Grofibrate

Package leaflet: Information for the patient

Grofibrat, 100 mg hard capsules
Fenofibrate
Please read the entire leaflet carefully before using the medicine, because
it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Grofibrat is and what it is used for

Grofibrat belongs to a group of medicines generally known as fibrates. These medicines are used to lower blood fat (lipid) levels. An example of such fats are triglycerides.
Grofibrat is used in combination with a low-fat diet and other non-medical treatment methods, such as physical exercise and weight loss, aimed at lowering blood fat levels.
In certain cases, Grofibrat may be used as an add-on 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

When not to use Grofibrat

• 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 liver, kidney or gallbladder disease;
• if the patient has pancreatitis (a condition causing abdominal pain) not caused by high levels of certain types of fats in the blood.

Grofibrat must not be taken if any of the above apply to the patient. If in doubt, consult a doctor or pharmacist before taking Grofibrat.

• there is hypothyroidism (reduced activity of the thyroid gland). If any of the above warnings apply to the patient (or in case of doubt), consult a doctor or pharmacist before starting treatment with Grofibrat.

Effect on muscles
Treatment must be stopped immediately and a doctor should be contacted if unexpected muscle cramps, pain, tenderness, or muscle weakness occur during treatment with Grofibrat.

• This medicine may cause muscle disorders, which can be severe.
• These disorders are rare, but include inflammation of the muscles and muscle breakdown. This may lead to kidney damage or even death. The doctor may order blood tests to check 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,
• kidney disease is present,
• thyroid disease is present,
• the patient drinks large amounts of alcohol,
• the patient or a family member has had inherited muscle disorders,
• the patient is taking cholesterol-lowering medicines called 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 warnings apply to the patient (or in case of doubt), consult a doctor or pharmacist before starting treatment with Grofibrat.

Grofibrat and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

• anticoagulants 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 may increase the risk of muscle damage,
• a medicine belonging to the class of drugs used in diabetes treatment (such as rosiglitazone or pioglitazone),
• cyclosporine (an immunosuppressive medicine).

Grofibrat with food and drink
It is important to take the medicine during a meal, as the medicine will be less effective if taken on an empty stomach.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

• Do not take Grofibrat and inform the doctor if pregnant, suspect pregnancy, or plan to become pregnant.
• Do not take Grofibrat during breastfeeding.

Consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Grofibrat has no effect on the ability to drive or operate machinery.
Grofibrat contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Grofibrat

This medicine should always be taken 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
treatment, 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 medicine during a meal, as absorption on an empty stomach is reduced.

Adults:
The recommended dose is 3 capsules per day taken with the main meal, either as a single dose or divided into several doses.
If cholesterol levels remain above 4 g/l despite dietary measures, the initial dose may be 4 capsules per day.
The initial dose should be maintained until serum cholesterol levels normalize. Once cholesterol levels are stable, your doctor may recommend reducing the dose to 2 capsules per day, provided that cholesterol levels are monitored every three months.
If lipid levels rise again, your doctor will advise returning to the dose of 3 capsules per day.
Patients with renal impairment
In patients with renal impairment, the doctor will reduce the dose. In such cases, consult your doctor or pharmacist. Grofibrat is contraindicated in patients with severe renal impairment (creatinine clearance < 20 ml/min).
Elderly patients
In elderly patients without renal impairment, the recommended dose is the same as for adults.
Patients with hepatic impairment
Grofibrat is not recommended in patients with hepatic impairment due to lack of clinical data in this patient group.
Use in children and adolescents:
Grofibrat is not recommended for use in children and adolescents under 18 years of age.
Taking more Grofibrat than recommended
If you take more than the recommended dose or if the medicine is accidentally taken by someone else, contact your doctor or the emergency department of your nearest hospital immediately.
Missing a dose of Grofibrat

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

Stopping Grofibrat
Do not stop treatment without consulting your doctor, unless the medicine causes adverse effects. Elevated cholesterol levels require long-term treatment. Remember that in addition to taking Grofibrat, the following are equally important:

• following a diet low in fat,
• regular physical exercise.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any of the following serious adverse effects occur, stop taking Grofibrat immediately and contact your doctor straight away – 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 or breakdown of muscles, which could lead to 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 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-mentioned adverse effects occur, stop taking Grofibrat immediately and contact your doctor without delay.
Other adverse effects
If any of the following adverse effects occur, contact your doctor or pharmacist:
Common: may affect up to 1 in 10 patients

• Diarrhoea
• Abdominal pain
• Bloating with passing of wind
• Nausea
• Vomiting
• Increased liver enzyme activity in blood – detected in laboratory tests
• Increased blood homocysteine levels (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 yet been established).

Uncommon: may affect up to 1 in 100 patients

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

Rare: may affect up to 1 in 1000 patients

• Hair loss, alopecia
• Increased urea excretion by the kidneys – detected in laboratory tests
• Increased sensitivity of the skin to sunlight, sunbed lamps and tanning beds
• Decreased haemoglobin concentration (the pigment carrying oxygen in the 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 effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Grofibrat

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.
Such measures will help protect the environment.

6. Contents of the packaging and other information

What Grofibrat contains
The active substance is fenofibrate.
The other ingredients are: lactose monohydrate, maize starch, magnesium stearate, titanium dioxide, gelatin.

What Grofibrat looks like and contents of the pack
Grofibrat is available as white capsules.
The pack contains 50 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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