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HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This medication is used to treat advanced prostate cancer in men. 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 in men, helps prostate cancer to grow and spread. Cyproterone is a type of progestin hormone.
Take this medication by mouth, usually 2 to 3 times a day after meals or as directed by your doctor. Dosage is based on your medical condition and response to treatment. Your dosage may be lower if you have had your testicle(s) surgically removed. 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 (e.g., 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.
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 persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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 any of these unlikely but serious side effects occur: breast lumps, mental/mood changes (e.g., 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 (e.g., fever, chills, persistent sore throat), signs of liver problems (e.g., persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine).
This medication may rarely cause blood clots. Seek immediate medical attention if any of these rare but 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, slurred speech, 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, seek immediate medical attention 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.
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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, depression, blood clots, diabetes, heart disease (e.g., congestive heart failure, coronary artery disease, high cholesterol/fats in the blood), decreased adrenal gland function.
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. This medication may lower sperm count or may cause abnormal sperm to form, possibly causing infertility. These effects are usually reversible after treatment is stopped. Consult your doctor for more details. Cyproterone should not be used in children. 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.
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: products containing testosterone. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting cyproterone.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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.
Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function tests, PSA blood test, blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
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.
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.
CYPROTERONE – ORAL