Anterone 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:

Cipla Australia 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 androgenisation. Moderately severe/severe forms of hirsutism. Moderately severe/severe androgen-dependent loss of scalp hair (moderately severe/severe andogenetic alopecia). 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 Cyproterone 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. Cyproterone 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 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 bevelled tablets, with breakline on one side and 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:

2016-10-19

Patient Information leaflet

Anterone 50
1
ANTERONE 50
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ANTERONE 50?
Anterone 50 contains the active ingredient cyproterone acetate.
Anterone 50 may slow or stop the growth of cancer and also
used to reduce abnormal sex drive in men. Anterone 50 tablets may slow
or stop excessive hairiness, loss of scalp hair, acne,
oily skin and dandruff.
For more information, see Section 1. Why am I using Anterone 50? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ANTERONE 50?
Do not use if you have ever had an allergic reaction to cyproterone
acetate or any of the ingredients listed at the end of the
CMI. Do not take this medicine if you are pregnant or suspect you may
be pregnant. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN
TO BECOME PREGNANT OR ARE BREASTFEEDING. For more
information, see Section 2. What should I know before I use Anterone
50? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Anterone 50 and affect how it works.
A list of these medicines is in Section 3. What if I am
taking other medicines? in the full CMI.
4.
HOW DO I USE ANTERONE 50?
•
The usual daily dose is 50‐300 mg of Anterone 50 tablets. Your
doctor will advise of the most suitable dose for you to take.
Follow all directions given to you by your doctor or pharmacist
carefully.
More instructions can be found in Section 4. How do I use Anterone 50?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ANTERONE 50?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Anterone 50.
•
Your doctor will check your red‐blood cell count to ensure you do
not become anaemic and will also
check liver function during treatment with Anterone 50 tablets.
THINGS YOU
SHOULD NOT DO
•
Anterone 50 tablets should not be taken by children and adolesc

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ANTERONE 50 (CYPROTERONE ACETATE) 50
MG TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anterone 50 tablets
Each tablet contains 50 mg cyproterone acetate
Excipient with known effects
Contains lactose
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
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 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 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 cyproterone 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
Cyproterone 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 therapy should be supplemented by ps