APO-CYPROTERONE ACETATE cyproterone acetate 50mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 50 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

cyproterone acetate

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; povidone; magnesium stearate

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 androgenisation. 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 androgenisation. APO-CYPROTERONE ACETATE 50mg inhibits the influence of male sex hormones which are also produced by the female. It is thus possible to treat diseases in women caused by either 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 APO-CYPROTERONE ACETATE 50mg 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 ethinyloestradiol taken as well to ensure contraception. This also promotes regular menstruation. MEN: Reduction of drive in sexual deviations. APO-CYPROTERONE ACETATE 50mg 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. APO-CYPROTERONE ACETATE 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period of reduced drive for personal and social reorientation. Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (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 to off white, flat, round tablet with '50' engraved over a break line on one face, the other a plain face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2004-06-22

Patient Information leaflet

APO-CYPROTERONE 50 MG TABLETS
1
APO-CYPROTERONE
50 MG TABLETS
_Contains the active ingredient cyproterone (as cyproterone acetate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about cyproterone. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Cyproterone 50 mg. It is an anti-
androgen medicine. It contains the
active ingredient cyproterone (as
cyproterone acetate).
It is used to treat:
•
women who have a problem with
facial or chest hair, are balding,
have severe acne and/or secrete
excess oil from the sweat glands.
•
men with cancer of the prostate.
It can also be used in conjunction
with other medications 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.
•
men with sexual deviations.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescrip

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – APO-CYPROTERONE
ACETATE (CYPROTERONE ACETATE) 50MG TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg cyproterone acetate as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate
For the full list of excipients, see SECTION 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets: White to off white, round, flat tablet with 50 engraved over
a break line on one face,
plain on the other.
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 alopecia)
•
moderately severe/severe forms of acne and/or seborrhoea associated
with other
features of androgenisation.
APO-Cyproterone Acetate 50 mg inhibits the influence of male sex
hormones which are also
produced by the female. It is thus possible to treat diseases in women
caused by either
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 APO-Cyproterone Acetate 50 mg 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
APO-Cyproterone Acetate 50 mg 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.
2
Abnormal patterns of sexual behaviour require treatment when they are
distressing to the
patient. A pre-requisite for therap