ANDROCUR TABLET 50 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CYPROTERONE ACETATE

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

G03HA01

Dosage:

50 mg

Pharmaceutical form:

TABLET

Composition:

CYPROTERONE ACETATE 50 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

DELPHARM LILLE S.A.S

Authorization status:

ACTIVE

Authorization date:

1990-06-13

Patient Information leaflet

Tablet
ANDROCUR®
 50 mg
Important information, please read carefully !
 COMPOSITION 
Each pack contains 50 round white tablets each with 50mg cyproterone
acetate 
 PHARMACODYNAMIC/PHARMACOKINETIC PROPERTIES 
 PHARMACODYNAMIC PROPERTIES 
Androcur is an antiandrogenic hormone preparation.
In the woman, androgen-dependent conditions such as pathological
hair growth in 
hirsutism, androgenetic alopecia and increased sebaceous gland
function in acne and 
seborrhea, are favorably influenced by competitive displacement
of the androgens at the 
target organs. The reduction of the androgen concentration which
results from the 
antigonadotropic property of cyproterone acetate has an additional
therapeutic effect. 
These changes are reversible following discontinuation of the
therapy. 
During the combined treatment with Diane-35, ovarian function is
inhibited. 
In the man, under treatment with Androcur, sexual drive and potency
are reduced and 
gonadal function is inhibited. These changes are reversible following
discontinuation of the 
therapy. Cyproterone acetate inhibits competitively the effect
of androgens at 
androgen-dependent target organs, e.g. it shields the prostate from
the effect of androgens 
originating from the gonads and/or the adrenal cortex. 
Cyproterone acetate has a central inhibiting effect. The
antigonadotropic effect leads to a 
reduction of testosterone synthesis in the testes and hence, to a
reduction of the serum 
concentration of testosterone.
The antigonadotropic effect of cyproterone acetate is also exerted
when the substance is 
combined with LHRH agonists. The initial increase of testosterone
provoked by this 
substance group is decreased by cyproterone acetate.
An occasional tendency for the prolactin levels to increase slightly
has been observed under 
higher doses of cyproterone acetate. 
 PHARMACOKINETIC PROPERTIES 
Following oral administration, cyproterone acetate is completely
absorbed over a wide dose 
range. The ingestion

Summary of Product characteristics

Androcur 50mg PI_CCDS 13_10 December 2018
1
NAME OF THE MEDICINAL PRODUCT
Androcur Tablet 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50mg cyproterone acetate. For full list of
excipients, see section ‘List of
excipients’.
PHARMACEUTICAL FORM
Tablet.
White to faintly yellowish tablets, scored on one side, with an
embossed “BV” in a regular
hexagon on the other side. The tablet can be divided into equal
halves.
THERAPEUTIC INDICATIONS
INDICATIONS IN THE MAN
•
Reduction of drive in sexual deviations.
•
Antiandrogen treatment in inoperable carcinoma of the prostate.
INDICATIONS IN THE WOMAN
•
Severe signs of androgenization, e.g. very severe hirsutism, severe
androgenetic
alopecia, often attended by severe forms of acne and/or seborrhoea.
DOSAGE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Oral use. The tablets are to be taken with some liquid after meals.
DOSAGE IN THE MAN
The maximum daily dose is 300mg.
Reduction of drive in sexual deviations
Generally, treatment is started with 1 Androcur 50mg 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. When a satisfactory result has been achieved, one
should try to maintain the
therapeutic effect with the lowest possible dose. Quite often 1/2
tablet twice daily is sufficient.
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 1/2 tablet, at intervals of several weeks.
To stabilize the therapeutic effect it is necessary to take Androcur
over a protracted period of
time, if possible with the simultaneous use of psychotherapeutic
measures.
Androcur 50mg PI_CCDS 13_10 December 2018
2
Antiandrogen treatment in inoperable carcinoma of the prostate
To eliminate the effect of adrenocortical androgens after orchiectomy
: 2 Androcur 50mg
tablets once to twice daily (= 100 - 200 mg). Wit