User Information: Package Insert

Secalip Supra 160 mg Film-Coated Tablets

Fenofibrate

Read this entire package insert carefully before starting to take the 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 for you, and you should not give it to others, even if they 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.

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 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:

1. You are allergic to fenofibrate or any of the other components of this medication (listed in section 6: Contents of the pack and additional information)
2. You are allergic to peanuts, peanut oil, soy lecithin oil, or related products
3. You have taken other medications (such as other fibrates or a medication called ketoprofen), have had an allergic reaction or skin lesion caused by sunlight or UV light
4. You have severe liver or kidney disease or problems with the gallbladder
5. You have pancreatitis (inflammation of the pancreas that causes abdominal pain) not caused by high levels of blood fat

Do not take Secalip if any of the above circumstances affect 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:

1. You have kidney or liver problems
2. You may be prone to liver inflammation (hepatitis) - signs include yellowing of the skin and white of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching
3. 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 Secalip.

Secalip and muscle effects

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

1. Unexplained muscle cramps
2. Muscle pain, sensitivity, or weakness

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 problems is higher in some patients. Specifically, 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 affect 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:

1. Anticoagulants to reduce blood thickness (such as warfarin)
2. 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
3. A type of medication to treat diabetes (such as rosiglitazone or pioglitazone)
4. Ciclosporin (an immunosuppressant)

If any of the above circumstances affect 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 advises it.

Do not use Secalip if you are breastfeeding or planning to breastfeed. 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 lactose and soy oil

Secalip contains lactose: 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 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. In case of doubt, consult your doctor or pharmacist.

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

Medication intake

Take the tablet with food, as it does not work as well if your stomach is empty.

• 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 often to take

The recommended dose is one tablet per day.

If you are currently taking a Secalip 200 mg capsule per day, you can switch to a Secalip 160 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 use in children and adolescents under 18 years old.

If you take more Secalip than you should

In case of overdose or accidental ingestion, consult the Toxicological Information Service

Telephone 91 562 04 20.

If you forget to take Secalip

• If you forget to take a dose, take the next dose with your next meal.

Then take the next dose at the usual time.

Do not take a double dose to make up 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 stops the medication, do not keep the remaining tablets unless your doctor tells you to. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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
• 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)

Rare:may affect up to 1 in 1,000 people

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

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 include:

• Frequent:may affect up to1 in 10 patients

• diarrhea
• stomach pain
• gas (flatulence)
• nausea (feeling unwell)
• vomiting
• high levels of liver enzymes in the blood – seen in blood tests

• high homocysteine levels (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 no causal relationship has been established)

• Rare:may affect up to1 in 100 patients

• headache
• gallstones
• decreased libido
• reactions such as skin rash, itching, hives on the skin
• high creatinine levels (substance excreted by the kidneys) – seen in blood tests

• Rare:may affect up to1 in 1,000 patients

• hair loss
• high urea levels (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

•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.

Keep this medication in the original packaging to protect it from moisture.Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack marked CAD or EXP. 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 the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Secalip

The active principle is fenofibrate. Each Secalip 160 mg tablet contains 160 mg of fenofibrate.

The other components are: lactose monohydrate, sodium lauryl sulfate, povidone, crospovidone, microcrystalline cellulose, anhydrous colloidal silica, and sodium stearate fumarate.

The coating filmor padry®is composed of the following components: polyvinyl alcohol, titanium dioxide (e171), talc, soy lecithin, xanthan gum.

Appearance of the product and content of the packaging

Secalip Supra 160 mg coated tablets are white tablets.

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

You may not have all formats 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

Delpharm L’Aigle

Zone Industrielle No. 1

Route Crulai

61300 L’Aigle

France

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

Germany:Lipidil-Ter 160 mg

France:Lipanthyl 160 mg

Spain:Secalip Supra 160 mg

United Kingdom:Supralip 160 mg

Last review date of this leaflet: December 2020

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