Prescription Information for the Patient

NUBEQA 300Film-Coated Tablets

darolutamida

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section4.

NUBEQA contains the active ingredient darolutamida.

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 any medical or surgical treatment that reduces testosterone (also known as non-metastatic castration-resistant prostate cancer)
• have spread to other parts of the body and respond to medical or surgical treatment that reduces testosterone (also known as 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, darolutamida prevents prostate cancer cells from growing and dividing.

Do not take NUBEQA if

• you are allergic to darolutamide or any of the other components of this medication (listed in section6);
• you are a woman and are or may become pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take NUBEQA if

• you have kidney problems;
• you have liver problems;
• you have heart problems, including heart rhythm problems, or if you are using medications for these conditions;
• you have undergone surgery to treat blood vessel problems.

This medication may affect your liver tests. If your blood tests show abnormal liver function results, your doctor may decide to permanently discontinue treatment.

Children and adolescents

This medication is not for use in children and adolescents under 18years. Prostate cancer does not occur in this age group.

Other medications and NUBEQA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The following medications may affect the effect of NUBEQA, or NUBEQA may affect the effect of these medications to treat:

• bacterial infections, such asrifampicin
• epilepsy, such ascarbamazepine,phenobarbital,phenytoin
• mildly depressed mood and anxiety symptoms:St. John's Wort(a herbal medication)
• high cholesterol, such asrosuvastatin, fluvastatin, atorvastatin, pitavastatin
• severe joint inflammation, severe skin disease psoriasis, and cancers:methotrexate
• inflammatory bowel diseases:sulfasalazine

Your doctor may change the dose of the medications you are taking.

Pregnancy, breastfeeding, and fertility

NUBEQA is not for use in women.

This medication may affect male fertility.

Follow these guidelines during and up to one week after completing treatment:

• Use a highly effective contraceptive method to prevent pregnancy if you have sex with a fertile woman;
• Use a condom to protect the fetus if you have sex with a pregnant woman.

Driving and operating machinery

This medication is unlikely to affect your ability to drive or operate machinery.

NUBEQA contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is

2tablets 2times a day.

Your doctor may reduce your dose to 1tablet 2times a day if you have liver or kidney problems.

Method of use

Swallow the tablets whole, take them with food and a glass of water.

Your doctor may also prescribe other medications while you are taking NUBEQA.

If you take more NUBEQA than you should

Continue treatment with the next dose as scheduled.

If you forgot to take NUBEQA

Take the 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 missed doses.

If you interrupt treatment with NUBEQA

Do not stop taking your medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects of NUBEQA occur with the following frequencies:

In patients with non-metastatic castration-resistant prostate cancer

Very common adverse effects(may affect more than 1 in 10people):

• fatigue
• reduction in the number of a type of white blood cell called neutrophils in the blood test
• increase in substances produced by the liver: bilirubin, aspartate transaminase in the blood test

Common adverse effects(may affect up to 1 in 10people):

• blockage of the coronary arteries
• heart failure

• skin rash
• pain in arms and legs
• muscle and bone pain
• bone fractures

In patients with metastatic hormone-sensitive prostate cancer

Very common adverse effects(may affect more than 1 in 10people):

• high blood pressure
• skin rash
• decrease in the number of a type of white blood cell called neutrophilsin the blood test
• increase in substances produced by the liver: bilirubin, alanine transaminase, and aspartate transaminase in the blood test

Common adverse effects(may affect up to 1 in 10people):

• bone fractures
• gynecomastia in men

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on each blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

NUBEQA Composition

The active ingredient is darolutamide. Each film-coated tablet contains 300mg of darolutamide.

The other components are:

• calcium hydrogen phosphate (E341)
• sodium croscarmellose
• hypromellose
• lactose monohydrate
• macrogol (E1521)
• magnesium stearate (E470b)
• povidone (E1201)
• titanium dioxide (E171)

For more information, see “NUBEQA contains lactose” in section2.

Appearance of the product and contents of the pack

The film-coated tablets (tablets) are white or off-white, oval, 16mm long by 8mm wide. Printed with “300” on one face and with “BAYER” on the other.

Each box contains 112film-coated tablets consisting of 7blister packs, each containing 16film-coated tablets.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Orion Corporation, Orion Pharma

24100 Salo

Finland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.