Patient Medication Information: uses, side effects, how to take - Mylan-Cyproterone
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-CYPROTERONE is indicated for the palliative treatment of patients with advanced prostate cancer.
What it does:
MYLAN-CYPROTERONE is a drug acting against male sex hormones (androgens). Androgens encourage the growth of prostate cancer and MYLAN-
CYPROTERONE inhibits this effect.
When it should not be used:
Do not take MYLAN-CYPROTERONE if you:
are allergic (hypersensitive) to
cyproterone acetate or any of the other ingredients of MYLAN-CYPROTERONE;
have a liver disease or reduced
liver function;
have Dubin-Johnson syndrome or
Rotor syndrome that affects the excretion of red blood cell pigment (bilirubin);
have or have had liver tumors that
are not due to the spread of prostate cancer;
- have reduced kidney function;
have wasting diseases that are not
related to prostate cancer;
suffer from severe chronic
depression;
have conditions that increase your
risk for developing blood clots (thromboembolic process).
What the medicinal ingredient is:
MYLAN-CYPROTERONE comes in tablets containing 50 milligrams (mg) of cyproterone acetate as the active ingredient.
What the nonmedicinal ingredients are:
Each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn/Maize Starch, Lactose, Magnesium Stearate, and Povidone.
What dosage forms it comes in:
MYLAN-CYPROTERONE comes in bottles of 60 tablets.
WARNINGS AND PRECAUTIONS
MYLAN-CYPROTERONE may decrease the function of the hormoneproducing glands attached to the kidney (adrenal glands). Therefore your doctor may conduct some tests to monitor this effect during treatment with MYLAN-
CYPROTERONE .
BEFORE you use MYLAN-
CYPROTERONE talk to your doctor or pharmacist if you have or have had any of the following conditions:
- Blood clots;
- Liver problem;
- Depression;
- Breathing problem (shortness of breath).
- Diabetes. Your doctor may need to adjust your antidiabetic medication. This requires strict supervision during treatment with MYLAN-CYPROTERONE.
- Anemia. Your doctor will monitor your red-blood cell count during treatment.
MYLAN-CYPROTERONE is not recommended for use in children and adolescents below 18 years of age and before the end of puberty, as it may have a negative effect on growth and the immature hormonal regulation functions.
MYLAN-CYPROTERONE is not recommended for use in women.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with
MYLAN-CYPROTERONE include:
Statins (medicines for reducing
blood fats)
Ketoconazole, itraconazole,
clotrimazole (for fungal infections)
- Ritonavir (for viral infections)
- Rifampicin (for tuberculosis)
- Phenytoin (for epilepsy)
St. John’s Wort (herbal remedy for
depression)
PROPER USE OF THIS MEDICATION
You should follow the dose prescribed by your doctor.
Usual dose
200 mg to 300 mg daily taken orally in two or three divided doses with liquid after meals. Maximum daily dose is 300 mg.
Overdose:
Missed Dose:
Do not take the missed MYLAN-CYPROTERONE (do not take a double dose to make up for the missed tablet). Continue taking the tablets at the regular time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
MYLAN-CYPROTERONE can have side effects, like all medicines, but not everybody gets them. For further information about any of these effects, ask a doctor or pharmacist.
If any of the side effects get serious, or if you notice any side effects not listed here, please tell your doctor or pharmacist.
Very frequent side effects:
Reduced sexual interest (decreased
libido)
Swelling of the breast, breast
soreness (gynecomastia)
- Impotence
- Abnormal sperm, low sperm count which may be reversible after MYLAN-CYPROTERONE is discontinued.
Other side effects:
- Hair loss or unusual increase in hair growth
- Constipation or diarrhea (loose stools)
- Weight gain
- Tiredness and weakness
- Shortness of breath
- Skin rash, blisters
- Vision change
- Decrease in blood pressure
- Increase in blood sugar
- Depression
Rare but serious side effects:
- Liver toxicity: generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching, yellowing of the skin and eyes, light-colored stools, dark-colored urine
Life-threatening internal bleeding
(intra-abdominal hemorrhage): unusual upper abdominal pains which do not disappear within a short time
- Blood clots: swelling of the calf or leg (blood clots in the leg), chest pain and being short of breath (blood clots in the lung), suddenly feeling weak, loss of coordination, slurred speech (a stroke or blood clots in the brain), temporary blindness (blood clots in the eye)
Bone loss (osteoporosis) and benign brain tumors (cerebral meningioma) have been reported with long term use of MYLAN-CYPROTERONE
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
Only if severe | In all cases | ||
| Inability to achieve or maintain an erection | √ | ||
Liver toxicity, (generally feeling unwell, fever, nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin or eyes, light colored bowel movements, dark urine) liver inflammation (hepatitis), liver failure | √ | ||
| Reduced sexual drive | √ | ||
| Reversible inhibition of sperm production | √ | ||
| Swelling of the calf or leg, chest pain, suddenly feeling weak | √ | ||
Unusual upper abdominal pains which do not disappear within a short time | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-CYPROTERONE , contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach and sight of children.
Do not take MYLAN_CYPROTERONE after the expiry date which is stated on the pack.
Medicines must not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
Store at room temperature between 15°C and 30°C.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance
Reporting Form and:
-Fax toll-free to 1-866-678-6789, or -Mail to: Canada Vigilance Program
Health Canada Postal Locator 0701D Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, please contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
NOTE: This CONSUMER
INFORMATION leaflet provides you with the most current information at the time of printing.
For the most current information, the Consumer Information leaflet plus the full Monograph, prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379 or at customerservice@mylan.ca.
85 Advance Rd.
Etobicoke, Ontario M8Z 2S6