Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nubeqa

Document Subject

Generated Narrative: MedicinalProductDefinition mp1cafc851e1f0aed5863b6a73ba46d0f7

identifier: http://ema.europa.eu/identifier/EU/1/20/1432/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NUBEQA 300 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1cafc851e1f0aed5863b6a73ba46d0f7

identifier: http://ema.europa.eu/identifier/EU/1/20/1432/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nubeqa

Attesters

What is in this leaflet

1. What NUBEQA is and what it is used for
2. What you need to know before you take NUBEQA
3. How to take NUBEQA
4. Possible side effects
5. How to store NUBEQA
6. Contents of the pack and other information

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 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 to treat:

• bacterial infections, such as rifampicin
• epilepsy, such as carbamazepine, phenobarbital, 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.

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

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.

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

Side effects of NUBEQA occur with the following frequencies:

In patients with non-metastatic castration-resistant prostate cancer 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, 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
• pain in muscles and bones
• broken bones

In patients with metastatic hormone-sensitive prostate cancer 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:

• 96 film-coated tablets consisting of 6 blisters or
• 112 film-coated tablets consisting of 7 blisters

Each blister contains 16 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany

Manufacturer Orion Corporation, Orion Pharma 24100 Salo Finland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Bayer SA-NV T l/Tel: +32-(0)2-5356Lietuva UAB Bayer Tel. +37 05 23 36

T .: +359 (0)2 424 72 Luxembourg/Luxemburg Bayer SA-NV T l/Tel: +32-(0)2-535 63 esk republika Bayer s.r.o. Tel: +420 266 101 Magyarorsz g Bayer Hung ria KFT Tel:+36 14 87-41 Danmark Bayer A/S Tlf: +45 45 23 50 Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 Nederland Bayer B.V. Tel: +31-23-799 1Eesti Bayer O
Tel: +372 655 8Norge Bayer AS Tlf: +47 24 11 18
Bayer
: +30 210-618 75 sterreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 Espa a Bayer Hispania S.L. Tel: +34-93-495 65 Polska Bayer Sp. z.o.o. Tel: +48 22 572 35 France Bayer HealthCare T l (N vert): +33-(0)800 87 54 Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 Rom nia SC Bayer s.r.l. Tel: +40 21 529 59 Ireland Bayer Limited Tel: +353 1 216 3Slovenija Bayer d. o. o. Tel: +386 1 58 14 sland Icepharma hf. S mi: +354 540 8Slovensk republika Bayer spol. s r.o. Tel. +421 2 59 21 31 Italia Bayer S.p.A. Tel: +39 02 397 Suomi/Finland Bayer Oy Puh/Tel: +358 20 785
NOVAGEM Limited T : +357 22 48 38 Sverige Bayer AB Tel: +46 (0) 8 580 223 Latvija SIA Bayer Tel: +371 67 84 55 United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: