Each tablet contains Cyproterone acetate 50 mg
Without a Prescription
Cyproterone is prescribed for the treatment of:
Reduction of drive in sexual deviations, antiandrogen treatment in inoperable carcinoma of the prostate.
Severe signs of androgenisation, eg very severe hirsutism, androgen-dependent severe loss of scalp hair eventually resulting in baldness (severe androgenic alopecia), often attended by severe forms of acne and/or seborrhoea.
Reduction of drive in sexual deviations
The individual dosage will be determined by the doctor.
The tablets are to be taken with a little liquid after meals.
Generally, treatment is started with 1 tablet twice daily. It may be necessary to increase the dose to 2 tablets twice daily, or even 2 tablets three times daily for a short period of time.
If a satisfactory result is achieved, one should try to maintain the therapeutic effect with the lowest possible dose.
50 per day may be adequate in some patients.
When establishing the maintenance dose or when discontinuing the preparation, one should not reduce the dosage abruptly, but gradually.
To this end, the daily dose should be reduced by 1 tablet, or better half a tablet, at intervals of several weeks.
To stabilise the therapeutic effect it is necessary to take Cyproterone over a protracted period of time, if possible with the simultaneous use of psychotherapeutic measures.
Antiandrogen treatment in inoperable carcinoma of the prostate.
2 tablets once to twice daily (= 100-200 ).
2 tablets twice to three times daily (= 200-300 ).
In both cases, the treatment and dosage prescribed by the doctor should not be changed or interrupted after improvement or remissions have occurred.
For severe signs of androgenisation
Before starting Cyproterone therapy a thorough general medical and gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out.
Since pregnant women may not take Cyproterone, pregnancy must be excluded.
In women of child bearing age
For the duration of Cyproterone therapy women of child-bearing age must also receive a combination oral contraceptive.
This will provide the necessary contraceptive protection and will stabilize the menstrual cycle.
Dosage and directions for use as per the package insert of that product must be strictly adhered to.
Prior to commencing Cyproterone treatment it is always necessary for the patient to receive one complete cycle of a combination oral contraceptive.
Extra non-hormonal methods (with the exception of the rhythm and temperature methods) should be employed during the first 3 weeks of the first cycle, which may be shorter than 4 weeks.
Subsequent cycles should then be regular.
In the subsequent cycle of the combination oral contraceptive (second cycle) which starts the very next day after completion of the first pack of combination oral contraceptive, Cyproterone treatment is commenced on the 5th day of the menstrual cycle (1st day of bleeding = 1st day of the menstrual cycle). 2 Cyproterone 50 tablets are to be taken with some liquid after a meal from the 5th to the 14th day of the cycle (i.e. for ten days).
Every 28 days (the usual duration of a menstrual cycle), the above dosage regimen is to be followed.
Women receiving the cyclical combined Cyproterone and combination oral contraceptive therapy, should keep to a particular time of the day for tablet taking.
If more than 12 hours elapse from this time, contraceptive protection in this cycle may be reduced.
The use of these two products should nevertheless be continued according to instructions, ignoring the missed tablet or tablets, in order to avoid premature bleeding in this cycle.
However, an additional non-hormonal method of contraception (with the exception of the rhythm and temperature methods) is to be employed for the rest of the cycle.
If bleeding fails to occur during the last days of the 28-day cycle, the doctor must be consulted.
Following clinical improvement, the doctor can reduce the daily dose of Cyproterone 50 to 1 or half a tablet daily during the first 10 days of the combination cyclical treatment with the oral contraceptive combination preparation.
In postmenopausal or hysterectomised patients
In postmenopausal or hysterectomised patients in whom the additional administration of a combination oral contraceptive is not required for cycle control or contraception, Cyproterone may be administered alone.
Depending upon the severity of the condition, the average dose should be 1 to half a Cyproterone 50 tablet (= 50-25 mg) once daily for 21 days, followed by a seven day tablet-free interval.
Cyproterone is contraindicated if you have any of the following conditions:
- A history of herpes of pregnancy;
- A history of jaundice or persistent itching during a previous pregnancy;
- Diabetes with vascular changes;
- Dubin-johnson syndrome;
- Liver disease;
- Previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases);
- Previous or existing thromboembolic processes;
- Rotor syndrome;
- Sickle-cell anaemia;
- Wasting diseases (with the exception of carcinoma of the prostate);
As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk: benefit ratio must be considered carefully in each individual case before the use of Cyproterone.
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