Liperial

PACKAGE LEAFLET: INFORMATION FOR THE USER

Liperial 145 mg film-coated tablets

Fenofibrate
Please read this leaflet carefully before using 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

2. What you need to know before taking Liperial
Do not take Liperial 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, soy 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", an anti-inflammatory medicine)
• 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 Liperial if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Liperial.

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

• you have any kidney or liver problems
• you may have an inflamed liver (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 Liperial.

Liperial and effects on muscles
Stop taking Liperial and contact your doctor immediately if you experience:

• unexplained muscle cramps
• muscle pain, tenderness, or weakness
  This medicine may cause muscle problems, which can 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 muscles before and during 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 have 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 Liperial.

Other medicines and Liperial
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 blood fat levels (such as statins or fibrates). Taking a statin together with Liperial may increase the risk of muscle problems
• a specific class of diabetes medicines (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant)
  If any of the above apply to you (or you are unsure), talk to your doctor or pharmacist before taking Liperial.

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 Liperial affects pregnancy. You should use Liperial only if instructed by your doctor.
• You must not take Liperial if you are breastfeeding or planning to breastfeed. It is not known whether Liperial is excreted in breast milk.

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

• Liperial contains sugars called lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
• Liperial 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 Liperial
Always take this medicine exactly as your doctor or pharmacist has told 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.

Remember that in addition to taking Liperial, it is also important for you to:

• follow a low-fat diet
• exercise regularly.

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 fenofibrate tablet daily, you can switch to one Liperial 145 mg 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 Liperial is not recommended in children and adolescents under 18 years of age.
If you take more Liperial than you should
If you have taken more Liperial than prescribed or if someone else has taken your medicine, inform your doctor or contact the nearest hospital immediately.
If you forget to take Liperial

• If you miss 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 Liperial
Do not stop taking Liperial unless your doctor tells you to, or unless the tablets make you feel unwell. This is because you may need long-term treatment.
If your doctor stops your treatment, do not take any remaining tablets unless your doctor tells you to.
If you have any questions about using 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 Liperial 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 be a sign of an inflamed 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 available data

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

Stop taking Liperial and contact 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: may affect up to 1 in 10 people

• diarrhoea
• stomach pain
• flatulence
• feeling unwell (nausea)
• malaise (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 sexual desire
• 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 your 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 available data

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

If you experience any of the side effects listed above, contact your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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. Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Liperial
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 you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Liperial contains

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

Description of the appearance of Liperial and contents of the pack

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

Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
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: Liperial 145 mg
• France: Fenofibrate Mylan Pharma 145 mg
• Italy: Liperial 145 mg