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1209 CYPROSTAT
®
-100 CMI
Page 1 of 4
CYPROSTAT
®
-100
(SIGH·PRO·STAT)
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Cyprostat-100.
It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Cyprostat-100 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 CYPROSTAT-
100 IS USED FOR
Cyprostat-100 is an anti-androgen
medicine. Androgens such as
testosterone are natural male sex
hormones. In some types of
prostate cancer, androgens may
help the cancer cells to grow. By
blocking these hormones,
Cyprostat-100 may slow or stop
the growth of cancer.
Cyprostat-100 may 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
CYPROSTAT-100
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CYPROSTAT-100 IF
YOU HAVE AN ALLERGY TO:
• cyproterone acetate, the
active ingredient in
Cyprostat-100
• 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 d
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101109 CYPROSTAT-100 PI
Page 1 of 9
CYPROSTAT
®
100MG PRODUCT INFORMATION
NAME OF THE MEDICINE
Cyprostat 100mg
Each pack contains tablets with 100mg cyproterone acetate.
Cyproterone acetate:
CH
3
CH
3
H
H
H
O
O
CH
3
O
Cl
O
Chemical Name:
6-chloro-17
α hydroxy-1α,2α-methylene-pregna-4,6-diene-3,20-dione
actetate
Molecular Formula:
C
24
H
29
CIO
4
Molecular Mass:
416.96
CAS No.:
427-51-0
DESCRIPTION
Cyproterone acetate is a white to pale
yellow 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.
PHARMACOLOGY
Cyprostat 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, cyproterone acetate
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.
The antigonadotropic effect of cyproterone acetate is also exerted
when the
substance is combined with LHRH agonists. The initi
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