Fenofibrate Pensapharma

Package leaflet: Information for the user

Fenofibrate Pensa Pharma 145 mg film-coated tablets

Fenofibrate
Generic 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Fenofibrato Pensa Pharma 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,
fats known as triglycerides.
Fenofibrato Pensa Pharma 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 Pharma 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 Fenofibrate Pensa Pharma

Do not take Fenofibrate Pensa Pharma if:

• you are allergic to fenofibrate or to any of the other ingredients of this medicine (listed in section 6)
• you 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 problems with your liver, kidneys, or gallbladder
• you have pancreatitis (inflamed pancreas causing abdominal pain) not caused by high levels of fat in the blood

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

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

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

Effects on muscles
Stop taking Fenofibrate Pensa Pharma 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 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 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 Pharma.

Other medicines and Fenofibrate Pensa Pharma
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 used 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 Pharma may increase the risk of muscle problems
• a particular 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), talk to your doctor or pharmacist before taking Fenofibrate Pensa Pharma.

Pregnancy and breastfeeding

• Inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. It is not known whether Fenofibrate Pensa Pharma affects pregnancy. You should take Fenofibrate Pensa Pharma only if your doctor considers it strictly necessary.
• You must not take Fenofibrate Pensa Pharma if you are breastfeeding or planning to breastfeed. It is not known whether Fenofibrate Pensa Pharma is excreted in human milk.

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

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

3. How to take Fenofibrate SU

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 tablet may 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 Fenofibrate Pensa Pharma, 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 per day.
Patients with kidney problems
If you have kidney problems, your doctor may instruct you to take a lower dose. Please consult your doctor or
pharmacist for advice.
Use in children and adolescents
The use of Fenofibrate Pensa Pharma is not recommended in children and adolescents under
18 years of age.
If you take more Fenofibrate Pensa Pharma than you should
If you have taken more Fenofibrate Pensa Pharma than prescribed, or if someone else has taken your medicine,
inform your doctor or contact the nearest hospital immediately.
If you forget to take Fenofibrate Pensa Pharma

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

If you stop taking Fenofibrate Pensa Pharma
Do not stop taking Fenofibrate Pensa Pharma unless your doctor tells you to do so, 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 leftover tablets unless your doctor instructs you to do so. If you have any doubts about using this medicine, consult your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Fenofibrate Pensa Pharma and contact a doctor immediately if you notice any
of the following serious side effects – urgent medical treatment may be required:
Uncommon: ( may affect up to 1 in 100 people):

• cramps or pain, tenderness or weakness in muscles – these may be signs of muscle inflammation or muscle damage, 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 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 form of skin rash with redness, peeling and swelling of the skin resembling serious burns
• long-term lung problems.

Stop taking Fenofibrate Pensa Pharma and contact a doctor immediately if you notice any
of the above side effects.
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)
• malaise (vomiting)
• increased liver enzyme levels 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 link 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 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 any of the above-listed side effects occur, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, 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.
How to store Fenofibrate Pensa Pharma
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 does not require any 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 Pharma Contains

• The active substance is fenofibrate. Each Fenofibrato Pensa Pharma 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, anhydrous colloidal 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 Pharma and Package Contents
Fenofibrato Pensa Pharma 145 film-coated tablets are white to off-white, oval-shaped, biconvex film-coated tablets, 19.1 mm x 9 mm in size, marked with 'RH 38' on one side and the other side plain.
Fenofibrato Pensa Pharma 145 film-coated tablets are packaged in PVC/PE/PVdC/Al blisters, in cardboard boxes containing 30, 90, and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milano – Italy

Legal Representative in Italy:
Sun Pharma Italia Srl - Viale Giulio Richard, 1 - 20143 Milano

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:
Germany Fenofibrat SUN 145 mg filmtabletten
Spain Fenofibrato Pensa Pharma 145 mg comprimidos recubiertos con película EFG
France Fenofibrate SUN 145 mg comprimé pelliculé
Italy Fenofibrato Pensa Pharma
Romania Fenofibrat Terapia 145 mg comprimate filmate