What enzalutamide is and what it is used for:

• Enzalutamide is used to treat adult men with prostate cancer that no longer responds to androgen deprivation therapy.

How enzalutamide works:

• Enzalutamide is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).


• By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.

What you need to know before you use enzalutamide:

Do not use enzalutamide:

• If you are allergic (hypersensitive) to enzalutamide any of the other ingredients in these tablets


• If you are pregnant or may become pregnant

Warnings and precautions:

Seizures:

• Seizures were reported in 4 in every 1,000 people taking enzalutamide, and fewer than one in every 1,000 people taking placebo


• If you are taking a medicine that can cause seizures or that can increase the susceptibility for having seizures


• If you have a seizure during treatment:


• See your doctor as soon as possible.


• Your doctor may decide that you should stop taking enzalutamide.

Posterior reversible encephalopathy syndrome (pres):

• There have been rare reports of pres, a rare, reversible condition involving the brain, in patients treated with enzalutamide.


• If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible


• Talk to your doctor before taking enzalutamide


• If you are taking any medicines to prevent blood clots (e.g.


• Warfarin, acenocoumarol, clopidogrel)


• If you use chemotherapy like docetaxel


• If you have problems with your liver


• If you have problems with your kidneys


• If you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.


• The risk of heart rhythm problems may be increased when using enzalutamide.

Children and adolescents:

• This medicine is not for use in children and adolescents.

Other medicines and enzalutamide:

Tell your doctor if you are taking any of the following medicines:

When taken at the same time as enzalutamide, these medicines may increase the risk of a seizure:

• Certain medicines used to treat asthma and 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).


• Certain medicines for the treatment of pain (e.g.Pethidine).


• Tell your doctor if you are taking the following medicines.


• These medicines may influence the effect of enzalutamide, or enzalutamide may influence the effect of these medicines.

This includes certain medicines used to:

• Lower cholesterol (e.g.Gemfibrozil, atorvastatin, simvastatin)


• Treat pain (e.g.


• Fentanyl, tramadol)


• Treat cancer (e.g.Cabazitaxel)


• Treat epilepsy (e.g.Carbamazepine, clonazepam, phenytoin, primidone, valproic acid)


• Treat certain psychiatric disorders such as severe anxiety or schizophrenia (e.g.


• Diazepam, midazolam, haloperidol)


• Treat sleep disorders (e.g.Zolpidem)


• Treat heart conditions or lower blood pressure (e.g.Bisoprolol, digoxin, diltiazem, felodipine, nicardipine, nifedipine, propranolol, verapamil)


• Treat serious disease related to inflammation (e.g.Dexamethasone, prednisolone)


• Treat hiv infection (e.g.Indinavir, ritonavir)


• Treat bacterial infections (e.g.Clarithromycin, doxycycline)


• Treat thyroid disorders (e.g.Levothyroxine)


• Treat gout (e.g.Colchicine)


• Treat stomach disorders (e.g.Omeprazole)


• Prevent heart conditions or strokes (e.g.Dabigatran etexilate)


• Prevent organ rejection (e.g.Tacrolimus)


• Enzalutamide might interfere with some medicines used to treat heart rhythm problems (e.g.Quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other medicines (e.g.Methadone, used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

How to take enzalutamide:

• Always take this medicine exactly as your doctor has told you.


• Check with your doctor if you are not sure.


• The usual dose is 160 mg (four soft capsules), taken at the same time once a day.

Taking enzalutamide:

• Swallow the soft capsules whole with water.


• Do not chew, dissolve or open the soft capsules before swallowing.


• Enzalutamide can be taken with or without food.


• Enzalutamide should not be handled by persons other than the patient and his caregivers, and especially not by women who are or may become pregnant.


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

Possible side effects:

• Stop using the product and seek immediate medical attention if
  Swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing

How to store enzalutamide:

• 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 cardboard wallet and outer carton after exp.


• The expiry date refers to the last day of that month.


• This medicine does not require any special storage conditions.


• Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.


• Do not throw away any medicines via wastewater or household waste.


• Ask your pharmacist how to throw away medicines you no longer use.


• These measures will help protect the environment.