In Canada—

• Antineoplastic

Cyproterone ( SYE-proe-te-rone) is used to treat cancer of the prostate gland. The prostate gland is present only in males; therefore, females do not get prostate cancer.

This medicine blocks the effect of the male hormone testosterone in the body. This decreases the amount of testosterone produced in the body and is one way of treating this type of cancer.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (Canada)

Parenteral
• Injection (Canada)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cyproterone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to cyproterone. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding— It is not known whether cyproterone passes into the breast milk. However, this medicine has not been reported to cause problems in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cyproterone in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cyproterone in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking cyproterone, it is especially important that your health care professional know if you are receiving any of the following:

• Ethinyl estradiol (eg, Estinyl)—Concurrent use with cyproterone may cause blood clotting problems

• Blood clots (or history of) or
• Circulation disease (or history of) or
• Stroke (or history of)—If these conditions already are already present, cyproterone may have a greater chance of causing blood clot problems

• Cardiac disease—May make the condition worse

• Depressive tendencies—May cause depression to occur

• Diabetes mellitus (sugar diabetes)—May cause a loss of control of diabetes by increasing blood and urine sugar

• Liver disease—Effects of cyproterone may be increased because of its slower removal from the body

At first, cyproterone often causes loss of strength and energy or tiredness. However, these effects are lessened after about the third month of treatment and it is very important that you continue to receive this medication.

This medication should not be discontinued even if improvement of the disease occurs.

Dosing—

The dose of cyproterone will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's body size, and whether or not other medicines are also being taken. If you are taking or receiving cyproterone at home, follow your doctor's orders or the directions on the label.If you have any questions about the proper dose of cyproterone, ask your doctor.

• For oral dosage form:
  • For treating prostate cancer:
    • Adults—100 to 200 milligrams (mg) (2 to 4 tablets) a day divided into 2 to 3 doses and taken after meals.

• For injection dosage form:
  • For treating prostate cancer:
    • Adult—300 mg (3 mL) injected into a muscle once a week.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Cyproterone may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

While you are taking cyproterone, be careful to limit the amount of alcohol you drink.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common or rare
  • Abdominal pain or tenderness;  agitation ;  back pain;  black, tarry stools;  blisters on skin;  bloody urine;  blurred vision;  chest pain;  chills;  clay colored stools;  confusion;  cough;  dark urine;  decreased appetite;  decreased urine output;  difficulty swallowing;  dilated neck veins;  dizziness;  drowsiness;  dry mouth;  fainting or light-headedness when getting up from a lying or sitting position;  fast heartbeat;  fatigue;  fever;  flushed, dry skin;  fruit-like breath odor;  general feeling of discomfort or illness;  hallucinations;  headache, sudden and severe;  hives;  inability to speak;  increased blood pressure;  increased hunger;  increased thirst;  increased urination;  irregular breathing;  irregular heartbeat ;  itching;  loss of consciousness ;  lower back/side pain;  mood or mental changes;  nausea and vomiting;  painful or difficult urination;  pains in chest, groin, or legs, especially calves of legs;  puffiness or swelling of the eyelids or around the eyes, face, lips or tongue ;  red, thickened, or scaly skin;  seizures;  shortness of breath;  skin rash;  slurred speech;  sores, ulcers, or white spots on lips or in mouth;  sore throat;  stiff neck;  stomachache;  sudden loss of coordination;  sweating;  swelling of feet or lower legs;  swollen and/or painful glands;  temporary blindness;  tightness in chest ;  unexplained weight loss;  unusual bleeding or bruising;  vision changes;  weakness in arm and/or leg on one side of the body, sudden and severe;  wheezing;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Decreased interest in sexual intercourse;  inability to have or keep an erection;  increase in sexual ability, desire, drive, or performance;  increased interest in sexual intercourse;  loss in sexual ability, desire, drive, or performance;  swelling of the breasts or breast soreness in both females and males;  unexpected or excess milk flow from breasts 
  
  

• Less common or rare
  • Bleeding, blistering, burning, coldness, or discoloration of skin;  change in walking and balance;  clumsiness or unsteadiness;  hair loss ;  inability to move legs or arms;  increased sensitivity of skin to sunlight;  increase in bowel movements;  loose stools;  loss of strength or energy;  muscle pain or weakness ;  paralysis of one side of the body;  redness or other discoloration of skin;  severe sunburn;  soft stools;  tiredness or weakness;  unusual increase in hair growth ;  weight gain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.