Patient leaflet - Nubeqa 300 mg film-coated tablets
1. 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 that: R 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)
or
R 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).
For this, your doctor may also give you docetaxel.
How NUBEQA works
NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone. Androgens can cause the prostate cancer to grow. By blocking these hormones, darolutamide stops prostate cancer cells from growing and dividing.
2. What you need to know before you take NUBEQA
Do not take NUBEQA if
R you are allergic to darolutamide or any of the other
ingredients of this medicine (listed in section 6) R you are a woman who is or may become pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before taking NUBEQA if R you have ever had seizures
R you have problems with your kidneys
R you have problems with your liver
R you have narrowing of arteries in the heart, or any
heart conditions including heart rhythm problems or if you are using medicines for these conditions R you had a surgery to treat blood vessel conditions R if you have high blood pressure.
Taking this medicine may affect your liver function. If your blood tests show abnormal results of your liver function, your doctor may decide that you stop taking NUBEQA 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines may influence the effect of NUBEQA, or NUBEQA may influence the effect of these medicines. These medicines are typically used to treat: R bacterial infections, such as rifampicin R epilepsy, such as carbamazepine, phenobarbital,
phenytoin
R slightly low mood and mild anxiety: St. John’s wort
(a herbal medicine)
R high cholesterol, such as rosuvastatin, fluvastatin,
atorvastatin, pitavastatin
R severe joint inflammation, severe cases of the skin
disease psoriasis, and cancers: methotrexate R 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 reduce male fertility.
Follow these advices during and for 1 week after stopping:
R use a condom or another highly effective method of
birth control to prevent pregnancy, if you are having sex with a woman who can become pregnant. Ask your doctor about the best method of birth control for you. R 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.
3. How to take NUBEQA
Always take this medicine 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. Do not take more than 4 tablets per day.
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 – do not split or crush them. Take the tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediately contact your doctor if you experience any of the following serious side effects: R Chest pain, pain in other parts of the body (spreading
from your chest to your arms, jaw, neck, back and tummy), feeling lightheaded or dizzy, sweating, shortness of breath, feeling sick (signs of heart disease caused by blockage of the blood vessels in the heart).
R Breathlessness after activity or at rest, tiredness
most of the time, feeling lightheaded or fainting and swelling of the ankles and legs (signs of heart failure). R Seizures
Please contact your doctor if symptoms that are occasionally related to signs of liver injury like, feeling sick (nausea), vomiting, abdominal discomfort or loss of appetite persist, yellowing of the skin or eyes and darkening of the urine occur.
Side effects of NUBEQA occur with the following frequencies:
In patients with non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer
Very common side effects (may affect more than 1 in 10 people):
R tiredness
R blood tests showing reduced number of a white blood
cell type called neutrophils
R blood tests showing increased levels of substances
produced by the liver: bilirubin, alanine transaminase and aspartate transaminase
R blood tests showing reduced number of red blood cells
Common side effects (may affect up to 1 in 10 people): R rash
R pain in arms and legs
R broken bones
Other side effects that have been reported with frequency not known (frequency cannot be estimated from the available data):
R swelling under the skin in areas such as the face, lips,
tongue and throat.
In patients with metastatic hormone-sensitive prostate cancer when used in combination with docetaxel
Very common side effects (may affect more than 1 in 10 people):
R high blood pressure
R rash
R blood tests showing increased levels of substances
produced by the liver: bilirubin, alanine aminotransferase and aspartate transaminase Other side effects that have been reported with frequency not known (frequency cannot be estimated from the available data):
R swelling under the skin in areas such as the face, lips,
tongue and throat.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store NUBEQA
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 on each blister after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What NUBEQA contains
The active substance is darolutamide. Each film-coated tablet contains 300 mg of darolutamide.
The other ingredients are:
R calcium hydrogen phosphate (E 341)
R croscarmellose sodium
R hypromellose
R lactose monohydrate
R macrogol (E 1521)
R magnesium stearate (E 470b)
R povidone (E 1201)
R titanium dioxide (E 171)
See “NUBEQA contains lactose” in section 2 for more information.
What NUBEQA looks like and contents of the pack
The film-coated tablets (tablets) are white to off-white, oval with a length of 16 mm and a width of 8 mm. They are marked with “300” on one side, and “BAYER” on the other side.
Each carton contains 112 film-coated tablets consisting of 7 blisters, each with 16 film-coated tablets.
Marketing Authorisation Holder
Bayer plc
400 South Oak Way
Reading, RG2 6AD
Manufacturer
The manufacturer can be identified by the batch number printed on the carton and on each blister:
R If the characters are numbers only, the manufacturer is
Orion Corporation, Orion Pharma
24100 Salo
Finland
R If the first and second characters are BX, the manufacturer is
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Bayer plc
Tel: +44-(0)118 206 3000
This leaflet was last revised in 07/2026.
B
305x626-004808