Grumabix

Package Leaflet: Information for the Patient

GRUMABIX, 250 mg, film-coated tablets

GRUMABIX, 500 mg, film-coated tablets

Abiraterone acetate

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is GRUMABIX and what is it used for
• 2. Before you take 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 works by stopping the production of testosterone in the body; this can slow down the growth of prostate cancer.

When Grumabix is used at an early stage of the disease in patients who are responding to hormone therapy, it is given together with a therapy to reduce testosterone levels (androgen deprivation therapy). During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the risk of high blood pressure, fluid retention (oedema), or low potassium levels in the blood.

2. Before you take GRUMABIX

Do not take GRUMABIX:

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

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Grumabix.

Warnings and precautions

Before taking this medicine, discuss with your doctor or pharmacist:

• if you have liver problems;
• if you have high blood pressure, heart failure, or low potassium levels in the blood (low potassium levels in the blood may increase the risk of abnormal heart rhythms);
• if you have had other heart or blood vessel problems;
• if you have irregular or rapid heart rhythm;
• if you have shortness of breath;
• if you have gained weight in a short period;
• if you have swelling of the feet, ankles, or legs;
• if you have taken a medicine called ketoconazole 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 you have high blood sugar levels.

Tell your doctor if you have any heart or blood vessel problems, including abnormal heart rhythms (arrhythmia), or if you are taking medicines for these conditions. Tell your doctor if you have yellowing of the skin or eyes, dark urine, severe nausea or vomiting, which may be signs of liver problems. Rarely, acute liver failure can occur, which can be life-threatening. Decreased red blood cell count, decreased sex drive, muscle weakness, and/or muscle pain may occur. Grumabix must not be taken in combination with Ra-223 due to the possible increased risk of bone fractures or death. If you plan to take Ra-223 after treatment with Grumabix and prednisone/prednisolone, you should wait 5 days before starting Ra-223 treatment. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Grumabix.

Blood tests

Grumabix may affect liver function, and you may not have any symptoms. During treatment with this medicine, your doctor will periodically prescribe 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, you should immediately go to the hospital, taking the package leaflet with you to show to the doctor.

Grumabix with other medicines

Before taking any medicine, consult your doctor or pharmacist. Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This is important because Grumabix may increase the effect of many medicines, including heart medicines, sedatives, certain anti-diabetic medicines, herbal medicines (e.g., St. John's Wort), and others. Your doctor may need to change the dose of these medicines. Other medicines may also increase or decrease the effect of Grumabix. This may result in side effects or Grumabix not working properly. Androgen deprivation therapy may increase the risk of abnormal heart rhythms. Tell your doctor if you are taking medicines:

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

Tell your doctor if you are taking any of the above medicines.

Taking Grumabix with food

• Do not take Grumabix 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.

• This medicine may harm an unborn child if taken by a pregnant woman.
• Women who are pregnant or may become pregnant should wear protective gloves when handling Grumabix.
• If you have sexual intercourse with a woman who may become pregnant, you should use a condom or other effective birth control method.
• If you have sexual intercourse with a pregnant woman, you should use a condom to protect the unborn child.

Driving and using machines

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

Grumabix contains lactose

Grumabix contains lactose (a type of sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this 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 is equivalent 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 is equivalent to 0.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take GRUMABIX

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your 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

• Take this medicine by mouth.
• Do not take Grumabix with food.
• Take Grumabix at least 1 hour before or at least 2 hours after food(see section 2, "Taking Grumabix with food").
• Swallow the tablets whole with water.
• Do not crush the tablets.
• Take Grumabix with a medicine called prednisone or prednisolone. Take prednisone or prednisolone as directed by your doctor.
• Take prednisone or prednisolone every day while taking Grumabix.
• The amount of prednisone or prednisolone you take may need to be changed. Your doctor will tell you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone without talking to your doctor.

Your doctor may also prescribe other medicines for you to take with Grumabix and prednisone or prednisolone.

If you take more GRUMABIX than you should

If you take more Grumabix than you should, contact your doctor or go to the hospital immediately.

If you forget to take GRUMABIX

• If you forget to take Grumabix, prednisone, or prednisolone, take your usual dose the next day.
• If you forget to take Grumabix, prednisone, or prednisolone for more than one day, contact your doctor immediately.

If you stop taking GRUMABIX

Do not stop taking Grumabix or prednisone/prednisolone without talking to your doctor. If you have any further questions on the use of 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.

Stop taking Grumabix and contact your doctor immediately if you notice any of the following:

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

Other side effects:

Very common(may affect more than 1 in 10 people):
Swelling of the feet or ankles, low potassium levels in the blood, increased liver function test results, high blood pressure, urinary tract infections, diarrhea.
Common(may affect up to 1 in 10 people):
High lipid levels in the blood, chest pain, abnormal heart rhythms (atrial fibrillation), heart failure, rapid heart rate, severe infection - sepsis, bone fractures, indigestion, blood in the urine, rash.
Uncommon(may affect up to 1 in 100 people):
Adrenal gland problems (related to electrolyte imbalance), abnormal heart rhythm (arrhythmia), muscle weakness, and/or muscle pain.
Rare(may affect up to 1 in 1,000 people):
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 (prolonged QT interval), and severe allergic reactions, causing difficulty swallowing or breathing, facial, lip, tongue, or throat swelling, or itchy rash.
Bone loss may occur in men treated for prostate cancer. Grumabix in combination with prednisone and prednisolone may increase this effect.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 GRUMABIX

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
• The expiry date refers to the last day of that month.
• There are no special storage conditions for this medicine.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Grumabix contains

• The active substance 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.

The 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 a white or almost white, oval, biconvex film-coated tablet (16 mm in length) with "250" engraved on one side.
• Grumabix 500 mg is a white or almost white, oval, biconvex film-coated tablet (21 mm in length) with "500" engraved 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 on this medicine, contact the Marketing Authorization Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
This medicine is authorized in the Member States of the European Economic Area under the following 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