Fenofibrate Viatri

Patient Information Leaflet

Fenofibrate Viatris 145 mg film-coated tablet

fenofibrate
equivalent medicine
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 questions, ask 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fenofibrato Viatris is and what it is used for

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

2. What you need to know before taking Fenofibrate Viatris

Do not take Fenofibrate Viatris if:

• you are allergic to fenofibrate or to 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 have previously experienced an allergic reaction or skin damage caused by sunlight or UV rays while taking other medicines (such as other fibrates or a medicine called “ketoprofen” used to treat inflammation)
• you have severe liver, kidney or gallbladder problems
• you have pancreatitis (inflammation of the pancreas causing abdominal pain) not caused by high levels of fat in the blood

Do not take Fenofibrate Viatris if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Fenofibrate Viatris.

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

• you have any liver or kidney problems
• you may have liver inflammation (hepatitis), signs of which include yellowing of the skin and whites of the eyes (jaundice), increased liver enzymes (detected 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), talk to your doctor or pharmacist before taking Fenofibrate Viatris.

Fenofibrate Viatris and effects on muscles
Stop taking Fenofibrate Viatris and contact a doctor immediately if you experience:

• unexplained muscle cramps
• muscle pain, tenderness or weakness

This medicine may cause muscle problems, even serious ones. These are rare but may include inflammation and breakdown of muscle tissue. This could lead to kidney damage or even death. Your doctor may request a blood test to monitor your muscles before and during treatment. The risk of muscle problems may be higher in some patients. In particular, inform 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 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 during treatment with statins or fibrates (such as fenofibrate, bezafibrate or gemfibrozil)

If any of the above apply to you (or you are unsure), talk to your doctor before taking Fenofibrate Viatris.

Other medicines and Fenofibrate Viatris
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 used 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 or another fibrate together with Fenofibrate Viatris 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), talk to your doctor or pharmacist before taking Fenofibrate Viatris.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. It is not known whether Fenofibrate Viatris may affect the unborn baby. You should use Fenofibrate Viatris only on medical advice.
• Do not use Fenofibrate Viatris if you are breastfeeding or plan to breastfeed. It is not known whether Fenofibrate Viatris passes into human breast milk.

Driving and using machines
This medicine does not impair your ability to drive or use machinery.

Fenofibrate Viatris contains lactose, sucrose and soybean oil

• Fenofibrate Viatris contains sugars called lactose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
• Fenofibrate Viatris 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 (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Fenofibrato Viatris

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will decide the dose suitable 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 day.

• Swallow the tablet with a glass of water.
• Do not crush or chew the tablet. Remember that in addition to taking Fenofibrato Viatris, it is also important that:
• you follow a low-fat diet
• you engage in regular physical exercise.

How much medicine to take
The recommended dose is one tablet daily.
If you are already taking a 200 mg capsule of Fenofibrato Viatris or a 160 mg tablet of Fenofibrato Viatris daily, you may switch to one 145 mg tablet of Fenofibrato Viatris daily. You will receive the same amount of medicine.
Patients with kidney problems
If you have kidney problems, your doctor may advise you to take a lower dose. Ask your doctor or pharmacist for advice.
Use in children and adolescents
The use of Fenofibrato Viatris is not recommended in children and adolescents under 18 years of age.
If you take more Fenofibrato Viatris than you should
If you take more Fenofibrato Viatris than you should, or if someone else has taken your medicine, inform your
doctor or contact the nearest hospital.
If you forget to take Fenofibrato Viatris

• 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 the forgotten dose.

If you stop taking Fenofibrato Viatris
Do not stop taking Fenofibrato Viatris unless your doctor has told you to do so, or unless the tablets make you feel unwell, because the treatment you need is long-term. If your doctor stops the treatment, do not keep any leftover tablets unless your doctor has told you to do so.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Fenofibrate Viatris and contact a doctor immediately if you experience any of the following serious side effects; urgent medical treatment may be required:

Uncommon: may affect up to 1 in 100 people

• muscle cramps or pain, tenderness or weakness. These may be signs of muscle inflammation or muscle breakdown, which can lead to kidney damage or even death
• stomach ache, which may be a sign of 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, which may include swelling of the face, lips, tongue or throat, possibly causing breathing difficulties
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzymes, which 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, resembling a severe burn
• long-term lung problems

Stop taking Fenofibrate Viatris and contact a doctor immediately if you notice any of the serious side effects listed above.

Other side effects
If you experience any of the following side effects, contact your doctor or pharmacist:

Common: may affect up to 1 in 10 people

• diarrhoea
• stomach ache
• gas in the stomach (flatulence)
• feeling unwell (nausea)
• feeling unwell (vomiting)
• increased levels of liver enzymes in the blood, detected by blood tests
• increased 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 people

• headache
• gallstones
• reduced sexual desire
• skin rash, itching or red spots on the skin
• increased creatinine (produced by the kidneys), detected by blood tests

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

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

Not known: frequency cannot be estimated from the available data

• muscle deterioration
• complications of gallstones
• feeling of weakness (tiredness)

If you notice any of the side effects listed above, contact your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to 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 Fenofibrate Viatris

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp./EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fenofibrato Viatris contains

• The active substance is fenofibrate. Each Fenofibrato Viatris 145 tablet contains 145 milligrams (mg) of fenofibrate.
• The other components are: sucrose, monohydrate lactose, silicified microcrystalline cellulose, crospovidone, hypromellose, sodium lauryl sulfate, sodium docusate, magnesium stearate.
• The tablet film coating of Opadry additionally contains: polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

Description of the appearance of Fenofibrato Viatris and the contents of the pack

• The film-coated tablets of Fenofibrato Viatris 145 mg are white, elongated tablets, with "145" engraved on one side and the "Fournier logo" on the other.
• The film-coated tablets are packed in blisters of 10 or 14 tablets in boxes containing 10, 20, 28, 30, 50, 60, 84, 90, 98, 100, 280, 300 tablets.
• It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Mylan SpA, via Vittor Pisani 20 – 20124 Milano
For further information, contact:
Viatris Italia S.r.l., via Vittor Pisani 20 – 20124 Milano
Manufacturer
Astrea Fontaine
Rue des Prés Potets
21121 Fontaine-les-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 authorized in the Member States of the European Economic Area under the following names:
Germany: Fenofibrat Viatris 145 mg Filmtabletten
Belgium: Fenofibraat Mylan 145 mg filmomhulde tabletten
Luxembourg: Fenofibraat Mylan 145 mg comprimés pelliculés
Italy: Fenofibrato Viatris