Nubeqa
Italy
Table of Contents
Package leaflet: Information for the patient
NUBEQA 300 mg film-coated tablets
darolutamide
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What NUBEQA is and what it is used for
- What you need to know before taking NUBEQA
- How to take NUBEQA
- Possible side effects
- How to store NUBEQA
- Contents of the pack and other information
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 who:
- have cancer that has not spread to other parts of the body and no longer responds to medical or surgical treatments aimed at reducing testosterone levels (also known as non-metastatic castration-resistant prostate cancer), or
- have cancer that has spread to other parts of the body and still responds to medical or surgical treatments aimed at reducing testosterone levels (also known as metastatic hormone-sensitive prostate cancer). In this case, your doctor may also prescribe docetaxel.
How NUBEQA works
NUBEQA blocks the activity of male sex hormones called androgens, such as testosterone.
Androgens can cause prostate cancer to grow. By blocking these hormones,
darolutamide stops the growth and division of prostate cancer cells.
2. What you need to know before taking NUBEQA
Do not take NUBEQA if
- you are allergic to darolutamide or to any of the other ingredients of this medicine (listed in section 6),
- you are a woman of childbearing age or pregnant.
Warnings and precautions
Talk to your doctor or pharmacist before taking NUBEQA if
- you have kidney problems,
- you have liver problems,
- you have any heart disease, including heart rhythm problems or if you are taking medicines for these conditions,
- you have undergone surgery for blood vessel diseases.
Taking this medicine may affect liver function. If blood tests show abnormal liver function results, your doctor may decide that you must permanently stop taking NUBEQA.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
Prostate cancer does not occur in this age group.
Other medicines and NUBEQA
Inform 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 therapeutic effect of these medicines. These medicines are usually used to treat:
- bacterial infections, such as rifampicin
- epilepsy, such as carbamazepine, phenobarbital, phenytoin
- mild depression 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 carcinomas: methotrexate
- inflammatory bowel disease: sulfasalazine
Therefore, your doctor may need to adjust the dose of the medicines you are taking.
Pregnancy, breastfeeding and fertility
NUBEQA must not be used in women.
This medicine may reduce male fertility.
Follow these recommendations during treatment and for 1 week after treatment:
- if you have sexual intercourse with a woman of childbearing age, use a condom or another highly effective contraceptive method to prevent pregnancy. Ask your doctor to advise you on the most suitable contraceptive method for you.
- if you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery.
NUBEQA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
3. How to take NUBEQA
Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
The recommended dose is
2 tablets twice daily. Do not take more than 4 tablets per day.
Your doctor may reduce your dose to 1 tablet twice daily if you have liver or
kidney problems.
Method of administration
Swallow the tablets whole, without dividing or crushing them. Take the tablets with food and
with 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 scheduled.
If you forget to take NUBEQA
Take the missed dose as soon as you remember, provided that it is before the time of the next scheduled dose. Do not
take a double dose to make up for the forgotten tablet or tablets.
If you stop taking NUBEQA
Do not stop treatment with this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of NUBEQA occur with the following frequencies:
Very common side effects (may occur in more than 1 in 10 people):
- tiredness
- blood tests showing a reduced number of a type of white blood cells called neutrophils
- blood tests showing increased levels of substances produced by the liver: bilirubin, alanine transaminase and aspartate transaminase
Common side effects (may occur in up to 1 in 10 people):
- blockage of the heart arteries
- heart failure
- rash
- pain in arms and legs
- broken bones
The side effects of NUBEQA used in combination with docetaxel occur with the following frequencies:
Very common side effects (may occur in more than 1 in 10 people):
- high blood pressure
- rash
- blood tests showing a reduced number of white blood cells 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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system listed in Annex V. 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 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What NUBEQA contains
The active substance is darolutamide. Each film-coated tablet contains 300 mg of darolutamide.
The other components are:
- calcium phosphate (E 341)
- sodium croscarmellose
- 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 further information.
Description of the appearance of NUBEQA and contents of the pack
The film-coated tablets (tablets) are white to off-white, oval, 16 mm in length and 8 mm in width. They are marked with “300” on one side and “BAYER” on the other.
Each box contains 112 film-coated tablets divided into 7 blisters, each containing 16 film-coated tablets.
Marketing Authorisation Holder
Bayer AG
51368 Leverkusen
Germany
Manufacturer
Orion Corporation, Orion Pharma
24100 Salo
Finland
Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-5356311 Tel. +37 05 23 36 868
България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359 (0)2 424 72 80 Tél/Tel: +32-(0)2-535 63 11
Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel: +36 14 87-41 00
Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf: +45 45 23 50 00 Tel: +35 621 44 62 05
Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: +31-23-799 1000
Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 24 11 18 00
Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30 210-618 75 00 Tel: +43-(0)1-711 46-0
España Polska
Bayer Hispania S.L. Bayer Sp. z.o.o.
Tel: +34-93-495 65 00 Tel: +48 22 572 35 00
France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00
Hrvatska România
Bayer d.o.o. SC Bayer s.r.l.
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00
Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 1 58 14 400
Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel. +421 2 59 21 31 11
Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 81 Puh/Tel: +358 20 785 21
Κύπρος Sverige
NOVAGEM Limited Bayer AB
Tηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 84 55 63
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu.