FENOFIBRATE PENSA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Fenofibrate Pensa 160 mg Film-Coated Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fenofibrate Pensa and what is it 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. Package Contents and Additional Information

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

Fenofibrate Pensa 160 mg film-coated tablets belong 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.

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

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

2. What you need to know before taking Fenofibrate Pensa

Do not take Fenofibrate Pensa

?

?

?

?

?

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

A

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

• If you have kidney or liver problems.
• If you may have liver inflammation (hepatitis) - signs that include yellowing of the skin and the whites of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching
• If you have an underactive thyroid gland (hypothyroidism)

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

Fenofibrate PensaandMuscle Effects

Stop taking Fenofibrate and consult your doctor immediately if you experience:

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

This is because this medication can cause muscle problems that can be serious.

• These problems occur rarely but include muscle inflammation and destruction. This can cause kidney damage or even death.

Your doctor may perform blood tests to check the condition of your muscles before and after starting treatment.

The risk of muscle problems 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 apply to you (or you have doubts), consult your doctor or pharmacist before taking Fenofibrate Pensa.

Other Medications and Fenofibrate Pensa

Tell your doctor or pharmacist if you are using, have recently used, 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 for treating diabetes (such as rosiglitazone or pioglitazone).
• Cyclosporin (an immunosuppressant).

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

Taking Fenofibrate 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 pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, 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 Fenofibrate Pensa if your doctor considers it absolutely necessary.

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

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

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

Fenofibrate Pensa Contains Soy Lecithin and Sodium

This medication contains soy lecithin. Do not use it if you are allergic to peanuts or soy.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to Take Fenofibrate Pensa

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

Taking the Medication

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 can switch to a 160 mg fenofibrate tablet.

Patients with Kidney Problems

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

Use in Children and Adolescents

The use of fenofibrate is not recommended in children and adolescents under 18 years old.

S

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

If You Missed a Dose of Fenofibrate Pensa.

Do not worry if you missed a dose (tablet) of 160 mg. Take a dose with your next meal and then continue with your treatment as usual.

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

If You Stop Taking Fenofibrate Pensa.

Do not stop taking the medication unless your doctor tells you to or the tablets do not agree with you. This is because abnormal blood fat levels need to be treated for a long 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 essential that you:

• Follow a low-fat diet
• Exercise regularly

If you have any other doubts about using this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone gets them:

Stop taking Fenofibrate Pensa and consult your doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

Uncommon:may affect up to 1 in 100 people

• • muscle cramps or pain, sensitivity, or weakness - these can be signs of muscle inflammation or rupture, which can cause kidney damage or even death
• stomach pain - this can be a sign that the pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath - these can be signs of a blood clot in the lungs (pulmonary embolism)
• pain, redness, or swelling in the legs - these can 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 the whites of the eyes (jaundice), or an increase in liver enzymes - these can be signs of liver inflammation (hepatitis)
• allergic reaction - signs can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing

Frequency Not Known:(cannot be estimated from the available data)

• severe skin rash that reddens, scales, and swells the skin and resembles a severe burn
• long-term lung problems

Stop taking Fenofibrate and consult your doctor immediately if you notice any of the above side effects.

Other side effects include:

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

• diarrhea
• stomach pain
• gas (flatulence)
• feeling of discomfort (nausea)
• discomfort (vomiting)
• high levels of 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 heart disease, stroke, and peripheral vascular disease, although a causal relationship has not been established)

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

• headache
• gallstones
• decreased sex drive
• reactions such as skin rash, itching, hives
• increased creatinine (substance excreted by the kidneys) - seen in blood tests
• pancreatitis (inflammation of the pancreas that causes abdominal pain)
• thromboembolism: pulmonary embolism (blood clot in the lung that causes chest pain and difficulty breathing), deep vein thrombosis (blood clot in the leg that causes 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
• decrease in hemoglobin (which carries oxygen in the blood) and decrease in white blood cells - seen in blood tests

•

Frequency Not Known:(cannot be estimated from the available data) • muscle wasting

• complications of gallstones
• feeling of fatigue

Reporting Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fenofibrate Pensa

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 stated on the package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Fenofibrate Pensa

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

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

Appearance of the Product and Package Contents

The tablets are white or almost white, oval, and biconvex, and film-coated, with the mark "RX901" on one of their faces.

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

This medication is available in packages of 30 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp,

Netherlands

Date of the Last Revision of this Package Leaflet:March 2022.

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