300 mg film-coated tablets
darolutamide
What NUBEQA is and what it is used for
NUBEQA contains the active substance darolutamide. It is used to treat adult men with prostate cancer who have not spread to other parts of the body and no longer respond to medical or surgical treatment that lowers testosterone levels (also called castration-resistant prostate cancer).
How NUBEQA works
NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. By blocking these hormones, darolutamide prevents prostate cancer cells from growing and dividing.
What you need to know before using NUBEQA
Do not take NUBEQA again
- you are allergic to darolutamide or any of the other ingredients of this medicine (listed in section 6)
- you are a woman and are or may become pregnant.
Warnings and cautions
Talk to your doctor or pharmacist before taking NUBEQA again
- you have kidney problems
- you have liver problems
- you have any heart condition including heart rhythm problems or if you are taking medicines for these conditions
- you have undergone surgery to treat vascular disease.
Children and young people
This medicine should not be used by children and adolescents under 18 years of age. Prostate cancer does not occur in this age group.
Other medicines and NUBEQA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The following medicines may affect the effect of NUBEQA, or NUBEQA may affect the effectiveness of these medicines used to treat:
- bacterial infections, such as rifampicin
- epilepsy , such as carbamazepine, phenobarbital, phenytoin
- symptoms of mild depression and mild anxiety: St. John’s wort (a (traditional) herbal medicine)
- high cholesterol , such as rosuvastatin, fluvastatin, atorvastatin, pitavastatin
- severe arthritis, severe cases of skin disease psoriasis and cancer: methotrexate
- inflammatory bowel disease: sulfasalazine
The doctor can thus change the dose of one of the medicines you are taking.
Pregnancy, breastfeeding and fertility
NUBEQA should not be used by women.
This medicine may affect male fertility.
Follow these tips during the treatment and for 1 week after you have finished the treatment
- use a very effective method of contraception to prevent pregnancy, if you have intercourse with a woman who may become pregnant.
- use a condom to protect the unborn baby if you have intercourse with a pregnant woman.
Driving and using machines
This medicine is unlikely to affect your ability to drive or 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.
How to use NUBEQA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
2 tablets 2 times a day
Your doctor may reduce your dose to 1 tablet twice a day if you have liver or kidney problems.
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 treatment with the next dose as planned.
If you forget to take NUBEQA
Take the missed dose as soon as you remember it before the next scheduled dose. Do not take a double dose to make up for a forgotten tablet.
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 product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects of NUBEQA with the following occurrence:
Very common side effects ( may affect more than 1 in 10 people):
- fatigue
Common side effects ( may affect up to 1 in 10 people):
- blockage of the arteries of the heart
- heart failure
- rash
- pain in arms and legs
- pain in muscles and bones
- fracture
Very common side effects that may show up in blood tests:
- decreased number of white blood cells of a type called neutrophils
- increased amount in the blood of substances formed by the liver: bilirubin , aspartate transaminase ( ASAT )
How to store NUB
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and each blister after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
The active substance is darolutamide. Each film-coated tablet contains 300 mg darolutamide.
Other ingredients are:
- calcium hydrogen phosphate (E 341)
- croscarmellose sodium
- hypromellos
- lactose monohydrate
- macrogol (E 1521)
- magnesium stearate (E 470b)
- povidone (E 1201)
- titanium dioxide (E 171)
See “NUBEQA contains lactose” in section 2 for more information.
What the medicine looks like and contents of the pack
The film-coated tablets (tablets) are white to off-white, oval, 16 mm long and
8 mm wide. They are marked with “300” on one side and “BAYER” on the other.
Each box contains:
- 96 film-coated tablets in 6 blisters or
- 112 film-coated tablets divided into 7 blisters
Each blister contains 16 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Orion Corporation, Orion Pharma
24100 Salo
Finland