CIPLA CYPROTERONE 100 cyproterone acetate 100mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

cyproterone acetate, Quantity: 100 mg

Tilgængelig fra:

Cipla Australia Pty Ltd

INN (International Name):

cyproterone acetate

Lægemiddelform:

Tablet, uncoated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

20, 50

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

Visual Identification: White capsule shaped biconvex tablet with "CPA 100" marked on one side and scored on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2011-03-25

Indlægsseddel

Cipla Cyproterone 100
1
CIPLA CYPROTERONE 100
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 100?
Cipla Cyproterone 100 contains the active ingredient cyproterone
acetate. Cipla Cyproterone 100 may slow or stop the growth
of cancer. Cipla Cyproterone 100 tablets may 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.
For more information, see Section 1. Why am I using Cipla Cyproterone
100? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CIPLA CYPROTERONE 100?
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.
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 100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Cipla Cyproterone 100 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 100?
Your doctor will tell you the dose that you should take. The usual
daily dose is 50‐300 mg (one half to three tablets) of Cipla
Cyproterone 100. Your doctor may request you take Cipla Cyproterone
100 with other medicines and/or change your dose
during treatment. More instructions can be found in Section 4. How do
I use Cipla Cyproterone 100? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CIPLA CYPROTERONE 100?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Cipla Cyproterone 100.
•
Your doctor will check your liver function and red blood cell cou