Grumabix

Leaflet accompanying the packaging: patient information

GRUMABIX, 250 mg, film-coated tablets

GRUMABIX, 500 mg, film-coated tablets

Abiraterone acetate

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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is GRUMABIX and what is it used for

Grumabix is a medicine that contains abiraterone acetate. It is used in adult men for the treatment of prostate cancer that has spread to other parts of the body. Grumabix inhibits the production of testosterone in the body; this can slow down the development of prostate cancer.
When Grumabix is used at an early stage of the disease that responds to hormonal therapy, it is given together with therapy that reduces testosterone levels (androgen suppression therapy).
During treatment with this medicine, the doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention, or low potassium levels in the blood.

2. Important information before taking GRUMABIX

When not to take Grumabix:

• if the patient is allergic to abiraterone or any of the other ingredients of the medicine (listed in section 6);
• in women, especially during pregnancy. Grumabix is used only in men;
• if the patient has severe liver damage;
• in combination with the medicine Ra-223 (used in the treatment of prostate cancer).

Do not take this medicine if any of the above situations apply to the patient. In case of doubts, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss it with a doctor or pharmacist:

• if the patient has liver problems;
• if the patient has high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of heart rhythm disorders);
• if the patient has had other heart or blood vessel diseases;
• if the patient has an irregular or rapid heart rhythm;
• if the patient has shortness of breath;
• if the patient's body weight has increased in a short time;
• if the patient has swelling of the feet, ankles, or legs;
• if the patient has taken the medicine ketokonazole in the past for the treatment of prostate cancer;
• the need to take this medicine with prednisone or prednisolone;
• the possibility of side effects related to bones;
• if the patient has high blood sugar levels.

Tell the doctor if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmia), or is taking medicines for these conditions.
Tell the doctor if the patient has yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be symptoms of liver function disorders. Rarely, acute liver failure may occur, which can be life-threatening.
There may be a decrease in the number of red blood cells, decreased libido, muscle weakness, and (or) muscle pain.
Grumabix should not be given in combination with Ra-223 due to the possible increased risk of bone fractures or death.
If the patient intends to take Ra-223 after treatment with Grumabix and prednisone/prednisolone, they should wait 5 days before starting Ra-223 treatment.
In case of doubts whether any of the above situations apply to the patient, consult a doctor or pharmacist before taking this medicine.

Blood tests

Grumabix may affect liver function, and the patient may not have any symptoms.
During treatment with the medicine, the doctor will periodically order blood tests to check the effect of the medicine on the liver.

Children and adolescents

This medicine is not used in children and adolescents. If Grumabix is accidentally swallowed by a child, go to the hospital immediately, taking the patient information leaflet to show the doctor in the emergency room.

Grumabix and other medicines

Before taking any medicine, consult a doctor or pharmacist.
Tell the 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. This is important because Grumabix may enhance the effect of many medicines, including heart medicines, sedatives, some antidiabetic medicines, herbal medicines (e.g., St. John's wort), and others. The doctor may change the doses of these medicines. Other medicines may also increase or decrease the effect of Grumabix. This may result in side effects or inadequate effect of Grumabix.
Androgen suppression may increase the risk of heart rhythm disorders. Tell the doctor if the patient is taking medicines:

• used to treat heart rhythm disorders (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of heart rhythm disorders [e.g., methadone (pain reliever and used to treat addiction), moxifloxacin (antibiotic), antipsychotic medicines (used to treat severe mental disorders)].

Tell the doctor if the patient is taking any of the above medicines.

Taking Grumabix with food

• The medicine should not be taken with food (see section 3, "How to take Grumabix").
• Taking Grumabix with food may cause side effects.

Pregnancy, breastfeeding, and fertility

Grumabix is not used in women.

• The medicine may harm an unborn child if taken by a pregnant woman.
• Women who are pregnant or may become pregnant should use protective gloves when handling Grumabix.
• If the patient has sexual intercourse with a woman who may become pregnant, a condom or other effective contraceptive method should be used.
• If the patient has sexual intercourse with a pregnant woman, a condom should be used to protect the unborn child.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or use tools and machines.

Grumabix contains lactose

Grumabix contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

Grumabix contains sodium

• Grumabix 250 mg film-coated tablets contain 5.88 mg of sodium (the main component of common salt) per tablet. This corresponds to 0.3% of the maximum recommended daily intake of sodium in the diet for adults.
• Grumabix 500 mg film-coated tablets contain 11.76 mg of sodium (the main component of common salt) per tablet. This corresponds to 0.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take GRUMABIX

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

How much to take

The recommended dose is 1000 mg (four 250 mg tablets or two 500 mg tablets) taken once a day.

