CYPROCUR 50 cyproterone acetate 50mg tablet blister pack

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

cyproterone acetate

זמין מ:

Aspen Pharma Pty Ltd

INN (שם בינלאומי):

cyproterone acetate

מצב אישור:

Registered

עלון מידע

CYPROCUR 50 – Consumer Medicine Information
Page 1 of 4
CYPROCUR 50 TABLETS
_cyproterone acetate 50 mg_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
CYPROCUR 50 tablets.
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
CYPROCUR 50 tablets 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 THE
MEDICINE.
You may need to read it again.
WHAT CYPROCUR 50
TABLETS ARE USED FOR
CYPROCUR 50 tablets are an
anti-androgenic hormone
medication containing the active
ingredient cyproterone acetate,
which is used to 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.
Androgenic hormones are
generally required for cancer of
the prostate gland to grow.
CYPROCUR 50 tablets work in
two ways. Firstly, they stop the
androgenic hormones
(testosterone) present in your
body from being able to attach
to the cancer cells. Secondly,
they decrease the amount of
androgen hormone present in
your blood stream by an effect
on the hormonal mechanisms
that control androgen production
by the body.
CYPROCUR 50 tablets can also
be used to reduce the sex drive
of men with sexual deviations.
It is also used in the treatment of
women who have a problem
with facial or chest hair, are
balding or have severe acne.
CYPROCUR 50 tablets are only
available on a doctor's
prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CYPROCUR 50 IF
YOU ARE ALLERGIC TO:
•
cyproterone acetate
•
any other ingredients listed
at the end of this leaflet.
Some of the symp

מאפייני מוצר

CYPROCUR 50 – Product Information
Page 1 of 8
PRODUCT INFORMATION
CYPROCUR 50 TABLETS
NAME OF THE DRUG
Cyproterone acetate. The chemical name is 6-chloro-17 -hydroxy-1
α
, 2
α
-methylene-pregna-4,6-
diene-3,20-dione acetate.
_ _
_Structural formula: _
_ _
_Molecular formula: _C
24
H
29
CIO
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.
CYPROCUR 50 contains the active ingredient cyproterone acetate 50 mg
and the following
excipients: lactose, starch (maize), povidone, magnesium stearate,
colloidal silicon dioxide and
pregelatinised starch (maize).
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 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.
CYPROCUR 50 – Product Information
Page 2 of 8
CYPROCUR 50 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 acetate also exerts a progestational and antigonadotropic
effect. 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
function of androgen-dependent target