Fenardin

Package Leaflet: Information for the User

Fenardin, 160 mg, Hard Capsules

Fenofibrate

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

• 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 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 pack and other information

1. What is Fenardin and what is it used for

Fenardin 160 mg 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 160 mg 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.
Fenardin 160 mg may also be used as an addition to other medicines (statins) if the level of fats in the blood cannot be controlled with statins alone.

2. Important information before taking Fenardin

When not to take Fenardin

• 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 or skin damage caused by sunlight or UV radiation while taking other medicines (such as other fibrates or an anti-inflammatory medicine called ketoprofen).
• If you have severe liver, kidney, or gallbladder disease.
• If you have pancreatitis (a disease that causes stomach pain) that is not caused by high levels of a certain type of fat in the blood.

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

Warnings and precautions

Before taking Fenardin, discuss with your doctor or pharmacist if you:

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

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

Muscle effects

Stop taking the medicine and contact your doctor immediately if you experience:

• unexplained muscle spasms;
• muscle pain, tenderness, or weakness. This medicine can cause muscle disorders, which can be severe. These disorders are rare but include muscle inflammation and breakdown, which 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. In particular, inform your doctor if:

• you are over 70 years old;
• you have kidney disease;
• you have thyroid disease;
• 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). If any of the above warnings apply to you (or if you are unsure), consult your doctor before taking Fenardin.

Fenardin and other medicines

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

• blood-thinning medicines (such as warfarin);
• other medicines used to control fat levels in the blood (such as statins or fibrates). Taking a statin or another fibrate at the same time as Fenardin may increase the risk of muscle damage;
• a specific group of diabetes medicines (such as rosiglitazone or pioglitazone);
• cyclosporin (an immunosuppressant medicine).

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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice, as it is not known how Fenardin affects the unborn child. Fenardin should only be used if your doctor decides it is necessary.
• Do not take Fenardin if you are breastfeeding or plan to breastfeed, as it is not known whether the product passes into breast milk.

Driving and using machines

This medicine has no effect on driving or using machines.

Fenardin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Fenardin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your health condition, current treatment, individual risk assessment, and other factors.

Taking the medicine

Take the capsules with food, as the medicine may not work as well if taken on an empty stomach.

• Swallow the capsules whole with water.
• Do not crush or chew the capsules.

Remember that, in addition to taking Fenardin, it is also important to:

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

Recommended dose
The recommended dose is one capsule per day with food, while maintaining a low-fat diet.
Regular medical check-ups are necessary, for example, to measure lipid levels in the blood.

Patients with kidney problems

In patients with kidney problems, your doctor may reduce the dose. Consult your doctor or pharmacist.

Use in children and adolescents

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

Taking more than the recommended dose of Fenardin

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

Missing a dose of Fenardin

• If you miss a dose, take the next dose with your next meal. Then, take your usual dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

Stopping treatment with Fenardin

Do not stop taking this medicine unless your doctor tells you to or if the capsules cause you discomfort. High levels of fats in the blood require long-term treatment.
If you stop taking the medicine, unless your doctor decides otherwise, do not store unused capsules.
If you have any further questions about taking this medicine, ask your 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 your doctor immediately - you may need urgent medical treatment:

Uncommon:may affect up to 1 in 100 people

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

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

• allergic reaction - symptoms can include swelling of the face, lips, tongue, or throat, which can cause difficulty breathing;
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzyme activity - these can 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.

If you experience any of the above side effects, stop taking Fenardin and contact your doctor immediately.

Other side effects

If you experience any of the following side effects, contact your doctor or pharmacist:
Common:may affect up to 1 in 10 people

• 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:may affect up to 1 in 100 people

• headache;
• gallstones;
• decreased sex drive;
• rash, itching, or hives;
• increased creatinine levels in the blood - confirmed by laboratory tests.

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

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

Frequency not known:cannot be estimated from the available data

• muscle breakdown;
• complications related to gallstones;
• feeling tired.

Tell your doctor or pharmacist if you experience any of the above side effects.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Fenardin

Keep out of the sight and reach of children.
Store in a temperature below 30 °C.
Store in the original package to protect from light and moisture.
Do not use this medicine after the expiry date stated on the package.
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 Fenardin contains

• The active substance is fenofibrate. Each Fenardin capsule contains 160 milligrams (mg) of fenofibrate.
• The other ingredients are:
• capsule contents: macrogol lauryl ether, macrogol 20,000, hydroxypropylcellulose, and sodium carboxymethylcellulose (type A)
• capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171), iron oxide black (E 172), indigo carmine (E 132)

What Fenardin looks like and contents of the pack

Green-orange hard capsules, size 0 (green upper part, orange lower part), containing a white-beige waxy mass.
Hard capsules in blisters (PVC/Aluminum) placed in a cardboard box.
Pack sizes: 30 or 60 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.
rue du Parc Industriel 39
B-6900 Marche-en-Famenne
Belgium
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów

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

Greece:
Fenobrat capsule hard 160 mg/cap
Poland:
Fenardin
Hungary:
FenoSwiss 160 mg hard capsule
Date of last revision of the package leaflet:November 2020