PHARMACOR CYPROTERONE 100 cyproterone acetate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate

Available from:

Cipla Australia Pty Ltd

Authorization status:

Registered

Patient Information leaflet

Pharmacor Cyproterone 100
1
PHARMACOR 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 PHARMACOR CYPROTERONE 100?
Pharmacor Cyproterone 100 contains the active ingredient cyproterone
acetate. Pharmacor Cyproterone 100 may slow or stop
the growth of cancer. Pharmacor 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 Pharmacor
Cyproterone 100? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHARMACOR 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
Pharmacor Cyproterone 100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pharmacor 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 PHARMACOR 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
Pharmacor Cyproterone 100. Your doctor may request you take Pharmacor
Cyproterone 100 with other medicines and/or
change your dose during treatment. More instructions can be found in
Section 4. How do I use Pharmacor Cyproterone 100? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHARMACOR CYPROTERONE 100?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Pharmacor Cyproterone
100.
•
Y

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - PHARMACOR CYPROTERONE 100
(CYPROTERONE ACETATE) 100 MG TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Cyproterone 100 tablets
Each tablet contains 100 mg cyproterone acetate
Excipient with known effect
Contains lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Capsule shaped, biconvex white tablets with 'CPA 100' marked on one
side and scored on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
The maximum daily dose is 300 mg.
INOPERABLE PROSTATIC CARCINOMA
.
Pharmacor Cyproterone 100 should be taken with some liquid after a
meal
TO REDUCE THE INITIAL INCREASE OF MALE SEX HORMONES ('FLARE') IN
TREATMENT WITH LHRH AGONISTS
Initially 1 Pharmacor Cyproterone 100 tablet twice daily (i.e. 200 mg
a day) alone for 5-7 days,
followed by 1 Pharmacor Cyproterone 100 tablet twice daily (i.e. 200
mg a day) for 3-4 weeks
together with an LHRH agonist in the dosage recommended by the
manufacturer.
IN LONG-TERM PALLIATIVE TREATMENT OF ADVANCED PROSTATE CANCER IN
PATIENTS WHO HAVE NOT HAD AN
ORCHIECTOMY
100 mg (1 Pharmacor Cyproterone 100 tablet) two to three times daily.
Treatment should not be
interrupted nor the dosage reduced after improvement or remissions
have occurred.
TO TREAT HOT FLUSHES IN PATIENTS UNDER TREATMENT WITH LHRH ANALOGUES
OR WHO HAVE HAD
ORCHIECTOMY
50 to 150 mg (half to one and a half tablets) per day with upward
titration up to 1 tablet three times
daily (300 mg) if necessary.
_ _
PAEDIATRIC USE
Pharmacor Cyproterone 100 tablets is not r