Zumenon

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol hemihydrate

Available from:

Abbott Australasia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ZUMENON
®

_oestradiol_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zumenon.
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.
WHEN YOU MUST NOT
USE ZUMENON
DO NOT USE ZUMENON OR OTHER
OESTROGENS, WITH OR WITHOUT
PROGESTOGEN TO PREVENT HEART
ATTACKS, STROKE OR DEMENTIA.
A study called the Women's Health
Initiative indicated increased risk of
heart attack, stroke, breast cancer,
and blood clots in the legs or lungs in
women receiving treatment with a
product containing conjugated
oestrogens 0.625 mg and the
progestogen medroxyprogesterone
acetate (MPA). The researchers
stopped the study after 5 years when
it was determined the risks were
greater than the benefits in this
group. The Women's Health
Initiative Memory Study indicated
increased risk of dementia in women
aged 65-79 years taking conjugated
oestrogens and MPA. There are no
comparable data currently available
for other doses of conjugated
oestrogens and MPA or other
combinations of oestrogens and
progestogens. Therefore, you should
assume the risks will be similar for
other medicines containing oestrogen
and progestogen combinations.
TALK REGULARLY WITH YOUR DOCTOR
ABOUT WHETHER YOU STILL NEED
TREATMENT WITH ZUMENON.
Treatment with oestrogens, with or
without progestogens should be used
at the lowest effective dose and for
the shortest period of time.
WHAT ZUMENON IS
USED FOR
Zumenon is a type of treatment
called hormone replacement therapy
(HRT). Zumenon tablets contain a
hormone called oestradiol.
Zumenon is used to help replace the
oestrogen that the body stops
producing around the time of the
menopause.

Summary of Product characteristics

 
_Zumenon PI _
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PRODUCT INFORMATION 
ZUMENON
®
 TABLETS 
WARNING 
Oestrogens  and  progestogens  should  not  be  used  for  the  prevention  of  cardiovascular 
disease or dementia. 
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, 
stroke,  invasive  breast  cancer,  pulmonary  emboli,  and  deep  vein  thrombosis  in 
postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated 
oestrogens  (0.625 mg)  combined  with  medroxyprogesterone  acetate  (2.5  mg)  relative  to 
placebo  (see 
’Clinical Trials’ and ’Precautions’). The WHI study reported increased risks of 
stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 
6.8  years  of  treatment  with  conjugated  oestrogens  (0.625 mg)  relative  to  placebo  (see 
’Clinical Trials’ and ’Precautions’). 
The  Women’s  Health  Initiative  Memory  Study  (WHIMS),  a  sub-study  of  WHI,  reported 
increased risk of developing probable dementia in postmenopausal women 65 years of age 
or  older  during  4  to  5.2  years  of  treatment  with  conjugated  oestrogens,  with  or  without 
medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies 
to younger postmenopausal women (
see ’Clinical Trials’ and ’Precautions’). 
Other  doses  of  conjugated  oestrogens  and  medroxyprogesterone  acetate,  and  other 
combinations  and  dosage  forms  of  oestrogens  and  progestogens  were  not  studied  in  the 
WHI clinical trials and, in the absence of comparable data, these risks should be assumed to 
be  similar.  Because  of  these  risks,  oestrogens  with