are presented in the form of white to off-white, oval, biconvex film-coated tablets, with dimensions of 19.1 mm x 9 mm, with one face engraved with “RH 38” and the other face flat.

The film-coated tablets are presented in PVC/PE/PVDC/Al blisters, in boxes containing 30, 90, and 100 film-coated tablets.

Not all formats may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

or

Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

This medicine is authorized in the EU member states with the following names:

GermanyFenofibrat SUN 145 mg filmtabletten

SpainFenofibrate pensa pharma 145 mg film-coated tablets

FranceFenofibrate SUN 145 mg coated tablet

ItalyFenofibrate Pensa Pharma

RomaniaFenofibrat Terapia 145 mg film-coated tablets

Last review date of this leaflet:February 2022

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