Package leaflet: Information for the user

Erleada 60 mg film-coated tablets

apalutamide
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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet

What Erleada is and what it is used for
What you need to know before taking Erleada
How to take Erleada
Possible side effects
How to store Erleada
Contents of the pack and other information

1. What Erleada is and what it is used for

What Erleada is
Erleada is an anticancer medicine that contains the active substance apalutamide.
What Erleada is used for
It is used to treat adult men with prostate cancer that:

has spread to other parts of the body and still responds to medical or surgical treatment aimed at reducing testosterone levels (also called hormone-sensitive prostate cancer).
has not spread to other parts of the body and no longer responds to medical or surgical treatment aimed at reducing testosterone levels (also called non-metastatic castration-resistant prostate cancer).

How Erleada works
Erleada works by blocking the activity of hormones called androgens (such as testosterone). Androgens
can cause tumour growth. By blocking the effect of androgens, apalutamide prevents prostate cancer cells from growing and dividing.

2. What you should know before taking Erleada

Do not take Erleada

if you are allergic to apalutamide or to any of the other ingredients of this medicine (listed in section 6);
if you are a woman of childbearing age or are pregnant (see the section “Pregnancy and contraception information” below for further details).

Do not take this medicine if you fall into any of the above conditions. If you have any doubts,
consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

you have previously experienced seizures/epileptic fits;
you are taking medicines to prevent blood clots (such as warfarin, acenocoumarol);
you suffer from a heart or vascular condition, including any heart rhythm problems (arrhythmia);
you have previously developed widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS), or severe skin rash or peeling, blisters and/or mouth ulcers (Stevens-Johnson syndrome/toxic epidermal necrolysis or SJS/TEN) after taking Erleada or related medicines.

If any of the above conditions apply to you (or if you are unsure), consult your doctor or
pharmacist before taking this medicine.
Falls and bone fractures
Falls have been observed in patients taking Erleada. Exercise increased caution to
reduce the risk of falling. Bone fractures have also been observed in patients taking
this medicine.
Heart disease, stroke or mini-stroke
During treatment with Erleada, some people have experienced blockage of heart arteries or
in a brain area, which may be fatal.
Your doctor will monitor you for signs and symptoms of heart or brain problems
during treatment with this medicine.
Contact your doctor or go immediately to the nearest emergency room if:

you experience chest pain or discomfort at rest or during activity, or
shortness of breath, or
muscle weakness/paralysis in any part of the body, or
difficulty speaking.

If you are taking any medicines, consult your doctor or pharmacist to determine whether they are associated with an increased risk of seizures, bleeding, or heart conditions.
Severe Cutaneous Adverse Reactions (SCARs)
Severe Cutaneous Adverse Reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS) or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), have been reported with the use of Erleada. DRESS may present with widespread rash, high body temperature, and swollen lymph nodes. SJS/TEN may initially appear as red spots on the trunk resembling targets or circular lesions, often with central blisters. Mouth, throat, nose, genital organs, and eyes (red, swollen eyes) may also develop ulcers. These severe skin reactions are often preceded by fever and/or flu-like symptoms. These skin reactions may progress to widespread skin peeling and potentially life-threatening or fatal complications.
If you develop a severe skin rash or any of these skin symptoms, stop treatment
with this medicine and contact your doctor immediately.
If you fall into any of the above conditions (or if you have any doubts), consult your doctor or
pharmacist before taking this medicine. See the beginning of section 4 “Serious side effects” for further information.
Interstitial lung disease
Cases of interstitial lung disease (non-infectious lung inflammation that may lead to permanent damage), including fatal cases, have been observed in patients taking Erleada. Symptoms of interstitial lung disease include cough and shortness of breath, sometimes accompanied by fever, not caused by physical activity. Consult a doctor immediately if you develop symptoms that may indicate interstitial lung disease.
Children and adolescents
This medicine is not intended for use by children and adolescents under 18 years of age.
If a child or young person accidentally takes this medicine:

go immediately to hospital;
bring this leaflet with you and show it to the emergency room doctor.

