Femoston

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol; Dydrogesterone

Available from:

Abbott Australasia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

FEMOSTON
®

_oestradiol and dydrogesterone_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Femoston.
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 FEMOSTON
DO NOT USE FEMOSTON 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 others doses of conjugated
oestrogens and MPA or others
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 FEMOSTON.
Treatment with oestrogens, with or
without progestogens should be used
at the lowest effective dose and for
the shortest period of time.
WHAT FEMOSTON IS
USED FOR
Femoston is a type of treatment
called hormone replacement therapy
(HRT). It contains the hormones
oestradiol and dydrogesterone.
This medicine helps to relieve the
discomfort many women feel during
and aft

Summary of Product characteristics

_Femoston 2/10 PI _
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_Version 4 _
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PRODUCT INFORMATION 
FEMOSTON

 2/10 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
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 
NON-PRO