SECALIP 145 mg FILM-COATED TABLETS

1. What Secalip 145 mg film-coated tablets are and what they are used for

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 called triglycerides.

Secalip is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce blood fat levels.

Secalip may be used in combination with other medicines (statins) in certain circumstances when a statin alone does not control blood fat levels.

2. What you need to know before taking Secalip 145 mg film-coated tablets

Do not takeSecalip if:

• you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Package contents and further information)
• you are allergic to peanuts, peanut oil, soy lecithin, or related products
• when taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen) you have had an allergic reaction or skin lesion caused by sunlight or UV light
• you have severe liver or kidney disease or gallbladder problems
• 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 have liver inflammation (hepatitis) - signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching
• you have an underactive thyroid gland (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 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 muscle inflammation and destruction. 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, 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 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 circumstances apply to you (or you are unsure), consult your doctor or pharmacist before taking Secalip.

Using Secalip with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• blood thinners to reduce blood thickness (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 at the same time as Secalip may increase the risk of muscle problems
• a type of medicine to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporin (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

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 how Secalip may affect the newborn. You should only use Secalip if your doctor advises you to.

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

Driving and using machines

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

Secalipcontains sucrose, lactoseand soybean oil

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

Secalip contains soybean oil. Do not use it if you are allergic to peanuts or soy.

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

3. How to take Secalip 145 mg film-coated tablets

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

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 Secalip, 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 Secalip 200 mg capsule or a Secalip Supra 160 mg tablet per day, you may switch to a Secalip 145 mg 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

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

If you take moreSecalipthan you should

Consult your doctor, pharmacist, 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 leaflet of the medicine 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 make up for forgotten doses.

If you stop taking Secalip

Do not stop taking Secalip 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 medicine, 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 Secalip 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 – signs can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing
• yellowing of the skin and 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 reddens, scales, and swells the skin, and resembles a severe burn
• long-term lung problems

Stop taking Secalip 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

• diarrhea
• stomach pain
• gas (flatulence)
• feeling unwell (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
• decreased 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
• skin more sensitive to sunlight, sunlamps, and sunbeds
• decrease in hemoglobin (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 with gallstones
• feeling tired (fatigue)

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

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Secalip 145 mg film-coated tablets

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging and blister 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 a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Secalip

The active substance is fenofibrate. One tablet contains 145 mg of fenofibrate.

The other ingredients are sucrose, lactose monohydrate, microcrystalline cellulose silicate, crospovidone, hypromellose, sodium lauryl sulfate, sodium docusate, and magnesium stearate. The Opadry film coating is composed of: polyvinyl alcohol, titanium dioxide (E-171), talc, soy lecithin, and xanthan gum.

Appearance and packaging of the product

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 "Fournier" logo.

The film-coated tablets are presented in blister packs of 10, 20, 28, 30, 50, 84, 90, 98, 100, 280, 300.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Manufacturer

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

Slovakia: Lipanthyl NT 145 mg

Spain: Secalip 145 mg

This leaflet was last revised in December 2020

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