Fenardin

Leaflet attached to the packaging: information for the user

Fenardin, 267 mg, hard capsules

Fenofibrate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fenardin and what is it used for

Fenardin 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 include triglycerides.
Fenardin is used in combination with a low-fat diet and other non-drug treatments, such as physical exercise and weight loss, which aim to lower the level of fats in the blood.

2. Important information before taking Fenardin

When not to take Fenardin

Do not take Fenardin 267 mg if any of the above information applies to you. In case of doubts, consult a doctor or pharmacist before taking Fenardin 267 mg.

Warnings and precautions

Before starting to take Fenardin, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease;
• you have hepatitis - symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests);
• you have decreased thyroid function (hypothyroidism);
• you are also taking oral anticoagulant medicines. Inform your doctor about this before starting treatment with Fenardin. Your doctor will regularly monitor your prothrombin (a factor involved in the blood clotting process).

If any of the above warnings apply to you (or in case of doubts), consult a doctor or pharmacist before starting to take Fenardin 267 mg.
Effect on muscles
Stop taking the medicine immediately and consult a doctor if you experience unexpected muscle cramps or pain, muscle tenderness, or weakness while taking Fenardin 267 mg.

• This medicine may cause muscle disorders, which can be severe.
• These disorders 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 your muscle condition before and after starting treatment. The risk of muscle breakdown may be higher in some patients. Inform your doctor if:
• you are over 70 years old;
• you have kidney problems;
• you have thyroid problems;
• you or a family member have had hereditary muscle disorders;
• you drink large amounts of alcohol;
• 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 in the past.

If any of the above warnings apply to you (or in case of doubts), consult a doctor or pharmacist before starting to take Fenardin 267 mg.

Fenardin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In particular, inform your doctor or pharmacist about taking medicines such as:

• Fenardin increases the effect of oral anticoagulant medicines. It is recommended to reduce their dosage by one-third. Inform your doctor about any anticoagulant therapy;
• it is contraindicated to take Fenardin and MAOIs at the same time;
• other medicines used to control fat levels in the blood (such as statins or fibrates). Taking statins at the same time as Fenardin may increase the risk of muscle damage;
• medicines used to treat diabetes (such as rosiglitazone, pioglitazone);
• cyclosporine - used to suppress the immune system.

Fenardin with food, drink, and alcohol

Swallow the capsules whole with a glass of water. Take the capsules with food, as the medicine works less effectively on an empty stomach.

Pregnancy, breastfeeding, and fertility

• Do not take Fenardin 267 mg and inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant.
• Do not take Fenardin 267 mg while breastfeeding or planning to breastfeed. If you are pregnant, breastfeeding, or think you may be pregnant, consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Fenardin does not affect the ability to drive or use machines.

Fenardin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Fenardin

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 health condition, current treatment, individual risk assessment.
The recommended dose for adults is one capsule per day.

Patients with kidney problems

In patients with kidney problems, the doctor may reduce the dose. In case of such disorders, consult a doctor or pharmacist.

Use in children and adolescents

Fenardin 267 mg is not recommended for use in children and adolescents under 18 years of age.

Method of administration

Swallow the capsule whole and drink a glass of water. Take the capsule with food, as the medicine works less effectively on an empty stomach.

Taking a higher dose of Fenardin than recommended

In case of taking a higher dose of the medicine or if someone else has taken the medicine, inform a doctor or contact the nearest hospital.

Missing a dose of Fenardin

• In case of missing a dose, take the next dose with the next meal.
• Then take the usual dose at the scheduled time.
• Do not take a double dose to make up for the missed capsule. In case of doubts, consult a doctor.

Stopping Fenardin treatment

Do not stop taking the medicine unless your doctor tells you to or if the capsules cause you to feel unwell. High cholesterol requires long-term treatment.
Remember that in addition to taking Fenardin, it is also important to:

• follow a low-fat diet
• regularly exercise.

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

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

• allergic reaction - symptoms may include swelling of the face, lips, tongue, or throat, which may cause difficulty breathing
• muscle cramps or pain, muscle tenderness, or weakness - these may be symptoms of muscle inflammation or breakdown, which can cause kidney damage or even death
• abdominal 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, or swelling of the legs - these may be symptoms of blood clots in the leg (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. If you experience any of the above side effects, stop taking Fenardin and contact a doctor immediately. Other side effects include:

Common (affecting 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 (excessive 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 yet).

Uncommon (affecting less than 1 in 100 people):

• headache
• gallstones
• decreased sex drive
• rash, itching, red spots on the skin
• increased creatinine levels in the blood - confirmed by laboratory tests.

Rare (affecting less than 1 in 1,000 people):

• hair loss
• increased urea levels in the blood - confirmed by laboratory tests
• increased skin sensitivity to sunlight, sunlamps, and sunbeds
• decreased hemoglobin levels (which carries oxygen in the blood) and decreased white blood cell count - confirmed by laboratory tests.

Frequency not known - it is not known how often they occur:

• severe skin rash with peeling, redness, and swelling of the skin, resembling severe burns
• long-term lung function disorders. If you experience breathing difficulties, inform your doctor immediately
• feeling of tiredness (fatigue).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 Fenardin

Keep the medicine out of the sight and reach of children.
Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
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 packaging and other information

What Fenardin contains

• The active substance is fenofibrate. Each hard capsule contains 267 milligrams (mg) of fenofibrate.
• The other ingredients are:
• capsule content: laurin macrogolglycerides, macrogol 20000, hydroxypropylcellulose, sodium carboxymethylcellulose,
• capsule shell:gelatin, iron oxide red (E 172), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide (E 171), indigo carmine (E 132).

What Fenardin looks like and contents of the pack

Hard gelatin capsules, green and caramel in color.
Pack sizes of 30, 50, 60, 90, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

SMB Technology S.A.
39 rue du Parc Industriel
B-6900 Marche-en-Famenne
Belgium
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium, Luxembourg: Fenogal Lidose 267 mg
Poland:
Fenardin
Portugal:
Fenofibrate Zentiva 267 mg
Date of last revision of the leaflet:December 2020