CYPROTERONE ACETATE

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyproterone Acetate Tablets 50 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyproterone Acetate 50 mg.
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
For control of libido in severe hypersexuality
and/or sexual deviation in the adult male.
For the management of patients with prostatic cancer (1) to
suppress “flare” with initial LHRH analogue therapy,
(2) in 
long-term palliative treatment where LHRH analogues or surgery
are contra-indicated, not tolerated, or where oral 
therapy is preferred, and (3) in
the treatment of hot flushes in patients under treatment with
LHRH analogues or who 
have had an orchidectomy.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration only.
Control of libido in severe hypersexuality
and/or sexual deviation
Adults and the elderly: The usual dose is 1
tablet twice daily. The daily dose should be divided and taken
after the 
morning and evening meals.
Children (under 18 years old): Not recommended.
The management of patients with prostatic cancer
Adults and the elderly: To suppress “flare” with
initial LHRH analogue therapy: 300mg/day which may
be reduced to 
200 mg if the higher dose is not tolerated.
In long
term palliative treatment where LHRH analogues or surgery
are contraindicated, not tolerated, or when oral 
therapy is preferred: 200 – 300mg/day.
In the treatment of hot flushes in
patients under treatment with LHRH analogues or who have had an
orchidectomy: 
50mg starting dose with upward titration if necessary within
the range 50 – 150mg/day.
Children (under 18 years old): Not recommended.
IRISH MEDICINES BOARD
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_Date Issued 28/10/2005_
_CRN 2016169_
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