Grofibrat 200

Package leaflet: Information for the patient

Grofibrat 200, 200 mg, hard capsules
Fenofibrate
Please read this leaflet carefully before taking this medicine because it
contains important information for you.

• Keep this leaflet for future reference.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Grofibrat 200 belongs to a group of medicines known as fibrates. These medicines are used to lower the levels of fats (lipids) in the blood, such as triglycerides.
Grofibrat 200 is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at reducing blood fat levels.
In certain cases, Grofibrat 200 may be used in addition to other medicines (statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin) when blood fat levels cannot be controlled by statins alone.

2. Important information before using Grofibrat 200

When not to use 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 previously experienced photosensitivity or skin damage during treatment with other medicines (such as other fibrates or the anti-inflammatory drug ketoprofen),
• if the patient has severe kidney, liver disease or gallbladder disease,
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of certain types of blood lipids.

Do not take Grofibrat 200 if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking Grofibrat 200.

Warnings and precautions

Before starting treatment with Grofibrat 200, consult a doctor or pharmacist if:

• the patient has liver or kidney disease;
• the patient has hepatitis: symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests);
• the patient has hypothyroidism (reduced thyroid gland activity).

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

Effect on muscles

Immediately discontinue taking Grofibrat 200 and contact a doctor if unexpected muscle cramps, pain, tenderness or weakness occur during treatment.

• This medicine may cause muscle disorders, which can be serious.
• These disorders are rare but include myositis (inflammation of the muscles) and rhabdomyolysis (muscle breakdown). This may lead to kidney damage or even death. The doctor may order blood tests to monitor muscle status before and during treatment.

The risk of muscle breakdown may be higher in certain patients. Inform the doctor if:

• the patient is over 70 years old,
• the patient has kidney disease,
• the patient has thyroid disease,
• the patient drinks large amounts of alcohol,
• the patient or a family member has a history of hereditary muscle disorders,
• the patient is taking cholesterol-lowering medicines known as statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin,
• the patient has previously experienced muscle disorders while taking statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil.

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

Grofibrat 200 and other medicines

Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. Especially inform the doctor if the patient is taking:

• anticoagulant medicines used to thin the blood (e.g. warfarin),
• other medicines used to control blood lipid levels (such as statins or fibrates). Taking a statin together with Grofibrat 200 may increase the risk of muscle damage,
• medicines used in the treatment of diabetes (such as rosiglitazone or pioglitazone),
• cyclosporine (an immunosuppressive medicine).

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

Grofibrat 200 with food and drink

It is important to take this medicine during a meal, as it will be less effective if taken on an empty stomach.

Pregnancy and breastfeeding

If the patient is pregnant, suspects she may be pregnant, plans to become pregnant, or is breastfeeding, she should consult a doctor or pharmacist before using this medicine.

• Do not take Grofibrat 200 and inform the doctor if pregnant, suspecting pregnancy, or planning pregnancy.
• Do not take Grofibrat 200 during breastfeeding or if planning to breastfeed. Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery

Grofibrat 200 has no influence on the ability to drive or operate machinery.

Grofibrat 200 contains lactose and sodium

If the patient has previously been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.

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

3. How to take Grofibrat 200

This medicine should always be taken exactly as directed 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 capsule whole with a glass of water.
• Do not open or chew the capsule.
• Take the capsule with a meal – absorption is reduced when taken on an empty stomach.

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

Patients with renal impairment
Your doctor may reduce the dose in patients with renal impairment. If you have such
conditions, consult your doctor or pharmacist. Grofibrat 200 is contraindicated in patients
with severe renal impairment (creatinine clearance < 20 ml/min).

Elderly patients
For elderly patients without renal impairment, the recommended adult dose applies.

Patients with hepatic impairment
Grofibrat 200 is not recommended in patients with hepatic impairment due to lack of
clinical data in this patient group.

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

Taking more Grofibrat 200 than recommended
If you take more than the recommended dose, or if someone else accidentally takes the
medicine, contact your doctor or the nearest hospital emergency department immediately.

Missed dose of Grofibrat 200

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

If in doubt, consult your doctor.

Stopping treatment with Grofibrat 200
Do not stop treatment without consulting your doctor, unless the medicine causes
unpleasant symptoms. Elevated cholesterol levels require long-term treatment.

Remember that in addition to taking Grofibrat 200, the following are equally important:

• following a diet low in fat,
• regularly performing physical exercise.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not
occur in everyone.
If any of the following serious adverse reactions occur, stop taking Grofibrat 200 and
contact your doctor immediately – prompt treatment may be necessary:
Uncommon: may affect up to 1 in 100 patients

• muscle cramps or muscle pain, tenderness or weakness – these may be symptoms of inflammation of the muscles or muscle breakdown, which may lead to kidney damage or even death,
• abdominal pain – these may be symptoms of inflammation of the pancreas,
• 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 1000 patients

• allergic reaction, symptoms may include swelling of the face, lips, tongue or throat, which may cause difficulty in breathing,
• yellowing of the skin and whites of the eyes (jaundice) or increased liver enzymes – these may be symptoms of liver inflammation.

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 any of the above adverse symptoms occur, stop taking Grofibrat 200 immediately and
contact your doctor.
Other adverse reactions
If any of the following adverse reactions occur, contact your doctor or pharmacist:
Common: may affect up to 1 in 10 patients

Uncommon: may occur in up to 1 in 100 patients

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

• muscle breakdown,
• complications associated with gallstones,
• feeling of fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions enables continuous monitoring of the safety of the medicinal product.

5. How to store Grofibrat 200

Keep this medicine out of 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 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.
This will help protect the environment.

6. Contents of the packaging and other information

What Grofibrat 200 contains
The active substance is micronized fenofibrate.
Other components: monohydrate lactose, pregelatinized corn starch, micronized crospovidone, magnesium stearate, sodium lauryl sulfate, red iron oxide, yellow iron oxide, titanium dioxide, gelatin.

What Grofibrat 200 looks like and contents of the pack
Grofibrat 200 is available as light orange capsules.
Pack contains 30 capsules.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
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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