Dizalet 40 mg Soft Gel Capsules

DIZALET contain a medicine called Enzalutamide. This belongs to a group of cytostatic medicine (medicine that inhibits cell growth). DIZALET is used for the treatment of adult men with metastatic castration-resistant prostate cancer (CRPC) (disease when cancer has spread to parts of the body other than the prostate, and it is able to grow and spread even though drugs or other treatments to lower the amount of male sex hormones are being used to manage the cancer.)

Do not take DIZALET:

• If you are allergic or sensitive to DIZALET or any of the ingredients of DIZALET.
• Not to be used in women.

Warnings and Precautions

Take special care with DIZALET:

• If you have a history of seizures or factors which may increase the risk of seizure. These include underlying brain injury, stroke (death of brain cells due to lack of oxygen, caused by blockage of blood flow), primary brain tumours (A tumour that starts in the brain, which can be either benign (not cancer) or malignant (cancerous) or brain metastases (cancer that has spread to the brain from another location in the body and is therefore considered a secondary brain tumour), or alcoholism addiction to the consumption of alcoholic drink).
• If you have an impaired Kidney condition
• If you have an impaired Liver condition.

Tell your doctor,

• If you have a rare genetic or inherited sorbitol intolerance condition. (Sorbitol is a commonly used sugar substitute in "sugar-free" food products. When your body cannot tolerate sorbitol, it presents with by abdominal pain, bloating, and diarrhea).

Taking other medicines with DIZALET

Always tell your healthcare professional if you are taking any other medicine. (This includes all complementary or traditional medicines Other medicines and DIZALET DIZALET may have an effect on other medicines or other medicines may have an effect on DIZALET. The following medicines could have an effect with DIZALET:

• Gemfibrozil, used to treat high cholesterol, may increase the effect of [PRPDUCT NAME];
• Rifampicin, used in the treatment of tuberculosis, may decrease the effect of DIZALET;
• Macrolide antibiotics such as clarithromycin, used to treat infections, may have its effect increased;
• Benzodiazepines such as diazepam and midazolam, used to treat anxiety, panic disorders and insomnia, may have its effect increase;
• Indinavir and ritonavir, used to treat HIV/AIDS, may have its effect increased;
• Phenobarbitone and phenytoin, used in the treatment of epilepsy, may have its effect increased;
• Warfarin, used to thin the blood, may have its effect increased;
• Colchicine, used to treat gout, may require a dose adjustment;
• Dabidatran etexilate, used to stop the blood clotting, may need a dose adjustment. Digoxin, used in the treatment of heart failure, may need a dose adjustment.

Tell your doctor if you are taking any of the following medicines as these may affect your heart function if taken with DIZALET:

• Quinidine and Disopyramide, use in the treatment of irregular heart beats;
• Amiodarone, used in the treatment of serious irregular heartbeat;
• Methadone, used to treat opiates drug addiction (for example heroin);
• Chlorpromazine, risperidone, haloperidol, and other antipsychotic medicines used to treat delusions, hallucinations and disordered thoughts.

Pregnancy and breastfeeding:

- DIZALET is strictly not for use by women. This medicine may cause harm to the unborn child or potential loss of pregnancy if taken by women who are pregnant.

- Contraception in males and females - A condom or extra contraceptive measure is required during and for 4 3 months after treatment with DIZALET, if you are engaged in sexual activity with a pregnant woman or a woman of child bearing potential. Women of childbearing potential and men must use effective methods of contraception both before and during DIZALET therapy. Your doctor will advise you on the contraception method to be used and duration of contraception use. Contraception is typically used for 4 months after completing treatment with DIZALET, in men and 6 - 12 months after completing treatment with DIZALET, in women.

- Breastfeeding Use of DIZALET is prohibited in woman If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking DIZALET.

Driving and using machinery: Effects on ability to drive and use machines DIZALET may influence your ability to drive and operate machinery. You should first see how DIZALET affects you before driving or using machinery.

Important information about some of the ingredients of DIZALET Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Do not share medicines prescribed for you with any other person. Always take DIZALET exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with DIZALET will last. If you have the impression that the effect of DIZALET is too strong or too weak, talk to your doctor or pharmacist.

Taking DIZALET with food and drink: DIZALET should be swallowed whole with water, and can be taken with or without food.

Dose The recommended dose of DIZALET is 160 mg (four 40 mg capsules) as a single oral daily dose. Your doctor will determine the correct dose for you depending on your condition. Paediatric population There is no relevant use of this medicine in the paediatric population, as prostate cancer is not present in children and adolescents. Your doctor will tell you how long your treatment with DIZALET will last. Do not stop treatment early because this may reoccurrence of your condition. If you have the impression that the effect of DIZALET is too strong or too weak, tell your doctor or pharmacist.

If you take more DIZALET 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.

Overdose In the event of an overdose, treatment with enzalutamide should be stopped and general supportive measures initiated. Patients may be at increased risk of seizures following an overdose. If you forget to take DIZALET: If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

Not all side effects reported for DIZALET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. DIZALET can have side effects: If any of the following happens, stop taking DIZALET and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Memory impairment
• Disturbance in attention
• Gynaecomastia (enlargement of a man's breasts)
• Any breakage of bones
• posterior reversible encephalopathy syndrome – presents with symptoms like, alterations in mental status, headache, loss of eye sight, seizure and confusion.

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

Tell your doctor if you notice any of the following: The following side effects occur frequently:

• Tiredness and abnormal physical weakness
• Anxiety
• Headaches
• Memory impairment
• Disturbance in attention
• Enlargement of male breast
• Hot flushes, dry skin and itching
• Hypertension
• Falling

The following side effects rarely occur:

• Seizure
• visual hallucinations - when you see things that aren't there
• leucopenia - reduction in the number of white cells in the blood
• neutropenia - presence of abnormally few neutrophils in the blood.

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via https://www.sahpra.org.za/documents/86422f1b6.04_ARF1_Jul16_v4.pdf. By reporting side effects, you can help provide more information on the safety of this medicine.

Store at or below 25 °C. Keep in the original container until required for administration. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).