Grofibrat

Package Leaflet: Information for the Patient

Grofibrat, 100 mg, Hard Capsules

Fenofibrate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Grofibrat 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 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.
Grofibrat may be used in some cases as an addition to other medicines (statins, such as simvastatin, atorvastatin, pravastatin, rosuvastatin, or fluvastatin), if the level of fats in the blood cannot be controlled by using statins alone.

2. Important information before taking Grofibrat

When not to take Grofibrat

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

Muscle effects

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

• 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 the condition of your muscles before and after starting treatment.

The risk of muscle breakdown may be higher in some patients. Tell 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 if in doubt), consult your doctor or pharmacist before taking Grofibrat.

Grofibrat and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Especially, tell 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 may increase the risk of muscle damage,
• a medicine used to treat diabetes (such as rosiglitazone or pioglitazone),
• cyclosporine (an immunosuppressant medicine).

Grofibrat with food and drink

It is important to take the medicine with a meal, as the absorption of the medicine is reduced when 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 your doctor or pharmacist before taking this medicine.

• Do not take Grofibrat and inform your doctor of pregnancy, suspected pregnancy, or planned pregnancy.
• Do not take Grofibrat during breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Grofibrat has no effect on driving or using machines.
Grofibrat contains lactose.If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Grofibrat

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

Taking the medicine

• Swallow whole with a glass of water.
• Do not open or chew the capsule.
• The medicine should be taken during a meal, as absorption on an empty stomach is reduced.

Adults:
The recommended dose is 3 capsules per day during the main meal, in one or several divided doses.
If the cholesterol level remains above 4g/l despite diet, the initial dose may be 4 capsules per day.
The initial dose should be used until the cholesterol level is normalized. Once the cholesterol level is stable, your doctor may recommend a dose of 2 capsules per day, provided that the cholesterol level is checked every three months.
If the lipid level increases again, your doctor will recommend returning to a dose of 3 capsules per day.

Patients with kidney impairment

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

Elderly patients

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

Patients with liver impairment

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

Use in children and adolescents:

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

Taking a higher dose of Grofibrat than recommended

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

Missing a dose of Grofibrat

• 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

Do not stop treatment without consulting your doctor, unless the medicine causes you to feel unwell. High cholesterol must be treated in the long term. Remember that, in addition to taking Grofibrat, it is also important to:

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

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Grofibrat and contact 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 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 you experience any of the above side effects, stop taking Grofibrat 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

• diarrhea,
• abdominal pain,
• bloating with gas,
• nausea,
• vomiting,
• increased liver enzyme activity in the blood - confirmed by laboratory tests,
• increased homocysteine level in the blood (high 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 level in the blood - confirmed by laboratory tests,

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

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

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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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

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 contains

The active substance is fenofibrate.
The other ingredients are: lactose monohydrate, corn starch, magnesium stearate, titanium dioxide, gelatin.

What Grofibrat looks like and contents of the pack

Grofibrat is available in the form of white capsules.
The pack contains 50 capsules.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o. o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
phone: +48 (22) 755 50 81
For more information, 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
lekalert@grodzisk.rgnet.org

Date of last revision of the leaflet:

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