Label: information for the user

Erleada 60 mg film-coated tablets

apalutamida

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 label. See section 4.

What is Erleada

Erleada is a cancer medication that contains the active ingredient apalutamida.

How is Erleada used

It is used to treat adult men with prostate cancer that:

• has metastasized to other parts of the body and still responds to medical or surgical treatments that reduce testosterone levels (also known as hormone-sensitive prostate cancer).
• does not have metastasized to other parts of the body and no longer responds to medical or surgical treatment that reduces testosterone levels (also known as castration-resistant prostate cancer).

How Erleada works

Erleada works by blocking the activity of hormones called androgens (such as testosterone). Androgens can cause cancer growth. By blocking the effect of androgens, apalutamida causes prostate cancer cells to stop growing and dividing.

Do not take Erleada

• if you are allergic to apalutamide or any of the other ingredients of this medicine (listed in section 6);
• if you are a woman and are pregnant or may become pregnant (for more information, see the section on Pregnancy and Contraception).

Do not take this medicine if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• you have ever had seizures or convulsions.
• you are taking any medicine to prevent the formation of blood clots (such as warfarin, acenocoumarol).
• you have any heart disease or blood vessel disease, including heart rhythm problems (arrhythmia).
• you have ever had a generalised rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS) or severe skin rash, skin peeling, blisters, and/or mouth ulcers (Stevens-Johnson syndrome/toxic epidermal necrolysis or SJS/NET) after taking Erleada or other related medicines.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine.

Falls and Bone Fractures

Falls have been observed in patients taking Erleada. Take special precautions to reduce the risk of falls. Bone fractures have been observed in patients taking this medicine.

Heart Disease, Stroke, or Mini-Stroke

Some people have experienced a blockage of the heart or brain arteries that can cause death during treatment with Erleada.

Your doctor will monitor you for signs and symptoms of heart or brain problems during treatment with this medicine.

Call your doctor or go to the nearest emergency center immediately if you have:

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

If you are taking any medicine, consult your doctor or pharmacist to see if they are associated with a higher risk of seizures, bleeding, or heart problems.

Severe Cutaneous Adverse Reactions (SCARs)

Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms or DRESS or Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/NET), have been reported with the use of Erleada. DRESS may appear as a generalised rash, high body temperature, and swollen lymph nodes. SJS/NET may appear initially on the trunk as red target-shaped patches or circular patches with central blisters. Additionally, they may produce ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin reactions often precede fever and/or flu-like symptoms. The skin reactions may progress to generalised skin peeling and potentially fatal or fatal complications.

If you develop a severe rash or any of these skin symptoms, stop taking this medicine and immediately contact your doctor or seek medical assistance.

If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before taking this medicine. See the section "Severe Adverse Reactions" in section 4 for more information.

Pulmonary Interstitial Disease

Cases of pulmonary interstitial disease (non-infectious inflammation in the lungs that can result in permanent damage) including fatal cases, have been reported in patients taking Erleada. The symptoms of pulmonary interstitial disease are cough and shortness of breath, sometimes with fever, not caused by physical activity. If you experience symptoms that may be indicative of pulmonary interstitial disease, seek medical assistance immediately.

Children and Adolescents

This medicine should not be used in children or adolescents under 18 years of age.

If a child or young person takes this medicine by mistake:

• go to the hospital immediately
• bring this leaflet with you to show to the emergency doctor.

Other Medicines and Erleada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, as Erleada may affect the functioning of other medicines. Other medicines may also affect the functioning of Erleada.

Specifically, inform your doctor if you are taking medicines for:

• reducing blood lipid levels (such as gemfibrozil)
• treating bacterial infections (such as moxifloxacino, claritromicina)
• treating fungal infections (such as itraconazol, ketoconazol)
• 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 (diseases in which there is too much acid in the stomach) (such as omeprazol)
• preventing blood clots (such as warfarin, clopidogrel, dabigatrán etexilato)
• treating pollen allergy and allergies (such as fexofenadina)
• reducing cholesterol levels (such as "statins" such as rosuvastatina, simvastatina)
• treating heart problems or reducing blood pressure (such as digoxina, felodipino)
• treating heart rhythm problems (such as quinidina, disopiramida, amiodarona, sotalol, dofetilida, ibutilida)
• treating thyroid problems (such as levotiroxina)
• treating gout (such as colchicina)
• reducing blood sugar levels (such as repaglinida)
• treating cancer (such as lapatinib, metotrexato)
• treating opioid dependence or pain (such as metadona)
• treating severe mental illnesses (such as haloperidol)

You should make a list of the names of the medicines you are taking and show it to your doctor or pharmacist when you start taking a new medicine. Inform your doctor that you are taking Erleada if your doctor wants to start any new treatment. It may be necessary to change the dose of Erleada or any of the other medicines you are taking.

Information on Pregnancy and Contraception for Men and Women

Information for Women

• Pregnant women, women who may become pregnant, or women who are breastfeeding should not take Erleada. This medicine may harm the fetus.

