CYROTONE-100 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:

Strides Pharma Science 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

Authorization status:

Registered

Authorization date:

2012-05-23

Patient Information leaflet

CYROTONE-100™
CONSUMER MEDICINE INFORMATION
Cyproterone acetate 100 mg tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about CYROTONE-100
tablets. 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
CYROTONE-100 tablets against the benefits the medicine is expected to
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 IS CYROTONE-100 USED FOR AND HOW DOES IT WORK
CYROTONE-100 is an anti-androgenic hormone medication containing the
active ingredient
cyproterone acetate which is used to treat cancer of the prostate
gland. 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 CYROTONE-100
may slow or stop the
growth of cancer.
CYROTONE-100 may also be used in conjunction with other medications 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.
CYROTONE-100 is only available on a doctor’s prescription.
There is no evidence that CYROTONE-100 tablets are addictive.
BEFORE YOU TAKE CYROTONE-100
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CYROTONE-100 IF YOU HAVE AN ALLERGY TO:
• cyproterone acetate, the active ingredient in CYROTONE-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; or
• rash, itching or hives on the skin.
DO NOT TAKE CYROTONE-100
IF YOU HAVE

Summary of Product characteristics

Page 1 of 8
PRODUCT INFORMATION
CYROTONE-100
100 MG
TABLETS
NAME OF THE MEDICINE
The active ingredient in CYROTONE-100 is: cyproterone acetate.
Chemical structure:
Molecular formula: C
24
H
29
ClO
4
Molecular mass: 416.96
CAS registry number: 427-51-0
Chemical name: 6-chloro-17

hydroxy-1

,2

-methylene-pregna-4,6-diene-3,20-dione
acetate.
DESCRIPTION
Cyproterone acetate is a white to almost white crystalline powder. It
is practically soluble in
water, very soluble in methylene chloride, freely soluble in acetone,
soluble in methanol,
sparingly soluble in anhydrous ethanol.
Along with cyproterone acetate CYROTONE-100 also contains:
microcrystalline cellulose,
lactose, croscarmellose sodium, povidone and magnesium stearate.
PHARMACOLOGY
ATC code: G03HA01
Pharmacotherapeutic group: Antiandrogens, plain.
Cyproterone acetate inhibits competitively the effect of androgens at
androgen-dependent
target organs, e.g. it shields the prostate from the effect of
androgens originating from the
gonads and/or the adrenal cortex. Prostatic carcinoma and its
metastases are in general
androgen-dependent, cyproterone acetate therefore exerts a direct
antiandrogenic action on
the tumour and its metastases.
Page 2 of 8
Cyproterone acetate in addition has a progoestogenic action exerting a
negative feedback
effect centrally on the hypothalamic receptors, so leading to a
reduction in gonadotropin
release, and hence to diminished production of testicular androgens.
Treatment with cyproterone acetate in men results in a reduction of
sexual drive and potency
and inhibition of gonadal function. These changes are reversible
following discontinuation of
the therapy. The function of androgen dependent target organs, such as
the prostate, is
restricted.
The anti-gonadotropic effect of cyproterone acetate is also exerted
when the substance is
combined with LHRH agonists. The initial increase of testosterone
provoked by this
substance group is decreased by cyproterone acetate.
Serum prolactin levels may increase with higher doses of CP