CYPROTERONE AN cyproterone acetate 100mg tablet bottle

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

cyproterone acetate, Quantity: 100 mg

MAH:

Amneal Pharma Australia Pty Ltd

INN:

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

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

Visual Identification: White to off white, capsule shaped tablet with '100' engraved on one face, and a break line on the other face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

authorization_status:

Registered

authorization_date:

2012-05-23

PIL

_Cyproterone AN tablets – Consumer Medicine Information _
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_Cyproterone AN CMI v2 _
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_Page 1 _
CYPROTERONE AN TABLETS (100 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.
Androgens such as testosterone
are natural male sex hormones.
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.
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
CYPROTERONE AN
•
any of the ingredients listed
at the end of this leaflet
Some
of
the
symptoms
of
an
allergic reaction may include:
•
shortness of breath
•
wheezing
or
difficulty
breathing
•
swelling
of
the
face,
lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
DO
NOT
TAKE
CYPROTERONE
AN
IF
YOU
HAVE
ANY
OF
THE
FOLLOWING MEDICAL CONDITIONS:
•
liver
disease,
p

SPC

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_ Amneal Pharma Australia Pty Ltd _
Cyproterone AN 100 mg PI v3
Page 1
CYPROTERONE AN
100 MG
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_(CYPROTERONE ACETATE TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Cyproterone acetate
CHEMICAL NAME:
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
Cyproterone acetate is a white to pale yellow crystalline powder.
Cyproterone acetate
is very soluble in chloroform and dioxane, freely soluble in acetone
and benzene,
soluble in ethanol, methanol and ethyl acetate, sparingly soluble in
hexane, and almost
insoluble in water.
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_ Amneal Pharma Australia Pty Ltd _
Cyproterone AN 100 mg PI v3
Page 2
Each Cyproterone AN 100 mg tablet contains cyproterone acetate 100 mg.
Excipients: lactose monohydrate, Povidone, microcrystalline cellulose,
croscarmellose
sodium and magnesium
stearate,
Actions:
Anti-androgenic hormone preparation.
PHARMACOLOGY
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. Prostatic carcinoma and its
metastases are in general
androgen dependent, cyproterone acetate therefore exerts a
direct anti-androgenic action
on the tumour and its metastases.
Cyproterone acetate in addition has a progestogenic action exerting a
negative feedback
effect centrally on the hypothalamic receptors, so leading to a
reduction in gonadotropin
release, and hence to diminished production of testicular androgens.
Treatment with
cyproterone acetate in men results in a reduction of sexual drive and
potency and
inhibition of gonadal function. These changes are reversible following
discontinuation
of the therapy.
The antigonadotropic effect of cyproterone acetate is also exerted
when the substance
is combined with luteinising hormone releasing hormone (LHRH)
agonists.