Before you take Abiraterone ACTe

Do not take Abiraterone ACTe

• If you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
• If you are a woman, especially if pregnant. Abiraterone ACTe is for use in male patients only.
• If you have severe liver damage.
• In combination with Ra-223 (which is used to treat prostate cancer).
• Warnings and precautions
• Talk to your doctor before taking Abiraterone ACTe:
• If you have liver problems
• If you have been told you have high blood pressure or heart failure or low blood potassium (low blood potassium may increase the risk of heart rhythm problems)
• If you have other heart or blood vessel problems
• If you have an irregular or rapid heart rate
• If you have shortness of breath
• If you have gained weight rapidly
• If you have swelling in the feet, ankles, or legs
• If you have taken a medicine known as ketoconazole in the past for prostate cancer
• If you need to take this medicine with prednisone or prednisolone
• If you need to know about possible effects on your bones
• If you have high blood sugar
• If you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions
• If you have decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur
• If you have yellowing of the skin or eyes, darkening of the urine, or severe nausea or vomiting, as these could be signs or symptoms of liver problems. Rarely, failure of the liver to function (acute liver failure) may occur, which can lead to death
• If you plan to take Ra-223 following treatment with Abiraterone ACTe and prednisone/prednisolone, you must wait 5 days before starting treatment with Ra-223; Abiraterone ACTe must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.

Blood monitoring: Abiraterone ACTe may affect your liver, and you may not have any symptoms. When you are taking this medicine, your doctor will check your blood periodically to look for any effects of this medicine on your liver.

Children and adolescents

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

Other medicines and Abiraterone ACTe

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and even those not prescribed. This is important because Abiraterone ACTe may increase the effects of a number of medicines including heart medicines, tranquilizers, herbal medicines (e.g., St John’s wort) and others. Your doctor may want to change the dose of these medicines. In addition, some medicines may increase or decrease the effects of Abiraterone ACTe. This may lead to side effects or to Abiraterone ACTe not working as well as it should.

Androgen deprivation treatment may increase the risk of heart rhythm problems. Tell your doctor if you are receiving medicine used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol); known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].

Abiraterone ACTe with food

This medicine must not be taken with food. Taking Abiraterone ACTe with food may cause side effects.

Pregnancy and breast-feeding

Abiraterone ACTe is not for use in women.

This medicine may cause harm to the unborn child if it is taken by pregnant women.

If you are having sex with a woman who can become pregnant, use a condom and other effective birth control methods.

If you are having sex with a pregnant woman, use a condom to protect the unborn child.

Driving and using machines

This medicine is not likely to affect your being able to drive and use any tools or machines.

Abiraterone ACTe contains lactose and sodium

Abiraterone ACTe contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine also contains sodium. To be taken into consideration by patients on a controlled sodium diet.