Abiraterone Abdi Farma

Package leaflet: Information for the user

Abiraterone Abdi Farma 500 mg film-coated tablets

abiraterone acetate
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Abiraterone Abdi Farma is and what it is used for
2. What you need to know before taking Abiraterone Abdi Farma
3. How to take Abiraterone Abdi Farma
4. Possible side effects
5. How to store Abiraterone Abdi Farma
6. Contents of the pack and other information

1. What Abiraterone Abdi Farma is and what it is used for

Abiraterone Abdi Farma contains a medicine called abiraterone acetate. It is used for the treatment of prostate cancer in adult men whose cancer has spread to other parts of the body. Abiraterone Abdi Farma stops the body's production of testosterone; this may slow down the growth of prostate cancer.
When Abiraterone Abdi Farma is prescribed at the early stage of the disease, which still responds to hormone therapy, it is used in combination with a treatment that lowers testosterone levels (androgen deprivation therapy).
When you take this medicine, your doctor will also prescribe another medicine called prednisone or prednisolone. This medicine helps reduce the risk of high blood pressure, fluid retention (too much fluid in the body), or low levels in the blood of a chemical known as potassium.

2. What you should know before taking Abiraterone Abdi Farma

Do not take Abiraterone Abdi Farma

• if you are allergic to abiraterone acetate or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman, especially if pregnant. Abiraterone Abdi Farma is intended for use only in men.
• if you have severe liver damage.
• in combination with Ra-223 (used for the treatment of prostate cancer).

Do not take this medicine if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you have liver problems
• if you have been diagnosed with high blood pressure, heart failure, or low blood potassium levels (low potassium levels may increase the risk of heart rhythm problems)
• if you have had other heart or blood vessel problems
• if you have irregular or rapid heartbeat
• if you have shortness of breath
• if you gain weight rapidly
• if you have swelling in your feet, ankles, or legs
• if you have previously taken a medicine called ketoconazole for prostate cancer
• regarding the need to take this medicine with prednisone or prednisolone
• regarding possible effects on bones
• if you have high blood sugar levels.

Inform your doctor if you have been diagnosed with any heart or blood vessel disorders, including heart rhythm problems (arrhythmia), or if you are being treated with medicines for these conditions.

Inform your doctor if you develop yellowing of the skin or eyes, dark-colored urine, or severe nausea or vomiting, as these may be signs or symptoms of liver problems. Rarely, a liver function problem (called acute liver failure) may occur, which can lead to death.

Possible side effects include decreased red blood cells, decreased sexual desire (libido), muscle weakness and/or muscle pain.

Abiraterone Abdi Farma must not be administered in combination with Ra-223 due to a possible increased risk of fractures or death.

If you are considering taking Ra-223 after treatment with Abiraterone Abdi Farma and prednisone/prednisolone, you must wait 5 days before starting Ra-223 treatment.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist before taking this medicine.

Blood monitoring

Abiraterone Abdi Farma may affect your liver, and you may not experience any symptoms. While taking this medicine, your doctor will periodically perform blood tests to check for any effects on the liver.

Children and adolescents

This medicine is not indicated for use in children and adolescents. If Abiraterone Abdi Farma is accidentally ingested by a child or adolescent, go to hospital immediately and bring the package leaflet to show the emergency doctor.

Other medicines and Abiraterone Abdi Farma

Talk to your doctor or pharmacist before taking any medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is important because Abiraterone Abdi Farma may increase the effects of certain medicines, including those for the heart, tranquilizers, certain diabetes medicines, herbal medicines (e.g. St. John’s wort), and others. Your doctor may decide to adjust the dose of these medicines.

Additionally, some medicines may increase or decrease the effects of Abiraterone Abdi Farma. This could lead to unwanted side effects or Abiraterone Abdi Farma may not work as intended.

Androgen deprivation therapy may increase the risk of heart rhythm problems. Inform your doctor if you are taking medicines:

• used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, sotalol);
• known to increase the risk of heart rhythm problems [e.g. methadone (used to relieve pain and for treatment of opioid dependence), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].

Inform your doctor if you are taking any of the medicines listed above.

Abiraterone Abdi Farma with food

• This medicine must not be taken with food (see section 3 “How to take this medicine”). Taking Abiraterone Abdi Farma with food may cause unwanted effects.
• Take Abiraterone Abdi Farma as a single daily dose on an empty stomach. Abiraterone Abdi Farma must be taken once daily on an empty stomach. Abiraterone Abdi Farma should be taken at least two hours after a meal, and no food should be consumed for at least one hour after taking Abiraterone Abdi Farma (see section 2 “Abiraterone Abdi Farma with food”).

Pregnancy and breastfeeding

Abiraterone Abdi Farma is not indicated for use in women.

