Enzalutamide Accord

Enzalutamide Accord 40 mg soft capsules
enzalutamide
Equivalent medicine

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 doubts, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor. See section 4.

What Enzalutamide Accord is and what it is used for
What you need to know before taking Enzalutamide Accord
Contents of the pack and other information

1. What Enzalutamide Accord is and what it is used for

Enzalutamide Accord contains the active substance enzalutamide. Enzalutamide Accord is used for the treatment of adult men with prostate cancer:

• That no longer responds to hormonal therapy or surgical treatment to reduce testosterone, or
• That has spread to other parts of the body and still responds to hormonal therapy or surgical treatment to reduce testosterone.

How Enzalutamide Accord works
Enzalutamide Accord is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops the growth and division of prostate cancer cells.

2. What you should know before taking

Do not take Enzalutamide Accord
if you are allergic to enzalutamide or to any of the other ingredients of this medicine
(listed in section 6)
if you are pregnant or may become pregnant (see "Pregnancy, breastfeeding and
fertility").
Warnings and precautions
Seizures
Seizure episodes have been reported in 6 out of 1,000 patients treated with enzalutamide and in fewer than 3 out of 1,000 patients treated with placebo (see “Other medicines and Enzalutamide Accord” below and section 4, “Possible side effects”).
If you are taking a medicine that may cause seizures or increase the risk of seizures, see “Other medicines and Enzalutamide Accord” below.
If you experience a seizure during treatment:
Contact your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide Accord.
Rare cases of PRES (posterior reversible encephalopathy syndrome), a rare reversible condition affecting the brain, have been reported in patients treated with enzalutamide. If you have seizures, worsening headache, confusion, blindness or other vision problems, contact your doctor as soon as possible (see also section 4 “Possible side effects”).
Risk of new tumours (secondary tumours)
New (secondary) tumours, including bladder and colon cancer, have been reported in patients treated with enzalutamide.
Contact your doctor as soon as possible if you notice signs of gastrointestinal bleeding, blood in the urine, or if you frequently feel a strong urge to urinate while taking Enzalutamide Accord.
Talk to your doctor before taking Enzalutamide Accord:
if you have previously developed a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Enzalutamide Accord or other medicines
if you are taking medicines to prevent blood clots (e.g. warfarin, acenocoumarol, clopidogrel)
if you are using a chemotherapeutic agent such as docetaxel
if you have liver problems
if you have kidney problems.
Inform your doctor if you have any of the following conditions:
Any heart or blood vessel disorder, including heart rhythm problems (arrhythmias), or if you are being treated with medicines for these conditions. The risk of heart rhythm problems may increase with the use of Enzalutamide Accord.
If you are allergic to enzalutamide, skin rashes or swelling of the face, tongue, lips or throat may occur. If you are allergic to enzalutamide or to any of the other ingredients of this medicine, do not take Enzalutamide Accord.
Severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers, including Stevens-Johnson syndrome, have been reported in association with treatment with Enzalutamide Accord. Stop using Enzalutamide Accord and contact your doctor immediately if you notice any of these symptoms associated with the serious skin reactions described in section 4.
If you are in any of the conditions listed above or if you are unsure, talk to your doctor before taking this medicine.
Children and adolescents
This medicine must not be used in children and adolescents.
Other medicines and Enzalutamide Accord
Inform your doctor if you are taking, have recently taken or might take any other medicines. It is important that you know the names of the medicines you are taking. Keep a list of them to show your doctor when you are prescribed a new medicine. Do not start or stop any treatment without first discussing it with the doctor who prescribed Enzalutamide Accord.
Inform your doctor if you are taking any of the following medicines. When taken together with Enzalutamide Accord, the following medicines may increase the risk of seizures:
some medicines used to treat asthma or other respiratory diseases (e.g. aminophylline, theophylline)
medicines used to treat certain psychiatric disorders such as depression and schizophrenia (e.g. clozapine, olanzapine, risperidone, ziprasidone, bupropion, lithium, chlorpromazine, mesoridazine, thioridazine, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
some medicines used to treat pain (e.g. meperidine)
Inform your doctor if you are taking any of the following medicines. These medicines may affect the action of Enzalutamide Accord, or Enzalutamide Accord may affect the action of these medicines:
This includes, for example, certain medicines used to:
treat pain (e.g. fentanyl, tramadol)
treat cancer (e.g. cabazitaxel)
treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g. diazepam, midazolam, haloperidol)
treat sleep disorders (e.g. zolpidem)
treat heart disease or lower blood pressure (e.g. bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)
treat HIV infections (e.g. indinavir, ritonavir)
treat thyroid disorders (e.g. levothyroxine)
treat gout (e.g. colchicine)
treat stomach disorders (e.g. omeprazole)
prevent heart disease or stroke (e.g. dabigatran etexilate)
prevent organ rejection (e.g. tacrolimus)
Enzalutamide Accord may interfere with certain medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or may increase the risk of heart rhythm problems when used with other medicines [e.g. methadone (used to relieve pain and in drug detoxification programmes), moxifloxacin (an antibiotic), antipsychotics (used for severe mental illnesses)].
Inform your doctor if you are taking any of the medicines listed above. It may be necessary to adjust the dose of Enzalutamide Accord or of any other medicine you are taking.
Enzalutamide Accord is not indicated for women. This medicine may harm the unborn child or potentially cause pregnancy loss if taken by pregnant women. It must not be taken by women who are pregnant, may become pregnant, or are breastfeeding.
This medicine may affect male fertility.
