darolutamide: package leaflet

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) or
- 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.

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 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:
- bacterial infections, such as rifampicin
- epilepsy, such as carbamazepine, phenobarbital, phenytoin
- 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 decrease male fertility.
Follow these advices during and for 1 week after stopping:
- 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.
- 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.

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects of NUBEQA occur with the following frequencies:
Very common side effects (may affect more than 1 in 10 people):
- 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, alanine transaminase and aspartate transaminase

Common side effects (may affect up to 1 in 10 people):
- blockage of the arteries in the heart
- heart failure
- rash
- pain in arms and legs
- broken bones

Side effects of NUBEQA when used in combination with docetaxel occur with the following frequencies:
Very common side effects (may affect more than 1 in 10 people):
- 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

Common side effects (may affect up to 1 in 10 people):
- broken bones
- breast enlargement in men

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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.

What NUBEQA contains
The active substance is darolutamide. Each film-coated tablet contains 300 mg of darolutamide.
The other ingredients are:
- calcium hydrogen phosphate (E 341)
- croscarmellose sodium
- hypromellose
- 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 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 AG
51368 Leverkusen
Germany

Manufacturer

The manufacturer can be identified by the batch number printed on the carton and on each blister:

- If the characters are numbers only, the manufacturer is
Orion Corporation, Orion Pharma
24100 Salo
Finland

- 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:

België/Belgique/Belgien
Bayer SA-NV
Tél/Tel: +32-(0)2-5356311
Lietuva
UAB Bayer
Tel. +37 05 23 36 868
България
Байер България ЕООД
Tел.: +359 (0)2 424 72 80
Luxembourg/Luxemburg
Bayer SA-NV
Tél/Tel: +32-(0)2-535 63 11
Česká republika
Bayer s.r.o.
Tel: +420 266 101 111
Magyarország
Bayer Hungária KFT
Tel:+36 14 87-41 00
Danmark
Bayer A/S
Tlf: +45 45 23 50 00
Malta
Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05
Deutschland
Bayer Vital GmbH
Tel: +49 (0)214-30 513 48
Nederland
Bayer B.V.
Tel: +31-23-799 1000
Eesti
Bayer OÜ
Tel: +372 655 8565
Norge
Bayer AS
Tlf: +47 24 11 18 00
Ελλάδα
Bayer Ελλάς ΑΒΕΕ
Τηλ: +30 210-618 75 00
Österreich
Bayer Austria Ges.m.b.H.
Tel: +43-(0)1-711 46-0
España
Bayer Hispania S.L.
Tel: +34-93-495 65 00
Polska
Bayer Sp. z.o.o.
Tel: +48 22 572 35 00
France
Bayer HealthCare
Tél (N° vert): +33-(0)800 87 54 54
Portugal
Bayer Portugal, Lda.
Tel: +351 21 416 42 00
Hrvatska
Bayer d.o.o.
Tel: +385-(0)1-6599 900
România
SC Bayer s.r.l.
Tel: +40 21 529 59 00
Ireland
Bayer Limited
Tel: +353 1 216 3300
Slovenija
Bayer d. o. o.
Tel: +386 1 58 14 400
Ísland
Icepharma hf.
Sími: +354 540 8000
Slovenská republika
Bayer spol. s r.o.
Tel. +421 2 59 21 31 11
Italia
Bayer S.p.A.
Tel: +39 02 397 81
Suomi/Finland
Bayer Oy
Puh/Tel: +358 20 785 21
Κύπρος
NOVAGEM Limited
Tηλ: +357 22 48 38 58
Sverige
Bayer AB
Tel: +46 (0) 8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 84 55 63

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.