• This medicine may harm the unborn baby if taken by pregnant women.
• If you have sexual intercourse with a woman of childbearing age, use a condom and another effective method of contraception.
• If you have sexual intercourse with a pregnant woman, 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 operate tools or machinery.

Abiraterone Abdi Farma contains lactose and sodium

• Abiraterone Abdi Farma contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
• This medicine contains approximately 27 mg of sodium in the two-tablet dose. This should be taken into consideration by patients on a low-sodium diet.

3. How to take Abiraterone Abdi Farma

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage
The recommended dose is 1,000 mg (two tablets) once daily.

How to take this medicine

• Take this medicine by mouth.
• Do not take Abiraterone Abdi Farma with food.
• Abiraterone Abdi Farma must be taken at least two hours after a meal and no food should be consumed for at least one hour after taking Abiraterone Abdi Farma (see section 2 “Abiraterone Abdi Farma with food”).
• Swallow the tablets whole with a glass of water.
• Do not break the tablets.
• Abiraterone Abdi Farma is taken together with a medicine called prednisone or prednisolone. Take prednisone or prednisolone exactly as directed by your doctor.
• You must take prednisone or prednisolone every day while you are taking Abiraterone Abdi Farma.
• Your doctor may need to adjust the dose of prednisone or prednisolone in case of medical emergencies. Your doctor will inform you if you need to change the dose of prednisone or prednisolone. Do not stop taking prednisone or prednisolone unless your doctor tells you to.

Your doctor may also prescribe other medicines while you are taking Abiraterone Abdi Farma and prednisone or prednisolone.

If you take more Abiraterone Abdi Farma than you should
If you take more Abiraterone Abdi Farma than you should, contact your doctor or go to hospital immediately.

If you forget to take Abiraterone Abdi Farma

• If you forget to take Abiraterone Abdi Farma or prednisone or prednisolone, take your usual dose the next day.
• If you forget to take Abiraterone Abdi Farma or prednisone or prednisolone for more than one day, speak with your doctor as soon as possible.

If you stop taking Abiraterone Abdi Farma
Do not stop taking Abiraterone Abdi Farma or prednisone or prednisolone unless your doctor tells you to.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the side effects listed below, stop taking
Abiraterone Abdi Farma and contact a doctor immediately:

• Muscle weakness, muscle spasms, or a pounding heartbeat (palpitations). These may be signs of low potassium levels in the blood.

Other side effects include:
Very common (may affect more than 1 in 10 people)
Fluid retention in the legs or feet, low potassium levels in the blood, increased liver function test values, high blood pressure, urinary tract infection, diarrhoea.
Common (may affect up to 1 in 10 people)
High levels of fats in the blood, chest pain, irregular heartbeat (atrial fibrillation), heart failure, increased heart rate, severe infections called sepsis, bone fractures, indigestion, blood in the urine, skin rash.
Uncommon (may affect up to 1 in 100 people)
Problems with the adrenal glands (related to salt and water imbalances), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Rare (may affect up to 1 in 1,000 people)
Lung irritation (also known as allergic alveolitis).
Liver function problems (also known as acute liver failure).
Not known (frequency cannot be estimated from the available data)
Heart attack, changes in ECG (electrocardiogram) – QT interval prolongation, and severe allergic reactions with difficulty swallowing or breathing, swelling of the face, lips, tongue or throat, or itchy rash.
Loss of bone tissue may occur in men treated for prostate cancer. Abiraterone Abdi Farma in combination with prednisone or prednisolone may increase bone tissue loss.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Abiraterone Abdi Farma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abiraterone Abdi Farma contains

• The active substance is abiraterone acetate. Each film-coated tablet contains 500 mg of abiraterone acetate.
• The other components are microcrystalline cellulose (silicized), sodium croscarmellose, hypromellose 2910, 3015 mPa (E464), monohydrate lactose, magnesium stearate, anhydrous colloidal silicon dioxide, sodium lauryl sulfate (see section 2 “Abiraterone Abdi Farma contains lactose and sodium”). The coating contains black iron oxide (E172), red iron oxide (E172), macrogol 3350, polyvinyl alcohol; talc and titanium dioxide.

Description of the appearance of Abiraterone Abdi Farma and pack sizes

• Abiraterone Abdi Farma tablets are purple, oval-shaped, biconvex, with “A 500” engraved on one side and smooth on the other.
• Abiraterone Abdi Farma is available in blisters packed in cardboard boxes containing 28, 56, 60, 112 or 120 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Abdi Farma GmbH
Donnersbergstraße 4
64646 Heppenheim
Germany
Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Flavine Pharma France
3 Voie d'Allemagne
13127 Vitrolles
France