Abiraterone g.l. pharma

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Abiraterone G.L. Pharma is and what it is 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 package and other information

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

Abiraterone G.L. Pharma 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). Abiraterone G.L. Pharma inhibits the production of testosterone in the body; this may slow the progression of prostate cancer.
When Abiraterone G.L. Pharma is used at an early stage of the disease that is responsive to hormonal therapy, it is administered together with androgen-deprivation therapy (treatment that lowers testosterone levels).
During treatment with this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This is to reduce the likelihood of developing high blood pressure, fluid retention (fluid accumulation), or low blood potassium levels.

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

When not to use Abiraterone G.L. Pharma:

• if the patient is allergic to abiraterone or any of the other ingredients of this medicine (listed in section 6);
• in women, especially during pregnancy. Abiraterone G.L. Pharma 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. If in doubt,
consult a doctor or pharmacist before taking this medicine.

Warnings and precautions

Before starting treatment with this medicine, discuss the following with your doctor or pharmacist:

• if the patient has liver disease;
• if the patient has hypertension, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm disorders);
• 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 has experienced rapid weight gain;
• if the patient has swelling of the feet, ankles, or legs;
• if the patient has previously taken ketoconazole for prostate cancer treatment;
• the necessity of taking this medicine with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• if the patient has high blood sugar levels.

Inform your doctor if the patient has any heart or blood vessel disorders, including heart rhythm disorders (arrhythmias), or if taking medications for these conditions.

Inform your doctor if the patient develops yellowing of the skin or eyes, dark urine, severe nausea or vomiting, as these may be signs of liver problems. Rarely, acute liver failure may occur, which can lead to death.

Decreased red blood cell count, reduced libido, muscle weakness and/or muscle pain may occur.

Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma 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, consult a doctor or pharmacist before using this medicine.

Blood tests

Abiraterone G.L. Pharma 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 Abiraterone G.L. Pharma is accidentally swallowed by a child, seek immediate medical attention at a hospital, bringing the patient leaflet to show the emergency room doctor.

Abiraterone G.L. Pharma and other medicines

Before taking any medicine, consult a doctor or pharmacist. Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. This is important because Abiraterone G.L. Pharma may enhance 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 need to adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone G.L. Pharma, potentially leading to adverse effects or reduced efficacy.

Androgen suppression may increase the risk of heart rhythm disorders. Inform the doctor if the patient is taking:

• medicines used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• medicines that may increase the risk of heart rhythm disorders [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe mental disorders)]. Inform the doctor if the patient is taking any of the above-mentioned medicines.

Taking Abiraterone G.L. Pharma with food

This medicine must not be taken with food (see section 3, "How to take Abiraterone G.L. Pharma").

Taking Abiraterone G.L. Pharma with food may cause adverse effects.

Pregnancy, breastfeeding and fertility

Abiraterone G.L. Pharma is not used in women.

Women who are pregnant or may become pregnant should wear protective gloves when handling Abiraterone G.L. Pharma.

This medicine may harm the unborn child if taken by a pregnant woman.

If the patient has sexual intercourse with a woman who may become pregnant, a condom and another effective method of contraception 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.

Abiraterone G.L. Pharma contains lactose and sodium

If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains 24 mg of sodium (the main component of table salt) in each dose consisting of two 500 mg tablets. This corresponds to 1% of the maximum recommended daily dietary sodium intake for adults.

3. How to take Abiraterone G.L. Pharma

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

How much medicine should be taken?
The recommended dose is 1000 mg (two 500 mg tablets) taken once daily.

How to take the medicine
Abiraterone G.L. Pharma should be taken orally.
Abiraterone G.L. Pharma must not be taken with food.
Abiraterone G.L. Pharma 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.
Do not crush the tablets.

Abiraterone G.L. Pharma is taken together with a medicine called prednisone or prednisolone.
You should take prednisone or prednisolone as directed by your doctor.
You should take prednisone or prednisolone every day during treatment with Abiraterone G.L. Pharma.

The amount of prednisone or prednisolone taken may need to be adjusted in certain situations. Your doctor will inform you if a dose adjustment of prednisone or prednisolone is necessary. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your 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, contact your doctor immediately or go to a hospital.

If you miss a dose of Abiraterone G.L. Pharma
If you forget to take Abiraterone G.L. Pharma, prednisone or prednisolone, take your usual dose the next day.

If you forget to take Abiraterone G.L. Pharma, prednisone or prednisolone for more than one day, contact your doctor immediately.

Stopping Abiraterone G.L. Pharma
Do not stop taking Abiraterone G.L. Pharma 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 effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Treatment with Abiraterone G.L. Pharma should be discontinued and medical advice should be sought immediately if the patient experiences any of the following symptoms:

• muscle weakness, muscle twitching (tremor), or rapid heartbeat (palpitations). These may be symptoms of low blood potassium levels.

Other adverse effects reported:
Very common (may occur in 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 occur in up to 1 in 10 people):

• high blood lipid levels
• chest pain, heart rhythm disorders (atrial fibrillation), heart failure, rapid heartbeat
• severe infections – sepsis
• bone fractures
• indigestion
• blood in urine
• rash

Uncommon (may occur in up to 1 in 100 people):

• adrenal gland disorders (associated with disturbances in water and electrolyte balance)
• irregular heartbeat (arrhythmia)
• muscle weakness and/or muscle pain

Rare (may occur in 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):

• heart attack, changes in ECG (prolonged QT interval)
• severe allergic reactions causing difficulty in swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.

Bone mass loss may occur in men treated for prostate cancer. Abiraterone G.L. Pharma in combination with prednisone and prednisolone may worsen this effect.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Abiraterone G.L. Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, bottle, or carton after "EXP". The expiry date refers to the last day of the specified month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abiraterone G.L. Pharma contains

• The active substance is abiraterone acetate.
• Each tablet contains 500 mg of abiraterone acetate.
• The other ingredients are: monohydrate lactose, 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 in length and 11 mm in width,
with the imprint “A7TN” on one side and “500” on the other side.
Pack sizes:

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

Not all pack sizes may be marketed.

Marketing Authorisation 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
The Netherlands

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

For any further information about this medicine, please contact the representative of the Marketing Authorisation 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]