ERLEADA 60 mg FILM-COATED TABLETS

2. What you need to know before you take Erleada

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 who is 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 not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to 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 blood clots (such as warfarin, acenocoumarol).
• you have any heart or blood vessel disease, including heart rhythm problems (arrhythmia).
• you have ever had a widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS) or severe skin rash, blistering, and/or ulcers in the mouth (Stevens-Johnson syndrome/toxic epidermal necrolysis or SJS/TEN) after taking Erleada or other related medicines.

If any of the above applies to you (or you are not sure), 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 suffered a blockage of the heart arteries or part of the brain 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 immediately to the nearest emergency center 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 it is associated with a higher risk of seizures, bleeding, or heart problems.

Severe skin reactions (SSR)

There have been reports of cases of Severe Skin Reactions (SSR), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) with the use of Erleada. DRESS may appear as a widespread rash, high body temperature, and swollen lymph nodes. SJS/TEN may appear initially on the trunk as red, target-like patches or circular patches that often have central blisters. Additionally, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and potentially life-threatening complications.

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

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before taking this medicine. See the "Serious side effects" section of section 4 for more information.

Interstitial Lung Disease

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

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

If a child or young person accidentally takes this medicine:

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

Other medicines and Erleada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, as Erleada may affect the way other medicines work. Also, other medicines may affect the way Erleada works.

In particular, tell your doctor if you are taking medicines for:

• lowering 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 (disorders in which there is too much acid in the stomach) (such as omeprazole)
• preventing blood clots (such as warfarin, clopidogrel, dabigatran etexilate)
• treating allergy to pollen and allergies (such as fexofenadine)
• lowering cholesterol levels (such as "statins" like rosuvastatin, simvastatin)
• treating heart problems or lowering blood pressure (such as digoxin, felodipine)
• treating heart rhythm problems (such as quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
• treating thyroid problems (such as levothyroxine)
• treating gout (such as colchicine)
• lowering blood sugar levels (such as repaglinide)
• treating cancer (such as lapatinib, methotrexate)
• treating opioid dependence or pain (such as methadone)
• treating severe mental disorders (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. Tell 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.

Pregnancy and contraception information 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 up to 3 months after stopping treatment

• 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 effective contraceptive method.

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

This medicine may reduce male fertility.

Driving and using machines

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

The side effects of this medicine include seizures. If you are at 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); this is essentially "sodium-free".

3. How to take Erleada

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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

How much to take

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

How to take Erleada

• Take this medicine by mouth.
• You can take this medicine with or without food.
• Swallow each tablet whole to make sure you take the full dose. Do not crush or break the tablets.

If you cannot swallow the tablets whole

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

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

• Place the prescribed dose of Erleada in a cup. Do not crush or break the tablets.
• Add about 20 ml (4 teaspoons) of non-carbonated water to cover the tablets.
• Wait 2 minutes until the tablets break up and disperse, then stir the mixture.
• Add 30 ml (6 teaspoons or 2 tablespoons) of one of the following non-carbonated drinks or soft foods: orange juice, green tea, apple sauce, drinkable yogurt, or more water, and stir the mixture.
• Swallow the mixture immediately.
• Rinse the cup with enough water to ensure you take the full dose and drink immediately.
• Do not save the medicine/food mixture for later.

• Tube feeding:This medicine can also be given through some tubes. Ask your doctor to tell you exactly how to administer the tablets through a tube.

If you take more Erleada than you should

If you take more than you should, stop taking this medicine and contact your doctor. You may have a higher 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 whole day, take your usual dose the next day.
• If you forget to take this medicine for more than one day, consult your doctor immediately.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Erleada

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

If you have any other questions about 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.

Serious side effects

Stop taking Erleada and seek medical attention 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)
• red, target-like patches or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome/toxic epidermal necrolysis).

Tell your doctor immediately if you notice any of the following serious side effects, your doctor may stop 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 are at 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 heart or brain problems during treatment. Call your doctor or go immediately to the nearest emergency center if you have chest pain or discomfort at rest or with activity, or shortness of breath, or if you have muscle weakness/paralysis in any part of the body or difficulty speaking during treatment with Erleada.

Uncommon: may affect up to 1 in 100 people

• seizure/convulsion. Your doctor will stop treatment with this medicine if you have a seizure during treatment.
• restless legs syndrome (urge to move the legs to stop painful or unusual sensations, which usually occurs at night)

Not known: frequency cannot be estimated from the available data

• cough and shortness of breath, possibly with fever, that are not caused by physical activity (inflammation in the lungs, known as interstitial lung disease)

Tell your doctor immediately if you notice any of the serious side effects mentioned above.

Side effects include

Tell 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
• decreased 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 sense 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 insufficient blood flow to a part of the brain
• underactive thyroid that can make you feel more tired and have difficulty getting up in the mornings, and in blood tests, an underactive thyroid can also be detected.

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

• seizure/convulsion.

Not known(frequency cannot be estimated from the available data):

• abnormal heart activity on an ECG (electrocardiogram).
• widespread rash, high body temperature, and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms or DRESS)
• red, target-like patches or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, which can be preceded by fever and flu-like symptoms. These severe rashes can be potentially life-threatening (Stevens-Johnson syndrome/toxic epidermal necrolysis).

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

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 through 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 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 carton (blister, inner carton, outer carton, bottle, and box) after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from moisture. This medicine does not require any special storage temperature.

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

6. Packaging Contents and Additional Information

Erleada Composition

• 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, hypromellose succinate, magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose. The film coating contains black iron oxide (E172), yellow iron oxide (E172), macrogol, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide (E171) (see Section 2, Erleada contains sodium).

Product Appearance and Packaging Contents

Erleada film-coated tablets are film-coated tablets that are slightly yellowish to grayish-green in color, oblong in shape (17 mm long by 9 mm wide), with “AR 60” engraved on one side.

The tablets may be presented in a bottle or a blister pack. Only certain package sizes may be marketed.

Bottle

The tablets are presented 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. Store in the original packaging. Do not ingest or discard the desiccant.

28-Day Box

Each 28-day box contains 112 film-coated tablets in 4 cardboard blister packs of 28 film-coated tablets each.

30-Day Box

Each 30-day box contains 120 film-coated tablets in 5 cardboard blister packs of 24 film-coated tablets each.

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

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

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu, and on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).