CLIMARA

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

 
CLIMARA
® 
CMI  

1 
CONSUMER MEDICINE INFORMATION 

CLIMARA 

_oestradiol  _

WARNING 

The Women’s Health Initiative (WHI) trial examined the health
benefits and risks of combined 
_oestrogen plus progestogen_ therapy (n=16,608)
and _oestrogen-alone_ therapy (n=10,739) in 
postmenopausal women aged 50 to 79 years. 

The _oestrogen plus progestogen_ arm of the WHI trial indicated an
increased risk of 
_myocardial infarction (MI), stroke, invasive breast cancer, pulmonary
embolism and deep vein _
_thrombosis _in postmenopausal women receiving treatment with
combined conjugated equine 
estrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA,
2.5 mg/day) for 5.2 
years compared to those receiving placebo. 

The _oestrogen-alone_ arm of the WHI trial indicated an increased
risk of_ stroke and deep vein _
_thrombosis _in hysterectomised women treated with CEE-alone (0.625
mg/day) for 6.8 years 
compared to those receiving placebo. 

Other doses of oral conjugated oestrogens with 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. 

Therefore, the following should be given serious consideration at the
time of prescribing: 

• 
Oestrogens with or without progestogens should not be prescribed for
primary or 
secondary prevention of cardiovascular diseases. 
• 
Oestrogens with or without progestogens should be prescribed at the
lowest effective 
dose for the approved indication.    
• 
Oestrogens with or without progestogens should be prescribed for the
shortest period 
possible for the approved indication. 
• 
For the prevention of osteoporosis, oestrogen treatment should be
considered in light 
of other available therapies. 

CLIMARA
®
 CMI 

      1_ _
CLIMARA
®

(CLIM·AR·RAH) 
_oestra

Summary of Product characteristics

Climara PI Feb2012 
Page 1 

PRODUCT INFORMATION 
CLIMARA
®

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 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 
CLIMARA is a transdermal delivery system containing oestradiol as the