Estalis Continuous

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Norethisterone acetate; Oestradiol

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ESTALIS
®
 CONTINUOUS

_oestradiol / norethisterone acetate (NETA)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about the menopause (the
"change of life"), hormone
replacement therapy and Estalis
Continuous.
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 ESTALIS
CONTINUOUS
DO NOT USE ESTALIS CONTINUOUS 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
ass

Summary of Product characteristics

1 

ESTALIS

 CONTINUOUS 
(OESTRADIOL/NORETHISTERONE ACETATE)

TRANSDERMAL MATRIX PATCH 

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 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. 

NAME OF THE MEDICINE

Oestradio