Other medicines and Erleada
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Erleada may affect how some other medicines work. In addition, some other medicines may affect how Erleada works.
In particular, inform your doctor if you are taking medicines used for:

lowering high blood lipid levels (such as gemfibrozil);
treating bacterial infections (such as moxifloxacin, clarithromycin);
treating fungal infections (such as itraconazole, ketoconazole);
treating HIV infection (such as ritonavir, efavirenz, darunavir);
treating anxiety (such as midazolam, diazepam);
treating epilepsy (such as phenytoin, valproic acid);
treating gastroesophageal reflux disease (conditions characterized by excessive stomach acid) (such as omeprazole);
preventing blood clots (such as warfarin, clopidogrel, dabigatran etexilate);
treating hay fever and allergies (such as fexofenadine);
lowering cholesterol levels (such as “statins” like rosuvastatin, simvastatin);
treating heart conditions or lowering blood pressure (such as digoxin, felodipine);
treating heart rhythm disorders (such as quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
treating thyroid disorders (such as levothyroxine);
treating gout (such as colchicine);
reducing blood glucose (such as repaglinide);
treating cancer (such as lapatinib, methotrexate);
treating opioid dependence or pain (such as methadone);
treating severe mental illnesses (such as haloperidol).

You must list the names of all medicines you are taking and show this list to your doctor or
pharmacist when starting treatment with a new medicine. Inform your doctor that you are
taking Erleada if your doctor intends to treat you with a new medicine. It may be necessary to adjust the dose of Erleada or of any other medicine you are taking.
Pregnancy and contraception information for men and women
Information for women
Erleada must not be taken by pregnant women, women who may become pregnant, or women who are breastfeeding. This medicine may cause harm to the unborn child.
Information for men: follow these instructions during treatment and for 3 months after treatment ends

If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
If you have sexual intercourse with a woman of childbearing age, use a condom and another highly effective contraceptive method.

Use contraceptive methods during treatment and for 3 months after treatment ends.
Consult your doctor for any questions regarding contraceptive methods.
This medicine may reduce male fertility.
Driving and using machines
It is unlikely that Erleada will affect your ability to drive or operate machinery.
Side effects of this medicine include seizures. If you have a higher risk of seizures (see section 2 “Warnings and precautions”), consult your doctor.
Erleada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 240 mg dose (4 tablets),
i.e., essentially “sodium-free”.

3. How to take Erleada

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor may also prescribe other medicines for you while you are taking Erleada.

Dosage
The recommended dose of this medicine is 240 mg (four 60 mg tablets) once daily.

Severe hepatic impairment
If you have severe liver disease, the recommended dose of this medicine is 120 mg (two 60 mg tablets) once daily.

Taking Erleada

Take this medicine by mouth.
You may take this medicine with or without food.
Swallow each tablet whole to ensure the entire dose is taken. Do not crush or split the tablets.

If you are unable to swallow the tablets whole

If you cannot swallow this medicine whole, you may:
o Mix with one of the following non-carbonated beverages or soft foods: orange juice, green tea, applesauce, drinkable yogurt, or additional water as follows:
- Place the entire prescribed dose of Erleada into a glass. Do not crush or split the tablets.
- Add approximately 20 mL (4 teaspoons) of non-carbonated water to ensure the tablets are completely submerged.
- Wait 2 minutes until the tablets have broken apart and disintegrated, then stir the mixture.
- Add 30 mL (6 teaspoons or 2 tablespoons) of one of the following non-carbonated beverages or soft foods: orange juice, green tea, applesauce, drinkable yogurt, or additional water, and mix thoroughly.
- Swallow the mixture immediately.
- Rinse the glass with sufficient water to ensure the entire dose is consumed and drink it immediately.
- Do not store the medicine/food mixture for later use.
o Feeding tube administration: This medicine can also be administered through certain feeding tubes. Ask your doctor for specific instructions on how to properly take the tablets via a feeding tube.

If you take more Erleada than you should
If you take more medicine than prescribed, stop taking this medicine and contact your doctor immediately. You may have an increased risk of side effects.

If you forget to take Erleada

If you forget to take your dose, take it as soon as you remember, on the same day.
If you forget to take your dose for the entire day, take your usual dose the next day.
If you forget to take your medicine for more than one day, contact your doctor immediately.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Erleada
Do not stop treatment with this medicine without first talking to your doctor.
If you have any questions 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.

