CIPLA CYPROTERONE 50 cyproterone acetate 50mg tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

cyproterone acetate, Quantity: 50 mg

Disponible desde:

Cipla Australia Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

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

Vía de administración:

Oral

Unidades en paquete:

20 tablets, 50 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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 increases 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 Meditab 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. Meditab 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. Meditab 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..

Resumen del producto:

Visual Identification: WHITE, CIRCULAR, FLAT-BEVELED WITH BREAKLINE ON ONE SIDE, 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

Estado de Autorización:

Registered

Fecha de autorización:

2002-08-13

Información para el usuario

Cipla Cyproterone 50
1
CIPLA CYPROTERONE 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 CIPLA CYPROTERONE 50?
Cipla Cyproterone 50 contains the active ingredient cyproterone
acetate. Cipla Cyproterone 50 may slow or stop the growth of
cancer and also used to reduce abnormal sex drive in men. Cipla
Cyproterone 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 Cipla Cyproterone
50? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA CYPROTERONE 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 Cipla
Cyproterone 50? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Cyproterone 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 CIPLA CYPROTERONE 50?
•
The usual daily dose is 50‐300 mg of Cipla Cyproterone 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 Cipla
Cyproterone 50? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA CYPROTERONE 50?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Cipla Cyproterone 50.
•
Your doctor will check your red‐blood cell count to ensure you do
not become anaemic and will also
check liver function