FENOFIBRATE PENSA PHARMA 145 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Fenofibrate Pensa Pharma 145 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fenofibrate Pensa Pharma and what is it used for
2. What you need to know before you take 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 other information

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

Fenofibrate belongs to a group of medicines known as fibrates. These medicines are used to lower 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-drug treatments such as exercise and weight loss, to lower the levels of fats in the blood.

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

2. What you need to know before you take Fenofibrate Pensa Pharma

Do not take Fenofibrate Pensa Pharmaif:

• you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• when taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen), you have had an allergic reaction or skin lesion caused by sunlight or UV light
• you have severe liver or kidney disease or problems with the gallbladder
• you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of fat in the blood

Do not take fenofibrate if any of the above circumstances apply to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and Precautions

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

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

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

Muscle Effects

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

• unexplained muscle cramps
• muscle pain, tenderness, or weakness

This is because this medicine can cause muscle problems that can be serious. These problems occur rarely but include inflammation and destruction of muscle. This can cause kidney damage or even death.

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

The risk of muscle problems 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 medicines 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 are unsure), consult your doctor or pharmacist before taking this medicine.

Other Medicines and Fenofibrate Pensa Pharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• blood thinners (such as warfarin)
• other medicines used to control fat levels in the blood (such as statins or fibrates). This is because taking a statin at the same time as fenofibrate may increase the risk of muscle problems
• a type of medicine for treating diabetes (such as rosiglitazone or pioglitazone)
• ciclosporin (an immunosuppressant)

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

Pregnancy and Breastfeeding

• Tell 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 fenofibrate in pregnancy, you should only use this medicine if your doctor considers it absolutely necessary.
• It is not known if fenofibrate passes into breast milk. Therefore, you should not use this medicine if you are breastfeeding or planning to breastfeed your baby.

Driving and Using Machines

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

Fenofibrate Pensa Pharmacontains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Fenofibrate Pensa Pharmacontains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Fenofibrate Pensa Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Taking the Medicine

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 indicate that you 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.

If you Take More Fenofibrate Pensa Pharmathan you Should

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

It is recommended to take the package and the package leaflet of the medicine 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 make up for forgotten doses.

If you Stop Taking Fenofibrate Pensa Pharma

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

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking fenofibrate 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, tenderness, or weakness – these can be signs of inflammation or rupture of muscle, 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

• allergic reaction – signs can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing
• yellowing of the skin and the whites of the eyes (jaundice), or increased liver enzymes – these can be signs of inflammation of the liver (hepatitis)

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:

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

Common:may affect up to 1 in 10 people

• diarrhea
• stomach pain
• gas (flatulence)
• feeling sick (nausea)
• being sick (vomiting)
• increased 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 people

• headache
• gallstones
• decreased sex drive
• reactions such as skin rash, itching, hives
• 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
• decrease in hemoglobin (which carries oxygen in the blood) and decrease in white blood cells - seen in blood tests

Not Known:cannot be estimated from the available data

• muscle rupture
• complications of gallstones
• feeling tired (fatigue)

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Pensa Pharma

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

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

Composition of Fenofibrate

• The active substance is fenofibrate. Each Fenofibrate Pensa Pharma 145 mg film-coated tablet EFG contains 145 milligrams (mg) of fenofibrate.
• The other ingredients are

In the core: sodium lauryl sulfate, hypromellose, sucrose, pregelatinized maize starch, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, sodium fumarate, and stearic acid.

In the film coating: poly(vinyl alcohol), titanium dioxide (E 171), macrogol/polyethylene glycol (E1521), talc.

Appearance of the Product and Contents of the Pack

Fenofibrate Pensa Pharma 145 mg film-coated tablets EFG 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 pack sizes may be marketed.

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

or

Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

This medicine is authorized in the Member States of the EU under the following names:

Germany Fenofibrat SUN 145 mg filmtabletten

Spain Fenofibrato pensa pharma 145 mg comprimidos recubiertos con película EFG

France Fenofibrate SUN 145 mg comprimé pelliculé

Italy Fenofibrato Pensa Pharma

Romania Fenofibrat Terapia 145 mg comprimate filmate

Date of Last Revision of this Leaflet:February 2022

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