Drug family: Antiandrogen
This drug is a generic of ANDROCUR
WHAT IS CYPROTERONE ACETATE SANDOZ PRESCRIBED FOR?
This medicine contains a derivative of progesterone . It has an antihormonal action: it opposes the action of androgen hormones , essentially testosterone . In men, its action slows down the growth of prostate cells . In women, androgen hormones are present in small quantities and are involved in hair disorders and excess sebum.
prostate cancer ;
hirsutism in women, when excessive hair has a serious effect on emotional and social life (50 mg tablet);
certain forms of paraphilia, in association with psychotherapeutic treatment (100 mg tablet).
PRESENTATIONS OF THE DRUG CYPROTERONE ACETATE SANDOZ
COMPOSITION OF THE DRUG CYPROTERONE ACETATE SANDOZ
| p cp | p cp | |
| Cyproterone acetate | 50mg | 100mg |
| Lactose | + | + |
CONTRAINDICATIONS OF THE DRUG CYPROTERONE ACETATE SANDOZ
severe liver disease, certain rare diseases causing excess bilirubin in the blood;
tuberculosis or deterioration in general condition linked to a serious illness;
thromboembolic accident ( phlebitis , pulmonary embolism, myocardial infarction , etc.) old or occurring during treatment;
severe depression ;
sickle cell anemia ;
meningioma ( brain tumor ) old or occurring during treatment;
history of herpes gestationis, jaundice or prolonged itching during pregnancy (50 mg tablet).
ATTENTION
This medication can, in high doses, be responsible for sometimes serious liver damage. A blood test is recommended before starting treatment. Promptly report to your doctor any symptom that could lead to fear of a toxic effect on the liver: abdominal pain, loss of appetite, dark urine, intense itching, jaundice. Analyzes may be necessary to ensure the absence of anomaly.
Medical monitoring should be reinforced in the event of diabetes or chronic liver disease. In addition, gynecological monitoring (breasts, uterus) is recommended in women.
Thromboembolic accidents have been reported during treatment: in the event of the occurrence of significant and unusual headaches, visual disturbances or increased blood pressure , do not continue treatment without medical advice.
Studies have shown a marked increase in the risk of occurrence of meningioma ( most often benign brain tumour ) in patients treated with cyproterone acetate at high doses over a long period. The duration of treatment should be as short as possible and the dose used as low as possible. A search for meningioma by brain imaging ( MRI ) must be carried out at the start of treatment, then regularly if the treatment is continued for several years. If a meningioma is diagnosed, treatment should be permanently discontinued. An information sheet will be given to you by the doctor at the time of the prescription.
If you must drive or use a dangerous machine, make sure beforehand that this medicine does not affect your alertness .
INTERACTIONS OF THE DRUG CYPROTERONE ACETATE SANDOZ WITH OTHER SUBSTANCES
This medication may interact with herbal products containing St. John's Wort.
Tell your doctor or pharmacist if you are taking an antidiabetic ( insulin , metformin, sulfonylureas ) or an antiepileptic (carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine).
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY :
This drug has no indication in pregnant women. It is necessary to ensure the absence of pregnancy before starting treatment.
Cyproterone blocks ovulation and therefore has a contraceptive effect . In women of childbearing age, this drug must always be combined with an estrogen . This combination provides contraception from the first month.
FEEDING WITH MILK :
The available data do not allow to know if this medicine passes into breast milk; a choice is therefore necessary between breastfeeding and taking the drug. This decision should be made in consultation with your doctor.
INSTRUCTIONS FOR USE AND DOSAGE OF THE DRUG CYPROTERONE ACETATE SANDOZ
This medication should be swallowed with a glass of water.
USUAL DOSE:
Prostate cancer : 4 to 6 tablets at 50 mg per day or 2 to 3 tablets at 100 mg per day, in 2 or 3 doses.
Hirsutism :
Premenopausal woman : 1 tablet at 50 mg per day for 20 days per month, in combination with an estrogen , followed by a 7-day break. As maintenance therapy , depending on clinical signs, the dose may be reduced to 1/2 50 mg tablet daily for 20 days per month, in combination with an estrogen , followed by a 7-day break
Postmenopausal woman : 1/2 or 1 50 mg tablet per day, if possible in combination with an estrogen .
Reduction of sexual urges: the dosage is individual.
TIPS
In premenopausal women, additional local contraception is necessary during the first 2 cycles. If you forget a tablet, take the tablet as soon as you remember. If the delay in taking exceeds 12 hours, contraceptive security is no longer assured. An additional contraceptive method (condoms) must be used until the onset of menstruation. In the absence of periods during the 7 days without treatment, a pregnancy test must be performed to verify the absence of pregnancy before resuming treatment.
POSSIBLE SIDE EFFECTS OF THE DRUG CYPROTERONE ACETATE SANDOZ
decrease in sperm production usually reversible on discontinuation of treatment, which may lead to temporary sterility;
gynecomastia , impotence , low libido, sweating, hot flushes, anemia ;
bone loss in case of prolonged treatment.
In women: breast tension, change in libido, menstrual disorders (slight bleeding between periods, cessation of periods, etc.).
In women as in men: weight change, shortness of breath, heavy legs, migraine , headaches, rash , fatigue, restlessness and depression .
Rarely: hepatitis , thromboembolic accident, meningioma (see Warning).
