Fulcrosupra

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fulcrosupra 145 mg film-coated tablets

Fenofibrate
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Fulcrosupra is and what it is used for
2. What you need to know before taking Fulcrosupra
3. How to take Fulcrosupra
4. Possible side effects
5. How to store Fulcrosupra
6. Contents of the pack and other information

1. What Fulcrosupra is and what it is used for
Fulcrosupra belongs to a group of medicines commonly known as “fibrates”. These
medicines are used to lower the levels of fats (lipids) in the blood, such as triglycerides.
Fulcrosupra is used, together with a low-fat diet and other non-medical treatments such as physical exercise and weight loss, to reduce fat levels in the blood.
Fulcrosupra may be used in addition to other medicines (statins) in certain circumstances where fat levels in the blood are not adequately controlled by a statin alone.

2. What you need to know before taking Fulcrosupra
Do not take Fulcrosupra if:

• 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)
• you are allergic to peanuts, peanut oil, soybean lecithin, or related products
• you previously experienced an allergic reaction or skin damage caused by sunlight or UV light while taking other medicines (these include other fibrates or a drug called “ketoprofen” used to treat inflammation)
• you have severe liver, kidney, or gallbladder problems
• you have pancreatitis (inflamed pancreas causing abdominal pain) not caused by high levels of fat in the blood
  Do not take Fulcrosupra if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Fulcrosupra.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fulcrosupra if:

• you have any 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 (shown in blood tests), stomach pain, and itching
• you have an underactive thyroid (hypothyroidism)
  If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Fulcrosupra.

Fulcrosupra and effects on muscles:
Stop taking Fulcrosupra and consult your doctor immediately if you experience:

• unexplained muscle cramps
• muscle pain, tenderness, or weakness.
  This medicine can cause muscle problems, which may be serious. These problems are rare but include inflammation and breakdown of muscle tissue. This can lead to kidney damage or even death.

Your doctor may perform a blood test to monitor your muscle function before and after starting treatment. The risk of muscle breakdown is higher in certain patients. Inform your doctor if:

• you are over 70 years old
• you have kidney problems
• you have thyroid problems
• you or a close family member has inherited muscle disorders
• you drink large amounts of alcohol
• you are taking cholesterol-lowering medicines called statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin
• you have previously experienced muscle problems while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil)
  If any of the above apply to you (or you are unsure), inform your doctor before taking Fulcrosupra.

Other medicines and Fulcrosupra
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• anticoagulants to thin the blood (such as warfarin)
• other medicines used to control fat levels in the blood (such as statins or fibrates). Taking a statin together with Fulcrosupra may increase the risk of muscle problems
• a specific class of medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant)
  If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Fulcrosupra.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. It is not known whether Fulcrosupra affects pregnancy. You should only take Fulcrosupra if your doctor has instructed you to do so.
• You must not take Fulcrosupra if you are breastfeeding or planning to breastfeed your baby. It is not known whether Fulcrosupra is excreted in breast milk.

Driving and using machines
This medicine has no effect on your ability to drive or operate tools or machinery.
Fulcrosupra contains lactose, sucrose, and soybean oil

• Fulcrosupra contains sugars called lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, contact him or her before taking this medicine.
• Fulcrosupra contains soybean oil. If you are allergic to peanuts, peanut oil, or soy, do not take this medicine.
• This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Fulcrosupra
Always take this medicine exactly as your doctor or pharmacist has instructed you.
If you are unsure, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you based on your condition, current treatment, and individual risk factors.
How to take this medicine
The tablet can be taken with or without food at any time of day.

• Swallow the tablet with a glass of water.
• Do not crush or chew the tablet.

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

• follow a low-fat diet
• engage in regular physical exercise.

How much medicine to take
The recommended dose is one tablet daily.
If you are currently taking a 200 mg fenofibrate capsule or a 160 mg Fulcrosupra tablet daily, you may switch to one 145 mg Fulcrosupra tablet daily. This will provide the same amount of active drug.
Patients with kidney problems
If you have kidney problems, your doctor may advise you to take a lower dose. Consult your doctor or pharmacist.
Use in children and adolescents
The use of Fulcrosupra is not recommended in children and adolescents under 18 years of age.
If you take more Fulcrosupra than you should
If you have taken more Fulcrosupra than prescribed or if someone else has taken your medicine, inform your doctor or contact the nearest hospital immediately.
If you forget to take Fulcrosupra

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

If you stop taking Fulcrosupra
Do not stop taking Fulcrosupra unless your doctor tells you to, or unless the tablets make you feel unwell. This is because long-term treatment is usually required.
If your doctor stops your treatment, do not take any remaining tablets unless your doctor instructs you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Fulcrosupra and contact a doctor immediately if you notice any of the following serious side effects – urgent medical treatment may be needed:
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 indicate inflammation of the pancreas (pancreatitis)
• chest pain and shortness of breath – these may be signs of a blood clot in the lung (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

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

Not known: frequency cannot be estimated from the available data

• severe skin rash with redness, peeling, and swelling of the skin resembling serious burns
• long-term lung problems

Stop taking Fulcrosupra and contact a doctor immediately if you notice any of the side effects listed above.
Other side effects
Inform your doctor or pharmacist if you notice any of the following side effects:
Common: may affect up to 1 in 10 people

• diarrhoea
• stomach pain
• flatulence
• feeling unwell (nausea)
• feeling unwell (vomiting)
• increased liver enzymes in the blood – shown 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 people

• headache
• gallstones
• reduced sex drive
• skin rash, itching, or red spots on the skin
• increased creatinine (a substance produced by the kidneys) – shown in blood tests

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

• hair loss
• increased urea (a substance produced by the kidneys) – shown in blood tests
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds
• decreased levels of haemoglobin (which carries oxygen in the blood) and white blood cells – shown in blood tests

Not known: frequency cannot be estimated from the available data

• muscle breakdown
• complications related to gallstones
• feeling exhausted (fatigue)

If you experience any of the side effects listed above, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Fulcrosupra
Keep this medicine out of the sight and reach of children.
Store this medicine below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What Fulcrosupra contains

• The active substance is fenofibrate. Each Fulcrosupra 145 mg tablet contains 145 milligrams (mg) of fenofibrate.
• The other ingredients are: sucrose, monohydrate lactose, silicified microcrystalline cellulose, crospovidone, hypromellose, sodium lauryl sulfate, sodium docusate, magnesium stearate.
• The tablet film coating (Opadry) also contains: polyvinyl alcohol, titanium dioxide (E171), talc, soybean lecithin, xanthan gum.

Description of Fulcrosupra and pack sizes

• Fulcrosupra 145 mg are white, elongated, film-coated tablets marked “145” on one side and the “Fournier logo” on the other. The film-coated tablets are packed in blisters of 10, 20, 28, 30, 50, 84, 90, 98, 100, 280, 300.
• Not all pack sizes may be marketed.

Marketing Authorisation Holder
Marketing Authorisation Holder: Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15 – Ireland
Manufacturer
Astrea Fontaine, Rue des Près Potets, 21121 Fontaine lès Dijon (France)
Mylan Laboratories SAS, Route de Belleville, Lieu-dit Maillard, 01400 Châtillon-sur-Chalaronne (France)
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
This medicine is authorised in all EEA Member States under 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: Lipidil 145 mg filmtabletta
• Ireland: Lipantil supra 145 mg
• Italy: Fulcrosupra 145 mg
• Poland: Lipanthyl NT 145 mg
• Slovakia: Lipanthyl NT 145 mg
• Spain: Secalip 145 mg