Fenofibrate Kern Pharma 145 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

FenofibrateKern Pharma 145 mg 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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 Kern Pharma is and what it is used for.
2. What you need to know before taking Fenofibrate Kern Pharma.
3. How to take Fenofibrate Kern Pharma.
4. Possible side effects.
5. How to store Fenofibrate Kern Pharma.
6. Contents of the pack and other information.

1. What Fenofibrato Kern Pharma is and what it is used for

Fenofibrato Kern Pharma 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 called triglycerides.

Fenofibrato Kern Pharma is used, together 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 Kern Pharma may be used in combination with other medicines [statins] under certain circumstances when a statin alone does not control fat levels in the blood.

2. What you need to know before taking Fenofibrato Kern Pharma

Do not take Fenofibrato Kern Pharma

• if you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6),
• if you have previously experienced an allergic reaction or skin injury caused by sunlight or UV light when taking other medicines (such as other fibrates or a medicine called ketoprofen used to treat inflammation),
• if you have severe liver or 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 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 this medicine:

• 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 (seen in blood tests), stomach pain, and itching,
• if you have an underactive thyroid gland (hypothyroidism).

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

Fenofibrato Kern Pharma 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 could lead to kidney damage or even death.

Your doctor may perform blood tests to check your muscle health before and after starting treatment.

The risk of muscle problems is higher in some patients. Specifically, inform 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 apply to you (or if you are unsure), consult your doctor or pharmacist before taking this medicine.

Taking Fenofibrato Kern Pharam with other medicines

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 used 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 or another fibrate together with this medicine may increase the risk of muscle problems,
• certain medicines used to treat diabetes (such as rosiglitazone or pioglitazone),
• ciclosporin (an immunosuppressant).

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

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. This is because it is unknown whether fenofibrate may affect the newborn. You should only use this medicine if your doctor specifically prescribes it.

You must not use this medicine if you are breastfeeding or planning to breastfeed. This is because it is unknown whether the active ingredient of this medicine passes into breast milk.

Driving and using machines

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

Fenofibrato Kern Pharma contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him or her before taking this medicine.

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

3. How to take Fenofibrate Kern Pharma

Follow exactly the administration instructions for this medicine as indicated 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 personal risk status.

Administration of the medicine

The tablet can 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 this medicine, it is also important that you:

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

How much to take

The recommended dose is one tablet daily.

If you are currently taking a 200 mg fenofibrate capsule or a 160 mg fenofibrate tablet daily, you may switch to a 145 mg fenofibrate tablet daily. You will continue to receive the same amount of medication.

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

This medicine is not recommended for use in children and adolescents under 18 years of age.

If you take more FenofibratoKernPharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take FenofibratoKernPharma

• 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 FenofibratoKernPharma

Do not stop taking this medicine unless your doctor tells you to, or if the tablets make you feel unwell. This is because it requires long-term treatment.

If your doctor discontinues the medicine, do not keep the remaining tablets unless your doctor tells you to. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

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

Stop taking fenofibrate 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, pain, tenderness, or weakness – these may be signs of muscle inflammation or breakdown, which could 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

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

Frequency not known: 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 Kern Pharma and contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects:

Consult 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 blood – observed in blood tests,
• increased homocysteine levels (elevated levels of this amino acid in blood have 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 sexual desire,
• skin reactions such as rash, itching, or hives,
• increased creatinine (a substance excreted by the kidneys) – observed in blood tests.

Rare: may affect up to 1 in 1,000 people:

• hair loss,
• increased urea (produced by the kidneys) – observed in blood tests,
• increased skin sensitivity to sunlight, sunlamps, and sunbeds,
• decreased haemoglobin (which carries oxygen in the blood) and decreased white blood cells – observed in blood tests.

Frequency not known: cannot be estimated from available data

• muscle wasting,
• complications related to gallstones.

Consult 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, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fenofibrate Kern Pharma

• The active substance is fenofibrate. Each tablet contains 145 mg of fenofibrate.
• The other components are lactose, hypromellose, sodium lauryl sulfate, simethicone emulsion 30%, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the pack

Fenofibrate Kern Pharma 145 mg tablets are presented as white or almost white tablets. Each pack contains 30 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

ETHYPHARM

Chemin de la Poudrière

76120 Grand-Quevilly

France

or

ETHYPHARM

Zi De Saint-Arnoult

28170 Châteaneuf-en-Thymerais

France

Date of the most recent review of this leaflet: May 2025.

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