Grofibrat 200

Leaflet accompanying the packaging: Patient information

Grofibrat 200, 200 mg, hard capsules

Fenofibrate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 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 200 and what is it used for
• 2. Important information before taking Grofibrat 200
• 3. How to take Grofibrat 200
• 4. Possible side effects
• 5. How to store Grofibrat 200
• 6. Contents of the pack and other information

1. What is Grofibrat 200 and what is it used for

Grofibrat 200 belongs to a group of medicines known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. Examples of such fats are triglycerides.
Grofibrat 200 is used in combination with a low-fat diet and other non-drug treatments, such as physical exercise and weight loss, to lower the level of fats in the blood.
In some cases, Grofibrat 200 may be used in addition to other medicines (statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin), if the level of fats in the blood cannot be controlled with statins alone.

2. Important information before taking Grofibrat 200

When not to take Grofibrat 200

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had an allergic reaction to sunlight or UV radiation, or skin damage (with medicines such as other fibrates or the anti-inflammatory medicine ketoprofen),
• if the patient has severe kidney, liver, or gallbladder disease,
• if the patient has pancreatitis (a disease that causes abdominal pain), which is not caused by high levels of a certain type of fat in the blood.

Do not take Grofibrat 200 if any of the above applies to you. In case of doubt, consult a doctor or pharmacist before taking Grofibrat 200.

Warnings and precautions

Before starting treatment with Grofibrat 200, 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 the above warnings apply to you (or in case of doubt), consult a doctor or pharmacist before starting treatment with Grofibrat 200.
• 200.

Muscle effects

Stop taking the medicine immediately and consult a doctor if you experience unexpected muscle cramps or pain, muscle tenderness, or muscle weakness while taking Grofibrat 200.

• This medicine may cause muscle disorders, which can be severe.
• These disorders are rare but include muscle inflammation and breakdown. This can cause kidney damage or even death. Your doctor may order a blood test to check the condition of your muscles 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 drink large amounts of alcohol,
• you or a family member have had hereditary muscle disorders,
• 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 the above warnings apply to you (or in case of doubt), consult a doctor or pharmacist before starting treatment with Grofibrat 200.

Grofibrat 200 and other medicines

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

• blood thinners (e.g., warfarin),
• other medicines used to control the level of fats in the blood (such as statins or fibrates). Taking a statin at the same time as Grofibrat 200 may increase the risk of muscle damage.
• medicines used to treat diabetes (such as rosiglitazone or pioglitazone),
• cyclosporine (an immunosuppressive medicine).

If any of the above warnings apply to you (or in case of doubt), consult a doctor or pharmacist before starting treatment with Grofibrat 200.

• 200.

Grofibrat 200 with food and drink

It is important to take the medicine with a meal, as its absorption will be reduced if taken on an empty stomach.

Pregnancy and breastfeeding

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

• Do not take Grofibrat 200 and inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
• Do not take Grofibrat 200 during breastfeeding and if you plan to breastfeed. Consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Grofibrat 200 has no effect on driving or using machines.

Grofibrat 200 contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Grofibrat 200

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of the medicine based on your condition, current treatment, and personal risk.

Taking the medicine

• Swallow the capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with a meal - absorption of the medicine is reduced when taken on an empty stomach.

How much to take

The recommended daily dose is 1 capsule of 200 mg once a day.

Patients with kidney failure

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

Elderly patients

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

Patients with liver failure

In patients with liver failure, Grofibrat 200 is not recommended due to the lack of clinical data for this group.

Children and adolescents

Grofibrat 200 is not recommended for children and adolescents under 18 years of age.

Taking a higher dose of Grofibrat 200 than recommended

If you have taken more than the recommended dose, or if someone else has taken your medicine, contact a doctor or the emergency department of your nearest hospital immediately.

Missing a dose of Grofibrat 200

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

In case of doubt, consult your doctor.

Stopping treatment with Grofibrat 200

Do not stop treatment without consulting your doctor, unless the medicine is causing you harm. High cholesterol must be treated for a long time.
Remember that, in addition to taking Grofibrat 200, it is also important to:

• follow a low-fat diet,
• perform regular physical exercise. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Grofibrat 200 can cause side effects, although not everybody gets them.

In case of any of the following serious side effects, stop taking Grofibrat 200 and contact your doctor immediately - you may need urgent medical attention:

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 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 from the available data

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

If you experience any of the above side effects, stop taking Grofibrat 200 and contact your doctor immediately.

Other side effects

If you experience any of the following side effects, contact your doctor or pharmacist:
Common:may affect up to 1 in 10 people
Uncommon:may affect up to 1 in 100 people

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

• muscle breakdown,
• complications related to gallstones,
• fatigue.

Reporting side effects

If you experience any side effects, including any 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Grofibrat 200

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
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

What Grofibrat 200 contains

The active substance is micronized fenofibrate.
Other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, crospovidone, magnesium stearate, sodium lauryl sulfate, iron oxide red, iron oxide yellow, titanium dioxide, gelatin.

What Grofibrat 200 looks like and contents of the pack

Grofibrat 200 is produced in the form of light orange capsules.
The pack contains 30 capsules.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o. o.
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
Poland
phone: +48 (22) 755 50 81
To obtain more detailed information, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
Poniatowskiego 5 Street
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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