Prospect: Patient Information

Fenofibrate Kern Pharma 160 mg Hard Capsules EFG

Fenofibrato Kern Pharma belongs to a group of medications known as fibrates. These medications are used to decrease the level of fats (lipids) in the blood. For example, fats known as triglycerides.

Fenofibrato Kern Pharma is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to decrease the levels of fats in the blood.

Fenofibrato Kern Pharma may be used along with other medications (statins) in certain circumstances when a statin alone does not control the levels of fat in the blood.

Do not take Fenofibrato Kern Pharma 160 mg capsules if:

• You are allergic to fenofibrate or to any other substance contained in this medication (listed in section 6).
• You have had an allergic reaction or skin lesion caused by sunlight or UV light while taking other medications (such as other fibrates or a medication called ketoprofen).
• You have severe liver, kidney, or gallbladder disease.
• You have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of blood fat.

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Warnings and precautions

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

• You have kidney or liver problems.
• You may be prone to liver inflammation (hepatitis – signs that include yellowing of the skin and the white of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching).
• You have a thyroid gland with low activity (hypothyroidism).

Muscle effects

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

• Unexplained muscle cramps.
• Pain, sensitivity, or muscle weakness while taking this medication.

This is because this medication can cause muscle problems that can be serious. These problems occur in rare cases but include inflammation and muscle destruction. This can cause kidney damage or even death.

Your doctor may do a blood test to check the condition of your muscles before and after starting treatment.

The risk of muscle destruction is higher in some patients. Consult your doctor if:

• You are over 70 years old.
• You have kidney problems.
• You have thyroid problems.
• You drink large amounts of alcohol.
• You or a close relative have a hereditary muscle problem.
• You are taking medications 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.

Other medications and Fenofibrato Kern Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly inform your doctor or pharmacist if you are taking any of the following medications:

• Anticoagulants to reduce blood thickness (such as warfarin).
• Other medications 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 medication to treat diabetes (such as rosiglitazona or pioglitazona).
• Ciclosporina (an immunosuppressant).

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

Taking Fenofibrato Kern Pharma with food, drinks, and alcohol

The capsules should be swallowed whole with water. It is essential to take the capsules with meals as their absorption and release into the bloodstream are reduced if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you are pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication. As there is not enough experience with the use of fenofibrate during pregnancy, you should only use fenofibrate if your doctor considers it absolutely necessary.

The active ingredient in fenofibrate is unknown to pass into breast milk. Therefore, do not use fenofibrate if you are breastfeeding or plan to breastfeed your baby.

Driving and operating machines

This medication does not affect your ability to drive and use machines.

Fenofibrato Kern Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Your doctor will determine the most suitable dose, depending on your condition, your regular medication, and your personal risk condition.

Medication intake

Swallow the entire capsule with a glass of water – as it does not work as well if your stomach is empty.

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

• follow a low-fat diet.
• engage in regular exercise.

How often to take

The recommended dosage for adults is one capsule per day during one of the main meals, in combination with an adequate diet.

Patients with kidney problems

If you have kidney problems, your doctor may recommend a lower dose. Consult your doctor or pharmacist about this.

Use in children and adolescents

Fenofibrate is not recommended for use in individuals under 18 years old.

If you take more Fenofibrate Kern Pharma than you should

In case of overdose, accidental ingestion, or if you suspect that another person has taken your medication, consult your doctor or call the Toxicological Information Service Telephone915620420.

If you forget to take Fenofibrate Kern Pharma

• If you forget to take a dose, take the next dose with your next meal.
• Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Fenofibrate Kern Pharma

Do not stop taking this medication unless your doctor tells you to or if the capsules make you feel unwell. This is because you require long-term treatment.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking fenofibrate and see your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

Rare(may affect up to 1 in 100 people):

• Muscle cramps or pain, sensitivity or weakness – these may be signs of inflammation or muscle rupture, which can cause kidney damage or even death.
• Abdominal 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).

Uncommon(may affect up to 1 in 1,000 patients):

• Allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing.
• Yellowing of the skin and the white of the eyes (jaundice), or an increase in liver enzymes – these may be signs of liver inflammation (hepatitis).

Unknown(cannot be estimated from available data)

• Severe skin rash that reddens, peels and swells the skin, and resembles a severe burn.
• Long-term respiratory problems.

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 patients):

• Diarrhea
• Abdominal pain
• Gas (flatulence)
• Unpleasant feeling (nausea)
• Discomfort (vomiting)
• Elevated 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 disease, stroke and peripheral vascular disease, although no causal relationship has been established).

Rare(may affect up to 1 in 100 people):

• Headache
• Bile stones
• Decreased libido
• Skin rash, itching or hives
• Increased creatinine (produced by the kidneys); appears in blood tests.

Uncommon(may affect up to 1 in 1,000 people):

• Hair loss
• Increased urea (produced by the kidneys); appears in blood tests
• Skin more sensitive to sunlight, sunlamp and sunbed
• Decrease in hemoglobin (which transports oxygen in the blood) and decrease in white blood cells – seen in blood tests

Unknown(cannot be estimated from available data)

Muscle wasting

Biliary stone complications

Feeling of exhaustion (fatigue)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above30°C. Store this medication in the original packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fenofibrato Kern Pharma The active ingredient is fenofibrate.

Each capsule contains 160 milligrams (mg) of fenofibrate.

The other components are: lauroyl macrogolglycerides, polyethylene glycol, hydroxypropylcellulose, and sodium glycolate Type A. The capsule is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171), and indigotin I (E132).

Appearance of the product and contents of the packaging

The fenofibrate capsules are green (cap)/orange (body), size 0.

The capsules are packaged in thermoformed blister strips (ALU/PVC) in containers of 30, 50, 60, 90, or 100 capsules.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

SMB TECHNOLOGY, S.A.

Rue du Parc Industriel 39

B-6900 Marche-en-Famenne

Belgium

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium Fenosup Lidose 160 mg capsule, hard

Spain Fenofibrato Kern Pharma hard capsules EFG

Last review date of this leaflet: September 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/ .