Abiraterone g.l. pharma

Package leaflet: Information for the patient

Abiraterone G.L. Pharma, 250 mg, tablets
abiraterone acetate
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please 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 pack 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 hormone-sensitive disease, it is given in combination 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 risk of high blood pressure, fluid retention (fluid buildup), 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 the 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 must not be used if any of the above situations apply. If in 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 disease;
• if the patient has hypertension, heart failure, or low blood potassium levels (low blood potassium may increase the risk of developing 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 need to take this medicine together with prednisone or prednisolone;
• the possibility of bone-related adverse effects;
• if the patient has high blood sugar levels.

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

A decrease in red blood cells, reduced libido, muscle weakness and/or muscle pain may occur.

Abiraterone G.L. Pharma must not be given 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, taking the patient leaflet along 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 adjust the doses of these medicines. Other medicines may also increase or decrease the effect of Abiraterone G.L. Pharma, which may result in adverse effects or reduced efficacy.

Androgen suppression may increase the risk of heart rhythm disturbances. Inform the doctor if the patient is taking any of the following medicines:

• used to treat heart rhythm disorders (e.g. quinidine, procainamide, amiodarone, sotalol);
• that may increase the risk of heart rhythm disturbances [e.g. methadone (a painkiller and used in addiction treatment), moxifloxacin (an antibiotic), antipsychotics (used in severe psychiatric disorders)]. Inform the doctor if the patient is taking any of the above 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 or coming into contact with Abiraterone G.L. Pharma.

The 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 using machines

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose of four 250 mg tablets, i.e. the medicine is considered "sodium-free".

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 to take

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

Taking the medicine

Abiraterone G.L. Pharma should be taken by mouth.

Abiraterone G.L. Pharma must 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 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 be adjusted if necessary. Your treating doctor will inform you if a dose adjustment of prednisone or prednisolone is required. Do not stop taking prednisone or prednisolone without consulting your doctor.

Your treating doctor may also prescribe other medicines to you while you are taking Abiraterone G.L. Pharma and prednisone or prednisolone.

Taking more than the recommended dose of Abiraterone G.L. Pharma

If you take more medicine than you should, contact your doctor immediately 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, 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 treating doctor immediately.

Stopping treatment with Abiraterone G.L. Pharma

Do not stop taking Abiraterone G.L. Pharma, 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.
Treatment with Abiraterone G.L. Pharma should be discontinued and immediate medical advice should be sought if the patient experiences any of the following symptoms:

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

Other adverse reactions reported:
Very common (may occur in more than 1 in 10 patients):

• swelling of the legs or feet
• low blood potassium levels
• elevated liver function test results
• high blood pressure
• urinary tract infections
• diarrhoea

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

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

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

• adrenal gland dysfunction (related to disturbances in water and electrolyte balance)
• irregular heartbeat (arrhythmia)
• muscle weakness and/or muscle pain

Rare (may occur in up to 1 in 1000 patients):

• lung inflammation (also known as allergic alveolitis)
• acute liver failure

Frequency not known (cannot be estimated from available data):

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

Loss of bone mass 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 reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 responsible entity.
Reporting adverse reactions 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 bottle and cardboard box after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply 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 packaging and other information

What Abiraterone G.L. Pharma contains

• The active substance is abiraterone acetate.
• Each tablet contains 250 mg of abiraterone acetate.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose type 102, sodium croscarmellose, 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 in length and 9.5 mm in width,
with the imprint “ATN” on one side and “250” on the other side.
Round, white HDPE bottle with a polypropylene cap and child-resistant closure, containing 120 tablets,
packaged in a cardboard box.
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 further information on 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]