Package leaflet: Information for the patient

Fibralipid, 200 mg, hard capsules
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because 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 give it to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Fibralipid is and what it is used for

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

2. Important information before taking Fibralipid

When not to take Fibralipid:

if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6);
if the patient previously experienced photosensitivity or UV-induced skin damage during treatment with other medicines such as other fibrates or the anti-inflammatory drug ketoprofen;
if the patient has severe liver, kidney or gallbladder disease;
if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of certain types of blood lipids.

Do not take Fibralipid if any of the above apply.
If in doubt, consult a doctor or pharmacist before taking Fibralipid.
Warnings and precautions
Before starting Fibralipid, discuss with your 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 thyroid gland activity).

Effect on muscles
Immediately stop taking Fibralipid and contact your 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 may include myositis (muscle inflammation) and rhabdomyolysis (muscle breakdown). This may lead to kidney damage or even death.
Your doctor may order blood tests to monitor muscle function before and during treatment.
The risk of muscle breakdown may be higher in certain patients. Inform your doctor if:

the patient is over 70 years of age;
the patient has kidney disease;
the patient has thyroid disorders;
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 called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin;
the patient previously experienced muscle disorders while taking statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil.

If any of the above warnings apply (or if in doubt), consult your doctor or pharmacist before starting Fibralipid.
Children and adolescents
Fibralipid is not recommended for use in children and adolescents under 18 years of age.
Fibralipid with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken or planned for use.
Especially inform your doctor if the patient is taking:

anticoagulant medicines used to thin the blood (e.g. warfarin);
other lipid-lowering medicines (such as statins or fibrates) – concomitant use of a statin with Fibralipid may increase the risk of muscle damage;
medicines used in the treatment of diabetes (such as rosiglitazone or pioglitazone);
cyclosporine (an immunosuppressive medicine used in organ transplant patients).

If any of the above apply (or if in doubt), consult your doctor or pharmacist before starting Fibralipid.
Fibralipid, food, drink and alcohol
It is important to take this medicine during a meal, as it will be less effective if taken on an empty stomach.
Pregnancy and breastfeeding

Do not take Fibralipid and inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Do not take Fibralipid during breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
Fibralipid has no effect or a negligible effect on the ability to drive and operate machinery.
Fibralipid contains sucrose, methyl and propyl parahydroxybenzoate, propylene glycol, sodium benzoate and sodium
Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Methyl and propyl parahydroxybenzoate
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (including delayed-type reactions).
Propylene glycol
The medicine contains 0.107 mg of propylene glycol in each capsule.
Sodium benzoate
The medicine contains 0.0244 mg of sodium benzoate in each capsule.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Fibralipid

This medicine should always be taken as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
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 poorer.

Recommended dose
Adults: 1 capsule (200 mg) once daily.
Patients with renal impairment
Your doctor may reduce the dose in patients with renal impairment. In such cases, consult your doctor or pharmacist. Fibralipid is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m²).
Elderly patients
In elderly patients (over 65 years of age) without renal impairment, no dose adjustment is necessary.
Patients with hepatic impairment
Fibralipid is not recommended in patients with hepatic impairment due to lack of clinical data in this patient group.
Use in children and adolescents
Fibralipid is not recommended for use in children and adolescents under 18 years of age.
Taking more Fibralipid than recommended
If you take more than the recommended dose or if someone else accidentally takes the medicine, contact your doctor or the nearest hospital emergency department immediately.
Missing a dose of Fibralipid
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the next dose with the following meal. Then continue taking the medicine at your usual time (according to the recommended dosing schedule).
If you have any doubts, consult your doctor.
Stopping Fibralipid treatment
Do not stop treatment without consulting your doctor, unless the medicine causes you to feel unwell. Elevated cholesterol levels require long-term treatment.
Remember that, in addition to taking Fibralipid, it is equally important to:

follow a diet low in fat;
perform 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 experiences them.
If any of the following serious adverse reactions occur,
discontinue taking Fibralipid immediately and contact your doctor without delay –
prompt medical treatment may be necessary:

allergic reaction, including swelling of the face, lips, tongue, and throat, which may cause difficulty in breathing;
muscle cramps, muscle pain, tenderness, or weakness – these may be symptoms of muscle inflammation and breakdown, which can lead to kidney damage or even death;
abdominal pain – this may be a sign 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);
yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme activity – these may be signs of liver inflammation;
severe skin rash with redness, peeling, and swelling of the skin resembling severe burns (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
interstitial lung disease that may lead to unusual breathing problems;
complications of gallstone disease (e.g. cholecystitis, cholangitis, biliary colic).

Other adverse reactions
If any of the following adverse reactions occur, contact your doctor or pharmacist:
Common (occur in 1 to 10 out of 100 people):

diarrhoea;
abdominal pain;
bloating with excessive wind;
nausea;
vomiting;
increased liver enzyme activity in blood – detected in laboratory tests;
increased homocysteine levels in blood (elevated levels of this amino acid in blood are associated with a higher risk of coronary heart disease, stroke, and peripheral vascular disease, although a causal relationship has not yet been established).

Uncommon (occur in 1 to 10 out of 1,000 people):

headache;
gallstones;
decreased libido;
rash, itching, or red skin eruptions;
increased creatinine levels (a substance excreted by the kidneys) – detected in laboratory tests.

Rare (occur in 1 to 10 out of 10,000 people):

hair loss;
dizziness;
fatigue;
increased urea levels (a substance excreted by the kidneys) – detected in laboratory tests;
increased sensitivity of the skin to sunlight, sunlamps, and sunbeds (in solariums);
decreased haemoglobin concentration (the red blood pigment responsible for oxygen transport);
decreased white blood cell count – detected in laboratory tests.

Frequency not known (frequency cannot be estimated from available data):

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 Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicinal product Fibralipid

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fibralipid contains

The active substance is 200 mg of micronized fenofibrate.
The other ingredients are: sucrose, beads, hypromellose (3 cPs), sodium lauryl sulfate, dimethicone emulsion 35%, dimethicone (polydimethylsiloxane), octylphenoxy polyethoxy ethanol, polysorbate 20, propylene glycol, sodium benzoate (E 221), methylparaben (E 218), propylparaben (E 216), simethicone emulsion 30%, simethicone, cetostearyl alcohol and ethoxylate, sodium benzoate (E 221), talc.
Composition of the hard gelatin capsule shell:
Body: gelatin, purified water, sodium lauryl sulfate.
Cap: yellow iron oxide (E172), titanium dioxide (E171), gelatin, purified water, sodium lauryl sulfate.

What Fibralipid looks like and contents of the pack
Fibralipid is a hard capsule with a yellow cap and a transparent body, filled with white to off-white, spherical pellets.
The medicine is packed in PVC/aluminum blisters. The pack contains 30 capsules in a cardboard box.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100

Importer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów