ANGELIQ 1/2

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Drospirenone; Oestradiol hemihydrate; oestradiol

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

ANGELIQ
®
 1/2 CMI

                             1 

CONSUMER MEDICINE INFORMATION 

ANGELIQ 1/2 
_oestradiol and drospirenone _

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 
oestrogens (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. 

ANGELIQ
®
 1/2 CMI

Summary of Product characteristics

 
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Page 1 of 20 
PRODUCT INFORMATION 

ANGELIQ
®
 1/2 

NAME OF THE MEDICINE 
ANGELIQ 1/2 is an HRT preparation containing the oestrogen oestradiol
and the progestogen 
drospirenone. Each red film-coated tablet contains: oestradiol 1.0 mg,
drospirenone 2.0 mg. 

Oestradiol is oestra-1,3,5(10)-triene-3, 17
-diol, the major estrogenic hormone produced by the 
human ovary and has the following chemical structure: 

CH
3
OH
O
H
H
H
H

Chemical formula: 
C
18
H
24
O
2

Molecular weight:  
281.4 
CAS No: 

50-28-2 

Drospirenone is a progestogen.  The chemical name for drospirenone
is 6
, 7, 15, 16-
Dimethylene-3-oxo-17
-pregn-4-ene-21, 17-carbolactone and has the following chemical 
structure: 

O
O
CH
3
H
3
C
O
H
H
H

Chemical formula: 
C
24 
H
30
 O
3 
Molecular weight: 
366.50 
CAS No: 

67392-87-4 
DESCRIPTION 
Oestradiol exists mostly as the hemihydrate, which is a non
hygroscopic, stable solid.  
Oestradiol is a white to almost white, crystalline powder and is
practically insoluble in water.  
The melting point is between 173 and 180
C. 

Drospirenone is a white to off-white crystalline powder.  It
is freely soluble in methylene chloride, 
soluble in acetone, methanol, sparingly soluble in ethylacetate and
ethanol 96% (v/v) and 

121206 ANGELIQ 1/2 PI 

Page 2 of 20 
practically insoluble in hexane and water. 

ANGELIQ 1/2 tablets contain the following excipients: Lactose, maize
starch, pregelatinised 
maize starch, povidone 25 000, magnesium stearate, hypromellose,
macrogol 6000, purified 
talc, titanium dioxide and iron oxide red. 
PHARMACOLOGY 
PHARMACODYNAMIC PROPERTIES 

ANGELIQ 1/2 contains 17
-oestradiol, which is chemically and biologically identical to 
endogenous human oestradiol, and the synthetic progestogen,
drospirenone.  17
-oestradiol 
provides hormone replacement during and after the climacteric.  The
addition of drospirenon