ANDROCUR 50

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

CYPROTERONE ACETATE

Beschikbaar vanaf:

BAYER ISRAEL LTD

ATC-code:

G03HA01

farmaceutische vorm:

TABLETS

Samenstelling:

CYPROTERONE ACETATE 50 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

BAYER WEIMAR GMBH UND CO.KG, GERMANY

Therapeutische categorie:

CYPROTERONE

Therapeutisch gebied:

CYPROTERONE

therapeutische indicaties:

For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma.

Autorisatie datum:

2011-10-31

Bijsluiter

PACKAGING TECHNOLOGY BERLIN GF
page 1
Bayer Pharma AG
client: GV04
itemno.: 81203571
PZ: 9307A-4A
code-no.: 131
name: LF-ANDROCUR 50MG TAB H6
country: IL BPH
colors: BLACK
version: 20.12.2012/02
approval:
replaces: 80816546
ANDROCUR
®
50
TABLETS
81203571_02.indd 1
81203571_02.indd 1
20.12.2012 11:57:48
20.12.2012 11:57:48

Productkenmerken

1
1.
NAME OF THE MEDICINAL PRODUCT
Androcur 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyproterone acetate.
Excipient with known effect: Lactose 108.75 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round tablet. White to faintly yellowish tablets, scored on one side,
with an embossed "BV"
in a regular hexagon on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For antiandrogen therapy in men: sexual disorders, inoperable
prostatic carcinoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The maximum daily dose is 300 mg.
_Adults _
_ _
_REDUCTION OF DRIVE IN SEXUAL DEVIATIONS IN MEN _
Generally, treatment is started with 1 tablet Androcur 50 mg 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.
_ANTIANDROGEN TREATMENT IN INOPERABLE CARCINOMA OF THE PROSTATE_
2 tablets Androcur 50 mg twice to three times daily (= 200 - 300 mg).
2
Treatment should not be interrupted nor the dosage reduced after
improvement or
remissions have occurred.
•
To reduce the initial increase of male sex hormones in combination
therapy with GnRH
agonists.
Initially 2 tablets Androcur 50 mg twice daily (= 200 mg) alone for 5
- 7 days, followed by 2
tablets Androcur 50 mg twice daily (= 200 mg) for 3 - 4 weeks together
with a GnRH agonist
in the dosage recommended