How to take

• The medicine should be taken orally.
• Grumabix should not be taken with food.
• Take Grumabix at least one hour before eating or at least two hours after eating(see section 2, "Taking Grumabix with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Grumabix is taken with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by the doctor.
• Take prednisone or prednisolone every day while taking Grumabix.
• The amount of prednisone or prednisolone taken may be changed if necessary. The doctor will inform the patient if there is a need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without consulting a doctor.

The doctor may also prescribe other medicines to the patient taking Grumabix and prednisone or prednisolone.

Taking more Grumabix than prescribed

If the patient takes more medicine than they should, they should immediately consult their doctor or go to the hospital.

Missing a dose of Grumabix

• If the patient forgets to take Grumabix, prednisone, or prednisolone, they should take the usual dose the next day.
• If the patient forgets to take Grumabix, prednisone, or prednisolone for more than one day, they should immediately consult their doctor.

Stopping Grumabix treatment

Do not stop taking Grumabix or prednisone/prednisolone without consulting a doctor.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Stop taking Grumabix and immediately consult a doctor if the patient notices any of the following symptoms:

• Muscle weakness, muscle tremors (tremors), or heart palpitations. These may be symptoms of low potassium levels in the blood.

Other observed side effects:

Very common(may occur in more than 1 in 10 patients):
Swelling of the feet or legs, low potassium levels in the blood, elevated liver function test results, high blood pressure, urinary tract infections, diarrhea.
Common(may occur in up to 1 in 10 patients):
High lipid levels in the blood, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heart rate, severe infection - sepsis, bone fractures, nausea, blood in the urine, rash.
Uncommon(may occur in up to 1 in 100 patients):
Adrenal gland disorders (related to electrolyte imbalance), abnormal heart rhythm (arrhythmia), muscle weakness, and (or) muscle pain.
Rare(may occur in up to 1 in 1000 patients):
Lung inflammation (also known as allergic alveolitis).
Acute liver failure.
Frequency not known(frequency cannot be estimated from the available data):
Heart attack, changes in ECG (QT interval prolongation), and severe allergic reactions, causing difficulty swallowing or breathing, facial swelling, lip swelling, tongue swelling, or throat swelling, or itchy rash.
There may be a loss of bone mass in men treated for prostate cancer. Grumabix in combination with prednisone and prednisolone may enhance this effect.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell the doctor or pharmacist.
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 the medicine.

5. How to store GRUMABIX

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after EXP.
• The expiry date refers to the last day of the month.
• There are no special precautions for storing the medicine.
• Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Grumabix contains

• The active substance of the medicine is abiraterone acetate. Grumabix 250 mg: Each film-coated tablet contains 250 mg of abiraterone acetate. Grumabix 500 mg: Each film-coated tablet contains 500 mg of abiraterone acetate.

Other ingredients are: lactose monohydrate, croscarmellose sodium, hypromellose 2910 (15 mPas), sodium lauryl sulfate, microcrystalline cellulose, silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc (see section 2, "Grumabix contains lactose and sodium").

What Grumabix looks like and contents of the pack

• Grumabix 250 mg is available in the form of white or almost white, oval, biconvex film-coated tablets (16 mm in length), with the inscription "250" on one side.
• Grumabix 500 mg is available in the form of white or almost white, oval, biconvex film-coated tablets (21 mm in length), with the inscription "500" on one side.

Grumabix 250 mg is available in blisters containing 120 film-coated tablets.
Grumabix 500 mg is available in blisters containing 60 or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
To obtain more detailed information about this medicine, consult the marketing authorization holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
This medicine is authorized for marketing in the Member States of the European Economic Area under the following trade names:
Bulgaria
ГРУМАБИКС 250 mg филмирани таблетки
ГРУМАБИКС 500 mg филмирани таблетки
Czech Republic
GRUMABIX
Denmark
GRUMABIX
France
GRUMABIX 250 mg, comprimé pelliculé
ABIRATERONE ARROW 500 mg, comprimé pelliculé
Spain
GRUMABIX 250 mg comprimidos recubiertos con película EFG
GRUMABIX 500 mg comprimidos recubiertos con película EFG
Germany
GRUMABIX
Poland
GRUMABIX
Slovakia
GRUMABIX
Hungary
GRUMABIX 250 mg filmtabletta
GRUMABIX 500 mg filmtabletta
Italy
GRUMABIX
Date of last revision of the leaflet: 06.2022