If you have sexual intercourse with a woman who may become pregnant, use a condom and another effective contraceptive method during treatment and for 3 months after stopping treatment. If you have sexual intercourse with a pregnant woman, use a condom to protect the unborn child.
If the patient is cared for by a woman, see section 3 “How to take Enzalutamide Accord” for instructions on use and handling.
Driving and using machines
Enzalutamide Accord may have a moderate effect on the ability to drive and use machines. Seizures have been reported in patients taking Enzalutamide Accord.
If you are at high risk of seizures, discuss this with your doctor.
This medicine contains 47.80 mg of sorbitol (E 420) per soft capsule.
3.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.
The usual dose is 160 mg (four soft capsules), taken once daily at the same time each day.
Swallow the soft capsules whole with sufficient water.
Do not chew, dissolve or open the soft capsules before swallowing.
Enzalutamide Accord may be taken with or without food.
Enzalutamide Accord must not be handled by anyone other than the patient or their caregiver. Women who are pregnant or who may become pregnant must not handle damaged or opened Enzalutamide Accord capsules without wearing protective gloves.
Your doctor may prescribe other medicines during treatment with Enzalutamide Accord.
If you take more Enzalutamide Accord than you should
If you take more soft capsules than prescribed, stop taking Enzalutamide Accord and contact your doctor. You may be at increased risk of seizures or other side effects.
If you forget to take Enzalutamide Accord
If you forget to take Enzalutamide Accord at the usual time, take your usual dose as soon as you remember.
If you forget to take Enzalutamide Accord for the entire day, take your usual dose the next day.
If you forget to take Enzalutamide Accord for more than one day, contact your doctor immediately.
Do not take a double dose to make up for a missed dose.
If you stop taking Enzalutamide Accord
Do not stop taking this medicine unless instructed by your doctor.
If you have any questions about how to use this medicine, talk to your doctor.
4.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Seizures
Seizure episodes have been reported in 6 out of 1,000 patients treated with enzalutamide and in fewer than 3 out of 1,000 patients treated with placebo.
The risk of seizures is higher if you take a dose of this medicine higher than recommended, if you take other medicines, or if you have a higher-than-normal risk of seizures.
If you have a seizure, contact your doctor as soon as possible. Your doctor may decide that you should stop taking Enzalutamide Accord.
Rare cases of PRES (may affect up to 1 in 1,000 people), a rare reversible condition affecting the brain, have been reported in patients treated with enzalutamide. If you have seizures, worsening headache, confusion, blindness or other vision problems, contact your doctor as soon as possible.
Very common side effects (may affect more than 1 in 10 people)
Fatigue, falls, bone fractures, hot flushes, high blood pressure
Common side effects (may affect up to 1 in 10 people)
Headache, anxiety, dry skin, itching, memory disturbances, blockage of the heart arteries (ischaemic heart disease), breast enlargement in men (gynaecomastia), nipple pain, breast tenderness, symptoms of restless legs syndrome (uncontrollable urge to move part of the body, usually the legs), reduced concentration, forgetfulness, altered sense of taste
Uncommon side effects (may affect up to 1 in 100 people)
Hallucinations, difficulty thinking clearly, low white blood cell count
Side effects of unknown frequency (frequency cannot be determined from available data)
Muscle pain, muscle cramps, muscle weakness, back pain, changes in electrocardiogram (ECG) (QT prolongation), difficulty swallowing this medicine, including choking, stomach ache including feeling unwell (nausea), skin reaction causing red spots or patches on the skin that may look like a target or “bull’s eye”, with a dark red centre surrounded by lighter red rings (erythema multiforme), or another serious skin reaction presenting with flat reddish spots on the trunk, resembling targets or circles, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, which may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome), skin rash, feeling unwell (vomiting), swelling of the face, lips, tongue and/or throat, reduced platelet count in the blood (increased risk of bleeding or bruising), diarrhoea, reduced appetite.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system listed on the website: .
Reporting side effects can help provide more information on the safety of this medicine.
5.
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 blister after Exp. The expiry date refers to the last day of that month.
Do not take soft capsules that are leaking, damaged or show signs of tampering.
Do not dispose of medicines 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 Enzalutamide Accord contains
The active substance is enzalutamide. Each soft capsule contains 40 mg of enzalutamide.
The other components of the soft capsule are caprylic/capric macrogol glycerides,
butylhydroxyanisole (E 320), and butylhydroxytoluene (E 321).
The components of the soft capsule shell are gelatin, partially dehydrated liquid sorbitol (E 420), glycerol, titanium dioxide (E 171), talc (E 553b), and purified water.
The components of the printing ink are shellac, iron oxide black, ammonium hydroxide, and propylene glycol.
Enzalutamide Accord soft capsules are oblong soft capsules (20 mm in length and 10 mm in thickness), white to off-white in colour, printed with "JG1" in black ink.
Enzalutamide Accord is available in PVC/PCTFE-Alu blisters containing 28 soft capsules per pack. Enzalutamide Accord is also available in multiple packs comprising 4 boxes, each containing 28 soft capsules.
Not all pack sizes may be marketed.
Accord Healthcare S.L.U.
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08039 Barcelona,
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Accord Healthcare Polska Sp.z.o.o
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Paola PLA 3000
Malta
Accord Healthcare single member S.A.
64th Km National Road Athens,
Lamia, Schimatari,
32009, Greece
Austria Enzalutamide Accord 40 mg Soft Capsules
Belgium Enzalutamide Accord 40 mg Soft Capsules
Accord Healthcare B.V., Netherlands
Germany Enzalutamide Accord 40 mg Soft Capsules
Estonia Enzalutamide Accord 40 mg Soft Capsules