Grofibrat s

Package leaflet: Information for the patient

Grofibrat S, 160 mg, coated tablets
Fenofibrate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further 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 someone else, even if their symptoms are identical.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Grofibrat S is and what it is 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. Contents of the pack and other information

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

Grofibrat S 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.

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 reducing blood fat levels.
In certain cases, Grofibrat S may be used in addition to other medicines (statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin) if blood fat levels cannot be controlled with statins alone.

2. Important information before taking Grofibrat S

When not to take 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 photosensitivity or skin damage during treatment with other medicines (such as other fibrates or the anti-inflammatory drug ketoprofen).
• You have severe liver, kidney, or gallbladder disease.
• You have pancreatitis (a condition causing abdominal pain) not caused by high levels of certain fats in the blood.

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

Warnings and precautions

Before starting Grofibrat S, consult your doctor or pharmacist if:

• You have liver or kidney disease.
• You have hepatitis—symptoms include yellowing of the skin or whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests).
• You have hypothyroidism (reduced thyroid gland activity).
  If any of the above apply (or if you are unsure), consult your doctor or pharmacist before starting treatment with Grofibrat S.

Effect on muscles

Immediately stop taking Grofibrat S and contact your doctor if you experience unexpected muscle cramps, pain, tenderness, or weakness while taking this medicine.

• This medicine may cause muscle disorders, which can be serious.
• These disorders, although rare, 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 have a history of inherited muscle disorders.
• You consume large amounts of alcohol.
• You are taking cholesterol-lowering medicines (statins) such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin.
• You have previously experienced muscle disorders while taking statins or fibrates (such as fenofibrate, bezafibrate, or gemfibrozil).
  If any of the above apply (or if you are unsure), consult your doctor before starting Grofibrat S.

Grofibrat S and other medicines

Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform them if you are taking:

• Anticoagulants used to thin the blood (e.g. warfarin).
• Other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin together with Grofibrat S may increase the risk of muscle damage.
• Medicines from the group used to treat diabetes (such as rosiglitazone, pioglitazone).
• Cyclosporine (an immunosuppressant medicine).
  If any of the above apply (or if you are unsure), consult your doctor or pharmacist before taking Grofibrat S.

Grofibrat S with food, drink, and alcohol

Swallow the tablet whole with a glass of water. It is important to take Grofibrat S during a meal, as the medicine is less effective when taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Inform your doctor if you become pregnant during treatment.
• Do not take Grofibrat S while breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Grofibrat S contains lactose and sodium

If you have been previously diagnosed with 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 prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition, current therapy, and individual risk factors.

Taking the medicine

• Swallow the tablet whole with a glass of water.
• Do not chew the tablet.
• Take the tablet with food—absorption is reduced when taken on an empty stomach.

Dosage

The recommended dose is 1 coated tablet of 160 mg once daily.
Patients previously taking 200 mg fenofibrate capsules (1 capsule daily) may switch directly to 1 tablet of 160 mg daily without dose adjustment.

Patients with kidney impairment

Your doctor may reduce the dose in patients with kidney impairment. Consult your doctor or pharmacist if you have such conditions.
Grofibrat S is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).

Elderly patients

For elderly patients without kidney impairment, the recommended dose is the same as for adults.

Patients with liver impairment

Grofibrat S is not recommended in patients with liver impairment due to lack of clinical data in this group.

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

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

Missed dose

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

Stopping treatment

Do not stop taking Grofibrat S without consulting your doctor, unless the medicine causes severe discomfort. High cholesterol levels require long-term treatment.
Remember that in addition to taking Grofibrat S, it is equally important to:

• Follow a low-fat diet.
• Engage in regular physical exercise.

If you stop treatment and your doctor does not advise otherwise, do not keep unused tablets. For any further questions regarding 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 will experience them.

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

Uncommon: may affect up to 1 in 100 patients

• Muscle cramps or pain, muscle tenderness or weakness—these may be symptoms of myositis or rhabdomyolysis, 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 pulmonary embolism (blood clots in the lungs).
• Pain, redness, and swelling in the legs—may be symptoms of deep vein thrombosis (blood clots in the legs).

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

• Allergic reaction, symptoms may include swelling of the face, lips, tongue, or throat, possibly causing breathing difficulties.
• Yellowing of the skin or whites of the eyes (jaundice) or increased liver enzymes—may be symptoms of hepatitis.

Frequency not known: frequency cannot be estimated from available data

• Severe skin rash with redness, peeling, and swelling resembling severe burns.
• Chronic lung disease.

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

Other side effects include:

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

Common: may affect up to 1 in 10 patients

• Diarrhea.
• Abdominal pain.
• Bloating with flatulence.
• Nausea.
• Vomiting.
• Increased liver enzyme activity in blood—detected in laboratory tests.
• Increased blood homocysteine levels (elevated levels of this amino acid are associated with increased 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 patients

• Headache.
• Gallstones.
• Decreased libido.
• Rash, itching, or urticaria.
• Increased renal creatinine levels—detected in laboratory tests.

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

• Hair loss.
• Increased renal urea levels—detected in laboratory tests.
• Increased skin sensitivity to sunlight, sunlamps, or tanning beds.
• Decreased hemoglobin levels (the oxygen-carrying pigment in blood) and reduced white blood cell count—detected in laboratory tests.

Frequency not known: frequency cannot be estimated from available data

• Rhabdomyolysis (muscle breakdown).
• Complications related to gallstones.
• Feeling of fatigue.

Reporting of side effects

If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects 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 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects 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 Grofibrat S

[Note: The original text ends abruptly here. The section likely continues with storage instructions such as "Keep this medicine out of the sight and reach of children," "Do not use after the expiry date," "Store below 25°C," etc., but these details are missing in the provided input.]

5. How to store Grofibrat S

Keep this medicine out of 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. Such measures help 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 160 mg coated tablet contains 160 mg of the active substance.
The other ingredients of Grofibrat S 160 mg coated tablets are:
Povidone, sodium lauryl sulfate, monohydrate lactose, sodium croscarmellose, microcrystalline cellulose, polyethylene glycol 6000, colloidal anhydrous silica, sodium stearyl fumarate.
Coating (Opadry 200 SERIES YELLOW 200F220002): polyvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), polyethylene glycol (E 1521), copolymer of methacrylic acid and ethyl acrylate (1:1), riboflavin (E 101 i), sodium bicarbonate (E 500 ii).
What Grofibrat S looks like and contents of the pack
Grofibrat S 160 mg coated tablets: Yellow, oval, biconvex coated tablets, approximately 15 mm in length and 9 mm in width, with the imprint “160” 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, 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]
((logo of the marketing authorisation holder))
((pharmacode))