Bixodalan contains an active substance called abiraterone acetate. The medicine is used to treat prostate cancer in adult men that has spread to other parts of the body and also to treat prostate cancer in adult men that has not spread to other parts of the body. Bixodalan stops your body from producing testosterone; this may slow down the growth of prostate cancer.

When Bixodalan is prescribed for the early stage of the disease where it still responds to hormone therapy, it is used together 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 will reduce the chance of you getting high blood pressure, water retention in your body (fluid retention) or low levels of a chemical in your blood called potassium.

Do not take Bixodalan:
- if you are allergic to abiraterone acetate or any of the other ingredients of this medicine.

Pregnancy and breastfeeding:
Bixodalan is not recommended for use in women.
- This medicine may harm the unborn baby if taken by women who are pregnant.
- Women who are pregnant or who may become pregnant should wear protective gloves if they need to touch or handle Bixodalan.
- If you have sexual activity with a woman who could become pregnant, use a condom and another effective contraceptive method.
- If you have sexual activity with a pregnant woman, use a condom to protect the unborn child.

Driving and using machines:
This medicine is unlikely to affect your ability to drive or use machines.

Bixodalan contains lactose and sodium
- Bixodalan 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 contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

Always take this medicine exactly as your doctor or pharmacist has told you.
Talk to your doctor or pharmacist if you are not sure.

How much should you take:
The recommended dose is 1000 mg (one tablet) taken once a day.

Use of this medicine:
- Take this medicine by mouth.
- Do not take Bixodalan with food. Taking Bixodalan with food may cause the body to absorb more of the medicine than necessary and this may cause side effects.
- Take Bixodalan as a single dose once a day, on an empty stomach. Bixodalan should be taken at least two hours after eating, and food should not be consumed for at least one hour after taking Bixodalan (see section 2 “Bixodalan with food”).
- Swallow the tablets with a glass of water. The tablet can be divided into two equal doses.
- Bixodalan should be taken together with a medicine called prednisone or prednisolone.
Take prednisone or prednisolone exactly as your doctor tells you.
- You must take prednisone or prednisolone every day during treatment with Bixodalan.
- If you have a medical emergency, it may be necessary to change the dose of prednisone or prednisolone you are taking. Your doctor will tell you if you need to change the dose of prednisone or prednisolone you are taking. Do not stop taking prednisone or prednisolone unless your doctor tells you to.
Your doctor may also prescribe other medicines while you are taking Bixodalan and prednisone or prednisolone.

- The active substance is abiraterone acetate. Each tablet contains 1000 mg of abiraterone acetate.
- The other components are:
Tablet core: Croscarmellose sodium (E468), sodium lauryl sulfate, povidone (E1201), microcrystalline cellulose (E460), lactose monohydrate, colloidal anhydrous silica (E551), magnesium stearate (E470b) (see section 2 “Bixodalan contains lactose and sodium”).
Film coating: Polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b)

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

30 film-coated tablets