Nubeqa 300 mg Film-Coated Tablets

NUBEQA contains the active substance darolutamide. It is used to treat adult men with prostate cancer that :

• has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (also called non - metastatic castration - resistant prostate cancer)
• has spread to other parts of the body and responds to medical or surgical treatment that lowers testosterone (also called metastatic hormone - sensitive prostate cancer).

How NUBEQA works

NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. By blocking these hormones, darolutamide stops prostate cancer cells from growing and dividing.

Do not take NUBEQA if

• you are allergic to darolutamide or any of the other ingredients of this medicine (listed in section 6)
• you are a woman who is or may become pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before taking NUBEQA if

• you have problems with your kidneys
• you have problems with your liver
• you have any heart conditions including heart rhythm problems or if you are using medicines for these conditions
• you had a surgery to treat blood vessel conditions.

Taking this medicine may affect your liver tests. If your blood tests show abnormal results of your liver function, your doctor may decide to stop treatment permanently.

Children and adolescents

This medicine is not for use in children and adolescents under 18 years. Prostate cancer does not occur in this age group.

Other medicines and NUBEQA

Always tell your health care provider if you are taking any other medicines. This includes all complementary or traditional medicines. The following medicines may influence the effect of NUBEQA, or NUBEQA may influence the effect of these medicines to treat:

• bacterial infections, such as rifampicin
• epilepsy, such as carbamazepine, phenobarbitone, phenytoin
• symptoms of slightly low mood and mild anxiety: St. John's wort (a herbal medicine)
• high cholesterol, such as rosuvastatin, fluvastatin, atorvastatin, pitavastatin
• severe joint inflammation, severe cases of the skin disease psoriasis, and cancers: methotrexate
• inflammatory bowel diseases: sulfasalazine

Your doctor may therefore change the dose of the medicines that you are taking.

Pregnancy, breast - feeding and fertility

NUBEQA is not for use in women. This medicine could possibly have an effect on male fertility. Follow these advices during and for 1 week after stopping:

• use a highly effective method of contraception to prevent pregnancy, if you are having sex with a woman who can become pregnant.
• use a condom to protect the unborn baby, if you are having sex with a pregnant woman.

Driving and using machines

This medicine is unlikely to affect your ability to drive and use machines.

NUBEQA contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Do not share medicines prescribed for you with any other person. Always take NUBEQA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 2 tablets 2 times daily. Your doctor may reduce your dose to 1 tablet 2 times daily, if you have problems with your liver or kidneys.

Method of use

Swallow the tablets whole, take them with food and a glass of water. Your doctor may also prescribe other medicines while you are taking NUBEQA.

If you take more NUBEQA than you should

Continue the treatment with the next dose as scheduled.

If you forget to take NUBEQA

Take your missed dose as soon as you remember before the next scheduled dose. Do not take a double dose to make up for 1 or more forgotten tablets.

If you stop taking NUBEQA

Do not stop taking this medicine unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

NUBEQA can have side effects. Not all side effects reported for NUBEQA are included in this leaflet. Should your general health worsen or if you experience any untowrd effects while taking NUBEQA, please consult your health care provider for advice.

Side effects of NUBEQA occur with the following frequencies:

In patients with non - metastatic castration - resistant prostate cancer

Frequent side effects:

• tiredness
• blood tests showing reduced number of a white blood cell type called neutrophils
• blood tests showing increased levels of substances produced by the liver: bilirubin, aspartate transaminase
• blockage of the arteries in the heart
• heart failure
• rash
• pain in arms and legs
• pain in muscles and bones
• broken bones

In patients with metastatic hormone sensitive prostate cancer

Frequent side effects:

• high blood pressure
• rash
• blood tests showing reduced number of a white blood cell type called neutrophils
• blood tests showing increased levels of substances produced by the liver: bilirubin, alanine transaminase and aspartate transaminase
• broken bones
• breast enlargement in men

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. Alternatively, you can report to Bayer SafeTrack site (https://www.safetrack - public.bayer.com). By reporting side effects, you can help provide more information on the safety of NUBEQA.

Keep this medicine out of the sight and reach of children. Store at or below 30 °C. Do not use this medicine after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.