Xtandi 40 mg enzalutamide Capsules × 112

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.

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.