Xzalu 40 mg Capsules

XZALU contains the active ingredient enzalutamide, and it is used in adult men for the treatment of prostate cancer that has spread to other parts of the body other than the prostate.

Do NOT take XZALU

• If you are allergic to enzalutamide or any of the other ingredients of XZALU (listed in section 6).
• If you are a woman.

Warnings and precautions

Special care should be taken with XZALU:

• If you have a history of seizures.
• If you are at high risk of getting seizures (fits).
• If you are taking medicines such as warfarin.
• If you have been diagnosed with severe kidney disease.
• If you have been diagnosed with severe liver disease.
• If you are at high risk of getting any type of heart disease.
• If you are on chemotherapy.

Tell your doctor:

• If you develop symptoms such as fits, headaches, confusion, blindness or other visual problems and increased blood pressure while taking XZALU.
• If you develop a rash or swelling of the face, tongue or lip.

Children and adolescents

XZALU is not suitable for use in children as prostate cancer is not present in children.

Other medicines and XZALU

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines).

The following medicines may increase the effect of XZALU:

• Gemfibrozil (used to treat cholesterol).

The following medicines may reduce the effects of XZALU:

• Rifampicin (used to treat tuberculosis (TB)).

XZALU may reduce the effect of the following medicines:

• Midazolam, Diazepam and Zolpidem (used to treat anxiety and sleeplessness).
• Warfarin (used to prevent the formation of blood clots).
• Tramadol and Fentanyl (used in the management of severe pain).
• Clarithromycin and Doxycycline (antibiotics used for the treatment of infections).
• Cabzitaxel (used in the treatment of cancer).
• Phenobarbitone. Phenytoin, Carbamazepine, Clonazepam, Phenytoin, Primodone and Valproic acid (used to treat epilepsy).
• Diltiazem, Felodipine, Nicardipine, Nifedipine and Verapamil (used to treat heart conditions and increased blood pressure).
• Colchicine (used to treat gout, may require a dose adjustment).
• Digoxin (used to treat heart conditions).
• Dexamethasone and Prednisolone (commonly used corticosteroids).
• Indinavir and Ritonavir (used in the treatment of HIV).
• Tacrolimus (used to reduce the response of your immune system).
• Omeprazole (used to treat ulcers and heartburn).
• Atorvastatin and Simvastatin (used to treat cholesterol).
• Levothyroxine (used to treat thyroid conditions).

XZALU may increase the effect of the following medicines:

• Methotrexate (used in the treatment of cancer and rheumatoid arthritis).

When XZALU is used together with the following medicines, in may increase the risk of heart related side effects:

• Quinidine, Disopyramide, Amiodarone, Sotalol, Dofetilide and Ibutilide (used to treat abnormal heart rhythm).
• Methadone (used for the management of pain).
• Moxifloxacin (an antibiotic used for bacterial infections).
• Antipsychotic medicines such as risperidone.

XZALU with food

Food does not affect exposure to XZALU.

Pregnancy, breastfeeding and fertility.

XZALU is not for use in women.

You should use a condom during and for 3 months after treatment with XZALU if you are engaged in sexual activity with a pregnant woman. If you engage in sexual intercourse with a woman who could potentially become pregnant, a condom and another form of birth control must be used during and for 3 months after treatment.

Since XZALU is not for use in women, it is not known whether or not it passes into human milk.

XZALU may affect fertility in men.

Do not share medicines prescribed for you with any other person. Always take XZALU 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 daily (four XZALU capsules) taken as a single dose.

If you take more XZALU than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center.

After an overdose of XZALU, you may be at an increased risk of seizures (fits).

If you forget to take XZALU

If you forget to take your dose of XZALU at the usual time, you should take the dose as close as possible to the usual time. If you forget to take your dose of XZALU for a whole day, you should continue with the usual daily dose on the next day. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking XZALU 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,
• Any heart related side effects such as chest pain.

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

Other side effects of XZALU:

Frequent side effects:

• Anxiety (feelings of worry or fear),
• Headache,
• Memory problems,
• Loss of memory,
• Disturbances in attention,
• An irresistible urge to move your legs,
• Ischemic heart disease,
• Hot flushes,
• Increased blood pressure,
• Dry skin,
• Fractures,
• Enlargement of the breasts,
• Weakness,
• Feeling tired,
• Falling.

Less frequent side effects:

• A reduction in white blood cells (determined through blood tests),
• Seeing things that are not there (hallucinations),
• Difficulties with learning,
• Seizures (fits).

Side effects where the frequency is unknown:

• A low number of platelets in the blood,
• The urge to vomit (nausea),
• Vomiting,
• Diarrhoea,
• Painful muscles,
• Muscle spasm,
• Muscle weakness,
• Back pain.

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

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. 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 or to Cipla Medpro (Pty) Ltd. by email: [email protected] or telephone: 080 222 6662 (toll free). By reporting side effects, you can help provide more information on the safety of XZALU.

Store all medicines out of reach of children. Store at or below 25 °C. Keep container tightly closed. Do not use after the expiry date stated on the packaging material. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).