Grofibrat S

Leaflet attached to the packaging: patient information

Grofibrat S, 160 mg, coated tablets

Fenofibrate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 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. Contents of the pack and other information

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

What is it used for
Grofibrat S belongs to a group of medicines commonly known as fibrates. These medicines 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-drug treatments, such as physical exercise and weight loss, to lower blood fat levels.
In some 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

Important information before taking the medicine

When not to take Grofibrat S

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

Warnings and precautions

Before starting to take Grofibrat S, discuss it with your doctor or pharmacist if:

• you have liver or kidney disease
• you have hepatitis - symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• you have hypothyroidism (reduced thyroid activity). If any of these situations apply to you (or if you are in doubt), consult your doctor or pharmacist before starting to take Grofibrat S.

Muscle effects

Stop taking Grofibrat S immediately and consult your doctor if you experience unexpected muscle cramps or pain, muscle tenderness, or muscle weakness while taking this medicine.

• This medicine may cause muscle disorders, which can be severe.
• These disorders are rare but include muscle inflammation and muscle breakdown. This can cause kidney damage or even death. Your doctor may order a blood test to check your muscle condition before and after starting treatment.

The risk of muscle breakdown may be higher in some 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 had hereditary muscle disorders
• you drink large amounts of alcohol
• you are taking cholesterol-lowering medicines called statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin
• you have had muscle disorders while taking statins or fibrates, such as fenofibrate, bezafibrate, or gemfibrozil. If any of these warnings apply to you (or if you are in doubt), consult your doctor before starting to take Grofibrat S.

Grofibrat S and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Especially, inform your doctor or pharmacist if you are taking medicines such as:

• blood-thinning medicines (e.g., warfarin)
• other medicines used to control blood fat levels (such as statins or fibrates). Taking a statin at the same time as Grofibrat S may increase the risk of muscle damage.
• medicines used to treat diabetes (such as rosiglitazone or pioglitazone)
• cyclosporine (an immunosuppressant). If any of these warnings apply to you (or if you are in doubt), consult your doctor or pharmacist before starting to take Grofibrat S.

Grofibrat S with food, drink, and alcohol

Swallow the tablet whole and drink a glass of water. It is important to take Grofibrat S with food, as the medicine will work less well if taken on an empty stomach.

Pregnancy, breastfeeding, and fertility

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

• Do not take Grofibrat S. Inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy.
• Do not take Grofibrat S during breastfeeding. Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Grofibrat S has no effect on driving or using machines.
Grofibrat S contains lactose and sodium.
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Grofibrat S

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
Your doctor will determine the correct dose of the medicine, depending on your condition, current therapy, and personal risk.

Taking the medicine

• Swallow the tablet whole and drink a glass of water.
• Do not chew the tablets.
• Take the tablet with food - absorption of the medicine is worse on an empty stomach.

How much to take

The recommended dose is one 160 mg coated tablet per day.
Patients who are taking capsules containing 200 mg of fenofibrate (one capsule per day) can start taking one 160 mg tablet per day without modifying the dosage.

Patients with kidney problems

In patients with kidney problems, the doctor may reduce the dose. If you have such disorders, consult your doctor or pharmacist. In patients with severe kidney problems (creatinine clearance <20 ml min), the medicine is contraindicated.< p>

Patients over 65 years old

In elderly patients without kidney problems, the recommended dose is the same as for adults.

Patients with liver problems

In patients with liver problems, Grofibrat S is not recommended due to the lack of clinical data for this group.

Use in children and adolescents

The use of Grofibrat S is not recommended in children and adolescents under 18 years old.

Taking more than the recommended dose of Grofibrat S

In case of taking a higher dose of Grofibrat S than recommended, or accidental ingestion by another person, consult your doctor or the emergency department of the nearest hospital immediately.

Missing a dose of Grofibrat S

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

Stopping treatment with Grofibrat S

Do not stop treatment without consulting your doctor, unless the medicine is causing you harm. Elevated cholesterol levels must be treated long-term.
Remember that, in addition to taking Grofibrat S, it is also important to:

• follow a low-fat diet,
• perform regular physical exercise.

If you stop taking the medicine, unless your doctor decides otherwise, do not store unused tablets. If you have any further doubts about using 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.

In case of any of the following serious side effects, stop taking Grofibrat S and consult your doctor immediately - you may need urgent medical treatment:

Uncommon:may affect up to 1 in 100 people

• muscle cramps or pain, muscle tenderness, or muscle weakness - these may be symptoms of muscle inflammation or muscle 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).

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

• 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 hepatitis.

Frequency not known:frequency cannot be estimated

• severe skin rash with redness, peeling, and swelling of the skin, resembling severe burns
• chronic lung disease.

If you experience any of the above symptoms, stop taking Grofibrat S and consult your doctor immediately.

Other side effects include:

If you experience any of the following side effects, consult your doctor or pharmacist:
Common:may affect up to 1 in 10 people

• diarrhea,
• abdominal pain,
• bloating with gas,
• nausea,
• vomiting,
• increased liver enzyme activity in the blood - confirmed 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:may affect up to 1 in 100 people

• headache,
• gallstones,
• decreased sex drive,
• rash, itching, or hives,
• increased creatinine levels in the blood - confirmed by laboratory tests.

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

• hair loss,
• increased urea levels in the blood - confirmed by laboratory tests,
• increased sensitivity of the skin to sunlight, sunlamps, and sunbeds,
• decreased hemoglobin levels (the protein that carries oxygen in the blood) and decreased white blood cell count - confirmed by laboratory tests.

Frequency not known:frequency cannot be estimated

• muscle breakdown,
• complications related to gallstones,
• feeling tired.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Grofibrat S

Keep the 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 month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 of the medicine 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, lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, macrogol 6000, colloidal anhydrous silica, sodium stearyl fumarate.
Coating (Opadry 200 SERIES YELLOW 200F220002): polyvinyl alcohol (E 1203), talc (E 553b), titanium dioxide (E 171), macrogol (E 1521), methacrylic acid, and ethyl acrylate copolymer (1:1), riboflavin (E 101), sodium bicarbonate (E 500 ii).

What Grofibrat S looks like and contents of the pack

Grofibrat S 160 mg coated tablets: Oval, biconvex, yellow coated tablets, approximately 15 mm long and 9 mm wide, with "160" embossed 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 leaflet.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o. o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
phone: +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
Phone: +48 (22) 755 96 48
[email protected]

Date of last revision of the leaflet:

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