60 mg film-coated tablets 
apalutamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Erleada is and what it is used for 
2. What you need to know before you take Erleada 
3. How to take Erleada 
4. Possible side effects 
5. How to store Erleada 
6. Contents of the packaging and other information 

1. What Erleada is and what it is used for

Erleada is a cancer drug that contains the active substance apalutamide.

It is used to treat adult men with prostate cancer such as:

  • has metastasized to other parts of the body and still responds to medical or surgical treatments that lower testosterone levels (also called hormone-sensitive prostate cancer)
  • has not metastasized to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone levels (also called castration-resistant prostate cancer).

Erleada works by blocking the activity of hormones called androgens (eg testosterone). Androgens can make your cancer grow. By blocking the effect of androgens, apalutamide prevents prostate cancer cells from growing and dividing.

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).
  • you are a woman and are pregnant or may become pregnant (see the section on pregnancy and contraceptives below for more information).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and cautions

Talk to your doctor or pharmacist before taking this medicine if:

  • you have ever had seizures or seizures
  • you are taking medicines to prevent blood clots (eg warfarin, acenocoumarol)
  • you have any cardiovascular disease, including problems with your heart rhythm ( arrhythmia ).

Cases have been observed in patients taking Erleada. Be extra careful to reduce the risk of falls. Broken bones have been observed in patients taking Erleada.

Blockage of the artery is in the heart can lead to death, which has occurred in some people under treatment with Erleada. During treatment with Erleada, the caregiver makes continuous checks to detect any signs and symptoms of heart problems. Contact your healthcare provider immediately or go to the nearest emergency room if you experience chest pain or feel discomfort in your chest during treatment or activity during treatment with Erleada, or if you become short of breath.

If you are taking any medicines, talk to your doctor or pharmacist to see if they are associated with an increased risk of seizures, bleeding, or heart disease.

Talk to your doctor or pharmacist before taking Erleada if any of the above apply to you (or if you are not sure).

Children and young people

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

If a child or adolescent accidentally ingests Erleada:

  • go to the hospital immediately
  • take this leaflet with you and show it 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. This is because Erleada can affect how other medicines work. Also, some other medicines may affect the way Erleada works.

Tell your doctor if you are taking medicines such as:

  • lowers high blood fats (eg gemfibrozil)
  • treats bacterial infections (eg moxifloxacin, clarithromycin)
  • treats fungal infections (eg itraconazole, ketoconazole )
  • treat HIV – infection (ritonavir, efavirenz, darunavir)
  • treats anxiety (eg midazolam, diazepam )
  • treats epilepsy (eg phenytoin, valproic acid )
  • treats gastroesophageal reflux disease (a condition in which there is too much acid in the stomach) (eg omeprazole)
  • prevents blood clots (eg warfarin , clopidogrel, dabigatran etexilate)
  • treats hay fever and allergies (eg fexofenadine)
  • lowers cholesterol levels (eg ‘statins’ such as rosuvastatin, simvastatin )
  • treats heart conditions or lowers blood pressure (eg digoxin, felodipine)
  • treats heart rhythm problems (eg quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
  • treats thyroid conditions (eg levothyroxine)
  • treats gout (eg colchicine)
  • lowers blood sugar (eg repaglinide)
  • treats cancer (eg lapatinib, methotrexate)
  • treats opioid dependence or pain (eg methadone )
  • treats serious mental illnesses (eg haloperidol )

You need to write down the names of the medicines you are taking on a list and show them to your doctor or pharmacist when you start taking a new medicine. Tell your doctor that you are taking Erleada if your doctor wants you to start taking a new medicine. Dosage one of Erleada or other medicines you are taking may need to be changed.

Information on pregnancy and contraception for men and women

Information for women

  • Erleada must not be taken by women who are pregnant, may become pregnant, or are breast-feeding. Erleada can harm your unborn baby.

Information for men – follow these tips during treatment and for 3 months after it has stopped

  • If you have sex with a pregnant woman – use a condom to protect the unborn baby.
  • If you have sex with a woman who may become pregnant – use a condom and another highly effective contraceptive.

