CYPROTERONE SANDOZ cyproterone acetate 100 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 100 mg

Available from:

Sandoz 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

Prescription type:

(S4) Prescription Only Medicine

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.

Product summary:

Visual Identification: White to off white, capsule shaped tablet with '100' engraved on one face, and a break line on the other face.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2004-11-15

Patient Information leaflet

CYPROTERONE SANDOZ
®
1
CYPROTERONE
SANDOZ
®
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cyproterone Sandoz.
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 this medicine
against the benefits they expect it
will 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 CYPROTERONE
SANDOZ IS USED FOR
Cyproterone Sandoz is an anti-
androgen medicine.
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, Cyproterone Sandoz may
slow or stop the growth of cancer. It
can also 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.
Cyproterone Sandoz is 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,
Cyproterone Sandoz 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.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
CYPROTERONE SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
cyproterone acetate, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description.
Some of the symptoms of an allergic
reac

Summary of Product characteristics

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Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
CYPROTERONE SANDOZ
® (CYPROTERONE ACETATE) 100 MG
TABLETS
1
NAME OF THE MEDICINE
Cyproterone acetate
_ _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyproterone Sandoz 100 mg tablet contains 100 mg cyproterone
acetate.
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cyproterone Sandoz 100 mg tablets are white to off white, capsule
shaped tablet with '100'
engraved on one face, and a break line on the other face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Cyproterone Sandoz 100 mg tablets are to be taken with some liquid
after meals.
_INOPERABLE PROSTATIC CARCINOMA _
_Suppression of “flare” with initial LHRH analogue therapy _
Initially 100 mg twice daily alone for 5-7 days, then 100 mg twice
daily for 3-4 weeks together
with an LHRH agonist at the dosage recommended by the manufacturer.
_Long-term palliative treatment without orchidectomy _
100 mg two or three times daily. Treatment should not be interrupted,
nor the dosage reduced,
after improvement or remissions have occurred.
_Treatment of hot flushes (in patients treated with LHRH analogues or
post-orchidectomy) _
Low initial dose of 50 mg once to three times daily, with upward
titration to 100 mg three times
daily if necessary.
210303-cyproterone-sandoz-pi
Page 2 of 11
See Sections 4.4 Special warnings and precautions for use, 4.8 Adverse
effects (Undesirable
effects) and 4.9 Overdose.
DOSAGE ADJUSTMENT IN:

renal impairment
There are no da