ANDROCUR cyproterone acetate 50 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 50 mg

Available from:

Bayer Australia Ltd

INN (International Name):

cyproterone acetate

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

50 tablets, 20 tablets

Class:

Medicine Registered

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 androgenic 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 Androcur 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 ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation.MEN:Reduction of drive in sexual deviations Androcur 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 pre-requisite for therapy is the desire by the patient for treatment.Androcur 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: Round white scored tablets marked with "bv" inside a hexagon; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2009-01-08

Patient Information leaflet

ANDROCUR
®
CMI vx1.0
Page 1 of 5
ANDROCUR
®
(ANNE·DRO·CUR)
_ _
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Androcur.
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
Androcur 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 ANDROCUR IS
USED FOR
Androcur 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,
Androcur may slow or stop the
growth of cancer. Androcur 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.
Androcur 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, Androcur 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
ANDROCUR
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ANDROCUR IF YOU
HAVE AN ALLERGY TO:
•
cyproterone acetate, the
active ingredient in Androcur
•
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
breat

Summary of Product characteristics

Androcur 50 PI VX2.0; CCDS 13♂, CCDS 14♀
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION – ANDROCUR
® 50 MG
(CYPROTERONE ACETATE) TABLET
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Androcur 50 mg tablets
Each Androcur 50 mg tablet contains 50 mg cyproterone acetate.
Excipients with known effect: sugars as lactose monohydrate.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Androcur 50 mg tablets
Round, white, scored tablets marked with “bv” inside a hexagon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
WOMEN:
_MODERATELY SEVERE TO SEVERE SIGNS OF ANDROGENISATION _
•
moderately severe/ severe forms of hirsutism
•
moderately severe/ severe androgen-dependent loss of scalp hair
(moderately
severe/severe
androgenic alopaecia)
•
moderately severe/ severe forms of acne and/or seborrhoea associated
with other
features of androgenisation
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 Androcur 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
ethinyloestradiol taken as well to
ensure contraception. This also promotes regular menstruation.
MEN:
_REDUCTION OF DRIVE IN SEXUAL DEVIATIONS _
Androcur 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 pre-requisite for
therapy