Abiraterone G.l. Pharma

Leaflet included in the packaging: patient information

Abiraterone G.L. Pharma, 250 mg, 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 for you only. 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 undesirable effects, including any undesirable effects not mentioned 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 to treat prostate cancer).

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

Warnings and precautions

Before starting treatment with this medicine, the patient should discuss it with their 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 rapidly;
• 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 bone-related side effects;
• if the patient has high blood sugar levels.

Tell the doctor if the patient has any heart or blood vessel disorders, including heart rhythm disturbances (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 signs of liver function disorders. Rarely, acute liver failure can occur, which can lead to death.
There may be a decrease in the number of red blood cells, decreased libido, weakness, and (or) muscle pain.
Abiraterone G.L. Pharma should not be taken 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.
In case of doubt whether any of the above situations apply to the patient, 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, they should immediately go to the hospital with the patient information leaflet to show it to the doctor on duty.

Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma can enhance the effect of many medicines, including heart medicines, sedatives, certain 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. Tell the doctor if the patient is 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 (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 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 become pregnant should use protective gloves when handling Abiraterone G.L. Pharma.
The medicine may harm an unborn child 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 child.

Driving and using machines

It is unlikely that this medicine will affect the ability to drive or operate machinery.

Abiraterone G.L. Pharma contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose of four 250 mg tablets, which means the medicine is considered "sodium-free".

3. How to take Abiraterone G.L. Pharma

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

How much medicine to take

The recommended dose is 1000 mg (four 250 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.
The medicine should be taken 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 water.
The tablets should not be crushed.
Abiraterone G.L. Pharma is taken with a medicine called prednisone or prednisolone.
Prednisone or prednisolone should be taken as directed by the doctor.
Prednisone or prednisolone should be taken every day while taking Abiraterone G.L. Pharma.
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 Abiraterone G.L. Pharma and prednisone or prednisolone.

Taking more Abiraterone G.L. Pharma than recommended

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

Missing a dose of Abiraterone G.L. Pharma

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

Stopping treatment with Abiraterone G.L. Pharma

Do not stop taking Abiraterone G.L. Pharma or prednisone/prednisolone without consulting a doctor.
In case of 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.

Stop taking Abiraterone G.L. Pharma and immediately consult a doctor if the patient notices any of the following symptoms:

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

Other side effects observed:

Very common(may affect more than 1 in 10 patients):

• swelling of the feet or ankles
• low potassium levels in the blood
• increased liver enzyme test results
• high blood pressure
• urinary tract infections
• diarrhea

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

• high lipid levels in the blood
• chest pain, heart rhythm disturbances (atrial fibrillation), heart failure, rapid heart rhythm
• severe infection - sepsis
• bone fractures
• indigestion
• blood in the urine
• rash

Uncommon(may affect 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 affect up to 1 in 1000 patients):

• lung inflammation (also called 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 side effects occur, including any side effects not mentioned in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, more information can be collected 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 bottle and 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. Ask a 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 250 mg of abiraterone acetate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose type 102, croscarmellose sodium, povidone K29/32, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.

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

White or almost white oval tablets, approximately 16 mm long and 9.5 mm wide, with the inscription "ATN" on one side and "250" on the other.
A round, white HDPE bottle with a polypropylene cap, with a child-resistant closure, containing 120 tablets, in a carton.

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, contact the representative of 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
biuro@gl-pharma.pl

Date of last revision of the leaflet: