Package Insert: Information for the User

Secalip 145 mg Film-Coated Tablets

Fenofibrate

Read this package insert carefully before starting to take the medicine as it contains important information for you.

• Keep this package insert, 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 should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

6. Contents of the pack andadditional information

Secalip 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 known as triglycerides.

Secalip 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.

Secalip 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.

Do not takeSecalip if:

• you are allergic to fenofibrate or any of the other components of this medication (listed in section 6: Contents of the pack and other information)
• you are allergic to peanuts, peanut oil, soy lecithin, or related products
• 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 or kidney disease or problems with the gallbladder
• you have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high blood fat levels

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

Warnings and precautions

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

• you have kidney or liver problems
• you may be prone to liver inflammation (hepatitis) - symptoms include yellowing of the skin and 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)

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

Secalip and muscle effects

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

• unexplained muscle cramps
• muscle pain, 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 problems is higher in some patients. In particular, consult your doctor if:

• you are over 70 years old

• you have kidney problems

• you have thyroid problems

• you or a close relative has 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 apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip.

Use of Secalip with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to take 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 warfarin)
• other medications used to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate at the same time as Secalip may increase the risk of muscle problems
• a type of medication to treat diabetes (such as rosiglitazone or pioglitazone)
• ciclosporin (an immunosuppressant)

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

Pregnancy and breastfeeding

Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. This is because it is unknown how Secalip may affect the newborn. Only use Secalip if your doctor tells you to.

Do not use Secalip if you are breastfeeding or planning to breastfeed your baby. This is because it is unknown if Secalip passes into breast milk.

Driving and operating machinery

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

Secalipcontains saccharose, lactoseand soy oil

Secalip contains sugars called lactose and saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Secalip contains soy oil. Do not use it in case of allergy to peanuts or soy.

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

Follow exactly the administration instructions for this medication 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, current treatment, and personal risk factors.

Medication intake

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 Secalip, it is also important that:

• You have 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 Secalip 200 mg capsule or a Secalip Supra 160 mg tablet per day, you can switch to a Secalip 145 mg tablet per day.You will still receive the same amount of medication.

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

Secalip is not recommended for children and adolescents under 18 years old.

If you take more Secalip than you should

Consult your doctor, pharmacist, or call the Toxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount taken.

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

If you forget to take Secalip

• If you forget to take a dose, take the next dose at the usual time.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Secalip

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

If your doctor interrupts the medication, do not keep the remaining tablets unless your doctor tells you to.If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Stop taking Secalip and see your doctor immediately if you notice any of the following serious 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)

Very rare:may affect up to 1 in 1,000 people

• Allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which can cause difficulty breathing

• Yellowing of the skin and 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 lung problems

Stop taking Secalip and see your doctor immediately if you notice any of the side effects listed above.

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

• Diarrhea

• Abdominal pain

• Gas (flatulence)

• Feeling unwell (nausea)

• Feeling queasy (vomiting)

• Elevated liver enzymes in the blood – seen in blood tests

• Elevated homocysteine (excess of this amino acid in the blood has been associated with an increased risk of coronary heart disease, stroke and peripheral vascular disease, although no causal relationship has been established)

Rare:may affect up to 1 in 100 people

• Headache

• Gallstones

• Decreased libido

• Reactions such as skin rash, itching, hives on the skin

• Elevated creatinine (substance excreted by the kidneys) – seen in blood tests

Very rare:may affect up to 1 in 1,000 people

• Hair loss

• Elevated urea (produced by the kidneys) – seen in blood tests

• Skin more sensitive to sunlight, sunlamps and sunbeds

• Decreased hemoglobin (which transports oxygen in the blood) and decreased leukocytes – seen in blood tests

Unknown:cannot be estimated from available data

• Muscle wasting

• Complications with gallstones

• Feeling of exhaustion (fatigue)

Consult your doctor or pharmacist if you experience any of the side effects listed above.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. 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 medicine.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Secalip

The active ingredient is fenofibrate. A tablet contains 145 mg of fenofibrate.

The other components aresucrose, lactose monohydrate, siliconized microcrystalline cellulose, crospovidone, hypromellose, sodium lauryl sulfate, sodium docusate, and magnesium stearate. Lthe coating film Opadryis composed of: polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin, and xanthan gum.

Appearance of the product and contents of the package

Secalip 145 mg film-coated tablets are presented in the form of white, oblong tablets, with one face engraved with “145”and the other with the logo “Fournier”.

The film-coated tablets are presented in blister packs of10, 20, 28, 30, 50, 84, 90, 98, 100, 280, 300.

Not all formats may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Responsible for manufacturing

Astrea Fontaine

Rue des Prés Potets

21121 Fontaine-les-Dijon (France)

or

Mylan Laboratories SAS

Route de Belleville

Lieu-dit Maillard

01400 Châtillon-sur-Chalaronne

France

or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

This medicine is authorized in the EU member states with the following names:

Germany:Lipidil 145 One

Austria:Lipanthyl Nanopartikel 145 mg

Belgium:Lipanthylnano 145 mg

Luxembourg:Lipanthylnano 145 mg

Czech Republic:Lipanthyl NT 145 mg

Finland:Lipanthyl Penta 145 mg

France:Lipanthyl 145 mg

Greece:Lipidil NT 145 mg

Hungary:Lipanthyl NT 145 mg

Ireland:Lipantil supra 145 mg

Italy:Fulcrosupra 145 mg

Poland:Lipanthyl NT 145 mg

Portugal:Lipanthyl 145 mg

Slovak Republic:Lipanthyl NT 145 mg

Spain:Secalip 145 mg

This leaflet has been reviewed in December 2020

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