CYPROTERONE AN cyproterone acetate 50mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 50 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

cyproterone acetate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate

Administration route:

Oral

Units in package:

50 tablets, 20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

WOMEN: Moderately severe to severe signs of androgenisation. Moderately severe/severe forms of hirsutism; moderately severe/severe androgen dependent loss of scalp hair (moderately severe/severe androgenic alopecia); moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenisation. CYPROTERONE AN inhibits the influence of male sex hormones which are also produced by the female. It is thus possible to treat diseases in women caused by either increased production of androgens or a particular sensitivity to these hormones. Hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment. If CYPROTERONE AN is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male fetus. Therefore, in women of childbearing potential, pregnancy must be excluded at the commencement of treatment and ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN: Reduction of drive in sexual deviations. CYPROTERONE AN reduces the force of the sexual urge in men with sexual deviations. Whilst under treatment the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. Abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. A prerequisite for therapy is the desire by the patient for treatment. CYPROTERONE AN should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to reduced drive for personal and social reorientation. Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (LHRH) analogue therapy; in long-term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy.

Product summary:

Visual Identification: White to off white, flat, round tablet with '50' engraved over a break line on one face, the other a plain face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-05-23

Patient Information leaflet

_Cyproterone AN tablets – Consumer Medicine Information _
_ _
_Cyproterone AN CMI v2 _
_ _
_ _
_Page 1 _
CYPROTERONE AN 50 MG TABLETS
_Cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
CYPROTERONE AN.
It
does
not
contain
all
of
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the
risks
of
you
taking
CYPROTERONE AN against the
benefits they expect it will have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT CYPROTERONE
AN IS USED FOR
CYPROTERONE
AN
is
an
antiandrogenic
hormone
medication
which
has
several
different uses.
Androgens such as testosterone
are natural male sex hormones
which are also produced, to a
slight extent, in females.
MEN
In
men,
androgens
may
help
cancer
cells
to
grow
in
some
types
of
prostate
cancer.
By
blocking
these
hormones,
CYPROTERONE AN may slow
or
stop
the
growth
of
cancer.
CYPROTERONE AN may also
be
used
in
combination
with
other
medicines
or
following
surgical removal of the testes to
treat side effects such as “hot
flushes”
or
“sweats”
and
to
prevent any initial worsening of
the disease.
CYPROTERONE
AN
is
also
used
to
reduce
abnormal
sex
drive in men.
WOMEN
In
women,
androgens
may
increase
hair
growth,
loss
of
scalp hair and secretion of oil
from
the
sweat
glands.
By
blocking
these
hormones,
CYPROTERONE AN may slow
or stop excessive hairiness, loss
of scalp hair, acne, oily skin and
dandruff.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your
doctor
may
have
prescribed it for another reason.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU TAKE
CYPROTERONE AN
_WHEN YOU MUST NOT TAKE _
_IT _
_ _
Do
not
take
CYPROTERONE
AN if you have an allergy to:
•
cyproterone
acetate,
the
active
ingredient
in
CYPROTE

Summary of Product characteristics

_ _
_ _
_Cyproterone AN 50 mg tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Cyproterone AN PI v3
Page 1
CYPROTERONE AN
50 MG TABLETS
_ _
_(CYPROTERONE ACETATE TABLETS) _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is cyproterone acetate.
_ _
_Structural formula:_
The chemical name is 6-chloro-17 -hydroxy-1 α, 2
α-methylene-pregna-4,6- diene-3,20-
dione acetate.
_ _
MOLECULAR FORMULA
: C
24
H
29
ClO
4
.
MOLECULAR WEIGHT_: _
416.95.
_CAS Number: _
427-51-0.
DESCRIPTION
White circular flat bevelled tablets, with breakline on one side and
plain on the other.
Each Cyproterone AN 50 mg tablet contains cyproterone acetate 50 mg.
CYPROTERONE AN contains the active ingredient cyproterone acetate 50
mg and the following
excipients: lactose monohydrate, povidone, magnesium stearate,
croscarmellose sodium .and
microcrystalline cellulose
PHARMACOLOGY
Following oral administration, cyproterone acetate is absorbed slowly.
Its bio-availability is
unknown. The maximum plasma level is reached 3 to 4 hours after
ingestion.
Cyproterone acetate is eliminated with a half-life of 38 ± 5 h. After
10 days, 33 ± 6 of the dose
can be demonstrated in the urine and 60 ± 8% in the faeces.
Cyproterone acetate is eliminated
_ _
_ _
_Cyproterone AN 50 mg tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Cyproterone AN PI v3
Page 2
with the urine mainly in the form of unconjugated metabolites and with
the bile in the form of
glucuronidized metabolites, the main one being 15
β-hydroxy-cyproterone acetate.
Radioimmunoassays show that about 0.2% of the dose is eliminated with
the breast milk.
CYPROTERONE AN is an antiandrogenic hormone preparation. Cyproterone
acetate is
believed to prevent the effect of endogenously produced and
exogenously administered
androgens at the target organs by means of competitive inhibition. The
stimulating effect of
male sex hormones on androgen-dependent structures and functions is
weakened or
counteracted by cyproterone acetate.
Cyproterone ace