Package leaflet: Information for the patient

Biofibrat
200 mg, hard capsules
Fenofibrate
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Biofibrat is and what it is used for
Important information before taking Biofibrat
How to take Biofibrat
Possible side effects
How to store Biofibrat
Contents of the pack and other information

1. What Biofibrat is and what it is used for

Biofibrat belongs to a group of medicines generally known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood. An example of such fats are triglycerides.
Biofibrat is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at reducing blood fat levels.
In certain cases, Biofibrat may be used together with other medicines (statins, such as: simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin), if blood fat levels cannot be controlled using statins alone.

2. Important information before using Biofibrat

When not to use Biofibrat
if the patient is allergic to fenofibrate or any of the other ingredients of this medicine
(listed in section 6);
if the patient has previously experienced photosensitivity or skin damage during treatment with
other medicines (such as other fibrates or the anti-inflammatory drug ketoprofen);
if the patient has severe liver disease or gallbladder disease;
if the patient has kidney disease;
if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of
certain types of blood lipids;
if the patient is under 18 years of age.
Do not take Biofibrat if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Biofibrat.

Warnings and precautions
Before starting treatment with Biofibrat, consult a doctor or pharmacist if:
the patient has liver or kidney disorders;
the patient has hepatitis: symptoms include yellowing of the skin and whites of the eyes (jaundice)
and increased liver enzyme activity (confirmed by laboratory tests);
the patient has hypothyroidism (reduced activity of the thyroid gland).
If any of the above warnings apply (or if in doubt), consult a doctor or pharmacist before starting
treatment with Biofibrat.

Effect on muscles
Immediately stop taking Biofibrat and contact a doctor if unexpected muscle cramps, pain,
tenderness, or weakness occur during treatment.
This medicine may cause muscle disorders, which can be serious.
These disorders are rare but include myositis and rhabdomyolysis. This may lead to kidney damage
or even death.
The doctor may order blood tests to monitor muscle status before and during treatment.
The risk of rhabdomyolysis may be higher in certain patients. Inform the doctor if:

the patient is over 70 years old;
the patient has kidney disease;
the patient has thyroid disease;
the patient consumes large amounts of alcohol;
the patient or a family member has a history of hereditary muscle disorders;
the patient is taking cholesterol-lowering medicines known as statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin;
the patient has previously experienced muscle disorders while taking statins or fibrates, such as fenofibrate, bezafibrate, or gemfibrozil.
If any of the above apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Biofibrat.

Children and adolescents
Biofibrat is not recommended for use in individuals under 18 years of age.

Biofibrat and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used, as well as any
medicines planned for future use.
In particular, inform the doctor if the patient is taking:
oral anticoagulants used to thin the blood (e.g. warfarin);
other medicines used to control blood lipid levels (such as statins or fibrates).
Concomitant use of a statin with Biofibrat may increase the risk of muscle damage;
a medicine used in the treatment of diabetes (such as rosiglitazone, pioglitazone);
cyclosporine (an immunosuppressive medicine).
If any of the above apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Biofibrat.

Biofibrat with food, drink and alcohol
Swallow the capsule with a glass of water.
It is important to take Biofibrat during a meal, as the medicine will be less effective if taken on an empty stomach.

Pregnancy and breastfeeding
Do not take Biofibrat and inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy.
Do not take Biofibrat during breastfeeding or when planning to breastfeed.
If the patient is pregnant or breastfeeding, suspects being pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Biofibrat has no influence on the ability to drive or operate machinery.

Biofibrat contains lactose (a sugar found in milk).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per recommended dose unit, meaning the medicine is considered "sodium-free".

3. How to take Biofibrat

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will determine the appropriate dose depending on the patient's condition, current
treatment, and individual risk factors.
Taking the medicine
Swallow the capsule whole with a glass of water.
Do not open or chew the capsule.
Take the capsule with a meal – absorption of the medicine on an empty stomach is reduced.
How much medicine to take
The recommended daily dose is 1 capsule of 200 mg once daily.
Patients with renal impairment
In patients with renal impairment, the doctor may reduce the dose. In such cases, consult a
doctor or pharmacist. Biofibrat is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).
Elderly patients
In elderly patients without renal impairment, the recommended dose is the same as for adults.
Patients with hepatic impairment
Biofibrat is not recommended in patients with hepatic impairment due to lack of clinical data in this group.
Use in children and adolescents
Biofibrat is not recommended for use in individuals under 18 years of age.
Taking more Biofibrat than recommended
If you take more than the recommended dose or if someone else accidentally takes the medicine,
contact a doctor or the nearest hospital emergency department immediately.
Missing a dose of Biofibrat
If you miss a dose, take the next dose with the following meal.
Then continue taking the medicine at the usual time.
Do not take a double dose to make up for a missed dose. If in doubt, consult your doctor.
Stopping treatment with Biofibrat
Do not stop treatment without consulting your doctor, unless the medicine causes adverse effects.
Elevated cholesterol levels require long-term treatment. Remember that in addition to taking Biofibrat, it is equally important to:
follow a diet low in fat,
engage in regular physical exercise.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur,
you must stop taking Biofibrat and contact your doctor immediately – prompt treatment may be necessary:

Uncommon: may affect up to 1 in 100 patients

Muscle cramps or pain, muscle tenderness or weakness – these may be symptoms of muscle inflammation or muscle breakdown, which can lead to kidney damage or even death
Abdominal pain – these may be symptoms of pancreatitis
Chest pain and shortness of breath – these may be symptoms of blood clots in the lungs (pulmonary embolism)
Pain, redness and swelling in the legs – these may be symptoms of blood clots in the legs (deep vein thrombosis)

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

Allergic reaction, symptoms 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 symptoms of liver inflammation

Frequency not known: frequency cannot be estimated from the available data

Severe skin rash with redness, peeling and swelling of the skin resembling severe burns
Chronic lung disease
If any of the above adverse symptoms occur, stop taking Biofibrat immediately and contact your doctor.

Other adverse reactions include:
Common (affects less than 1 in 10 patients):
Diarrhea,
abdominal pain,
flatulence with passage of wind,
nausea,
vomiting,
increased liver enzyme activity in blood – detected in laboratory tests,
increased homocysteine levels in blood (excess of this amino acid in blood is associated with higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not yet been established).

Uncommon (affects less than 1 in 100 patients):
headache,
gallstones,
decreased libido,
rash, itching or red skin lesions,
increased creatinine levels (a substance excreted by the kidneys) – detected in laboratory tests.

Rare (affects less than 1 in 1,000 patients):
hair loss,
increased urea levels (a substance excreted by the kidneys) – detected in laboratory tests,
increased skin sensitivity to sunlight, sunlamps and tanning beds,
decreased hemoglobin levels (the red blood pigment carrying oxygen) and decreased white blood cell count – detected in laboratory tests.

Adverse reactions with unknown frequency:
muscle breakdown,
complications associated with gallstones,
feeling of fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Biofibrat

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Biofibrat contains

The active substance is fenofibrate. One capsule contains 200 mg of micronized fenofibrate.
Other components are: capsule filling: monohydrate lactose, pregelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate, colloidal anhydrous silica; capsule shell composition: gelatin, black iron oxide (E 172), titanium dioxide (E 171), erythrosine (E 127), indigo carmine (E 132).

What Biofibrat looks like and contents of the pack
Biofibrat 200 mg are hard, violet-colored gelatin capsules.
The capsules are packed in blisters made of PVC/Aluminum foil (10 capsules per blister), placed in a cardboard box.
Pack sizes:
10, 30, 50 or 60 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Laboratoires B. T. T.
Z.I. de Krafft
67150 Erstein
France