Information for Men: Follow these guidelines during treatment and for 3 months after stopping

• If you have sex with a pregnant woman: use a condom to protect the fetus.
• If you have sex with a woman who may become pregnant: use a condom and another high-efficacy contraceptive method.

Use contraception during treatment and for 3 months after stopping. Consult your doctor if you have any questions about contraception.

This medicine may reduce male fertility.

Driving and Using Machines

It is unlikely that Erleada will affect your ability to drive or use any tools or machines.

The 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 dose of 240 mg (4 tablets); this is, essentially, "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor may prescribe other medications while you are taking Erleada.

How much to take

The recommended dose of this medication is 240 mg (four 60 mg tablets) once a day.

How to take Erleada

• Take this medication orally.
• You can take this medication with food or between meals.
• Swallow each tablet whole to ensure you take the full dose. Do not crush or break the tablets.

If you cannot swallow the tablets

• If you cannot swallow this medication whole, you can:

• Mix with one of the following non-carbonated beverages or soft foods: orange juice, green tea, apple sauce, drinkable yogurt, or more water, as follows:

• Place the full prescribed dose of Erleada in a cup. Do not crush or break the tablets.
• Add approximately 20 ml (4 teaspoons) of non-carbonated water to cover the tablets completely.
• Wait 2 minutes until the tablets break down and disperse, and 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, apple sauce, drinkable yogurt, or more water, and stir the mixture.
• Swallow the mixture immediately.
• Wash the cup with enough water to ensure the full dose is taken and drink immediately.
• Do not store the medication/food mixture for later use.

• Tube:This medication can also be administered through some tubes. Ask your doctor to indicate exactly how to administer the tablets correctly through a tube.

If you take more Erleada than you should

If you take more than you should, stop taking this medication and contact your doctor. You may be at a higher risk of experiencing side effects.

If you forget to take Erleada

If you forget to take this medication, take the usual dose as soon as you remember on the same day.

• If you forget to take this medication all day, take the usual dose the next day.
• If you forget to take this medication for more than a day, consult your doctor immediately.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Erleada

Do not stop taking this medication without consulting your doctor first.

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

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

Severe side effects

Stop taking Erleada and seek medical attention immediately if you notice any of the following symptoms:

• generalized rash, high body temperature, and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
• flat red patches in the shape of a target or circles on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor immediately if you notice any of the following severe side effects, your doctor may suspend treatment:

Very common: may affect more than 1 in 10 people

• falls or fractures (bone breaks). Your doctor may monitor you more closely if you have a risk of fractures.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• seizure or convulsion. Your doctor will suspend treatment with this medicine if you experience a seizure during treatment.
• restless legs syndrome (urgency to move legs to stop uncomfortable or strange sensations, which usually occurs at night)

Unknown:frequency cannot be estimated from available data

• shortness of breath and lack of air, possibly accompanied by fever, not caused by physical activity (inflammation in the lungs, known as interstitial lung disease)

Inform your doctor immediately if you notice any of the severe side effects mentioned above.

Side effects include

Inform your doctor if you notice any of the following side effects:

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

• feeling very tired
• joint pain
• skin rash
• loss of appetite
• high blood pressure
• headaches
• diarrhea
• bone fractures
• falls
• weight loss.

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

• muscle spasms
• itching
• hair loss
• alteration of taste
• blood tests showing high cholesterol levels 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 inadequate blood flow to a part of the brain
• underactive thyroid gland that may make you feel more tired and have difficulty waking up in the morning, and blood tests may also detect an underactive thyroid gland.

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

• convulsion/attack.

Unknown(frequency cannot be estimated from available data):

• abnormal result of heart activity in an ECG (electrocardiogram).
• generalized rash, high body temperature, and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
• flat red patches in the shape of a target or circles on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, which may be preceded by fever and flu-like symptoms. These severe skin eruptions may be potentially fatal (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor if you notice any of the side effects mentioned above.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in Appendix V. By reporting side effects, you can contribute to providing more information on 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 packaging (blister, inner pouch, outer pouch, bottle, and box) after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. This medication does not require any special storage temperature.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Erleada

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

Appearance of the product and contents of the pack

Erleada film-coated tablets are light yellow to greenish-grey, oblong-shaped (17 mm long by 9 mm wide), with "AR 60" engraved on one face.

The tablets may be presented in a bottle or a carton. Only some pack sizes may be marketed.

Bottle

The tablets are presented in a child-resistant plastic bottle with a safety 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 dispose of the desiccant.

28-day pack

Each 28-day pack contains 112 film-coated tablets in 4 cartons of 28 film-coated tablets each.

30-day pack

Each 30-day pack contains 120 film-coated tablets in 5 cartons of 24 film-coated tablets each.

Marketing authorisation holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Responsible for manufacturing

Janssen Cilag SpA

Via C. Janssen

Borgo San Michele

04100 Latina, Italy

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).