Use contraception during treatment and for 3 months after it has stopped. Talk to your doctor if you have any questions about contraception.

Erleada may reduce male fertility.

Driving and using machines

This medicine is unlikely to have any effect on the ability to drive and use machines. A possible side effect of Erleada is seizures. Talk to your doctor if you are at increased risk of having seizures (see section 2 Warnings and precautions).

Erleada contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 240 mg dose (4 tablets), ie essentially ‘sodium-free’.

3. How to take Erleada

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much to take

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

Intake of Erleada

  • Take the medicine by mouth.
  • You can take Erleada with food or between meals.
  • Swallow the tablets whole.

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

If you take more Erleada then you should

If you have taken too much, stop taking Erleada and contact your doctor. You may have an increased risk of getting side effects.

If you forget to take Erleada

If you forget to take Erleada, take your regular dose as soon as you remember.

  • If you forget to take Erleada for a whole day – take your regular dose the following day.
  • If you forget to take Erleada for more than one day – talk to your doctor immediately.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Erleada

Do not stop taking Erleada without first talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using Erleada and seek medical help immediately if you notice any of the following symptoms:

  • reddish, not raised, target-like, or round spots on the torso, often with blisters in the middle, peeling of the skin, sores in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms( toxic epidermal necrolysis ).

Serious side effects are

Tell your doctor immediately if you notice any of the following serious side effects – your doctor may stop treatment:

  • seizures or seizures – this is less common (may affect up to 1 in 100 people). The caregiver will discontinue treatment with Erleada if you have a seizure during treatment.
  • fall or fracture (broken bones) – this is very common (may affect more than 1 user in 10). The caregiver may have you under closer supervision if you are at risk of fracture.
  • heart disease – this is common (may affect up to 1 in 10 people). During treatment, the caregiver makes continuous checks to detect any signs and symptoms of heart problems. Contact your healthcare provider immediately or go to the nearest emergency department if you experience chest pain or feel discomfort in your chest during treatment or activity during treatment with Erleada, or if you become short of breath.

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

Other side effects include

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

  • the noticeable feeling of tiredness
  • joint pain
  • rash
  • reduced appetite
  • high blood pressure
  • heatwave
  • diarrhea
  • skeletal fracture
  • case
  • weight loss

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

  • muscle spasms
  • itching
  • taste disturbance
  • blood tests that show high cholesterol levels in the blood
  • blood tests that show high levels of a type of fat called “triglycerides” in the blood
  • heart disease
  • an underactive thyroid gland that can make you feel tired and that it is difficult to get started in the morning. Blood tests may also show an underactive thyroid gland.

No known frequency (occurs in an unknown number of users):

  • abnormal cardiac activity on an ECG ( electrocardiogram ).
  • life-threatening rash with blisters and scaly skin on large parts of the body ( toxic epidermal necrolysis ).

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 container (blister foil, inner crease, outer crease, jar, and carton) after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. No special temperature instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is apalutamide. Each film-coated tablet contains 60 mg of apalutamide.
  • The other ingredients in the tablet core are colloidal anhydrous silica, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and microcrystalline cellulose with silica. The film coating contains black iron oxide (E 172), yellow iron oxide (E 172), macrogol, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Erleada film-coated tablets are slightly yellowish to gray-green, oblong, film-coated tablets (16.7 mm long x 8.7 mm wide) embossed with “AR 60” on one side.

The tablets can be delivered either in a jar or in a folding package. Not all pack sizes may be marketed.

Can

The tablets are delivered in a plastic jar with a child-resistant closure. Each jar contains 120 tablets and a total of 6 g of desiccant. Each carton contains a jar. Store in the original package. The desiccant must not be swallowed or discarded.

28-day carton

Each 28-day carton contains film-coated tablets in 4 fold packs with 28 film-coated tablets in each.

30-day carton

Each 30-day carton contains 120 film-coated tablets in 5 fold packs with 24 film-coated tablets in each.

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

Contact the representative of the marketing authorization holder to find out more about this medicine:

Janssen ‑ Cilag AB

Tel: +46 8 626 50 00

jacse@its.jnj.com

Muhammad Nadeem

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