Leaflet: information for the user

Fenofibrate pensa 160 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 or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What is Fenofibrate Pensa and what it is used for

2. What you need to know before taking Fenofibrate Pensa

3. How to take Fenofibrate Pensa

4. Possible side effects

5. Storage of Fenofibrate Pensa

6. Contents of the pack and additional information

Fenofibrato Pensa 160 mg film-coated tablets belong 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 known as triglycerides.

Fenofibrato 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.

Fenofibrato may be used along with other medicines [statins] in certain circumstances when a statin alone does not control the levels of fat in the blood.

Do not take Fenofibrato Pensa

?if you are allergic to fenofibrato or any of the other components of this medication (listed in section 6).

?if this medication contains lecithin from soy. Do not use in case of allergy to peanuts or soy.

?if you have taken other medications (such as other fibrates or a medication called ketoprofen), you have had an allergic reaction or skin lesion caused by sunlight or UV light.

?if you have severe liver, kidney, or gallbladder disease.

?if you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of blood fat.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fenofibrato Pensa.

• If you have kidney or liver problems.
• If you may be prone to liver inflammation (hepatitis) – signs that include yellowing of the skin and the white of the eyes (jaundice), increase in liver enzymes (present in blood tests), stomach pain and itching
• If you have a thyroid gland with low activity (hypothyroidism)

If any of the above circumstances affect you (or you have doubts), consult your doctor or pharmacist before taking Fenofibrato Pensa.

Fenofibrato Pensa and muscle effects

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

• unexplained muscle cramps,
• pain, sensitivity, or muscle weakness while taking this medication.

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 blood tests to check the condition of your muscles before and after starting treatment.

The risk of muscle problem is higher in some patients. 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 simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.

- You have had muscle problems during treatment with statins or fibrates such as fenofibrate, bezafibrate, or gemfibrozil.

If any of the above circumstances affect you (or you have doubts), consult your doctor or pharmacist before taking Fenofibrato Pensa.

Other medications and Fenofibrato Pensa

Tell your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In particular, tell your doctor or pharmacist if you are taking any of the following medications:

• Anticoagulants to reduce blood thickness (such as warfarin).
• Other medications used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as fenofibrate may increase the risk of muscle problems.
• A type of medication to treat diabetes (such as rosiglitazone or pioglitazone).
• Ciclosporin (an immunosuppressant).

If any of the above circumstances affect you (or you have doubts), consult your doctor or pharmacist before taking Fenofibrato Pensa.

Taking Fenofibrato Pensa with food, drinks, and alcohol

It is essential to take the tablet with food, as it does not work as well if your stomach is empty.

Pregnancy, breastfeeding, and fertility

If you are pregnantor breastfeeding,believe you may be pregnant or intend to becomepregnant, consult your doctor or pharmacist before using this medication. As there is not enough evidence on the use of fenofibrate during pregnancy, you should only use Fenofibrato Pensa if your doctor considers it absolutely necessary.

It is unknown whether fenofibrate passes into breast milk. Therefore, do not use Fenofibrato Pensa if you are breastfeeding or plan to breastfeed your baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Fenofibrato Pensa contains lecithin from soy and sodium

This medication contains lecithin from soy. Do not use in case of allergy to peanuts or soy.

This medication contains less than 23 mg of sodium (1 mmol) per 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.

Medication Intake

Swallow the tablet with a glass of water.

Do not crush or chew the tablet.

Take the tablet with food, as it does not work as well if your stomach is empty.

How Much to Take

The recommended dose is one tablet per day.

If you are currently taking a 200 mg fenofibrate capsule, you may switch to a 160 mg fenofibrate tablet.

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.

What if You Take More Fenofibrate Pensa than You Should

In case of overdose, accidental ingestion, or if you suspect a child has swallowed several whole tablets, consult your doctor as soon as possible or call the Toxicology Information Service at Teléfono 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

What if You Forget to Take Fenofibrate Pensa

Do not worry if you have forgotten to take a 160 mg dose. Take a dose with the next meal and then continue with your treatment as usual.

Do not take a double dose to make up for the missed doses. If you have any doubts, consult your doctor or pharmacist.

What if You Stop Taking Fenofibrate Pensa

Do not stop taking the medication unless your doctor tells you to, or unless the tablets do not agree with you. This is because abnormal levels of fat in the blood need to be treated for a long period of time.

If your doctor stops the treatment, do not keep the remaining tablets unless your doctor tells you to.

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

- Follow a low-fat diet

- Exercise regularly

If you have any other doubts 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:

Stop taking Fenofibrate Pensa and see your doctor immediately if you notice any of the following serious 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

• stomach 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

-yellowing of the skin and white of the eyes (jaundice), or an increase in liver enzymes – these may be signs of liver inflammation (hepatitis)

-allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing

Unknown frequency: (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 previous side effects.

Other side effects include:

Common(may affect up to 1 in 10 patients):

• diarrhea

• stomach pain

• gas (flatulence)

• feeling unwell (nausea)

• discomfort (vomiting)

• elevated liver enzymes in the blood – seen in blood tests

• increase in homocysteine (excess of this amino acid in the blood has been associated with an increased risk of coronary artery disease, stroke and peripheral vascular disease, although no causal relationship has been established)

Rare(may affect up to 1 in 100 patients):

• headache

• gallstones

• decreased libido

• reactions such as skin rash, itching, hives on the skin

• increased creatinine (substance excreted by the kidneys) – seen in blood tests

• pancreatitis (inflammation of the pancreas that produces abdominal pain)

• thromboembolism: pulmonary embolism (blood clot in the lung that produces chest pain and difficulty breathing), deep vein thrombosis (blood clot in the leg that produces pain, redness or swelling)

•

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

• hair loss

•

• increased urea (produced by the kidneys) – seen in blood tests

• increased sensitivity of the skin to sunlight, sunlamps and sunbeds

• decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes – seen in blood tests

•

Unknown frequency: (cannot be estimated from available data)• muscle wasting

• complications of gallstones

• if you experience any unusual respiratory discomfort, inform your doctor immediately.

•feeling of exhaustion (fatigue)

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 leaflet. You can also report them directly through the Spanish 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.

This medication does not require special storage conditions.

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

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.

Fenofibrate Pensa Composition

The active ingredient is fenofibrate. Each tablet contains 160 mg of fenofibrate.

The other components (excipients) are: pregelatinized cornstarch, povidone, sodium lauryl sulfate, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, sodium stearate fumarate, partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, soy lecithin, and xanthan gum.

Product appearance and packaging content

The tablets are white or almost white, oval, and biconvex, and coated with a film, with the mark “RX901” on one of its faces.

The tablets are contained in a thermoformed PVC/Aclar-Alu blister.

This medication is presented in packs of 30 tablets.

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

Last review date of this leaflet: March 2022.

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