CYPROCUR 100 cyproterone acetate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate

Available from:

Aspen Pharma Pty Ltd

INN (International Name):

cyproterone acetate

Authorization status:

Registered

Patient Information leaflet

CYPROCUR 100 – Consumer Medicine Information Page 1 of 4
Cyprocur 100
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Cyprocur 100.
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 Cyprocur 100 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 CYPROCUR
100 IS USED FOR
Cyprocur 100 tablets contain
cyproterone acetate as the
active ingredient. Cyproterone
acetate belongs to a group of
medicines called anti-
androgens. It blocks the
actions of male sex hormones
(androgens) which are
released naturally in the body.
It also reduces the production
of androgens.
It has been shown that the
growth of tumours of the
prostate gland may be
dependent on male
hormones. Since cyproterone
acetate blocks the action of
androgens and reduces the
amount of androgens
produced by the body, it can
be used to help treat cancer of
the prostate gland.
It can also be used in
conjunction with other
medications or following
surgical removal of the testes
to treat side effects such as
“sweats” or “hot flushes” and
to prevent any initial
worsening of the disease.
Cyprocur 100 is for use only in
men.
This medicine is available only
with a doctor's prescription.
There is no evidence that
Cyprocur 100 tablets are
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE CYPROCUR 100 IF
YOU ARE ALLERGIC TO:
•
cyproterone acetate
•
any other ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include
skin rash, itching or hives;
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing; wheezing or
shortness of breath.
DO NOT TAKE CYPROCUR

Summary of Product characteristics

CYPROCUR 100 – Product Information
Page 1 of 9
PRODUCT INFORMATION
NAME OF THE MEDICINE
CYPROCUR 100
Active:
Cyproterone acetate
Molecular Formula: C
24
H
29
ClO
4
MW 416.9
CAS: 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.
Each Cyprocur 100 tablet contains cyproterone acetate 100 mg.
Excipients: lactose, maize starch, Povidone, pregelatinised maize
starch, magnesium
stearate, Colloidal silica.
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.
CYPROCUR 100 – Product Information
Page 2 of 9
The antigonadotropic effect of cyproterone acetate is also exerted
when the substance
is combined with luteinising hormone releasing hormone (LHRH)
agonists. The
initial increase of testosterone provoked by this substance group is
decreased by
cyproterone acetate.
Prolactin levels can increase slightly under higher doses of
cyproterone acetate.
Studies showed increased prolactin levels up to 20 nanogram/mL (normal
range 5 to
15 nanogram/mL). Th