Serious side effects
Stop taking Erleada and contact your doctor immediately if you experience any of the
following symptoms:

widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
reddish, flat spots on the trunk resembling targets or rings, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Contact your doctor immediately if you experience any of the following serious side effects; your doctor may decide to stop treatment:

Very common: may affect more than 1 in 10 people

Falls or fractures (broken bones). Your doctor may monitor you more closely if you are at risk of fractures.

Common: may affect up to 1 in 10 people

Heart problems, stroke, or mini-stroke. Your doctor will monitor you for signs and symptoms of heart or brain problems during treatment. Call your doctor or go immediately to the nearest emergency room if, during treatment with Erleada, you experience chest pain or discomfort at rest or during activity, shortness of breath, or if you develop muscle weakness/paralysis anywhere in the body or difficulty speaking.

Uncommon: may affect up to 1 in 100 people

Seizures or epileptic fits. Your doctor will stop administering this medicine if you have a seizure during treatment.
Restless legs syndrome (an urge to move the legs to relieve painful or unusual sensations, which often occur at night).

Not known: frequency cannot be determined from available data.

Cough and shortness of breath, sometimes accompanied by fever, not caused by physical activity (inflammation of the lungs, known as interstitial lung disease).

Contact your doctor immediately if you experience any of the serious side effects described above.

Side effects include
Contact your doctor immediately if you experience any of the following side effects:

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

extreme tiredness
joint pain
skin rash
reduced appetite
high blood pressure
hot flushes
diarrhoea
bone fractures
falls
weight loss.

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

muscle spasms
itching
hair loss
altered taste
blood tests showing high levels of cholesterol in the blood
blood tests showing high levels of a type of fat called “triglycerides” in the blood
heart disease
stroke or mini-stroke caused by reduced blood flow to areas of the brain
underactive thyroid gland, which may make you feel more tired and cause difficulty getting up in the morning; blood tests may also show an underactive thyroid
low levels of a type of white blood cells, which may make infections more likely (neutropenia).

Uncommon (may affect up to 1 in 100 people):

seizures/epileptic fits
skin or mucous membrane rash (lichenoid eruption).

Not known (frequency cannot be determined from available data):

abnormalities in heart rhythm on ECG (electrocardiogram)
widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
reddish, flat spots on the trunk resembling targets or rings, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genital organs, and eyes, which may be preceded by fever and flu-like symptoms. These severe skin reactions can potentially be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis)
very low levels of a type of white blood cells, which may make infections more likely (agranulocytosis).

Contact your doctor immediately if you experience any of the side effects listed above.

Reporting of side effects
If you get any side effects, including ones 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 Erleada

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 packaging (blister, inner carton, outer carton, bottle, and box) after Scad./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Erleada contains

The active substance is apalutamide. Each film-coated tablet contains 60 mg of apalutamide.
The other components of the tablet core are: colloidal anhydrous silica, sodium croscarmellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The coating contains black iron oxide (E172), yellow iron oxide (E172), macrogol, polyvinyl alcohol (partially hydrolysed), talc, and titanium dioxide (E171) (see section 2 “ Erleada contains sodium”).

Description of the appearance of Erleada and the contents of the pack
Erleada film-coated tablets are oblong-shaped, film-coated tablets ranging in colour from slightly yellowish to greyish green (17 mm long and 9 mm wide), with the imprint “AR 60” on one side.
The tablets may be supplied in a bottle or in a carton. Not all pack sizes may be marketed.
Bottle
The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 120 tablets and a total of 6 g of desiccant. Each carton contains one bottle. Keep in the original packaging. Do not ingest or discard the desiccant.
28-day carton
Each 28-day carton contains 112 film-coated tablets in 4 cardboard boxes, each containing 28 film-coated tablets.
30-day carton
Each 30-day carton contains 120 film-coated tablets in 5 cardboard boxes, each containing 24 film-coated tablets.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100, Italy

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor ehf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: ++357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 678 93561
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu .
To obtain the most up-to-date patient information leaflet, scan the QR code shown here or on the packaging. The same information is also available at the following URL: https://epi.jnj.

