CYROTONE 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:

Strides Pharma Science 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:

50 tablets, 20 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. Cyrotone 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 Cyrotone 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. Cyrotone 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. Cyrotone 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.

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:

2012-05-23

Patient Information leaflet

CYROTONE™
CONSUMER MEDICINE INFORMATION
Cyproterone acetate 50 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about CYROTONE
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
CYROTONE tablets against the benefits the medicine is expected to 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 CYROTONE IS USED FOR
CYROTONE is an anti-androgenic hormone medication which has several
different uses.
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, CYROTONE may slow or stop the growth of cancer.
CYROTONE 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.
CYROTONE tablets are 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, CYROTONE 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.
CYROTONE is only available on a doctor’s prescription.
There is no evidence that CYROTONE tablets are addictive
BEFORE YOU TAKE
CYROTONE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYROTONE IF YOU HAVE AN ALLERGY TO:
• cyproterone acetate, the active ingredient in CYROTONE
• any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
• shortness of b

Summary of Product characteristics

Page 1 of 13
PRODUCT INFORMATION
CYROTONE
50 MG
TABLETS
NAME OF THE MEDICINE
The active ingredient in CYROTONE is: cyproterone acetate.
Chemical structure:
Molecular formula: C
24
H
29
ClO
4
Molecular mass: 416.96
CAS registry number: 427-51-0
Chemical name: 6-chloro-17

hydroxy-1

,2

-methylene-pregna-4,6-diene-3,20-dione acetate
DESCRIPTION
Cyproterone acetate is a white to almost white crystalline powder. It
is practically soluble in
water, very soluble in methylene chloride, freely soluble in acetone,
soluble in methanol,
sparingly soluble in anhydrous ethanol.
Along with cyproterone acetate CYROTONE also contains: lactose,
microcrystalline
cellulose, croscarmellose sodium, povidone and magnesium stearate.
PHARMACOLOGY
ATC code: G03HA01
Pharmacotherapeutic group: Anti-androgens plain
Cyproterone acetate inhibits competitively the effect of androgens at
androgen-dependent
target organs, e.g. it shields the prostate from the effect of
androgens originating from the
gonads and/or the adrenal cortex. Prostatic carcinoma and its
metastases are in general
androgen-dependent, cyproterone acetate therefore exerts a direct
anti-androgenic action on
the tumour and its metastases.
Cyproterone acetate in addition has a progoestogenic action exerting a
negative feedback
effect centrally on the hypothalamic receptors, so leading to a
reduction in gonadotropin
release, and hence to diminished production of testicular androgens.
Treatment with
Page 2 of 13
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 anti-gonadotropic effect of cyproterone acetate is also exerted
when the substance is
combined with LHRH agonists. The initial increase of testosterone
provoked by this
substance group is decreased by cyproterone acetate.
In women, hirsutism is diminished, but also androgen-dependent loss of
scalp hair and
elevated sebaceous gland function are reduced. During the treatment
ovar