Fenofibrate PensA

Package leaflet: Information for the user

Fenofibrate Pensa 145 mg film-coated tablets

Fenofibrate
Equivalent medicine
Please read all of this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it could 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 Pensa is and what it is used for
2. What you need to know before taking Fenofibrate Pensa
3. How to take Fenofibrate Pensa
4. Possible side effects
5. How to store Fenofibrate Pensa
6. Contents of the pack and other information

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

Fenofibrato Pensa 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 Pensa 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.
Fenofibrato Pensa 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 Pensa

Do not take Fenofibrate Pensa if:

• you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6)
• you have previously experienced an allergic reaction or skin damage caused by sunlight or UV light while taking other medicines (these medicines include other fibrates or an anti-inflammatory drug called “Ketoprofen”)
• you have severe liver, kidney, or gallbladder problems
• you have pancreatitis (inflamed pancreas causing abdominal pain) that is not caused by high levels of fat in the blood

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

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

• you have any liver problems
• you have any kidney problems
• you may have liver inflammation (hepatitis) – 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 underactive thyroid (hypothyroidism)

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Fenofibrate Pensa.

Effects on muscles:
Stop taking Fenofibrate Pensa and consult your doctor immediately if you experience any of the
following symptoms while taking the medicine:

• unexplained muscle cramps
• muscle pain, tenderness, or weakness.

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 carry out 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 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 ever had muscle-related 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), inform your doctor before taking Fenofibrate Pensa.

Other medicines and Fenofibrate Pensa
Inform 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 Fenofibrate Pensa may increase the risk of muscle problems
• a specific class of medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• ciclosporin (an immunosuppressant)

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before taking Fenofibrate Pensa.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Since there is insufficient experience with the use of Fenofibrate Pensa during pregnancy, you should use Fenofibrate Pensa only if your doctor considers it absolutely necessary.
• It is not known whether the active ingredient of Fenofibrate Pensa passes into breast milk; therefore, you must not use Fenofibrate Pensa if you are breastfeeding or planning to breastfeed.

Driving and use of machines
This medicine has no effect on your ability to drive or operate tools or machinery.

Fenofibrate Pensa contains sucrose (a type of sugar). If your doctor has told you that you cannot tolerate or digest certain sugars (you have an intolerance to certain sugars), consult your doctor before taking this medicine.

Fenofibrate Pensa contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. How to take Fenofibrato Pensa

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, 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 factors.
How to take this medicine
The film-coated tablet can be taken with or without food at any time of day.

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

Please remember that, in addition to taking Fenofibrato Pensa, 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 film-coated tablet daily.
Patients with kidney problems
If you have kidney problems, your doctor may advise you to take a lower dose. Please consult your doctor or pharmacist.
Use in children and adolescents
The use of Fenofibrato Pensa is not recommended in children and adolescents under 18 years of age.
If you take more Fenofibrato Pensa than you should
If you have taken more Fenofibrato Pensa than you should, or if someone else has taken your medicine, inform your doctor or contact the nearest hospital immediately.
If you forget to take Fenofibrato Pensa

• 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 Pensa
Do not stop taking Fenofibrato Pensa unless your doctor tells you to do so, or unless the film-coated tablets make you feel unwell. This is because you may need long-term treatment. If your doctor decides to stop treatment, do not take any leftover tablets unless your doctor tells you to do so. If you have any doubts 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 Fenofibrato Pensa and consult a doctor immediately if you notice any of the
following serious side effects – you may need 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 your pancreas is inflamed (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 or 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 severe burns
• long-term lung problems

Stop taking Fenofibrato Pensa and consult a doctor immediately if you notice any of the above side effects.
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 (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 solariums
• 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 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, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Pensa

Keep this medicine out of the sight and reach of children.
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.
This medicine requires no special storage conditions.
Medicines must 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. Package contents and other information

What Fenofibrato Pensa contains

• The active substance is fenofibrate. Each Fenofibrato Pensa 145 mg tablet contains 145 milligrams (mg) of fenofibrate.
• The other components are:
• In the tablet core: sodium lauryl sulfate, hypromellose, sucrose, pregelatinized starch, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, sodium stearyl fumarate.
  In the film coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol/polyethylene glycol (E1521), talc.

Description of the appearance of Fenofibrato Pensa and contents of the pack
Fenofibrato Pensa 145 film-coated tablets are white to off-white, oval-shaped, biconvex film-coated tablets, 19.1 mm x 9 mm in size, imprinted with 'RH 38' on one side and the other side smooth.
Fenofibrato Pensa 145 film-coated tablets are packed in PVC/PE/PVdC/Al blisters, in cardboard boxes containing 30 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia S.A.
Str. Fabricii nr. 124
Cluj-Napoca, 400632
Romania

This medicinal product is authorized in all EEA Member States under the following names:
Spain Fenofibrato pensa 145 mg comprimidos recubiertos con película EFG
Portugal Fenofibrate toLife 145 mg Comprimidos revestidos por película
Italy Fenofibrato Pensa