Black QR code on white background with the text SCAN ME in large letters and the

Package leaflet: information for the user

Erleada 240 mg film-coated tablets

apalutamide
Please read this leaflet carefully before you start taking this medicine, as 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 their symptoms
are the same as yours, as it may be harmful to them.
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 Erleada is and what it is used for
What you need to know before taking Erleada
How to take Erleada
Possible side effects
How to store Erleada
Contents of the pack and other information

1. What Erleada is and what it is used for

What Erleada is
Erleada is an anticancer medicine that contains the active substance apalutamide.
What Erleada is used for
It is used to treat adult men with prostate cancer that:

has spread to other parts of the body and still responds to medical or surgical treatment aimed at reducing testosterone levels (also called hormone-sensitive prostate cancer).
has not spread to other parts of the body and no longer responds to medical or surgical treatment aimed at reducing testosterone levels (also called castration-resistant prostate cancer).

2. What you need to know before taking Erleada

Do not take Erleada

if you are allergic to apalutamide or to any of the other ingredients of this medicine (listed in section 6);
if you are a woman of childbearing age or pregnant (see the section “Pregnancy and contraception information” below for further details).

Do not take this medicine if you fall into any of the above conditions. If you have any doubts,
consult your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

you have previously had seizures/epileptic fits;
you are taking medicines to prevent blood clots (such as warfarin, acenocoumarol);
you have a heart or vascular condition, including any problems with your heart rhythm (arrhythmia);
you have previously experienced widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS), or severe skin rash or peeling, blisters and/or mouth ulcers (Stevens-Johnson syndrome/toxic epidermal necrolysis or SJS/TEN) after taking Erleada or other related medicines.

If any of the above conditions apply to you (or if you are unsure), consult your doctor or
pharmacist before taking this medicine.
Falls and bone fractures
Falls have been observed in patients taking Erleada. Exercise increased caution to
reduce the risk of falling. Bone fractures have also been observed in patients taking
this medicine.
Heart disease, stroke or mini-stroke
During treatment with Erleada, some people have experienced blockage of heart arteries or
in an area of the brain, which may be fatal.
Your doctor will monitor you for signs and symptoms of heart or brain problems
during treatment with this medicine.
Contact your doctor or go immediately to the nearest emergency room if:

you experience chest pain or discomfort at rest or during activity, or
you have shortness of breath, or
you experience muscle weakness/paralysis in any part of your body, or
you have difficulty speaking.

If you are taking any medicines, consult your doctor or pharmacist to determine whether they are associated with an increased risk of seizures, bleeding, or heart conditions.
Severe Cutaneous Adverse Reactions (SCARs)
Severe Cutaneous Adverse Reactions (SCARs) have been reported with the use of Erleada, including
drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN). DRESS may present as widespread rash,
high body temperature, and swollen lymph nodes. SJS/TEN may initially appear as red spots on the trunk resembling targets or circular lesions, often with central blisters. Mouth, throat, nose, genital organs, and eyes (red, swollen eyes) may also develop ulcers. These serious skin reactions are often preceded by fever and/or flu-like symptoms. These skin rashes may progress to widespread skin peeling and potentially life-threatening or fatal complications.
If you develop a severe skin rash or any of these other skin symptoms, stop treatment
with this medicine and contact your doctor immediately.
If you fall into any of the conditions described above (or if you have any doubts), consult your doctor or
pharmacist before taking this medicine. See section 4 “Serious undesirable effects” at the beginning of section 4 for further information.
Interstitial lung disease
Cases of interstitial lung disease (non-infectious inflammation of the lungs that may lead to permanent damage), including fatal cases, have been observed in patients taking Erleada. Symptoms of interstitial lung disease include cough and shortness of breath, sometimes accompanied by fever, not caused by physical activity. Consult a doctor immediately if you develop symptoms that may indicate interstitial lung disease.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
If a child or young person accidentally takes this medicine:

go immediately to hospital;
take this leaflet with you and show it to the emergency room doctor.

