Fenardin

Package leaflet: Information for the user

Fenardin, 267 mg, hard capsules
Fenofibrate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet

1. What Fenardin is and what it is 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 Fenardin is and what it is used for

Fenardin belongs to a group of medicines known as fibrates. These medicines are used to lower levels of fats (lipids) in the blood. An example of such fats are triglycerides.
Fenardin 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.

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 photosensitivity or skin damage during exposure to sunlight or UV radiation while taking other medicines (such medicines include other fibrates or an anti-inflammatory drug called ketoprofen);
• if the patient has severe liver, kidney, or gallbladder disorders;
• if the patient has pancreatitis (characterized by abdominal pain) not caused by high levels of blood lipids.

Do not take Fenardin 267 mg if any of the above conditions apply.
If in doubt, consult a doctor or pharmacist before taking Fenardin 267 mg.

Warnings and precautions

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

• the patient has liver or kidney disorders;
• the patient has hepatitis – symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests);
• the patient has reduced thyroid gland function (hypothyroidism);
• the patient is also taking oral anticoagulants. Inform the treating physician before starting Fenardin therapy. The doctor will regularly monitor prothrombin (a factor involved in blood clotting).

If any of the above warnings apply (or if in doubt), contact a doctor or pharmacist before starting Fenardin 267 mg.

Effect on muscles

Immediately stop taking the medicine and contact a doctor if unexpected muscle cramps, pain, tenderness, or muscle weakness occur during treatment with Fenardin 267 mg.

• This medicine may cause muscle disorders, which can be severe.
• These disorders are rare but include myositis and rhabdomyolysis. This may lead to kidney damage or even death. The doctor may order blood tests to monitor muscle status before and during treatment. The risk of rhabdomyolysis may be higher in certain patients. Inform the doctor if:
  • the patient is over 70 years old;
  • the patient has kidney problems;
  • the patient has thyroid problems;
  • the patient or a family member has a history of hereditary muscle disorders;
  • the patient consumes large amounts of alcohol;
  • the patient is taking cholesterol-lowering medicines known as 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 warnings apply (or if in doubt), contact a doctor or pharmacist before starting Fenardin 267 mg.

Fenardin with other medicines

Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for future use.

In particular, inform your doctor or pharmacist if the patient is taking:

• Fenardin enhances the effect of oral anticoagulants. A reduction in anticoagulant dosage by one-third is recommended. Always inform the treating physician about any anticoagulant therapy;
• concomitant use of Fenardin and MAO inhibitors (IMAO) is contraindicated;
• other medicines used to control blood lipid levels (such as statins or fibrates). Taking statins together with Fenardin may increase the risk of muscle damage;
• medicines used in diabetes treatment (such as rosiglitazone, pioglitazone);
• cyclosporine – used to suppress the immune system.

Fenardin with food, drink, and alcohol

Swallow the capsules whole with water. Take the capsules with food, as the medicine is less effective when taken 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 are planning a pregnancy.
• Do not take Fenardin 267 mg during breastfeeding or if planning to breastfeed. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Fenardin has no influence on the ability to drive motor vehicles or operate machinery.

Fenardin contains sodium

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

3. How to take Fenardin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
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.
The recommended dose for adults is one capsule per day.
Patients with renal impairment
In patients with kidney impairment, your doctor may reduce the dose. In such cases, consult your 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
The capsule should be swallowed whole with a glass of water. The capsule should be taken during a meal,
as the medicine is less effective when taken on an empty stomach.
Taking more Fenardin than recommended
If you take more than the recommended dose, or if someone else takes this medicine, inform your doctor
or contact the nearest hospital immediately.
Missed dose of Fenardin

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

Stopping treatment with Fenardin
Do not stop taking this medicine unless instructed by your doctor or if the capsules cause discomfort.
Elevated cholesterol levels require long-term treatment.
Remember that, in addition to taking Fenardin, it is equally important to:

• follow a diet low in fat
• perform regular physical exercise.

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

4. Possible adverse reactions

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

• allergic reaction – symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing
• muscle cramps or pain, muscle tenderness or muscle weakness – these may be symptoms of muscle inflammation or breakdown, which can lead to kidney damage or even death
• abdominal pain – this may be a sign of pancreatitis
• chest pain and shortness of breath – these may be symptoms of blood clots in the lungs (pulmonary embolism)
• pain, redness or swelling in 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 signs of liver inflammation. If any of the above adverse reactions occur, stop taking Fenardin and contact your doctor without delay.

Other adverse reactions include:
Common (affects less than 1 in 10 people):

• diarrhoea
• abdominal pain
• bloating with passing of wind
• nausea
• vomiting
• increased liver enzyme activity in blood – detected in laboratory tests
• increased blood homocysteine levels – (excess of this amino acid in the blood is associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not yet been established).

Uncommon (affects less than 1 in 100 people):

• headache
• gallstones
• decreased sexual drive
• skin rash, itching, red skin spots
• increased creatinine excretion by the kidneys – detected in laboratory tests.

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

• 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 (which carries oxygen in the blood) and decreased white blood cell count – detected in laboratory tests.

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

• severe skin rash with skin peeling, redness and swelling resembling severe burns
• long-term lung function disorders. If breathing problems occur, inform your doctor immediately
• feeling of exhaustion (fatigue).

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

5. How to store Fenardin

Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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 contents: glyceryl monostearate, polyethylene glycol 20000, hydroxypropylcellulose, sodium carboxymethyl starch,
  • 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
Green and caramel-coloured hard gelatin capsules.
Pack sizes of 30, 50, 60, 90 or 100 hard 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.
39 rue du Parc Industriel
B-6900 Marche-en-Famenne
Belgium
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium, Luxembourg: Fenogal Lidose 267 mg
Poland: Fenardin
Portugal: Fenofibrato Zentiva 267 mg