Abiraterone G.l. Pharma

Leaflet included in the packaging: patient information

Abiraterone G.L. Pharma, 500 mg, film-coated tablets
abiraterone acetate
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Abiraterone G.L. Pharma and what is it used for

Abiraterone G.L. Pharma 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. Abiraterone G.L. Pharma inhibits the production of testosterone in the body; this can slow down the development of prostate cancer.
When Abiraterone G.L. Pharma 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 recommend taking another medicine called prednisone or prednisolone. This is to reduce the likelihood of high blood pressure, fluid retention, or low potassium levels in the blood.

2. Important information before taking Abiraterone G.L. Pharma

When not to take Abiraterone G.L. Pharma:

• 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. Abiraterone G.L. Pharma 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).

You should not take this medicine if any of the above situations apply to you. If in doubt, consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, you should discuss it with your doctor or pharmacist:

• if the patient has liver disease;
• 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 disturbances);
• 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 to treat 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.

You should tell your doctor if you have any heart or blood vessel disorders, including heart rhythm disturbances (arrhythmia), or if you are taking medicines for these conditions.
You should tell your doctor if you have jaundice or eye discoloration, dark urine, severe nausea, or vomiting, which may be symptoms of liver function disorders. Rarely, acute liver failure may occur, which can lead to death.
There may be a decrease in the number of red blood cells, a decrease in libido, muscle weakness, and (or) muscle pain.
Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma and prednisone/prednisolone, they should wait 5 days before starting Ra-223 treatment.
If in doubt whether any of the above situations apply to you, consult a doctor or pharmacist before taking this medicine.

Blood tests

Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma is accidentally ingested by a child, you should immediately go to the hospital, taking the patient information leaflet with you to show it to the doctor in the emergency room.

Abiraterone G.L. Pharma and other medicines

Before taking any medicine, you should consult a doctor or pharmacist. You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is important because Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma. This can result in side effects or inadequate effect of Abiraterone G.L. Pharma.
Androgen suppression may increase the risk of heart rhythm disturbances. You should tell your doctor if you are taking medicines:

• used to treat heart rhythm disturbances (e.g., quinidine, procainamide, amiodarone, and sotalol);
• that may increase the risk of heart rhythm disturbances [e.g., methadone (a pain reliever and a medicine used to treat addiction), moxifloxacin (an antibiotic), antipsychotic medicines (used to treat severe mental disorders)]. You should tell your doctor if you are taking any of the above medicines.

Taking Abiraterone G.L. Pharma with food

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

Pregnancy, breastfeeding, and fertility

Abiraterone G.L. Pharma is not used in women.
Women who are pregnant or may be pregnant should use protective gloves when handling Abiraterone G.L. Pharma.
The medicine may harm an unborn baby if taken by a pregnant woman.
If the patient has sexual intercourse with a woman who may become pregnant, they should use a condom and another effective method of contraception.
If the patient has sexual intercourse with a pregnant woman, they should use a condom to protect the unborn baby.

Driving and using machines

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

Abiraterone G.L. Pharma contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains 24 mg of sodium (the main component of common salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily sodium intake in the diet for adults.

3. How to take Abiraterone G.L. Pharma

This medicine should always be taken according to the doctor's instructions. If in doubt, consult a doctor or pharmacist.

How much medicine to take

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

How to take the medicine

Abiraterone G.L. Pharma should be taken orally.
Abiraterone G.L. Pharma should not be taken with food.
You should take Abiraterone G.L. Pharma at least one hour before or at least two hours after eating (see section 2, "Taking Abiraterone G.L. Pharma with food").
The tablets should be swallowed whole, with a glass of water.
The tablets should not be crushed.
Abiraterone G.L. Pharma is taken with a medicine called prednisone or prednisolone.
You should take prednisone or prednisolone according to the doctor's instructions.
You should take prednisone or prednisolone every day while taking Abiraterone G.L. Pharma.
The amount of prednisone or prednisolone used may be changed if necessary. The doctor will inform you if there is a need to change the dose of prednisone or prednisolone being taken. You should not stop taking prednisone or prednisolone without consulting a doctor.
The doctor may also prescribe other medicines to you while you are taking Abiraterone G.L. Pharma and prednisone or prednisolone.

Taking more Abiraterone G.L. Pharma than recommended

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

Missing a dose of Abiraterone G.L. Pharma

If you forget to take Abiraterone G.L. Pharma, prednisone, or prednisolone, you should take the usual dose the next day.
If you forget to take Abiraterone G.L. Pharma, prednisone, or prednisolone for a period longer than one day, you should immediately contact your doctor.

Stopping treatment with Abiraterone G.L. Pharma

You should not stop taking Abiraterone G.L. Pharma or prednisone or prednisolone without consulting a doctor.
If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

You should stop taking Abiraterone G.L. Pharma and immediately contact your doctor if you notice any of the following symptoms:

• muscle weakness, tremors (shaking), or heart palpitations (palpitations). These may be symptoms 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
• high liver enzyme levels
• high blood pressure
• urinary tract infections
• diarrhea

Common(may affect up to 1 in 10 people):

• high lipid levels in the blood
• chest pain, heart rhythm disturbances (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 disorders (related to electrolyte imbalance)
• abnormal 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 the available data):

• heart attack, changes in ECG (QT interval prolongation)
• severe allergic reactions, causing difficulty swallowing or breathing, facial, lip, tongue, or throat swelling, or hives.

Bone loss may occur in men treated for prostate cancer. Abiraterone G.L. Pharma in combination with prednisone and prednisolone may enhance this effect.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Abiraterone G.L. Pharma

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

6. Contents of the packaging and other information

What Abiraterone G.L. Pharma contains

• The active substance of the medicine is abiraterone acetate.
• Each tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose type 102, sodium croscarmellose, hypromellose 2910, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), iron oxide black (E172).

What Abiraterone G.L. Pharma looks like and contents of the pack

Purple, oval, film-coated tablets, approximately 19 mm long and 11 mm wide, with "A7TN" embossed on one side and "500" on the other.
Pack sizes:

• blister pack (PVC/PVDC/Aluminum) containing 60 film-coated tablets, in a carton;
• unit dose blister pack (PVC/PVDC/Aluminum) containing 60 x 1 film-coated tablets, in a carton;
• round, white HDPE bottle with a polypropylene cap, with a child-resistant closure, containing 60 film-coated tablets, in a carton.

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

Synthon Hispania S.L.
Castelló 1
08830 Sant Boi de Llobregat
Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands
G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For more information about this medicine, please contact the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of last revision of the leaflet: