NUBEQA 300 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

NUBEQA 300mg film-coated tablets

darolutamida

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is NUBEQA and what is it used for

NUBEQA contains the active substance darolutamida.

It is used to treat adult men with prostate cancerthat:

• has not spread to other parts of the body and no longer responds to any 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).

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 prostate cancer to grow. By blocking these hormones, darolutamida prevents prostate cancer cells from growing and dividing.

2. What you need to know before you take NUBEQA

Do not take NUBEQA if

• you are allergic to darolutamida or any of the other ingredients of this medicine (listed in section 6);
• you are a woman and are or may become pregnant.

Warnings and precautions

Tell your doctor or pharmacist before you start taking NUBEQA if

• you have kidney problems;
• you have liver problems;
• you have heart problems, including heart rhythm problems, or if you are taking medicines for these conditions;
• you have had surgery to treat blood vessel problems.

Taking this medicine may affect your liver function. If your blood tests show abnormal liver function results, your doctor may decide to stop your treatment with 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 affect the effect of NUBEQA, or NUBEQA may affect the effect of these medicines. These medicines are commonly used to treat:

• bacterial infections, such as rifampicin
• epilepsy, such as carbamazepine, phenobarbital, phenytoin
• mildly depressed mood and mild anxiety: St. John's Wort(a herbal medicine)
• high cholesterol, such as rosuvastatin, fluvastatin, atorvastatin, pitavastatin
• severe joint inflammation, severe skin disease psoriasis and cancer: methotrexate
• inflammatory bowel disease: sulfasalazine

Therefore, your doctor may change the dose of the medicines you are taking.

Pregnancy, breast-feeding and fertility

NUBEQA is not for use in women.

This medicine may reduce male fertility.

Follow these tips during and up to one week after finishing treatment:

• Use a condom or other highly effective contraceptive method to prevent pregnancy if you have sex with a woman of childbearing age. Ask your doctor which contraceptive method is best for you.
• Use a condom to protect the fetus if you have sex with a pregnant woman.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

NUBEQA contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take NUBEQA

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose is

2 tablets 2 times a day. Do not take more than 4 tablets per day.

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

Method of administration

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 you other medicines while you are taking NUBEQA.

If you take more NUBEQA than you should

Continue treatment with the next scheduled dose.

If you forget 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 stop taking NUBEQA

Do not stop taking your 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.

The side effects of NUBEQA are as follows:

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

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

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

• blockage of the heart arteries
• heart failure

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

The side effects of NUBEQA when used in combination with docetaxelare as follows:

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

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

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

• bone fractures
• breast enlargement in men

Reporting of side effects

If you experience 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.

5. Storage of 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 is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What NUBEQA contains

The active substance is darolutamida. Each film-coated tablet contains 300 mg of darolutamida.

The other ingredients are:

• calcium hydrogen phosphate (E 341)
• croscarmellose sodium
• hypromellose
• macrogol (E 1521)
• magnesium stearate (E 470b)
• povidone (E 1201)
• titanium dioxide (E 171)

For more information, see “NUBEQA contains lactose” in section 2.

Appearance and packaging

The film-coated tablets (tablets) are white or almost white, oval, 16 mm long and 8 mm wide. They are engraved with “300” on one side and with “BAYER” on the other.

Each carton contains 112 film-coated tablets, which consist 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 only numbers, 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

You can get more information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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