Uses

This medication is used to treat advanced prostate cancer. It is not a cure. Cyproterone is used to control flare-up of disease symptoms or hot flashes caused by other treatments. It also helps slow or stop the spread of prostate cancer by blocking the effects of testosterone and by reducing the amount of testosterone that the body makes. Testosterone, a natural hormone, helps prostate cancer to grow and spread. Cyproterone is a type of progestin hormone.

How To Use

Take this medication by mouth as directed by your doctor, usually 2 to 3 times a day after meals. The dosage is based on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens (such as urination becomes more difficult, bone pain increases).

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Side Effects

Tiredness is common during the first few weeks of treatment but usually improves by the third month. Dry skin, temporary loss of patches of body hair, weakness, dizziness, headache, nausea, stomach upset, flushing of the face/neck, sweating, decreased sexual interest/ability, and male breast enlargement/tenderness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• breast lumps
• mental/mood changes (such as new/worsening depression)
• new/worsening bone pain
• fast heartbeat
• rapid weight change
• swelling of the ankles/feet
• increased thirst/urination
• easy bleeding/bruising
• signs of infection (such as sore throat that doesn't go away, fever, chills)
• signs of liver problems (such as nausea that doesn't stop, vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine)

This medication may rarely cause blood clots. Get medical help right away if any of these very serious side effects occur:

• pain/redness/swelling/weakness of the arms or legs
• calf pain/swelling that is warm to the touch
• new/worsening shortness of breath
• coughing up blood
• sudden vision changes
• confusion
• trouble speaking
• weakness on one side of the body
• sudden severe headache
• chest/jaw/left arm pain
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking cyproterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• kidney disease
• depression
• blood clots
• diabetes
• heart disease (such as heart failure, coronary artery disease)
• high cholesterol/fats in the blood
• decreased adrenal gland function
• tumor of the coverings of the brain (meningioma)

If you have diabetes, this medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may make you dizzy or very tired. Alcohol or marijuana (cannabis) can make you more dizzy or tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may worsen this drug's side effects and may interfere with the way this drug works.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Cyproterone should not be used by children.

This medication can affect fertility in males. Ask your doctor for more details.

This medication should not be used in women. Women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. It may harm an unborn baby.

It is not known whether this drug passes into breast milk. Women who are breast-feeding should also avoid exposure to this medication. Consult your doctor for more information.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• products containing testosterone

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function, PSA blood test, blood counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.