Fenardin

Patient Information Leaflet

Fenardin, 160 mg, hard capsules
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Leaflet Contents

1. What Fenardin is and what it is used for
2. What you need to know 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 Fenardin is and what it is used for

Fenardin 160 mg belongs to a group of medicines known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood. An example of such fats are triglycerides.
Fenardin 160 mg is used in combination with a low-fat diet and other non-medical treatments such as physical exercise and weight loss, all aimed at reducing blood fat levels.
In certain cases, Fenardin 160 mg may be used in addition to other medicines (statins) when blood fat levels cannot be controlled with statins alone.

2. Important information before using Fenardin

When not to use Fenardin

• If the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6).
• If the patient has previously experienced an allergic reaction or skin damage caused by sunlight or UV light while taking other medicines (such as other fibrates or a drug called ketoprofen used to treat inflammation).
• 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 fats in the blood.

Do not take Fenardin if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Fenardin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fenardin if:

• the patient has liver or kidney disease;
• the patient has hepatitis – symptoms include yellowing of the skin and whites of the eyes (jaundice), increased liver enzyme activity (confirmed by laboratory tests), abdominal pain and itching;
• the patient has hypothyroidism (underactive thyroid gland).

If any of the above warnings apply (or if in doubt), contact a doctor or pharmacist before starting treatment with Fenardin.
Effect on muscles
Stop taking the medicine immediately and contact your doctor if any of the following occur:

• unexpected muscle cramps;
• muscle pain, tenderness or weakness.

This medicine may cause muscle disorders, which can be serious. These disorders are rare but may include inflammation of the muscles and muscle breakdown. This could lead to kidney damage or even death.

Your doctor may order blood tests to check muscle function before and during treatment.
The risk of muscle breakdown may be higher in certain patients. Inform your doctor especially if:

• the patient is over 70 years old;
• the patient has kidney disease;
• the patient has thyroid disease;
• the patient or a family member has a history of inherited muscle disorders;
• the patient drinks large amounts of alcohol;
• the patient is taking cholesterol-lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin);
• the patient has previously experienced muscle disorders while taking statins or fibrates (such as fenofibrate, bezafibrate or gemfibrozil).

If any of the above apply (or if in doubt), contact your doctor before starting treatment with Fenardin.

Fenardin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.
In particular, inform your doctor or pharmacist if the patient is taking:

• anticoagulant medicines used to thin the blood (e.g. warfarin);
• other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin or another fibrate together with Fenardin may increase the risk of muscle damage;
• a specific group of medicines used to treat diabetes (such as rosiglitazone or pioglitazone);
• cyclosporine (an immunosuppressant medicine).

If any of the above apply (or if in doubt), contact your doctor or pharmacist before starting treatment with Fenardin.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor, as it is unknown how Fenardin affects the unborn child. Fenardin should only be used if so decided by a doctor.
• Do not take Fenardin during breastfeeding or if the patient plans to breastfeed, as it is unknown whether Fenardin passes into human milk.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery and equipment.

Fenardin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "sodium-free".

3. How to use Fenardin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your health condition, current treatment, and individual
risk assessment.

Taking the medicine
The capsules should be taken during a meal, because the medicine will not work properly if taken on an empty stomach.

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

It is important to remember that in addition to taking Fenardin, the following are also important:

• following a low-fat diet;
• regularly performing physical exercise.

Recommended dose
The recommended dose is one capsule per day taken during a meal, while maintaining a proper diet.
Regular medical check-ups are necessary, for example, to monitor blood lipid levels.

Patients with kidney impairment
In patients with kidney impairment, your doctor may reduce the dose. Please 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 take more Fenardin than recommended, or if the medicine is accidentally taken by someone else,
you should immediately contact your doctor or the emergency department of the nearest hospital.

Missed dose of Fenardin

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

Stopping Fenardin treatment
Do not stop taking this medicine unless your doctor advises otherwise or if the capsules cause discomfort.
Elevated blood fat levels require long-term treatment.
If you discontinue treatment and your doctor has not advised otherwise, do not keep the unused capsules.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following serious side effects occur, stop taking Fenardin and contact your doctor immediately –
prompt medical treatment may be necessary:

Uncommon: may occur in up to 1 in 100 patients

• muscle cramps or pain, tenderness to touch or muscle weakness – these may be symptoms of muscle inflammation or muscle breakdown, which could lead to kidney damage or even death;
• abdominal pain – these may be symptoms 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).

Rare: may occur in up to 1 in 1000 patients

• 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 – these may be symptoms of liver inflammation.

Frequency not known: frequency 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 any of the above-mentioned side effects occur, stop taking Fenardin and contact your doctor immediately.

Other side effects
If any of the following side effects occur, contact your doctor or pharmacist:

Common: may occur in up to 1 in 10 patients

• diarrhoea;
• abdominal pain;
• bloating with flatulence;
• 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 increased risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established).

Uncommon: may occur in up to 1 in 100 patients

• headache;
• gallstones;
• decreased libido;
• rash, itching or urticaria;
• increased creatinine excretion by the kidneys – detected in laboratory tests.

Rare: may occur in up to 1 in 1000 patients

• hair loss;
• increased urea excretion by the kidneys – detected in laboratory tests;
• increased skin sensitivity to sunlight, sunbed lamps and tanning beds;
• decreased haemoglobin concentration (oxygen-carrying pigment in blood) and decreased white blood cell count – detected in laboratory tests.

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

• muscle breakdown;
• complications associated with gallstones;
• feeling of fatigue.

Tell your doctor or pharmacist if any of the side effects listed above occur.

Reporting of side effects
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store the medicine Fenardin

Keep out of the sight and reach of children.
Store below 30 °C.
Keep the medicine in the original packaging to protect it from light and moisture.
Do not use this medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging 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 glyceryl monostearate, macrogol 20,000, hydroxypropylcellulose, and sodium carboxymethyl starch (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 of size 0 (upper part green, lower part orange), containing a white to beige waxy mass.
Hard capsules are packed in blisters made of foil (PVC/aluminum) and placed in a cardboard box.
Pack sizes: 30 or 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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. Kosztowska 21
41-409 Mysłowice
Poland

This medicinal product is authorised 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 kemény kapszula