Package Insert: Patient Information

FenofibrateKern Pharma145 mg EFG Tablets

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Fenofibrato Kern Pharma belongs to a group of medications commonly known as fibrates. These medications are used to reduce 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 reduce 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 FenofibrateKernPharma

• if you are allergic to fenofibrate or any of the other components of this medication (listed in section 6),
• if you are allergic to peanuts or peanut oil or soy lecithin or related products,
• if you have had an allergic reaction or skin lesion caused by sunlight or UV light while taking other medications (including other fibrates and ketoprofen anti-inflammatory medication),
• if you have severe liver or kidney disease or problems with the gallbladder,
• if you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high blood fat levels.

Do not take fenofibrate if any of the above circumstances affect you. If you are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and Precautions

Consult your doctor or pharmacist or nurse before starting to take this medication:

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

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking this medication.

Muscle Effects:

Stop taking fenofibrate and see your doctor immediately if you experience unexplained muscle cramps or pain, muscle sensitivity or 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 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 or a close relative have a hereditary muscle problem,
• you drink large amounts of alcohol,
• 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, bezafibrate or gemfibrozil.

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking this medication.

Taking Fenofibrate KernPharmawith other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

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

• blood thinners to reduce blood thickness (such as acenocoumarol or 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 pioglitazone),
• ciclosporin (an immunosuppressant).

If any of the above circumstances affect you (or you are unsure), consult your doctor or pharmacist before taking this medication.

Taking Fenofibrate KernPharmawith food, drinks and alcohol

It is important to take the tablet with food or without food, at any time of the day.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacistbefore using this medication.

As there is not enough experience with the use of fenofibrate during pregnancy, you should only use this medication if your doctor considers it absolutely necessary.

It is unknown whether the active ingredient of this medication passes into breast milk. Therefore, do not use fenofibrate if you are breastfeeding or plan to breastfeed your baby.

Driving and using machines

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

Fenofibrate KernPharmacontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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

The recommended dose is one tablet per day.

If you are currently taking a capsule of fenofibrate 200 mg or a tablet of 160 mg, you can switch to a tablet of Fenofibrato Kern Pharma 145 mg.

Medication intake

Swallow the tablet with a glass of water.

Do not crush or chew the tablet.

Patients with kidney problems

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

Use in children and adolescents

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

If you take more Fenofibrato Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Fenofibrato Kern Pharma

Do not take a double dose to compensate for the missed doses. Take the next dose with your next meal and then continue taking your tablets as usual. If you are concerned, consult your doctor.

If you interrupt treatment with Fenofibrato Kern Pharma

Do not stop taking this medication unless your doctor tells you to or unless the tablets make you feel unwell. This is because abnormal levels of fats in the blood need to be treated for a long period of time.

Remember that in addition to taking fenofibrate, you should:

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

If your doctor stops the medication, do not store the remaining tablets unless your doctor tells you to. If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

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

• allergic reaction – symptoms may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing,
• muscle cramps or pain, sensitivity, or weakness – these may be signs of inflammation or muscle rupture, which may 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),
• 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).

Stop taking Fenofibrate Kern Pharma and see your doctor immediately if you notice any of the previously described side effects.

Other side effects include:

Frequent (affect less than 1 in 10 people):

• diarrhea,
• stomach pain,
• gas (flatulence),
• nausea,
• vomiting,
• elevated liver enzymes in the blood – seen in blood tests.

Rare (affect less than 1 in 100 people):

• headache,
• gallstones,
• decreased libido,
• reactions such as skin rash, itching, hives,
• increased creatinine (a substance excreted by the kidneys) – seen in blood tests,
• pancreatitis (inflammation of the pancreas that produces abdominal pain),
• thromboembolism: pulmonary embolism (blood clot in the lung that produces chest pain and difficulty breathing), deep vein thrombosis (blood clot in the leg that produces pain, redness, or swelling),
• muscle pain, muscle inflammation, muscle cramps, and weakness.

Rare (affect less than 1 in 1,000 people):

• hair loss,
• dizziness,
• fatigue,
• increased urea (produced by the kidneys) – seen in blood tests,
• increased skin sensitivity to sunlight, sunlamps, and sunbeds,
• decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes – seen in blood tests,
• hepatitis (inflammation of the liver), mild jaundice (skin and white of the eyes turn yellow), stomach pain, and itching,
• hypersensitivity (allergic reaction).

Unknown frequency (cannot be estimated from available data):

• long-term lung problems,
• muscle wear and tear,
• bile stone complications,
• If you experience any unusual respiratory discomfort, report it to your doctor immediately.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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 medicine.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus.

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

No special storage conditions are required.

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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Fenofibrate Kern Pharma

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

Appearance of the product and content of the packaging

Fenofibrate Kern Pharma 145 mg tablets are presented in the form of white or almost white tablets. Each package contains 30 tablets.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72-Pol. Ind. Colón II

08228 Terrassa-Barcelona

Spain

Responsible for manufacturing

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

Z.I. de Saint-Arnoult

28170 Châteaneuf-en-Thymerais

France

Last review date of this leaflet: October 2014 of 2014

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.gob.es /