Secalip Supra 160 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Secalip Supra 160 mg film-coated tablets

Fenofibrate

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Secalip Supra 160 mg film-coated tablets are and what they are used for
2. What you need to know before taking Secalip Supra 160 mg film-coated tablets
3. How to take Secalip Supra 160 mg film-coated tablets
4. Possible side effects
5. How to store 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 reduce the level of fats (lipids) in the blood. For example, fats called triglycerides.

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

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

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

Do not take Secalip 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 further information)
2. you are allergic to peanuts, peanut oil, soy lecithin oil, or related products
3. when taking other medicines (such as other fibrates or a medicine used for inflammation called ketoprofen), you have had an allergic reaction or skin injury caused by sunlight or UV light
4. you have severe liver or kidney disease or gallbladder problems
5. you have pancreatitis (inflammation of the pancreas causing abdominal pain) not caused by high levels of fat in the blood

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

1. you have kidney or liver problems
2. you may have liver inflammation (hepatitis) – signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (seen in blood tests), stomach pain, and itching
3. you have an underactive thyroid gland (hypothyroidism)

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Secalip.

Secalip and muscle effects

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

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

This is because this medicine may cause muscle problems, which can be serious.

These problems are rare but may include inflammation and breakdown of muscle tissue.

This can lead to kidney damage or even death.

Your doctor may perform blood tests to check your muscle condition before and during treatment.

The risk of muscle problems is higher in certain patients. Specifically, consult your doctor if:

• you are over 70 years of age
• you have kidney problems
• you have thyroid problems
• you or a close family member has an inherited muscle disorder
• you drink large amounts of alcohol
• you are taking medicines called “statins” to lower cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatina, or fluvastatin)
• you have previously experienced muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil)

If any of the above apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Secalip.

Use of Secalip with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

1. anticoagulants to reduce blood clotting (such as warfarin)
2. other medicines used to control blood fat levels (such as statins or fibrates). This is because taking a statin or another fibrate together with Secalip may increase the risk of muscle problems
3. a type of medicine used to treat diabetes (such as rosiglitazone or pioglitazone)
4. cyclosporine (an immunosuppressant)

If any of the above situations apply to you (or if you have any doubts), 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 unknown how Secalip may affect the newborn. You should only use Secalip if your doctor recommends it.

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

Driving and operating machinery

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

Secalip contains lactose and soybean oil

Secalip contains lactose: if your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Secalip contains soybean oil: Must not be used if allergic to peanuts or soybeans.

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

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

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

How to take 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.

Please remember that in addition to taking Secalip, it is also important that you:

• follow a low-fat diet
• exercise regularly.

How much to take

The recommended dose is one tablet daily.

If you are currently taking a Secalip 200 mg capsule daily, you may switch to one Secalip 160 mg tablet daily. You will continue to receive the same amount of medication.

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

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

If you take more Secalip than you should

In case of overdose or accidental ingestion, contact the Toxicology 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 following dose at your 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 if the tablets make you feel unwell. This is because long-term treatment is required.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Secalip and contact your doctor immediately if you experience any of the following serious adverse effects – you may require urgent medical treatment:

Uncommon: may affect up to 1 in 100 people

• muscle cramps or pain, tenderness, or weakness – these may be signs of muscle inflammation or breakdown, which can lead to 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 whites of the eyes (jaundice), or increased liver enzymes – these may be signs of liver inflammation (hepatitis)
• allergic reaction – signs may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing

Not known: frequency 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 contact your doctor immediately if you notice any of the above adverse effects.

Other adverse effects include:

• Frequent: may affect up to 1 in 10 patients

  • diarrhoea
  • stomach pain
  • gas (flatulence)
  • feeling unwell (nausea)
  • discomfort (vomiting)
  • elevated liver enzyme levels in the blood – seen in blood tests

• increased homocysteine (elevated levels of this amino acid in the blood have 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 sexual desire
  • reactions such as skin rash, itching, hives
  • increased creatinine (a 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 haemoglobin (which carries oxygen in the blood) and decrease in white blood cells – seen in blood tests

• Not known: frequency 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 adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse 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 packaging to protect it from moisture. Do not store above 30°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 components are: monohydrate lactose, sodium lauryl sulfate, povidone, crospovidone, microcrystalline cellulose, anhydrous colloidal silica, and sodium stearyl fumarate.

The film coating opadry® is composed of the following ingredients: polyvinyl alcohol, titanium dioxide (e171), talc, soy lecithin, xanthan gum.

Appearance of the product and contents of the pack

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

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer Responsible

Marketing Authorization Holder

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Manufacturing Responsible Party

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 medicinal product is authorized in 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 latest review of this leaflet: December 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es