NUBEQA 300 MG FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

NUBEQA 300mg film-coated tablets

darolutamide

Read the entire leaflet carefully before you start taking this medicine, because 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What NUBEQA is and what it is used for
2. What you need to know before taking NUBEQA
3. How to take NUBEQA
4. Possible side effects
5. How to store NUBEQA
6. 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 is no longer responding to any medical or surgical treatments that lower testosterone (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 that lower testosterone (also known as metastatic hormone-sensitive prostate cancer).

In this case, your doctor may also administer docetaxel to you.

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 prevents prostate cancer cells from growing and dividing.

2. What you need to know before taking NUBEQA

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 and are or may become pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before taking NUBEQA if

• you have kidney problems;
• you have liver problems;
• you have heart problems, including irregular heart rhythm, or if you are taking medicines for these conditions;
• you have undergone 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 permanently discontinue treatment with 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may affect the action of NUBEQA, or NUBEQA may affect the action of these medicines. These medicines are commonly 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 cancers: methotrexate
• inflammatory bowel diseases: sulfasalazine

Therefore, your doctor may need to adjust the dose of the medicines you are taking.

Pregnancy, breastfeeding and fertility

NUBEQA is not for use in women.

This medicine may reduce male fertility.

Follow these recommendations during treatment and for one week after stopping treatment:

• Use a condom or another highly effective method of contraception to prevent pregnancy if you have sexual intercourse with a woman of childbearing potential. Ask your doctor which contraceptive method is best for you.
• Use a condom to protect the fetus if you have sexual intercourse 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 diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take NUBEQA

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 splitting or crushing them. Take the tablets 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 scheduled dose.

If you forget to take NUBEQA

Take the missed dose as soon as you remember, provided the next scheduled dose is not due. Do not take a double dose to make up for one or more missed doses.

If you stop taking NUBEQA

Do not stop taking this medicine unless instructed by your doctor.

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

4. Possible adverse effects

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

The adverse effects of NUBEQA occur with the following frequencies:

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

• fatigue
• reduction in the number of a type of white blood cells called neutrophils in blood tests
• increased levels of substances produced by the liver: bilirubin, alanine transaminase, and aspartate transaminase in blood tests

Common adverse 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 adverse effects of NUBEQA when used in combination with docetaxel occur with the following frequencies:

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

• high blood pressure
• skin rash
• decrease in the number of a type of white blood cells called neutrophils in blood tests
• increased levels of substances produced by the liver: bilirubin, alanine transaminase, and aspartate transaminase in blood tests

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

• bone fractures
• breast enlargement in men

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and on each blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the container and other information

Composition of NUBEQA

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

The other components are:

• calcium hydrogen phosphate (E 341)
• sodium croscarmellose
• hypromellose
• lactose monohydrate
• 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 of the product and contents of the container

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

Each carton contains 112 film-coated tablets, consisting of 7 blisters, each containing 16 film-coated tablets.

Marketing Authorization 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

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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