FENOFIBRATO 145 mg Фильм-Coated Таблетки

Содержание инструкции

1. Fenofibrato Pensa Pharma 145 mg film-coated tablets
   1. What is Fenofibrato Pensa Pharma and what is it used for
   2. What you need to know before taking Fenofibrato Pensa Pharma
   3. How to take Fenofibrato SU
   4. Package contents and other information

Fenofibrato Pensa Pharma 145 mg film-coated tablets

Fenofibrato

Generic medicine

Read this leaflet carefully before you start using this medicine as it containsimportant
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 they have the same symptoms as you, 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 Fenofibrato Pensa Pharma is and what it is used for
• 2. What you need to know before you take Fenofibrato Pensa Pharma
• 3. How to take Fenofibrato Pensa Pharma
• 4. Possible side effects
• 5. How to store Fenofibrato Pensa Pharma
• 6. Contents of the pack and other information

1. What is Fenofibrato Pensa Pharma and what is it 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 the levels of fats in the blood.
Fenofibrato Pensa Pharma may 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 taking Fenofibrato Pensa Pharma

Do not take Fenofibrato Pensa Pharma if:

• you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• 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 “Ketoprofene”)
• you have severe problems with your liver, kidneys or gallbladder
• you have pancreatitis (inflamed pancreas that causes abdominal pain) that is not caused by high levels of fat in the blood Do not take Fenofibrato Pensa Pharma if any of the above information applies to you. If you are not sure, consult your doctor or pharmacist before taking Fenofibrato Pensa Pharma

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

• you have any problems with your liver
• you have any problems with your kidneys
• you may have an inflamed liver (hepatitis) - signs include yellowing of the skin and the whites of your eyes (jaundice), increased liver enzymes (shown by blood tests) stomach pain and itching
• you have an underactive thyroid (hypothyroidism)

If any of the above information applies to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrato Pensa Pharma.

Effects on muscles:
Stop taking Fenofibrato Pensa Pharma and consult your doctor immediately if you experience:

• unexplained cramps
• pain, tenderness or muscle weakness. In fact, this medicine can cause muscle problems that can be serious. These problems are rare but include inflammation and deterioration of the 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 deterioration is much higher in some patients. Tell your doctor if:
• you are over 70 years old
• 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 while being treated with statins or with fibrates (such as fenofibrate, bezafibrate or gemfibrozil)

If any of the above information applies to you (or you are not sure), tell your doctor
before taking Fenofibrato Pensa Pharma.

Other medicines and Fenofibrato Pensa Pharma
Tell your doctor or pharmacist if you are taking or 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 Fenofibrato Pensa Pharma may increase the risk of muscle problems
• a particular class of medicines for the treatment of diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant) If any of the above information applies to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrato Pensa Pharma. Pregnancy and breastfeeding
• Tell your doctor if you are pregnant, suspect you may be pregnant or are planning a pregnancy. It is not known whether Fenofibrato Pensa Pharma affects pregnancy. You should only use Fenofibrato Pensa Pharma if your doctor considers it strictly necessary.
• Do not take Fenofibrato Pensa Pharma if you are breastfeeding or are planning to breastfeed your baby. It is not known whether Fenofibrato Pensa Pharma is excreted in breast milk.

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

Fenofibrato Pensa Pharma containssucrose (a type of sugar). If your doctor has told you that you cannot
tolerate or digest certain sugars (you have an intolerance to some sugars), talk to your doctor before
taking this medicine.

Fenofibrato Pensa Pharma containsless than 1 mmol of sodium (23 mg) per film-coated tablet,
which is essentially "sodium-free"

3. How to take Fenofibrato SU

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The doctor will establish 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 Fenofibrato Pensa Pharma it is also important that you:

• follow a low-fat diet
• practice regular physical exercise.

How much medicine to take
The recommended dose is one tablet a day.

People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or
pharmacist for advice

Use in children and adolescents
The use of Fenofibrato Pensa Pharma is not recommended in children and adolescents under
18 years of age.

If you take more Fenofibrato Pensa Pharma than you should
If you have taken more Fenofibrato Pensa Pharma than you should or if someone has taken your medicine,
inform your doctor or contact the nearest hospital

If you forget to take Fenofibrato Pensa Pharma

• 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 the missed dose.

If you stop taking Fenofibrato Pensa Pharma
Do not stop taking Fenofibrato Pensa Pharma 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 any remaining tablets unless your doctor has told you to do so. If you have any doubts about using this medicine, ask
your doctor or pharmacist.

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

Stop taking Fenofibrato Pensa Pharma and consult a doctor immediately if you notice anyof the following serious side effects – medical treatment may be urgently needed:
Uncommon: (can affect up to 1 in 100 people):

• cramps or pain, sensitivity or muscle weakness - these can be signs of muscle inflammation or deterioration, which can cause 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: (can affect up to 1 in 1,000):

• allergic reaction - signs may 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 may be signs of liver inflammation (hepatitis).

Not known:(frequency cannot be estimated from available data):

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

Stop taking Fenofibrato Pensa Pharma and consult 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 people):

• diarrhea
• stomach pain
• flatulence
• feeling unwell (nausea)
• feeling 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 people):

• headache
• gallstones
• decreased sexual desire
• 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 (substance produced by the kidneys) - shown in tests
• increased sensitivity of your skin to sunlight, sunlamps and tanning beds
• decreased levels of hemoglobin (which carries oxygen in the blood) and white blood cells - shown in tests

Not known:(frequency cannot be estimated from available data):

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

If any of the side effects listed above occur, see your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including 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.

How to store Fenofibrato Pensa Pharma
Keep this medicine out of the sight and reach of children.
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.
This medicine does not require special storage conditions.
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. Package contents and other information

What Fenofibrato Pensa Pharma contains

• The active ingredient is fenofibrate. Each Fenofibrato Pensa Pharma 145 mg tablet contains 145 milligrams (mg) of fenofibrate.
• The other ingredients 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 film-coated tablets of
white to off-white color, oval shape, biconvex, dimensions 19.1 mm x 9 mm, with 'RH 38'
imprinted on one side and the other side smooth.
Fenofibrato Pensa Pharma 145 film-coated tablets are packaged in blisters in
PVC/PE/PVdC/Al, in cartons containing 30, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.

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

Legal Representative for Italy:
Sun Pharma Italia Srl - Viale Giulio Richard, 1 - 20143 Milan

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 authorised in all EEA Member States with the following names:
Germany Fenofibrat SUN 145 mg filmtabletten
Spain Fenofibrato Pensa Pharma 145 mg comprimidos recubiertos con
peliculaEFG
France Fenofibrate SUN 145 mg comprimé pelliculé
Italy Fenofibrato Pensa Pharma
Romania Fenofibrat Terapia 145 mg comprimate filmate