Grofibrat S

Package Leaflet: Information for the Patient

Grofibrat S, 215 mg, Film-Coated Tablets

Fenofibrate

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

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

Package Leaflet Contents:

• 1. What is Grofibrat S and what is it used for
• 2. Important information before taking Grofibrat S
• 3. How to take Grofibrat S
• 4. Possible side effects
• 5. How to store Grofibrat S
• 6. Package contents and other information

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

What is it used for
Grofibrat S contains 215 mg of the active substance, fenofibrate, which belongs to a group of medications known as fibrates. These medications are used to lower the level of fats (lipids) in the blood.
Examples of such fats include triglycerides.
Grofibrat S is used in combination with a low-fat diet and other non-medical treatments, such as physical exercise and weight loss, aimed at lowering the level of fats in the blood.

2. Important information before taking Grofibrat S

When not to take Grofibrat S

• if the patient is allergic to fenofibrate or any of the other ingredients of this medication (listed in section 6)
• if the patient has previously experienced an allergic reaction or skin damage due to sunlight or UV radiation while taking other medications (such as other fibrates or the anti-inflammatory medication ketoprofen)
• if the patient has severe liver, kidney, or gallbladder disease
• if the patient has pancreatitis (a disease that causes abdominal pain), which is not caused by high levels of fats in the blood.

If any of the above situations apply to the patient, they should not take Grofibrat S.
In case of doubts, consult a doctor or pharmacist before taking Grofibrat S.

Warnings and precautions

Before starting to take Grofibrat S, the patient should discuss it with their doctor or pharmacist if they have:

• liver or kidney disease
• experienced symptoms of liver inflammation: yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme levels (as shown by blood tests)
• reduced thyroid function (hypothyroidism). If any of the above situations apply to the patient (or in case of doubts), they should consult their doctor or pharmacist before taking Grofibrat S.

Effect on muscles

The patient should immediately stop taking Grofibrat S and contact their doctor if they experience:

• unexpected muscle cramps or pain
• muscle tenderness to the touch or weakness while taking the medication.

The medication may cause muscle diseases, which can be severe.
These diseases are rare but include muscle inflammation and breakdown. This can cause kidney damage and even death. The doctor may order a blood test to check the muscle condition before and after starting treatment. The risk of muscle breakdown may be higher in some patients. The patient should inform their doctor if they:

• are over 70 years old
• have kidney disease
• have thyroid disease
• have a family history of muscle disorders
• consume large amounts of alcohol
• are taking cholesterol-lowering medications called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin)
• have previously experienced muscle diseases while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil). If any of the above situations apply to the patient (or in case of doubts), they should consult their doctor before starting to take Grofibrat S.

Grofibrat S and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
They should especially inform their doctor or pharmacist about taking medications such as:

• oral blood thinners (e.g., warfarin)
• other medications used to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as Grofibrat S may increase the risk of muscle damage.
• certain medications used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressive medication). If any of the above situations apply to the patient (or in case of doubts), they should consult their doctor or pharmacist before taking Grofibrat S.

Grofibrat S with food, drink, and alcohol

It is essential to take Grofibrat S with a meal, as the medication will not work well if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medication.

• The patient should not take Grofibrat S and should inform their doctor about pregnancy, suspected pregnancy, or plans to become pregnant.
• The patient should not take Grofibrat S during breastfeeding or if they plan to breastfeed. They should consult their doctor or pharmacist before taking this medication.

Driving and using machines

The medication has no effect on driving or using machines.
Grofibrat S contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medication.
The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free).

3. How to take Grofibrat S

3. How to take Grofibrat S

This medication should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The doctor will determine the appropriate dose based on the patient's condition, current therapy, and personal risk.

Taking the medication

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

How much to take

The recommended dose is one 160 mg tablet of Grofibrat S per day.
However, the doctor may increase the dose to 215 mg per day, i.e., one 215 mg tablet of Grofibrat S (higher dose).
For patients currently taking one capsule containing 267 mg of fenofibrate, the doctor may replace it with one 215 mg tablet of Grofibrat S.

Patients with kidney disease

In case of kidney disease, the doctor may reduce the dose. If in doubt, consult a doctor or pharmacist.

Use in children and adolescents

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

Taking more than the recommended dose of Grofibrat S

In case of taking a higher dose than recommended, or if someone else has taken the medication by mistake, the patient should immediately contact their doctor or go to the emergency room of the nearest hospital.

Missing a dose of Grofibrat S

• In case of missing a dose, the patient should take the next dose with the next meal.
• Take the next tablet at the usual time.
• Do not take a double dose to make up for the missed dose.

In case of doubts, consult a doctor.

Stopping treatment with Grofibrat S

The patient should not stop treatment unless their doctor decides to or if the medication causes discomfort.
Abnormal fat levels in the blood require long-term treatment.
During treatment with Grofibrat S, it is essential to:

• follow a low-fat diet
• engage in regular physical activity. If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

4. Possible side effects

Like all medications, Grofibrat S can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, the patient should stop taking Grofibrat S and contact their doctor immediately – they may need urgent medical treatment:

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

If the patient experiences any of the above symptoms, they should immediately stop taking Grofibrat S and contact their doctor.

Other side effects include:

Common(occurring in less than 1 in 10 patients)

• diarrhea
• abdominal pain
• bloating with gas
• nausea
• vomiting
• increased liver enzyme activity in the blood - as shown 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).

Uncommon(occurring in less than 1 in 100 patients)

• headache
• gallstones
• decreased sex drive
• rash, itching, or hives
• increased creatinine levels (a substance excreted by the kidneys) - as shown by laboratory tests.

Rare(occurring in less than 1 in 1000 patients)

• hair loss
• increased urea levels (a substance excreted by the kidneys) - as shown by laboratory tests
• increased sensitivity of the skin to sunlight, sunlamps, and tanning beds
• decreased hemoglobin levels (a protein that carries oxygen in the blood) and decreased white blood cell count - as shown by laboratory tests.

Side effects with unknown frequency

• chronic pulmonary diseases. If the patient experiences unexpected breathing difficulties, they should immediately contact their doctor
• a severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• feeling tired.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their 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, more information can be collected on the safety of the medication.

5. How to store Grofibrat S

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister.
The expiration date refers to the last day of the specified month.
Do not store above 25°C.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Package contents and other information

Package contents and other information

What Grofibrat S contains

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

What Grofibrat S looks like and package contents

Grofibrat S, 215 mg, film-coated tablets: Oval, biconvex, orange film-coated tablets, approximately 17 mm long and 9 mm wide, with "215" engraved on one side.
30, 60, or 90 tablets packaged in aluminum/PVC/PE/PVDC blisters. The blisters are packaged in a cardboard box with a package leaflet.

Marketing authorization 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 more detailed 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]

Date of last revision of the package leaflet:

((marketing authorization holder's logo))
((pharmacode))