Enzutix 40 mg Capsules

ENZUTIX contains the active substance enzalutamide. It is used to treat adult men with prostate cancer that no longer responds to lowering of testosterone levels by either medical or surgical castration.

ENZUTIX works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing.

Do not take ENZUTIX:

• if you are hypersensitive (allergic) to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, may become pregnant or breastfeeding a baby (see ‘Pregnancy, breast-feeding and fertility’), as ENZUTIX is not for use in women.

Warnings and Precautions

Take special care with ENZUTIX:

• if you ever had or are at risk of having a seizure (a fit) (see ‘Warnings and precautions: seizures’ below).
• If you have been diagnosed by your doctor with a condition called posterior reversible encephalopathy syndrome (PRES). (see ‘Warnings and precautions: Posterior Reversible Encephalopathy Syndrome’ below).
• if you are taking any medicines to prevent blood clots (e.g. warfarin, clopidogrel). Your doctor will regularly send you for blood tests to check that your medicine to prevent blood clots are working.
• if you have problems with your kidneys.
• if you have problems with your liver.
• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia) or uncontrolled high blood pressure, or if are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using ENZUTIX.
• if you have been diagnosed with changes in heart rhythm (QT prolongation).
• if you currently receive docetaxel chemotherapy.
• if you are hypersensitive (allergic) to enzalutamide or any of the other ingredients of this medicine (listed in section 6).
• if you have been diagnosed with sorbitol intolerance. ENZUTIX contains sorbitol.

Do not share medicines prescribed for you with any other person.

Always take ENZUTIX exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 160 mg (4 soft capsules), taken at the same time once a day.

Taking ENZUTIX:

• Swallow the capsules whole with water.
• Do not chew, dissolve, or open the soft capsules before swallowing.
• ENZUTIX can be taken with or without food.
• ENZUTIX should not be handled by persons other than the patient and his caregivers.
• ENZUTIX should not be handled by women who are or may become pregnant.

Your doctor will tell you how long your treatment with ENZUTIX will last. Do not stop treatment early. If you have the impression that the effect of ENZUTIX is too strong or too weak, tell your doctor or pharmacist.

If you take more ENZUTIX than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you take more ENZUTIX than prescribed, stop taking ENZUTIX and contact your doctor. You may have an increased risk of seizure or other side effects.

If you forget to take ENZUTIX

• Do not take a double dose to make up for forgotten individual doses.
• If you forget to take ENZUTIX at the usual time, take your usual dose as soon as you remember.
• If you forget to take ENZUTIX for the whole day, take your usual dose the following day.
• If you forget to take ENZUTIX for more than one day, talk to your doctor without delay.

If you stop taking ENZUTIX

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

ENZUTIX can have side effects. Not all side effects reported for ENZUTIX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ENZUTIX, please consult your health care provider for advice.

If any of the following happens, stop taking ENZUTIX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to ENZUTIX. You may need urgent medical attention or hospitalisation.

If any of the following happens, stop taking ENZUTIX and tell your doctor immediately:

• seizure (or fit). ENZUTIX can cause seizures. This is more likely to happen if you take more than the recommended dose, if you take certain other medicines, or if you are at higher than usual risk of seizures.
• seizure, worsening headache, confusion, blindness, or other vision problems. This may be due to Posterior Reversible Encephalopathy Syndrome (PRES), a rare, reversible condition involving the brain.

These are all serious side effects. You may need urgent medical attention.

Other possible side effects include:

Frequent side effects:

• High blood pressure and hot flushes.
• Fatigue (feeling tired), weakness, broken bones and falls.
• Dry and itchy skin.
• Feeling anxious, headache, difficulty remembering, reduced concentration and forgetfulness.
• Blockage of the arteries in the heart (ischemic heart disease).
• Breast enlargement in men (gynaecomastia).
• Symptom of restless legs syndrome (an uncontrollable urge to move a part of the body, usually the leg).

Less frequent side effects:

• Hallucinations, difficulty thinking clearly and seizure.
• Low white blood cell count.
• Seizures (fits)
• Difficulty with learning

Side effects of an unknown frequency:

• Muscle pain, muscle spasms, muscular weakness, and back pain.
• Changes in ECG (QT prolongation).
• Upset stomach including feeling sick (nausea), being sick (vomiting) and diarrhoea.
• Rash and swelling of the face, lips, tongue and / or throat.
• Reduction in blood platelets (which increases risk of bleeding or bruising).
• Posterior Reversible Encephalopathy Syndrome (PRES), a rare, reversible condition involving the brain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effect

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ENZUTIX.

Store at or below 30 °C. Store all medicines out of reach of children. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).