CYPRONE 50 cyproterone acetate 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 50 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

cyproterone acetate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: maize starch; magnesium stearate; povidone; colloidal anhydrous silica; lactose monohydrate; pregelatinised maize starch

Administration route:

Oral

Units in package:

20 tablets, 50 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

WOMEN -moderately severe to severe signs of androgenization -moderately severe/severe forms of hirsutism -moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe androgenetic alopecia) -moderately severe/severe forms of acne and/or seborrhoea associated with other features of androgenization,Cyproterone acetate inhibits the influence of male sex hormones, which are also produced by the female. It is thus possible to treat diseases in women caused either by increased production of androgens or a particular sensitivity to these hormones. Hirsutism and alopecia may be expected to recur over a period of time after cessation of treatment.,If Cyprone 50 is taken during pregnancy, the properties of the preparation may lead to signs of feminisation in the male foetus. Therefore, in women of child bearing potential, pregnancy must be excluded at the commencement of treatment and ethinyl oestradiol taken as well to ensure contraception. This also promotes regular menstruation.,MEN - Reduction of drive in sexual deviations,Cyprone 50 reduces the force of the sexual urge in men with sexual deviations. Whilst under treatment, the man can control himself better in a predisposing stimulatory situation, but there is no influence on any deviating direction of sexual drive. Abnormal patterns of sexual behaviour require treatment when they are distressing to the patient. A prerequisite for therapy is the desire by the patient for treatment.,Cyprone 50 therapy should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social re-orientation. - Inoperable prostatic carcinoma - to suppress "flare" with initial 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

Product summary:

Visual Identification: WHITE, CIRCULAR, FLAT-BEVELED WITH BREAKLINE ON ONE SIDE, PLAIN ON THE OTHER DIAMETER: 8.5MM. THICKNESS: 2.7MM.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-06-01

Patient Information leaflet

CYPRONE 50
_contains cyproterone acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Cyprone 50.
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 50
against the benefits expected 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 50
IS USED FOR
Cyprone 50 is an antiandrogenic
hormone medication containing the
active ingredient cyproterone acetate,
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.
Cyprone 50 is only available on a
doctor's prescription.
There is no evidence that Cyprone 50
is addictive.
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
•
Swell

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CYPRONE 50
_Cyproterone acetate tablets _
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyprone 50 tablet contains 50 mg of cyproterone acetate as the
active ingredient.
Excipients with known effect: Contains sugars (as lactose).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Cyprone 50
:
White circular flat bevelled tablets, with breakline on one side and
plain on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
WOMEN
Moderately severe to severe signs of androgenization
•
moderately severe/severe forms of hirsutism
•
moderately severe/severe androgen
‐
dependent loss of scalp hair (moderately severe/severe
androgenetic alopecia)
•
moderately severe/severe forms of acne and/or seborrhoea associated
with other features of
androgenization
Cyproterone acetate inhibits the influence of male sex hormones which
are also produced by the female. It is
thus possible to treat diseases in women caused either by increased
production of androgens or a particular
sensitivity to these hormones. Hirsutism and alopecia may be expected
to recur over a period of time after
cessation of treatment.
If Cyprone 50 is taken during pregnancy, the properties of the
preparation may lead to signs of feminisation
in the male foetus. Therefore, in women of childbearing potential,
pregnancy must be excluded at the
commencement of treatment and ethinylestradiol taken as well to ensure
contraception. This also promotes
regular menstruation.
MEN
Reduction of drive in sexual deviations
Cyprone 50 reduces the force of the sexual urge in men with sexual
deviations. Whilst under treatment, the
man can control himself better in a predisposing stimulatory
situation, but there is no influence on any
deviating direction of sexual drive. Abnormal patterns of sexual
behaviour require treatment when they are
distressing to the patient. A prerequisite for therapy is the desire
by the patient for treatment.
Cyprone 50 th