CYPROSTAT cyproterone acetate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cyproterone acetate, Quantity: 100 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; povidone; lactose monohydrate; maize starch

Administration route:

Oral

Units in package:

50, 100 tablets, 30, 60, 90, 120 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Inoperable prostatic carcinoma. Because of its anti-androgenic effect Cyprostat is indicated for the treatment of inoperable prostatic carcinoma in patients who have failed primary hormonal manipulation or who are at risk from cardiovascular disease and/or intolerant of oestrogen therapy. INDICATIONS AS AT 18 MAY 2005 : Inoperable prostatic carcinoma. * To suppress flare with initial LHRH analogues 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 pateinets treated with LHRH analogues or who have had orchiectomy.

Product summary:

Visual Identification: White to slightly yellowish capsule-shaped scored tablets; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1995-06-20

Patient Information leaflet

CYPROSTAT
®
-100 CMI vx1.0
Page 1 of 4
CYPROSTAT
®
-100
(SIGH·PRO·STAT)
_cyproterone acetate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Cyprostat-100.
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
Cyprostat-100 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 CYPROSTAT-
100 IS USED FOR
Cyprostat-100 is an anti-androgen
medicine. Androgens such as
testosterone are natural male sex
hormones. In some types of
prostate cancer, androgens may
help the cancer cells to grow. By
blocking these hormones,
Cyprostat-100 may slow or stop
the growth of cancer.
Cyprostat-100 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.
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
CYPROSTAT-100
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CYPROSTAT-100 IF
YOU HAVE AN ALLERGY TO:
•
cyproterone acetate, the
active ingredient in
Cyprostat-100
•
any of the ingredients listed at
the end of this leaflet
_ _
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
DO NOT TAKE CYPROSTAT-100 IF
YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
liver disease, previous or
existing liver tumours unless
they are caused by metastases
from prostate cancer (your
doctor

Summary of Product characteristics

Cyprostat 100 PI VX1.0, CCDS 11
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION - CYPROSTAT
® 100 MG
(CYPROTERONE ACETATE) TABLET
1
NAME OF THE MEDICINE
Cyproterone acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cyprostat 100 mg tablets
Each tablet contains 100 mg cyproterone acetate.
Excipients with known effect: sugars as lactose monohydrate.
For a full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Cyprostat 100 mg tablets
Capsule-shaped, white to slightly yellowish, scored tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
The maximum daily dose is 300 mg.
INOPERABLE PROSTATIC CARCINOMA
Cyprostat tablets 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 tablet Cyprostat twice daily (i.e. 200 mg a day) alone for
5-7 days, followed
by 1
tablet Cyprostat 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 tablet Cyprostat) two to three times daily. Treatment should
not be
interrupted
nor the dosage reduced after improvement or remissions have occurred.
Cyprostat 100 PI VX1.0, CCDS 11
Page 2 of 10
TO TREAT HOT FLUSHES IN PATIENTS UNDER TREATMENT WITH LH-RH ANALOGUES
OR WHO HAVE HAD
ORCHIECTOMY
50 mg-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.
PEDIATRIC USE
Cyprostat is not recommended for use in male children and adolesc