Fibralipid

Package Leaflet: Information for the Patient

Fibralipid, 200 mg, Hard Capsules

Fenofibrate

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Fibralipid and what is it used for
• 2. Important information before taking Fibralipid
• 3. How to take Fibralipid
• 4. Possible side effects
• 5. How to store Fibralipid
• 6. Contents of the pack and other information

1. What is Fibralipid and what is it used for

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

2. Important information before taking Fibralipid

When not to take Fibralipid:

• if you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to sunlight or UV radiation, or skin damage, while taking other medicines, such as other fibrates or the anti-inflammatory medicine ketoprofen;
• if you have severe liver, kidney, or gallbladder disease;
• if you have pancreatitis (a disease that causes stomach pain), which is not caused by high levels of a certain type of fat in the blood.

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

Warnings and precautions

Before starting to take Fibralipid, discuss the following with your doctor or pharmacist:

• if you have liver or kidney disease;
• if you have hepatitis - symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests);
• if you have hypothyroidism (reduced activity of the thyroid gland).

Muscle effects

Stop taking the medicine and contact your doctor immediately if you experience unexpected muscle cramps, muscle pain, tenderness, or weakness while taking Fibralipid. This medicine may cause muscle disorders, which can be severe. These disorders are rare but include muscle inflammation and breakdown. This can lead to kidney damage or even death. Your doctor may order a blood test to check your muscle condition before and after starting treatment. The risk of muscle breakdown may be higher in some patients. Tell your doctor if:

• you are over 70 years old;
• you have kidney disease;
• you have thyroid disease;
• you drink large amounts of alcohol;
• you or a family member have had hereditary muscle disorders;
• you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin;
• you have had muscle disorders while taking statins or fibrates, such as fenofibrate, bezafibrate, or gemfibrozil.

If any of the above warnings apply to you (or if you are unsure), consult your doctor or pharmacist before starting to take Fibralipid.

Children and adolescents

Fibralipid is not recommended for use in children and adolescents under 18 years of age.

Fibralipid and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including:

• blood-thinning medicines (e.g., warfarin);
• other medicines used to control the levels of fats in the blood (such as statins or fibrates) - taking a statin at the same time as Fibralipid may increase the risk of muscle damage;
• medicines used to treat diabetes (such as rosiglitazone or pioglitazone);
• cyclosporin (an immunosuppressant medicine used in patients who have had organ transplants).

If any of the above warnings apply to you (or if you are unsure), consult your doctor or pharmacist before starting to take Fibralipid.

Fibralipid with food, drink, and alcohol

It is important to take the medicine with a meal, as it will work less well if taken on an empty stomach.

Pregnancy and breastfeeding

• Do not take Fibralipid if you are pregnant, think you may be pregnant, or plan to become pregnant. Inform your doctor if you become pregnant while taking Fibralipid.
• Do not take Fibralipid while breastfeeding. Consult your doctor or pharmacist before taking Fibralipid.

Driving and using machines

Fibralipid has no or negligible influence on the ability to drive and use machines.

Fibralipid contains sucrose, methyl and propyl parahydroxybenzoate, propylene glycol, sodium benzoate, and sodium

Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Methyl and propyl parahydroxybenzoate

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (which may be delayed).

Propylene glycol

This medicine contains 0.107 mg of propylene glycol in each capsule.

Sodium benzoate

This medicine contains 0.0244 mg of sodium benzoate in each capsule.

Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is considered to be essentially sodium-free.

3. How to take Fibralipid

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask 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 is reduced when taken on an empty stomach.

Recommended dose

Adults: 1 capsule (200 mg) once a day.

Patients with kidney problems

In patients with kidney problems, your doctor may reduce the dose. If you have kidney problems, consult your doctor or pharmacist. In patients with severe kidney problems (creatinine clearance <30 ml min 1.73 m), the medicine is contraindicated.< p>

Patients over 65 years of age

In patients over 65 years of age without kidney problems, no dose adjustment is necessary.

Patients with liver problems

In patients with liver problems, Fibralipid is not recommended due to the lack of clinical data for this group.

Use in children and adolescents

Fibralipid is not recommended for use in children and adolescents under 18 years of age.

Overdose of Fibralipid

If you have taken more than the recommended dose or if someone else has taken your medicine, contact your doctor or the nearest hospital emergency department immediately.

Missed dose of Fibralipid

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take the next dose with your next meal. Then take your usual dose at the scheduled time (according to the recommended dosing schedule). If you are unsure, consult your doctor or pharmacist.

Stopping treatment with Fibralipid

Do not stop treatment without consulting your doctor, unless the medicine causes you discomfort. High cholesterol must be treated for a long time. Remember that, in addition to taking Fibralipid, it is also important to:

• follow a low-fat diet;
• perform regular physical exercise.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fibralipid can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Fibralipid and contact your doctor immediately - you may need urgent medical treatment:

• 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;
• stomach pain - this may be a symptom of pancreatitis;
• chest pain and shortness of breath - these may be symptoms of blood clots in the lungs (pulmonary embolism);
• pain, redness, and swelling of 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 symptoms 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, which may cause unusual breathing problems;
• complications of gallstones (e.g., cholecystitis, cholangitis, biliary colic).

Other side effects

If you experience any of the following side effects, contact your doctor or pharmacist:

Common(affecting 1 to 10 people in 100):

• diarrhea;
• stomach pain;
• bloating with gas;
• nausea;
• vomiting;
• increased liver enzyme activity in the blood - confirmed by laboratory tests;
• increased homocysteine levels in the blood (high levels of this amino acid in the blood are associated with a higher risk of coronary heart disease, stroke, and peripheral vascular disease, although a causal relationship has not been established).

Uncommon(affecting 1 to 10 people in 1,000):

• headache;
• gallstones;
• decreased sex drive;
• skin rash, itching, or redness;
• increased creatinine levels in the blood (a substance excreted by the kidneys) - confirmed by laboratory tests.

Rare(affecting 1 to 10 people in 10,000):

• hair loss;
• dizziness;
• fatigue;
• increased urea levels in the blood (a substance excreted by the kidneys) - confirmed by laboratory tests;
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds;
• decreased hemoglobin levels (the red pigment in the blood that carries oxygen);
• decreased white blood cell count - confirmed by laboratory tests.

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

• fatigue.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fibralipid

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month. There are no special storage precautions for this medicine. Medicines should 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 Fibralipid contains

• The active substance is 200 mg of micronized fenofibrate.
• The other ingredients are: sucrose, maize starch, hypromellose (3 cPs), sodium lauryl sulfate, dimeticone emulsion 35%, dimeticone (polydimethylsiloxane), octoxynol 10, polysorbate 20, propylene glycol, sodium benzoate (E 221), methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), simeticone emulsion 30%, simeticone, cetostearyl alcohol and ethoxylate, sodium benzoate (E 221), talc. The composition of the hard capsule shell is: Body: gelatin, purified water, sodium lauryl sulfate. Cap: iron oxide yellow (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 packaged in PVC/Aluminum blisters. The pack contains 30 capsules in a cardboard box.

Marketing authorization 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

Date of last revision of the package leaflet