Other medicines and Erleada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Erleada may affect how some other medicines work. In addition, some other medicines may affect how Erleada works.
In particular, inform your doctor if you are taking medicines used for:

lowering high blood lipid levels (such as gemfibrozil);
treating bacterial infections (such as moxifloxacin, clarithromycin);
treating fungal infections (such as itraconazole, ketoconazole);
treating HIV infection (such as ritonavir, efavirenz, darunavir);
treating anxiety (such as midazolam, diazepam);
treating epilepsy (such as phenytoin, valproic acid);
treating gastroesophageal reflux disease (conditions characterized by excessive stomach acid) (such as omeprazole);
preventing blood clots (such as warfarin, clopidogrel, dabigatran etexilate);
treating hay fever and allergies (such as fexofenadine);
lowering cholesterol levels (such as “statins” like rosuvastatin, simvastatin);
treating heart conditions or lowering blood pressure (such as digoxin, felodipine);
treating heart rhythm disorders (such as quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
treating thyroid disorders (such as levothyroxine);
treating gout (such as colchicine);
lowering blood glucose (such as repaglinide);
treating cancer (such as lapatinib, methotrexate);
treating opioid dependence or pain (such as methadone);
treating severe mental illnesses (such as haloperidol).

You must list the names of all medicines you are taking and show this list to your doctor or
pharmacist when starting treatment with a new medicine. Inform your doctor that you are
taking Erleada if your doctor plans to prescribe you a new medicine. It may be necessary to adjust the dose of Erleada or of any other medicine you are taking.
Pregnancy and contraception information for men and women
Information for women
Erleada must not be taken by pregnant women, women who may become pregnant, or women who are breastfeeding. This medicine may cause harm to the unborn child.
Information for men: follow these instructions during treatment and for 3 months after treatment ends

If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
If you have sexual intercourse with a woman of childbearing potential, use a condom and another highly effective method of contraception.

Use contraceptive methods during treatment and for 3 months after treatment ends.
Talk to your doctor about any questions you may have regarding contraception methods.
This medicine may reduce male fertility.
Driving and using machines
It is unlikely that Erleada will affect your ability to drive or use tools or machinery.
One of the side effects of this medicine is seizures. If you have an increased risk of
seizures (see section 2 “Warnings and precautions”), consult your doctor.
Erleada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 240 mg dose (one
tablet), i.e. essentially “sodium-free”.

3. How to take Erleada

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor may also prescribe other medicines for you to take while you are taking Erleada.

Dosage

The recommended dose of this medicine is 240 mg (one tablet) once daily.

Severe hepatic impairment

If you have severe liver disease, the recommended dose of this medicine is 120 mg (two tablets of 60 mg) once daily.

How to take Erleada

Take this medicine by mouth.
You may take this medicine with or without food.
Swallow the tablet whole to ensure the full dose is taken. Do not crush or split the tablets.

If you are unable to swallow the tablet whole

If you are unable to swallow the tablet whole, you may either:
Mix with one of the following non-carbonated beverages or soft foods: orange juice, green tea, applesauce, drinkable yogurt, or additional water as described below:
- Place the whole tablet in a glass. Do not crush or split the tablet.
- Add about 10 mL (2 teaspoons) of non-carbonated water to ensure the tablet is completely submerged.
- Wait 2 minutes until the tablet breaks apart and disintegrates, then stir the mixture.
- Add 30 mL (6 teaspoons or 2 tablespoons) of one of the following non-carbonated beverages or soft foods: orange juice, green tea, applesauce, drinkable yogurt, or additional water, and mix the mixture.
- Swallow the mixture immediately.
- Rinse the glass with enough water to ensure the entire dose is taken and drink it immediately.
- Do not store the medicine/food mixture for later use.
  OR
  Feeding tube administration: this medicine can also be administered through certain feeding tubes. Ask your doctor for specific instructions on how to properly take the tablet via a feeding tube.

If you take more Erleada than you should

If you take more medicine than you should, stop taking this medicine and contact your doctor. You may have an increased risk of side effects.

If you forget to take Erleada

If you forget to take this medicine, take your usual dose as soon as you remember on the same day.
If you forget to take this medicine for the entire day, take your usual dose the next day.
If you forget to take this medicine for more than one day, contact your doctor immediately.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Erleada

Do not stop treatment with this medicine without first talking to your doctor.
If you have any questions 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 everyone experiences them.
Serious side effects
Stop taking Erleada and contact your doctor immediately if you notice any of the following symptoms:

Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms, or DRESS)
Reddish, flat spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Contact your doctor immediately if you experience any of the following serious side effects; your doctor may decide to discontinue treatment:
Very common: may affect more than 1 in 10 people

Falls or fractures (broken bones). Your doctor may monitor you more closely if you are at risk of fractures.

