Genox

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tamoxifen citrate

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

GENOX

_contains the active ingredient tamoxifen (as citrate)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Genox.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Genox against the
benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT GENOX IS USED
FOR
Genox is used to treat breast cancer.
Genox contains the active ingredient
tamoxifen, which works by blocking
the actions of oestrogen, a female sex
hormone. The exact way in which
Genox works against breast cancer
cells is not exactly known, however
it may be related to the way it blocks
oestrogen in the body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GENOX HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Genox for another reason.
Genox is not approved for use in
children.
This medicine is available only with
a doctor's prescription.
There is no evidence that Genox is
addictive.
BEFORE YOU TAKE
GENOX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE GENOX IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
TAMOXIFEN OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
DO NOT TAKE GENOX IF YOU ARE
PREGNANT OR PLAN TO BECOME
PREGNANT.
Genox should not be used during
pregnancy. A small number of
unwanted complications, such as
birth defects, have been reported in
the unborn baby of women who have
taken this medicine. However, it has
not been shown whether these were
due to Genox. If sexually active, your
doctor may suggest you use a non-
hormonal form of contraception
while you are taki

Summary of Product characteristics

GENOX 
_Tamoxifen citrate _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Tamoxifen (as citrate) 
Chemical name: 
_trans-_1-[4-(2-dimethylaminoethoxy)phenyl]1,2-diphenyl-1-butene 
Structural formula: 

Molecular formula: 
C
26
H
29
NO,C
6
H
8
O
7

Molecular weight: 
563.6 

CAS Registry No.: 
54965-24-1 
DESCRIPTION 
Tamoxifen citrate is a white or almost white, crystalline powder, slightly soluble in water, soluble in methanol, 
slightly soluble in acetone. 
Each Genox tablet contains the active ingredient tamoxifen citrate equivalent to 10 mg or 20 mg of tamoxifen.

The tablets also contain the following inactive
ingredients: mannitol, starch – maize,
croscarmellose sodium and 
magnesium stearate.  _The tablets are gluten free_. 
PHARMACOLOGY 
Tamoxifen  is  a  non-steroidal  triphenylethylene  based  drug  which  displays  a  complex  spectrum  of  oestrogen 
antagonist and oestrogen agonist-like pharmacological effects in different tissues.  In breast cancer patients, at 
the tumour level, tamoxifen acts primarily as an anti-oestrogen, preventing oestrogen binding to the oestrogen 
receptor.  However, clinical studies have shown some benefit in oestrogen receptor negative tumours
in patients 
older than 50 years which may indicate other mechanisms
of action.   
PHARMACOKINETICS 
_Absorption._  Tamoxifen is absorbed from the gastrointestinal tract, however the site and extent of absorption is 
not known.  Peak serum levels of 15 to 25 nanogram/mL were observed three to six hours after administration 
of a single oral dose of 10 mg tamoxifen.  Steady state serum levels are achieved after approximately 4 weeks 
therapy.  Mean steady state values after dosing at 20 mg twice daily were 285 

 19 nanogram/mL and 477 
