Fenofibrate Pensa 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fenofibrate Pensa 160 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

1. What Fenofibrate Pensa is 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. How to store Fenofibrate Pensa
6. Contents of the pack and other information

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

Fenofibrato Pensa 160 mg film-coated tablets belongs 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 called triglycerides.

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

Fenofibrate may be used together 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 starting to take Fenofibrate Pensa

Do not take Fenofibrate Pensa

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

? This medicine contains soybean lecithin. It must not be used in case of allergy to peanuts or soya.

? if, 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.

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

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

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

Warnings and precautions

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 include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (detected in blood tests), stomach pain, and itching.
• If you have an underactive thyroid gland (hypothyroidism).

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

Fenofibrate and muscle effects

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

• unexplained muscle cramps,
• muscle pain, tenderness, or weakness while taking this medicine.

This is because this medicine may cause muscle problems, which can be serious.

• These problems are rare but may include muscle inflammation and muscle breakdown. This can lead to kidney damage or even death.

Your doctor may perform blood tests to check your muscle condition before and during 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 family member has a hereditary 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 conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Fenofibrate Pensa.

Other medicines and Fenofibrate Pensa

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 reduce blood thickness (such as warfarin).
• Other medicines 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 medicine used to treat diabetes (such as rosiglitazone or pioglitazone).
• Cyclosporine (an immunosuppressant).

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

Taking Fenofibrate Pensa with food, drinks and alcohol

It is important 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 might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Since there is insufficient evidence regarding the use of fenofibrate during pregnancy, Fenofibrate Pensa should only be used if your doctor considers it absolutely necessary.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

This medicinal product does not affect the ability to drive or operate tools or machinery.

Fenofibrate Pensa contains soya lecithin and sodium

This medicinal product contains soya lecithin. It must not be used in case of allergy to peanuts or soya.

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

3. How to take Fenofibrate Pensa

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

How to take the medicine

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 daily.

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 advise you to take 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 of age.

If you take more Fenofibrato Pensa than you should

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 Telephone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medicine package and the patient information leaflet to the healthcare professional.

If you forget to take Fenofibrato Pensa.

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

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

If you stop taking Fenofibrato Pensa.

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

If your doctor discontinues the treatment, do not keep any remaining tablets unless your doctor specifically instructs you to.

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

• Follow a low-fat diet
• Exercise regularly

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 experiences them:

Stop taking Fenofibrate Pensa and contact your doctor immediately if you experience any of the following serious adverse effects – you may require 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

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

Frequency not known: (cannot be estimated from available data)

• severe skin rash that reddens, peels and swells the skin and resembles 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 include:

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

• diarrhoea
• stomach pain
• gas (flatulence)
• feeling unwell (nausea)
• discomfort (vomiting)
• elevated liver enzymes in the blood – seen in blood tests
  • increased homocysteine (elevated levels of this amino acid in 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 patients):

• headache
• gallstones
• decreased sexual desire
• skin reactions such as rash, itching, hives
• increased creatinine (a substance excreted by the kidneys) – seen in blood tests
• pancreatitis (inflammation of the pancreas causing abdominal pain)
• thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and difficulty breathing), deep vein thrombosis (blood clot in the leg causing 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 solariums
• decrease in haemoglobin (which carries oxygen in the blood) and decrease in white blood cells – seen in blood tests

Frequency not known: (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 adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Pensa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Pensa

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

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

Appearance of the product and contents of the pack

The tablets are white or almost white, oval, biconvex, and film-coated, with the mark “RX901” on one side.

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

This medicine is available in packs 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,

The Netherlands

Date of the most recent revision of this leaflet: March 2022.

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