Estraderm MX

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Oestradiol; Oestradiol hemihydrate

Commercializzato da:

Novartis Pharmaceuticals Australia Pty Ltd

Classe:

Medicine Registered

Foglio illustrativo

ESTRADERM MX

_oestradiol_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause
("change of life"), hormone
replacement therapy and Estraderm
MX.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT 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 ESTRADERM MX
DO NOT USE ESTRADERM MX OR OTHER
OESTROGENS, WITH OR WITHOUT A
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 oestr

Scheda tecnica

1 
ESTRADERM MX 
OESTRADIOL, TRANSDERMAL PATCH 

WARNING 

Oestrogens with or without progestogens should not be used
for the prevention of 
cardiovascular disease or dementia. 

The Women’s Health Initiative (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 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 Women’s Health
Initiative Memory Study (WHIMS), a substudy 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
or without progestogens should be prescribed 
at the lowest effective doses and for the shortest duration
consistent with treatment goals and 
risks for the individual woman. 

2 
NAME OF THE MEDICINE 

The active ingredient is oestradiol or oestra-1,3,5
(