Fenofibrate Pensapharma 145 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fenofibrato 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, 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Fenofibrato pensa pharma is and what it is used for
2. What you need to know before taking Fenofibrato pensa pharma
3. How to take Fenofibrato pensa pharma
4. Possible side effects
5. How to store Fenofibrato pensa pharma
6. Contents of the pack and other information

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

Fenofibrate belongs to a group of medicines commonly known as fibrates. These medicines are used to reduce the level of fats (lipids) in the blood, such as fats known as triglycerides.

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

2. What you need to know before taking Fenofibrato pensa pharma

Do not take Fenofibrato pensa pharma if:

• you are allergic to fenofibrate or to 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 injury caused by sunlight or UV light
• you have severe liver or kidney disease or gallbladder problems
• you have pancreatitis (inflammation of the pancreas causing abdominal pain) not caused by high levels of fat in the blood

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

Warnings and precautions

Talk to your doctor or pharmacist before starting fenofibrate if:

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

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

Muscle effects

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

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

This is because this medicine may cause muscle problems, which can be serious. These problems are rare but may include muscle inflammation and breakdown. This can lead to kidney damage or even death.

Your doctor may perform a blood test to check your muscle health before and during treatment.

The risk of muscle problems is higher in certain patients. Specifically, consult your doctor if:

• you are over 70 years old
• you have kidney problems
• you have thyroid problems
• you or a close family member has an inherited muscle disorder
• 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 previously experienced muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before taking this medicine.

Other medicines and Fenofibrato pensa pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• anticoagulants to thin the blood (such as warfarin)
• other medicines used to control blood fat levels (such as statins or fibrates). This is because taking a statin together with fenofibrate may increase the risk of muscle problems
• a type of medicine used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant)

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

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Since there is insufficient evidence regarding the use of fenofibrate during pregnancy, this medicine should only be used if your doctor considers it absolutely necessary.
• It is unknown whether fenofibrate passes into breast milk. Therefore, you should not use this medicine if you are breastfeeding or planning to breastfeed.

Driving and using machines

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

Fenofibrato pensa pharma contains sacarose

This medicine contains sacarose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Fenofibrato pensa pharma contains sodium

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

3. How to take Fenofibrato pensa pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

How to take the medicine

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

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

Please remember that, in addition to taking fenofibrate, it is also important that you:

• follow a low-fat diet.
• exercise regularly.

How much to take

The recommended dose is one film-coated tablet daily.

Patients with kidney problems

If you have kidney problems, your doctor may advise 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 of age.

If you take more Fenofibrato pensa pharma than you should

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

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

If you forget to take Fenofibrato 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 Fenofibrato pensa pharma

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

If your doctor discontinues the medicine, do not keep the remaining tablets unless your doctor instructs you to do so.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Stop taking fenofibrate and contact your doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

Uncommon: may affect up to 1 in 100 people

• muscle cramps or pain, tenderness or weakness – these may be signs of muscle inflammation or breakdown, which can lead to 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

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

Not known: frequency cannot be estimated from available data

• severe skin rash causing redness, peeling and swelling of the skin resembling a severe burn
• long-term lung problems

Stop taking fenofibrate and contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects:

Contact your doctor or pharmacist if you experience any of the following adverse effects:

Common: may affect up to 1 in 10 people

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling unwell (nausea)
• discomfort (vomiting)
• elevated liver enzymes in the blood – seen in blood tests
• increased homocysteine levels (elevated levels of this amino acid in the blood have been associated with an increased 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 sexual desire
• skin reactions such as rash, itching, hives
• increased creatinine (a 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 becoming more sensitive to sunlight, sunlamps and solariums
• decrease in haemoglobin (which carries oxygen in the blood) and decrease in white blood cells – seen in blood tests

Not known: frequency cannot be estimated from available data

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

Contact your doctor or pharmacist if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse 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 stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This 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 components are

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

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

Appearance of the product and contents of the container

Fenofibrate pensa pharma 145 mg film-coated tablets EFG are white to off-white film-coated tablets, oval-shaped, biconvex, with dimensions of 19.1 mm x 9 mm, marked with "RH 38" on one side and the other side plain.

The film-coated tablets are supplied in PVC/PE/PVDC/Al blisters, in cardboard 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
The Netherlands

or

Terapia S.A.
Str. Fabricii nr. 124
Cluj-Napoca, 400632
Romania

This medicinal product is authorized in EU Member States 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 the most recent revision of this leaflet: February 2022

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