Pronunciation:

sye-PROE-ter-one

Uses of This Medicine:

Cyproterone 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.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• 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 clotting problems.

• Cardiac disease—May make the condition worse.

• Depressive tendencies—May cause depression to occur.

• Type 2 diabetes mellitus—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.

Proper Use of This Medicine:

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 this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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

• For injection dosage form:
  • For treating prostate cancer:
    • Adult—300 milligrams (mg) 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

Abdominal pain or tenderness

agitation

back pain

black, tarry stools

blisters on the 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 suddenly

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 or side pain

mood or mental changes

nausea and vomiting

painful or difficult urination

pains in the chest, groin, or legs, especially the 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

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

stomachache

sudden loss of coordination

sweating

swelling of the feet or lower legs

swollen and/or painful glands

temporary blindness

tightness in the chest

unexplained weight loss

unusual bleeding or bruising

vision changes

weakness in the arm and/or leg on one side of the body, sudden and severe

wheezing

yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Bleeding, blistering, burning, coldness, or discoloration of the 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 the skin

severe sunburn

soft stools

tiredness or weakness

unusual increase in hair growth

weight gain

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.