FENOFIBRATE KERN PHARMA 145 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

FenofibrateKern Pharma145 mg film-coated tablets

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Fenofibrate Kern Pharma is and what it is used for.
2. What you need to know before you take Fenofibrate Kern Pharma.
3. How to take Fenofibrate Kern Pharma.
4. Possible side effects.
5. Storage of Fenofibrate Kern Pharma.
6. Contents of the pack and other information.

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

Fenofibrate Kern Pharma belongs to a group of medicines commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example, fats called triglycerides.

Fenofibrate Kern Pharma 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 Kern Pharma may be used along 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 Kern Pharma

Do not take Fenofibrate Kern Pharma

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6),
• if you have had an allergic reaction or skin lesion caused by sunlight or UV light when taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen),
• if you have severe liver or kidney disease or problems with your gallbladder,
• if 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 applies 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 this medicine:

• if you have kidney or liver problems,
• if 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,
• if you have an underactive thyroid gland (hypothyroidism).

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

Fenofibrate Kern Pharma and muscle effects:

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

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

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, inform 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 applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Using Fenofibrate Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or 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:

• anticoagulants to reduce blood thickness (such as warfarin),
• other medicines used to control fat levels in the blood (such as statins or fibrates). This is because taking a statin or another fibrate at the same time as this medicine 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 applies to you (or 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 not known whether fenofibrate can affect the newborn.

You should only use this medicine if your doctor advises you to.

Do not use this medicine if you are breastfeeding or planning to breastfeed your baby. This is because it is not known 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 use tools or machines.

Fenofibrate Kern Pharma contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially “sodium-free”.

3. How to take Fenofibrate Kern Pharma

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Taking the medicine

The 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 this medicine, it is also important that:

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

How much to take

The recommended dose is one tablet per day.

If you are currently taking a 200 mg fenofibrate capsule or a 160 mg fenofibrate tablet per day, you may switch to a 145 mg fenofibrate tablet per day. You will still receive the same amount of medicine.

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 Fenofibrate Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Fenofibrate Kern 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 Kern Pharma

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

If your doctor stops the medicine, do not keep the remaining tablets unless your doctor advises you to. If you have any further questions about the use of this product, 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 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

• allergic reaction – these 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 liver inflammation (hepatitis).

Not known: cannot be estimated from the available data

• severe skin rash that causes redness, peeling and swelling of the skin, similar to a severe burn
• long-term lung problems

Stop taking Fenofibrate Kern Pharma 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:

• diarrhoea,
• 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,
• reduced 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,
• increased sensitivity of the skin to sunlight, sunlamps and sunbeds,
• decrease in haemoglobin (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 wasting,
• complications of gallstones,

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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fenofibrate Kern Pharma

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to 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 ingredients are lactose, hypromellose, sodium lauryl sulfate, simeticone emulsion 30%, sodium croscarmellose and magnesium stearate.

Appearance and packaging of the product

Fenofibrate Kern Pharma 145 mg film-coated tablets are white or almost white tablets. Each pack contains 30 tablets.

Marketing authorisation 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 last revision of this leaflet: May 2025.

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