Vagifem

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Oestradiol hemihydrate

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

Vagifem
®

Page 1 of 4 
Vagcmi10a.doc 
VAGIFEM
® 

_Oestradiol _

CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
WHAT VAGIFEM
®
 IS USED FOR ......... 1

BEFORE YOU USE VAGIFEM
®
............ 1

HOW TO USE VAGIFEM
®
................... 2

WHILE YOU ARE USING VAGIFEM
®
.... 2

SIDE EFFECTS.................................... 2

STORAGE.......................................... 3

PRODUCT DESCRIPTION .................... 3

DIRECTIONS FOR USE ........................ 4

This leaflet answers some common 
questions about Vagifem
®
. 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 using Vagifem
®
 against the benefits 
they expect it will have for you. 
ASK YOUR DOCTOR OR PHARMACIST IF YOU 
HAVE ANY CONCERNS ABOUT USING THIS 
MEDICINE. 
KEEP THIS LEAFLET WITH THE MEDICINE. 
You may need to read it again. 
Vagifem
®
 is available only by 
prescription at pharmacies. 
WHAT VAGIFEM
®
 IS USED 
FOR 
Vagifem
®
 is a local hormone 
replacement therapy (HRT). Vagifem
®
 is 
a modified release pessary containing 
the female sex hormone, oestradiol.  The 
oestradiol in Vagifem
®
 is identical to the 
oestradiol produced in the ovaries of 
women, and is classified as a natural 
oestrogen. 
Vagifem
®
 is prescribed to treat a 
condition called atrophic vaginitis.  The 
symptoms include dryness and irritation 
in the vagina, and pain during sexual 
intercourse.  Atrophic vaginitis is caused 
by a loss of the female sex hormone, 
oestrogen, which occurs around the 
menopause.  
Vagifem
®
 when placed in the vagina 
allows oestradiol to be released.  This 
will increase the moisture of the vagina 
and relieve or stop discomfort in the 
vagina.   
Your doctor may ha

Summary of Product characteristics

Product Information 
Vagpi5a.doc 

Page 1 of 9 

PRODUCT INFORMATION 

VAGIFEM
® 
(25 ΜG)  

NAME OF THE MEDICINE 
Oestradiol (as hemihydrate) 

DESCRIPTION 
Vagifem is an oestrogen preparation for intravaginal application
based on the active human 
oestrogen oestradiol. The Vagifem modified release pessary
formulation is based on a 
hydrophilic cellulose-derived matrix which on contact with moisture
hydrates and provides a 
controlled release of oestradiol.   

Active ingredients: oestradiol - chemical name:
estra-1,3,5(10)-triene-3,17β-diol (as 
hemihydrate). Oestradiol hemihydrate is a white or almost white
crystalline powder which is 
practically insoluble in water and soluble in acetone.  Oestradiol
 hemihydrate has 5 chiral 
centres.  The molecular formula is C
18
H
24
O
2
, ½ H
2
O. Oestradiol hemihydrate has a molecular 
weight of 281.39. 

STRUCTURE 
Oestradiol hemihydrate 

CAS no.: 35380-71-3 

EXCIPIENTS_ _
Pessary core: hypromellose, lactose, maize starch,
magnesium stearate. 
Film coating: hypromellose, macrogol 6000. 

PHARMACOLOGY 
’½H
2
O’ 
Product Information 
Vagpi5a.doc 

Page 2 of 9 

During the climacteric the decline in endogenous oestrogen production
causes atrophic 
changes in the vaginal mucosa which may induce symptoms such as
vaginal dryness, irritation 
and dyspareunia. 

PHARMACODYNAMICS 
Vagifem relieves the symptoms of atrophic vaginitis due to oestrogen
deficiency following the 
menopause. Vagifem therapy reverses the atrophic changes due to
oestrogen deficiency found 
in the affected post-menopausal vagina. The active ingredient,
synthetic 17β-oestradiol, is 
chemically and biologically identical to endogenous human
oestradiol. 
Endogenous 17β-oestradiol induces and maintains the primary and
secondary female sexual 
characteristics. The biological effect of 17β-oestradiol is carried
out through a number of 
specific oestrogen receptors. The steroid receptor compl