Grofibrat m

Patient Information Leaflet

Grofibrat M, 267 mg, hard capsules
Fenofibrate
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Grofibrat M is and what it is used for
2. Important information before taking Grofibrat M
3. How to take Grofibrat M
4. Possible side effects
5. How to store Grofibrat M
6. Contents of the pack and other information

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

Grofibrat M 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 M 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.

2. Important information before taking Grofibrat M

When not to take Grofibrat M

• if the patient is allergic to fenofibrate or any of the other ingredients of this medicine (listed in section 6)
• if in the past, during treatment with other medicines, the patient has experienced photosensitivity or UV sensitivity or skin damage (such medicines include other fibrates or the anti-inflammatory drug ketoprofen)
• if the patient has severe liver, kidney or gallbladder disease
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of blood lipids.

Do not take Grofibrat M if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Grofibrat M.
Warnings and precautions
Talk to a doctor or pharmacist before taking Grofibrat M if:

• liver or kidney disorders are present
• hepatitis occurs: symptoms include yellowing of the skin and whites of the eyes (jaundice) and increased liver enzyme activity (confirmed by laboratory tests)
• hypothyroidism (reduced activity of the thyroid gland) is present. If any of the above warnings apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Grofibrat M.

Effect on muscles
Immediately stop taking the medicine and contact a doctor if unexpected muscle cramps, pain, tenderness or weakness occur during treatment with Grofibrat M.

• The medicine may cause muscle disorders, which can be serious.
• These disorders are rare but include myositis and rhabdomyolysis. This may lead to kidney damage or even death. The doctor may order blood tests to check muscle status before and after starting treatment.

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

• the patient is over 70 years old
• kidney disease is present
• thyroid disease is present
• 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 called statins such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin
• there has been a history of muscle disorders during treatment with statins or fibrates such as fenofibrate, bezafibrate or gemfibrozil.

If any of the above warnings apply (or if in doubt), consult a doctor or pharmacist before starting treatment with Grofibrat M.
Grofibrat M and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor or pharmacist 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 M may increase the risk of muscle damage.
• medicines used in the treatment of diabetes (such as rosiglitazone, 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 M.

Grofibrat M with food, drink and alcohol
It is important to take the medicine during a meal, as it will be less effective if taken on an empty stomach.
Pregnancy, breastfeeding and fertility

• Do not take Grofibrat M and inform the doctor if the patient is pregnant, suspects pregnancy or plans to become pregnant.
• Do not take Grofibrat M during breastfeeding. Consult a doctor or pharmacist before using this medicine.

Driving and using machines
Grofibrat M has no influence on the ability to drive or operate machinery.
Grofibrat M contains lactose and sodium.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Grofibrat M

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose based on your condition, current treatment, and individual risk factors.

How to take 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 poorer when taken on an empty stomach.

Dosage
The recommended daily dose is 1 capsule of 200 mg once daily.
Your doctor may increase the dose to 1 capsule of 267 mg once daily.

Patients with renal impairment
In patients with renal impairment, your doctor may reduce the dose. Consult your doctor or pharmacist if such conditions exist. Grofibrat M is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).

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

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

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

Accidental overdose of Grofibrat M
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 M

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

If you have any doubts, consult your doctor.
Stopping treatment with Grofibrat M
Do not stop treatment without consulting your doctor, unless the medicine causes you to feel unwell. Elevated cholesterol levels require long-term treatment.
Remember that in addition to taking Grofibrat M, it is equally important to:

• follow a diet low in fat,
• engage in regular 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,
discontinue treatment with Grofibrat M immediately and contact your doctor
without delay; prompt medical treatment may be necessary:

Uncommon: may occur in up to 1 in 100 patients

• Muscle cramps or muscle pain, tenderness or weakness – these may be symptoms of inflammation or breakdown of muscles, which may lead to kidney damage or even death;
• Abdominal pain – may be symptoms of pancreatitis;
• Chest pain and shortness of breath – may be symptoms of blood clots in the lungs (pulmonary embolism);
• Pain, redness and swelling in the legs – may be symptoms of blood clots in the legs (deep vein thrombosis).

Rare: may occur in 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 – 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 symptoms listed above occur, stop taking Grofibrat M immediately and contact your doctor without delay.

Other adverse reactions:
If any of the following occur, contact your doctor or pharmacist:

Common: may occur in 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 – detected in laboratory tests (elevated levels of this amino acid in blood are associated with increased risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established).

Uncommon: may occur in up to 1 in 100 patients

• Headache;
• Gallstones;
• Decreased libido;
• Rash, itching or urticaria;
• Increased creatinine excretion by the kidneys – detected in laboratory tests.

Rare: may occur in up to 1 in 1000 patients

• Hair loss;
• Increased urea excretion by the kidneys – detected in laboratory tests;
• Increased skin sensitivity to sunlight, sunlamps and tanning beds;
• Decreased haemoglobin concentration (oxygen-carrying pigment in blood) and decreased white blood cell count – detected in laboratory tests.

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

• Muscle breakdown;
• Complications related to gallstones;
• Feeling of fatigue.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Grofibrat M

Keep this 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 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 pack and other information

What Grofibrat M contains
The active substance is 267 mg of micronized fenofibrate.
Other ingredients: monohydrate lactose, corn starch gelatinized, crospovidone (type B),
magnesium stearate, sodium lauryl sulfate.
Composition of the gelatin capsule shell: body: titanium dioxide (E 171), gelatin; cap: titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), gelatin.
What Grofibrat M looks like and contents of the pack
The medicine is in the form of elongated hard capsules, size no. 0, colour: cap – orange, body – white.
Available pack sizes: 30, 60 or 90 capsules packed in aluminium/PVC transparent blisters, in a cardboard box.
Not all pack sizes may be marketed.
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, 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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