GROFIBRAT S

Package leaflet: Information for the patient

Grofibrat S, 215 mg, coated tablets
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, 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Grofibrat S is and what it is used for
2. What you need to know before taking Grofibrat S
3. How to take Grofibrat S
4. Possible side effects
5. How to store Grofibrat S
6. Contents of the pack and other information

1. What Grofibrat S is and what it is used for

Grofibrat S contains 215 mg of the active substance, fenofibrate, which 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.

Grofibrat S is used together with a low-fat diet and other non-medical treatments, such as physical exercise and weight loss, aimed at lowering blood fat levels.

2. What you need to know before taking Grofibrat S

Do not take Grofibrat S if:

• you are allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• you have previously experienced an allergic reaction or skin damage caused by sunlight or UV radiation while taking other medicines (e.g. other fibrates or a non-steroidal anti-inflammatory drug called ketoprofen)
• you have severe liver, kidney or gallbladder disease
• you have pancreatitis (a condition causing abdominal pain) not caused by high levels of fats in the blood.

If any of the above apply to you, do not take Grofibrat S.
If in doubt, consult your doctor or pharmacist before taking Grofibrat S.

Warnings and precautions

Talk to your doctor or pharmacist before taking Grofibrat S if:

• you have liver or kidney disease
• you have symptoms indicating liver inflammation, such as yellowing of the skin or whites of the eyes (jaundice), or elevated liver enzymes (shown in blood tests)
• you have reduced thyroid gland activity (hypothyroidism).

If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Grofibrat S.

Effect on muscles

Stop taking Grofibrat S immediately and contact your doctor if you experience unexpected muscle cramps or pain, tenderness to touch, or muscle weakness during treatment.

• This medicine may cause muscle disorders, which can be serious.
• These disorders are rare but include myositis (muscle inflammation) and rhabdomyolysis (muscle breakdown). This may lead to kidney damage or even death. Your doctor may order blood tests to monitor muscle function before and during treatment. The risk of muscle breakdown may be higher in certain patients. Inform your doctor if:
  • you are over 70 years old
  • you have kidney disease
  • you have thyroid disease
  • you or a family member has had inherited muscle disorders
  • you consume large amounts of alcohol
  • you are taking cholesterol-lowering medicines called statins (e.g. simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin)
  • you have previously experienced muscle disorders while taking statins or fibrates (e.g. fenofibrate, bezafibrate or gemfibrozil).

If any of the above apply to you (or if you are in doubt), consult your doctor before starting treatment with Grofibrat S.

Grofibrat S with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

In particular, inform your doctor or pharmacist if you are taking:

• oral anticoagulants (e.g. warfarin)
• other medicines used to control blood fat levels (e.g. statins or fibrates). Taking a statin together with Grofibrat S may increase the risk of muscle damage.
• certain medicines used to treat diabetes (e.g. rosiglitazone, pioglitazone)
• cyclosporine (an immunosuppressive medicine).

If any of the above apply to you (or if you are in doubt), consult your doctor or pharmacist before taking Grofibrat S.

Grofibrat S with food, drink and alcohol

It is important to take Grofibrat S during a meal, as the medicine will not work properly if taken on an empty stomach.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

• Do not take Grofibrat S and inform your doctor if you are pregnant, suspect pregnancy, or are planning to become pregnant.
• Do not take Grofibrat S during breastfeeding or if you are planning to breastfeed. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Grofibrat S has no effect on the ability to drive or operate machinery.

Grofibrat S contains lactose and sodium

If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

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

3. How to take Grofibrat S

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Your doctor will determine the appropriate dose based on your condition, current treatment, and individual risk factors.

How to take the medicine

• Swallow the tablet whole with a glass of water.
• Do not crush or chew the tablet.
• Take the tablet during a meal. The medicine does not work well if taken on an empty stomach.

How much to take

The recommended dose is 1 tablet of Grofibrat S 160 mg per day.

However, your doctor may increase the dose to 215 mg per day, i.e. 1 tablet of Grofibrat S 215 mg (higher dose).

For patients currently taking one capsule containing 267 mg of fenofibrate, your doctor may replace it with one tablet of Grofibrat S 215 mg.

Patients with kidney disease

If you have kidney disease, your doctor may reduce your dose. Consult your doctor or pharmacist if you have any questions.

Use in children and adolescents

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

If you take more Grofibrat S than you should

If you take more than the prescribed dose, or if someone else accidentally takes this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

If you miss a dose of Grofibrat S

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

If in doubt, consult your doctor.

Stopping treatment with Grofibrat S

Do not stop treatment unless your doctor advises you to do so or if the medicine causes you discomfort. Abnormal blood fat levels require long-term treatment.

Remember that during treatment with Grofibrat S, the following are important:

• a low-fat diet
• regular physical activity.

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 everybody gets them.

If any of the following serious side effects occur, stop taking Grofibrat S and contact your doctor immediately – prompt medical treatment may be necessary:

• allergic reaction, which may include swelling of the face, lips, tongue or throat, possibly causing breathing difficulties
• muscle cramps or pain, tenderness to touch or muscle weakness – these may be symptoms of muscle inflammation or breakdown, which can lead to 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 in the legs – may be symptoms of blood clots in the legs (deep vein thrombosis)
• yellowing of the skin or whites of the eyes (jaundice), or increased liver enzyme activity – may be symptoms of liver inflammation.

If any of the above symptoms occur, stop taking Grofibrat S immediately and contact your doctor.

Other side effects include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache
• gallstones
• decreased libido
• rash, itching or urticaria
• increased creatinine levels (a substance excreted by the kidneys) – detected in laboratory tests.

Rare (may affect up to 1 in 1,000 people)

• hair loss
• increased blood urea levels (a substance excreted by the kidneys) – detected in laboratory tests
• increased sensitivity of the skin to sunlight, sunbeds or tanning lamps
• decreased haemoglobin levels (the oxygen-carrying pigment in blood) and decreased white blood cell count – detected in laboratory tests.

Side effects with unknown frequency

• chronic lung disease. If unexpected breathing difficulties occur, contact your doctor immediately
• severe skin rash with redness, peeling and swelling of the skin resembling severe burns
• feeling of fatigue.

Reporting of 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:

Department of Monitoring of 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

Side effects can also be reported to the marketing authorisation holder.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Grofibrat S

5. How to store Grofibrat S

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

Contents of the pack and other information
What Grofibrat S contains
The active substance is micronized fenofibrate.
Each Grofibrat S 215 mg coated tablet contains 215 mg of the active substance.
The other ingredients of Grofibrat S 215 mg coated tablets are:
Povidone, sodium lauryl sulfate, lactose monohydrate, sodium croscarmellose, microcrystalline cellulose, polyethylene glycol 6000, colloidal anhydrous silica, sodium stearyl fumarate.
Coating (Opadry 200 SERIES ORANGE 200F230006): polyvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), polyethylene glycol (E 1521), methacrylic acid and ethyl acrylate copolymer (1:1), iron oxide yellow (E 172), Allura red AC aluminium lake (E 129), sodium hydrogen carbonate (E 500 ii).

What Grofibrat S looks like and contents of the pack
Grofibrat S 215 mg, coated tablets: Orange, oval, biconvex coated tablets approximately 17 mm in length and 9 mm in width, with the inscription "215" embossed on one side.
Available in packs containing 30, 60 or 90 tablets in blisters made of Aluminium/PVC/PE/PVDC. The blisters are packed in a cardboard box with an enclosed leaflet.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: +48 (22) 755 50 81

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

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