SECALIP SUPRA 160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Secalip Supra 160 mg film-coated tablets

Fenofibrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Secalip Supra 160 mg film-coated tablets are and what they are used for
2. What you need to know before you take Secalip Supra 160 mg film-coated tablets
3. How to take Secalip Supra 160 mg film-coated tablets
4. Possible side effects
5. Storage of Secalip Supra 160 mg film-coated tablets
6. Contents of the pack and other information

1. What Secalip Supra 160 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 lower 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 lower the levels of fats in the blood.

Secalip may be used in combination with other medications [statins] in certain circumstances when a statin alone does not control the levels of fat in the blood.

2. What you need to know before you take Secalip Supra 160 mg film-coated tablets

Do not takeSecalip if:

1. you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information)
2. you are allergic to peanuts, peanut oil, soy lecithin, or related products
3. when taking other medications (such as other fibrates or an anti-inflammatory medication called ketoprofen), you 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 fat in the blood

Do not take Secalip if any of the above circumstances apply to you. If you are not sure, 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 have inflammation of the liver (hepatitis) - signs that include yellowing of the skin and the whites of the eyes (jaundice), increased liver enzymes (present in blood tests), stomach pain, and itching
3. you have an underactive thyroid gland (hypothyroidism)

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

Secalip and muscle effects

Stop taking Secalip and go to your doctor immediately if you experience:

1. unexplained muscle cramps
2. Muscle pain, tenderness, or weakness.

This is because this medicine can cause muscle problems that can be serious.

These problems occur rarely but include inflammation and destruction of muscle.

This can cause kidney damage or even death.

Your doctor may perform 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. 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 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 in doubt), consult your doctor or pharmacist before taking Secalip.

Use of 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:

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 for treating diabetes (such as rosiglitazone or pioglitazone)
4. cyclosporine (an immunosuppressant)

If any of the above circumstances apply to you (or you are in doubt), 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 indicates it.

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 lactose and soybean oil

Secalip contains lactose: if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Secalip contains soybean oil: Do not use it in case of peanut or soy allergy.

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

3. How to take Secalip Supra 160 mg film-coated tablets

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

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

Taking the medicine

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 much to take

The recommended dose is one tablet per day.

If you are currently taking a 200 mg Secalip capsule per day, you can switch to a 160 mg Secalip tablet per day. You will still receive the same amount of medicine.

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

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

If you take moreSecalipthan you should

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

Phone 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 forgotten doses.

If you stop taking Secalip

Do not stop taking Secalip unless your doctor tells you to or 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 indicates it. If you have any other 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 go to 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

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

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 go to your doctor immediately, if you notice any of the above side effects.

Other side effects include:

• Frequent: may affect up to 1 in 10 patients
  • diarrhea
  • stomach pain
  • gas (flatulence)
  • feeling of discomfort (nausea)
  • discomfort (vomiting)
  • high levels of liver enzymes in the blood - seen in blood tests

• increase in 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 patients
  • 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 patients
  • 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 of fatigue

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es.

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

5. Storage of Secalip Supra 160 mg film-coated tablets

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

Keep this medicine in the original package to protect it from moisture. Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the packaging and blister after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Secalip

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

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

The coating Opadry is composed of the following ingredients: polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, and xanthan gum.

Appearance of the product and pack contents

Secalip Supra 160 mg film-coated tablets are white tablets.

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

Delpharm L’Aigle

Zone Industrielle No. 1

Route Crulai

61300 L’Aigle

France

This medicine is authorized in the EU Member States under the following names:

Germany: Lipidil-Ter 160 mg

France: Lipanthyl 160 mg

Spain: Secalip Supra 160 mg

United Kingdom: Supralip 160 mg

Date of last revision of this leaflet: 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