Grumabix

Package leaflet: Information for the patient

GRUMABIX, 250 mg, film-coated tablets
GRUMABIX, 500 mg, film-coated tablets
Abiraterone acetate
Please read all of this leaflet carefully before taking this 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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What GRUMABIX is and what it is used for
2. What you need to know 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 GRUMABIX is and what it is used for

GRUMABIX is a medicine containing abiraterone acetate. It is used in adult men for the treatment of metastatic prostate cancer (cancer of the prostate gland that has spread to other parts of the body). GRUMABIX inhibits the production of testosterone in the body; this may slow down the progression of prostate cancer.
When GRUMABIX is used at an early stage of hormone-sensitive disease, it is given in combination with androgen-deprivation therapy (hormonal therapy that reduces testosterone levels).
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 (fluid build-up in the body), or low blood potassium levels.

2. Important information before using GRUMABIX

When not to use 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 intended for use in men only;
• if the patient has severe liver impairment;
• in combination with Ra-223 (used in the treatment of prostate cancer).

This medicine should not be used if any of the above situations apply to the patient. In case of
doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting treatment with this medicine, discuss the following with your doctor or pharmacist:

• if the patient has liver problems;
• if the patient has high blood pressure, heart failure, or low blood potassium levels (low blood potassium may increase the risk of heart rhythm disturbances);
• if the patient has other heart or blood vessel diseases;
• if the patient has irregular or rapid heartbeat;
• if the patient has shortness of breath;
• if the patient's body weight has increased rapidly;
• if the patient has swelling of the feet, ankles, or legs;
• if the patient has previously taken ketoconazole for the treatment of prostate cancer;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of adverse effects affecting the bones;
• if the patient has high blood sugar levels.

Tell your doctor if the patient has any heart or blood vessel disorders, including heart rhythm
disturbances (arrhythmia), or is taking medications for these conditions.
Tell your doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or
vomiting, which may be signs of liver function disorders. Rarely, acute liver failure may occur, which
can lead to death.
A decrease in red blood cell count, reduced libido, muscle weakness and/or muscle pain may occur.
Grumabix must not be used in combination with Ra-223 due to the possible increased risk of bone
fractures or death.
If the patient intends to receive Ra-223 after treatment with Grumabix and
prednisone/prednisolone, a 5-day interval should be observed before starting Ra-223 therapy.
If in doubt whether any of the above situations apply to the patient, consult a doctor or pharmacist
before using this medicine.
Blood tests
Grumabix may affect liver function, and the patient may not experience any symptoms.
During treatment, the doctor will periodically order blood tests to monitor the medicine's effect on
the liver.
Children and adolescents
This medicine is not intended for use in children and adolescents. If Grumabix is accidentally
swallowed by a child, seek immediate medical attention at a hospital, taking the patient leaflet
along to show the emergency room doctor.
Grumabix and other medicines
Before taking any medicine, consult a doctor or pharmacist.
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as
any medicines the patient plans to use. This is important because Grumabix may intensify the
effects of many medicines, including heart medications, sedatives, certain antidiabetic drugs,
herbal remedies (e.g. St. John's wort), and others. The doctor may adjust the doses of these
medicines. Other medicines may also increase or decrease the effect of Grumabix, potentially
leading to adverse effects or reduced efficacy of Grumabix.
Androgen suppression may increase the risk of heart rhythm disturbances. Inform your doctor if
the patient is taking any of the following medicines:

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

Inform your doctor if the patient is taking any of the medicines listed above.
Taking Grumabix with food

• Do not take this medicine with food (see section 3, "How to take Grumabix").
• Taking Grumabix with food may cause adverse effects.

Pregnancy, breastfeeding and effects on 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 be pregnant should wear protective gloves when handling or coming into contact with Grumabix.
• If the patient has sexual intercourse with a woman who could become pregnant, a condom or other effective contraceptive method must be used.
• If the patient has sexual intercourse with a pregnant woman, a condom must be used to protect the unborn child.

Driving and operating machinery
It is unlikely that this medicine affects the ability to drive, use tools, or operate machinery.
Grumabix contains lactose
Grumabix contains lactose (a type of sugar). If the patient has previously been diagnosed with an
intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Grumabix contains sodium

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

3. How to take GRUMABIX

This medicine should always be taken exactly as recommended by your doctor. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take

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

Administration of the medicine

• This medicine should be taken orally.
• GRUMABIX must not be taken with food.
• GRUMABIX should be taken at least one hour before food or at least two hours after food (see section 2, "Taking GRUMABIX with food").
• Tablets should be swallowed whole with water.
• Do not crush the tablets.
• GRUMABIX is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• Prednisone or prednisolone should be taken daily during treatment with GRUMABIX.
• The dose of prednisone or prednisolone may be adjusted if necessary. Your doctor will inform you if any changes to your prednisone or prednisolone dose are required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your doctor may also prescribe other medicines for you while you are taking GRUMABIX and prednisone or prednisolone.

Taking more GRUMABIX than recommended

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

Missed dose of 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.

Stopping treatment with GRUMABIX

Do not stop taking GRUMABIX or prednisone or prednisolone without consulting your doctor.

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 not everyone experiences them.
You should stop taking Grumabix and contact your doctor immediately if
the patient notices any of the following symptoms:

• Muscle weakness, muscle tremors (shaking), or rapid heartbeat (palpitations). These may be signs of low blood potassium levels.

Other adverse reactions reported:
Very common (may affect more than 1 in 10 people):
Swelling of the legs or feet, low blood potassium levels, increased liver function test results, high blood pressure, urinary tract infections, diarrhoea.
Common (may affect up to 1 in 10 people):
High blood lipid levels, chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat, severe infection – sepsis, bone fractures, indigestion, blood in urine, rash.
Uncommon (may affect up to 1 in 100 people):
Adrenal gland dysfunction (related to disturbances in water and electrolyte balance), irregular heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1000 people):
Lung inflammation (also known as allergic alveolitis).
Acute liver failure.
Frequency not known (cannot be estimated from available data):
Myocardial infarction (heart attack), changes in ECG (prolongation of QT interval), and severe allergic reactions causing difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Bone mineral loss may occur in men treated for prostate cancer. GRUMABIX in combination with prednisone and prednisolone may worsen this effect.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine GRUMABIX

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the outer carton and blister pack after EXP.
• The expiry date refers to the last day of the stated month.
• No special storage instructions are required for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package 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: monohydrate lactose, sodium croscarmellose, hypromellose 2910 (15 mPas),
sodium lauryl sulfate, microcrystalline cellulose, colloidal anhydrous silica, 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 the imprint "250" on one side.
• Grumabix 500 mg is a white or almost white, oval, biconvex film-coated tablet (21 mm in length) with the imprint "500" on one side.

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

Marketing Authorisation 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

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in 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