CYPROTERONE SANDOZ cyproterone acetate 50 mg tablet bottle

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

cyproterone acetate, Quantity: 50 mg

Disponibbli minn:

Sandoz Pty Ltd

INN (Isem Internazzjonali):

cyproterone acetate

Għamla farmaċewtika:

Tablet, uncoated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

20 and 50 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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. CYPROTERONE SANDOZ 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 CYPROTERONE SANDOZ 50mg 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 to drive in sexual deviations. CYPROTERONE SANDOZ 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. CYPROTERONE SANDOZ 50mg should be supplemented by psychotherapeutic and sociotherapeutic measures in order to exploit the period to 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.

Sommarju tal-prodott:

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; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2004-11-15

Fuljett ta 'informazzjoni

CYPROTERONE SANDOZ
®
1
CYPROTERONE
SANDOZ
®
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cyproterone Sandoz.
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 this medicine
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 CYPROTERONE
SANDOZ IS USED FOR
Cyproterone Sandoz 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, Cyproterone Sandoz may
slow or stop the growth of cancer. It
can 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.
Cyproterone Sandoz 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,
Cyproterone Sandoz 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
CYPROTERONE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
cyproterone acetate, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description.
Some of the symptoms of an allergic
reac

Karatteristiċi tal-prodott

210303-cyproterone-sandoz-pi
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION
CYPROTERONE SANDOZ
® (CYPROTERONE ACETATE) 50 MG TABLETS
1.
NAME OF THE MEDICINE
Cyproterone acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyproterone Sandoz 50 mg tablet contains 50 mg cyproterone
acetate.
_Excipients with known effect:_
lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Cyproterone Sandoz 50 mg tablet is a white to off white, flat, round
tablet with ‘50’ engraved
over a break line on one face, the other a plain face
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC 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 seborrhea associated
with other features of
androgenisation
Cyproterone Sandoz 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 Cyproterone Sandoz 50 mg is taken during pregnancy, the properties
of the preparation may
lead to signs of feminisation in the male fetus. 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 _
Cyproterone Sandoz 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. Abnormal
patterns of sexual behaviour require treatment wh