CYPRONE cyproterone acetate 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate

Available from:

Alphapharm Pty Ltd

Authorization status:

Registered

Patient Information leaflet

CYPRONE
_cyproterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cyprone.
It does not contain all 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 Cyprone against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT CYPRONE IS USED
FOR
Cyprone is an anti-androgen
medicine.
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, Cyprone may slow or stop
the growth of cancer. Cyprone 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.
Cyprone 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,
Cyprone 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
CYPRONE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYPRONE IF YOU HAVE
AN ALLERGY TO:
•
cyproterone acetate, the active
ingredient in Cyprone
•
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,

Summary of Product characteristics

CYPRONE
_Cyproterone Acetate _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
cyproterone acetate
Chemical name
:
6-chloro-17α-hydroxy-1α,2α-methylene-pregna-4,6-diene-3,20-dione
acetate
Structural formula
:
Molecular formula
:
C
24
H
29
ClO
4
Molecular weight
:
416.94
CAS Registry no.
:
427-51-0
DESCRIPTION
Cyproterone acetate is a white to pale yellow, odourless crystalline
powder. M.P. 206-213°C. 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 solvent hexane, and almost
insoluble in water.
Each Cyprone tablet contains 50 mg of cyproterone acetate.
The tablets also contain the following inactive excipients: lactose,
maize starch, povidone, colloidal anhydrous
silica and magnesium stearate. The tablets are gluten free.
PHARMACOLOGY
Cyprone is an antiandrogenic hormone preparation.
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,
Androcur
therefore
exerts
a
direct
antiandrogenic 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.
CYPRONE – Product Information
2
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.
In women, hirsutism is dim