Common: may affect up to 1 in 10 people

Heart problems, stroke, or mini-stroke. Your doctor will monitor you for signs and symptoms of cardiac or cerebrovascular issues during treatment. Call your doctor or go immediately to the nearest emergency room if, during treatment with Erleada, you experience chest pain or discomfort at rest or during activity, shortness of breath, or if you develop muscle weakness/paralysis in any part of your body or difficulty speaking.

Uncommon: may affect up to 1 in 100 people

Seizures or epileptic fits. Your doctor will discontinue administration of this medicine if you experience a seizure during treatment.
Restless legs syndrome (urge to move legs to relieve painful or unusual sensations, often occurring at night).

Not known: frequency cannot be determined from available data.

Cough and shortness of breath, possibly accompanied by fever, not caused by physical activity (lung inflammation, known as interstitial lung disease).

Contact your doctor immediately if you notice any of the serious side effects described above.
The side effects include
Contact your doctor immediately if you notice any of the following side effects:
Very common (may affect more than 1 in 10 people):

Extreme tiredness
Joint pain
Skin rash
Reduced appetite
High blood pressure
Hot flushes
Diarrhea
Bone fractures
Falls
Weight loss

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

Muscle spasms
Itching
Hair loss
Altered taste
Blood tests showing high levels of cholesterol in the blood
Blood tests showing high levels of a type of fat called "triglycerides" in the blood
Heart disease
Stroke or mini-stroke caused by reduced blood flow to areas of the brain
Underactive thyroid gland, which may make you feel more tired and cause difficulty getting up in the morning; blood tests may also show an underactive thyroid
Low levels of a type of white blood cell, which may increase the risk of infections (neutropenia)

Uncommon (may affect up to 1 in 100 people):

Seizures/epileptic fits
Skin or mucous membrane rash (lichenoid eruption)

Not known (frequency cannot be determined from available data):

Abnormalities in the heart's electrical activity on ECG (electrocardiogram)
Widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms, or DRESS)
Reddish, flat spots on the trunk, target-like or circular in appearance, often with central blisters, skin peeling, and sores in the mouth, throat, nose, genital organs, and eyes, which may be preceded by fever and flu-like symptoms. These severe skin rashes may potentially be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Very low levels of a type of white blood cell, which may increase the risk of infections (agranulocytosis)

Contact your doctor immediately if you notice any of the side effects listed above.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Erleada

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (blister, inner carton, outer carton, bottle and box) after Scad./EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. This medicine requires no special storage conditions.
Do not dispose of any medicine 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 Erleada contains

The active substance is apalutamide. Each film-coated tablet contains 240 mg of apalutamide.
The other components of the tablet core are: colloidal anhydrous silica, sodium croscarmellose, hypromellose acetate succinate, magnesium stearate and silicified microcrystalline cellulose. The coating contains glycerol monocaprylocaprate, black iron oxide (E172), polyvinyl alcohol, talc and titanium dioxide (E171), and poly (vinyl alcohol) graft copolymer with macrogol (see section 2 “ Erleada contains sodium”).

Description of the appearance of Erleada and contents of the pack
Erleada film-coated tablets are oval-shaped, blue-grey to grey film-coated tablets (21 mm long and 10 mm wide), with the imprint “E240” on one side.
The tablets may be supplied in a bottle or in a carton. Not all pack sizes may be marketed.

Bottle
The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 30 tablets and a total of 2 g of desiccant. Each carton contains one bottle. Keep in the original packaging. Do not ingest or discard the desiccant.

28-day pack
Each 28-day pack contains 28 film-coated tablets in 2 cardboard cartons, each containing 14 film-coated tablets.

30-day pack
Each 30-day pack contains 30 film-coated tablets in 3 cardboard cartons, each containing 10 film-coated tablets.

84-day pack (3 x 28 days)
Each 84-day pack (3 x 28 days) contains 84 film-coated tablets in 6 cardboard cartons, each containing 14 film-coated tablets.

Marketing Authorization Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100, Italy

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder: