Biofibrat

Package Leaflet: Information for the Patient

Biofibrat

200 mg, Hard Capsules

Fenofibrate

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

• Keep this 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 leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Biofibrat and what is it used for

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

2. Important information before taking Biofibrat

When not to take Biofibrat

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 (with medicines such as other fibrates or the anti-inflammatory medicine ketoprofen); if you have severe liver disease or gallbladder disease; if you have kidney disease; if you have pancreatitis (a disease that causes abdominal pain) that is not caused by high levels of a certain type of fat in the blood; if you are under 18 years old. Do not take Biofibrat if any of the above applies to you. If in doubt, consult your doctor or pharmacist before taking Biofibrat.

Warnings and precautions

Before starting treatment with Biofibrat, discuss it with your doctor or pharmacist if you have liver or kidney disease; if you have liver inflammation: 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 thyroid activity). If any of the above warnings apply to you (or if in doubt), consult your doctor or pharmacist before starting treatment with Biofibrat.

Muscle effects

Stop taking the medicine immediately and consult your doctor if you experience unexpected muscle cramps or muscle pain, tenderness, or weakness while taking Biofibrat. This medicine may cause muscle disease, which can be severe. These diseases are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death. Your doctor may order a blood test to check the condition of your muscles 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; if you or a family member have had hereditary muscle diseases; if you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin; if you have had muscle diseases while taking statins or fibrates, such as fenofibrate, bezafibrate, or gemfibrozil. If any of the above warnings apply to you (or if in doubt), consult your doctor or pharmacist before starting treatment with Biofibrat.

Children and adolescents

Biofibrat is not recommended for use in children under 18 years of age.

Biofibrat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, tell your doctor about medicines such as: oral anticoagulants taken to thin the blood (e.g., warfarin); other medicines used to control the level of fats in the blood (such as statins or fibrates). Taking a statin at the same time as Biofibrat may increase the risk of muscle damage; a medicine used to treat diabetes (such as rosiglitazone or pioglitazone); cyclosporin (an immunosuppressant medicine). If any of the above warnings apply to you (or if in doubt), consult your doctor or pharmacist before starting treatment with Biofibrat.

Biofibrat with food, drink, and alcohol

Swallow the capsule whole with a glass of water. It is important to take Biofibrat with food, as it will work less well if taken on an empty stomach.

Pregnancy and breastfeeding

Do not take Biofibrat and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Do not take Biofibrat while breastfeeding or planning to breastfeed. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Biofibrat has no effect on the ability to drive or use machines. Biofibrat contains lactose(a sugar found in milk). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially sodium-free.

3. How to take Biofibrat

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will determine the appropriate dose based on your condition, current therapy, and personal risk.

Taking the medicine

Swallow the capsule whole and wash it down with a glass of water. Do not open or chew the capsule. Take the capsule with food - absorption of the medicine on an empty stomach is worse.

How much to take

The recommended daily dose is 1 capsule of 200 mg once a day.

Patients with kidney problems

In patients with kidney problems, your doctor may reduce the dose. If you have such disorders, consult your doctor or pharmacist. In patients with severe kidney problems (creatinine clearance <20 ml min), the medicine is contraindicated.< p>

Patients over 65 years of age

In elderly patients without kidney problems, the recommended dose is the same as for adults.

Patients with liver problems

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

Use in children and adolescents

Biofibrat is not recommended for use in children under 18 years of age.

Overdose of Biofibrat

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

Missed dose of Biofibrat

If you miss a dose, take the next dose with the next meal. Then take your usual dose at the scheduled 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 you discomfort. Elevated cholesterol levels must be treated for a long time. Remember that, in addition to taking Biofibrat, it is also important to: follow a low-fat diet; exercise regularly. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

Uncommon:may affect up to 1 in 100 people

• muscle cramps or muscle pain, muscle tenderness or weakness - these may be symptoms of muscle inflammation or breakdown, which can cause kidney damage or even death
• abdominal pain - may be symptoms of pancreatitis
• chest pain and shortness of breath - may be symptoms of blood clots in the lungs (pulmonary embolism)
• pain, redness, and swelling of the legs - may be symptoms of blood clots in the legs (deep vein thrombosis)

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

• 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 enzyme activity - may be symptoms of liver inflammation

Frequency not known:cannot be estimated from the available data

• severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• chronic lung disease

Other side effects include:

Common (affects less than 1 in 10 people):

diarrhea, abdominal 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 (affects less than 1 in 100 people):

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

Rare (affects less than 1 in 1,000 people):hair loss, increased urea levels (a substance excreted by the kidneys) - confirmed by laboratory tests, increased sensitivity of the skin to sunlight, sunlamps, and sunbeds, decreased hemoglobin levels (red blood cell pigment that carries oxygen) and decreased white blood cell count - confirmed by laboratory tests.

Side effects with unknown frequency:

muscle breakdown, complications related to gallstones, feeling tired

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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. Side effects can also be reported 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 Biofibrat

Keep the medicine out of the sight and reach of children. Store in a temperature 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 stated. 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 Biofibrat contains

• The active substance is fenofibrate. One capsule contains 200 mg of micronized fenofibrate.
• The other ingredients are: capsule filling: lactose monohydrate, pregelatinized starch, sodium lauryl sulfate, crospovidone, magnesium stearate, colloidal anhydrous silica; capsule shell: 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 purple, hard gelatin capsules. The capsules are packaged in PVC/Aluminum blisters (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 authorization 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

Date of last revision of the leaflet: