FULCROSUPRA 145 mg Film-Coated Tablets

Зміст інструкції

1. Fulcrosupra 145 mg film-coated tablets

Fulcrosupra 145 mg film-coated tablets

Fenofibrate
Read this leaflet carefully before you start using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What is Fulcrosupra and what it is used for
• 2. What you need to know before you take 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 is Fulcrosupra and what it is used for
Fulcrosupra 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, the
fats known as triglycerides.
Fulcrosupra is used, together with a low-fat diet and other non-medicinal treatments, such
as exercise and weight loss, to reduce the levels of fats in the blood.
Fulcrosupra can be used in addition to other medicines (statins) in some circumstances where
blood fat levels are not controlled by a statin alone.

2 What you need to know before you take 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 or peanut oil or soy lecithin or related products
• while taking other medicines you have had an allergic reaction or skin damage due to sunlight or UV light (these medicines include other fibrates or an anti-inflammatory drug called “Ketoprofen”)
• you have severe problems with your liver, kidneys or gallbladder
• you have pancreatitis (inflamed pancreas causing abdominal pain) that is not caused by high levels of fat in the blood Do not take Fulcrosupra if any of the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Fulcrosupra.

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

• you have any problems with your kidneys or liver
• you may have an inflamed liver (hepatitis) - the signs include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (shown by blood tests), stomach pain and itching
• you have an underactive thyroid (hypothyroidism) If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Fulcrosupra.

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

• unexplained muscle cramps
• muscle pain, tenderness or weakness. In fact, this medicine can cause muscle problems that can be serious. These problems are rare but include inflammation and breakdown of muscle. 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 breakdown is much higher in some
patients. Tell your doctor if:

• you are over 70 years of age
• you have kidney problems
• you have thyroid problems
• you or a close family member have hereditary muscle problems
• you drink large amounts of alcohol
• you are taking medicines to lower cholesterol called statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
• you have ever had muscle problems during treatment with statins or with fibrates (such as fenofibrate, bezafibrate or gemfibrozil) If any of the above applies to you (or you are not sure), tell 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, tell 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 at the same time as Fulcrosupra may increase the risk of muscle problems
• a particular class of medicines for treating diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant) If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Fulcrosupra.

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant, or are trying to become pregnant. It is not known whether Fulcrosupra affects pregnancy. You should only use Fulcrosupra if your doctor has told you to.
• Do not take Fulcrosupra if you are breastfeeding or planning to breastfeed your baby. It is not known whether Fulcrosupra passes into breast milk.

Driving and using machines
This medicine does not affect 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 some sugars, contact them 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, that is to say essentially “sodium-free”.

3 How to take Fulcrosupra
Always take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dosage for you, depending on your condition, your
current treatment and your personal risk status.

How to take this 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 Fulcrosupra it is also important that you:

• follow a low-fat diet
• get regular exercise.

How much medicine to take
The recommended dose is one tablet a day.
If you are taking a 200 mg fenofibrate capsule or a 160 mg Fulcrosupra
tablet a day, you can switch to a 145 mg Fulcrosupra tablet a day. This will be like receiving
the same amount of medicine.

People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose. Ask 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 you should or if someone has taken your medicine, tell
your doctor or go to the nearest hospital.

If you forget to take Fulcrosupra

• 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 a missed dose.

If you stop taking Fulcrosupra
Do not stop taking Fulcrosupra unless your doctor has told you to do so or
unless the tablets make you feel unwell. This is because you need to be treated for a
long period of time.
If your doctor stops the treatment, do not take the remaining tablets unless your doctor
tells you to. If you have any questions about taking this medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone
gets them.

Stop taking Fulcrosupra and see a doctor immediately if you notice any of the
following serious side effects – medical attention may be needed urgently:
Uncommon:can affect up to 1 in 100 people

• cramps or pain, tenderness or weakness in muscles - these can be signs of inflammation or breakdown of muscle, which can cause kidney damage or even death
• stomach pain - this can be a sign that your pancreas is inflamed (pancreatitis)
• chest pain and shortness of breath - these can be signs of a blood clot in the lung (pulmonary embolism)
• pain, redness or swelling in the legs - these can be signs of a blood clot in the leg (deep vein thrombosis)

Rare:can affect up to 1 in 1,000

• allergic reaction - the 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 an increase in liver enzymes - these can be signs of inflammation of the liver (hepatitis).

Not known:frequency not known

• severe form of skin rash with redness, blistering and swelling of the skin that resembles burns
• long-term lung problems.

Stop taking Fulcrosupra and see a doctor immediately if you notice any of the
side effects listed above.

Other side effects
Tell your doctor or pharmacist if you notice any of the following side effects:

Common:can affect up to 1 in 10

• diarrhoea
• stomach pain
• flatulence
• feeling sick (nausea)
• being sick (vomiting)
• increased levels of liver enzymes in the blood - shown in tests
• increased homocysteine (high 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 link has not been established)

Uncommon:can affect up to 1 in 100

• headache
• gallstones
• decreased sexual drive
• skin rash, itching or red spots on the skin
• increased creatinine (produced by the kidneys) - shown in tests

Rare:can affect up to 1 in 1,000

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

Not known:frequency not known

• muscle breakdown
• complications of gallstones
• feeling exhausted (fatigue)

If you get any side effects, talk to your doctor or
pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through 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 at a temperature below 30°C.
Do not use this medicine after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6 Contents of the pack and other information
What Fulcrosupra contains

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

Description of the appearance of Fulcrosupra and contents of the pack

• Fulcrosupra 145 mg are film-coated tablets, white, elongated in shape bearing the inscription “145” on one side and the “Fournier logo” on the other. The film-coated tablets are packaged 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 medicinal product is authorised in all EEA Member States with the following names:

• Germany: Lipidil 145 ONE
• Austria: Lipanthyl Nanoparticles 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 film-coated tablet
• Ireland: Lipantil supra 145 mg
• Italy: Fulcrosupra 145 mg
• Poland: Lipanthyl NT 145 mg
• Slovakia: Lipanthyl NT 145 mg
• Spain: Secalip 145 mg