QLAIRA

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Estradiol valerate; Dienogest

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

121204Qlaira_dCMI 

Page 1 of 9 
QLAIRA
®

Contraceptive tablets for women 
_oestradiol valerate and dienogest  _

CONSUMER MEDICINE INFORMATION  

WHAT IS IN THIS 
LEAFLET 

This leaflet answers some 
common questions about Qlaira. 
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 
Qlaira against the benefits they 
expect it will have for you. 

IF YOU HAVE ANY CONCERNS, OR 
ARE UNSURE ABOUT TAKING THIS 
MEDICINE, ASK YOUR DOCTOR OR 
PHARMACIST FOR MORE ADVICE. 

KEEP THIS LEAFLET WITH THE 
MEDICINE.  
You may need to read it again. 
WHAT QLAIRA IS 
USED FOR 

Qlaira is a combined oral 
contraceptive, commonly known 
as a ‘birth control pill’ or ‘the 
Pill’.  

Qlaira is used to prevent 
pregnancy. It is also used for the 
treatment of heavy and/or 
prolonged menstrual bleeding 
(not caused by any disease of the 
womb) in women who wish to 
use oral contraception. 

Whilst using Qlaira you may 
likely experience lighter and 
shorter menstrual bleeds. 

You may also experience the 
following benefits: 
  a decrease in anaemia (iron 
deficiency)  
  a decrease in period pain 

Some conditions such as pelvic 
inflammatory disease, ovarian 
cysts, ectopic pregnancy, 
fibrocystic breast changes and 
cancer of the uterus (womb) and 
ovaries may be less common in 
women taking the Pill.  

Qlaira contains two female sex 
hormones called oestradiol 
valerate (an oestrogen) and 
dienogest (a progestogen). 
The oestrogen in Qlaira 
(oestradiol valerate) is broken 
down in the body into a hormone 
called 17β-oestradiol, which is 
identical to the natural oestrogen 
produced by the female body. 
The oestrogen in Qlaira is 
therefore different from the 
synthetic oestrogen usually used 
in the Pill. 

When taken c

Summary of Product characteristics

 
PRODUCT INFORMATION 

QLAIRA
®
 (OESTRADIOL VALERATE / DIENOGEST) 

NAME OF THE MEDICINE 

QLAIRA is a combined oral contraceptive (COC) pill containing the
oestrogen oestradiol 
valerate and the progestogen dienogest.   

Oestradiol valerate is 1,3,5(10)-estratriene-3,17
β-diol-17-valerate. The chemical formula is 
C
23
H
32
O
3
, molecular weight 356.5 and CAS No 979-32-8. The chemical structure
of oestradiol 
valerate is as follows: 

O
CH
3
O
H
H
H
H
O

Dienogest is a progestogen. The chemical name for dienogest is 17
α-cyanomethyl-17β-
hydroxy-4,9-estradien-3-one. The chemical formula is C
20
H
25
NO
2
, molecular weight 311.42 and 
CAS No 65928-58-7. The chemical structure of dienogest is as
follows: 

OH
CH
3
O
H
H
C
N

DESCRIPTION 

Oestradiol valerate exists as white to yellowish-white crystals or
crystalline powder. The 
substance is freely soluble in acetone and dichloromethane,
soluble in ethanol, methanol, 
dioxane and diethylether, very slightly soluble in n-hexane and
practically insoluble in petroleum 
ether and water. The melting point is 143
°C to 150°C. 

Dienogest exists as a white to off-white crystalline powder. The
substance is freely soluble in 
dimethylsulfoxide, sparingly soluble in acetone and methanol, slightly
soluble in ethanol and 
ethyl acetate and practically insoluble in water. The melting point is
210
°C to 218°C. 

QLAIRA tablets are available as packs of 1 x 28 or 3 x 28
film-coated tablets consisting of 2 
dark yellow tablets each containing 3mg oestradiol valerate, 5 medium
red tablets each 
containing 2mg oestradiol valerate and 2mg dienogest, 17 light
yellow tablets each containing 
2mg oestradiol valerate and 3mg dienogest, 2 dark red tablets each
containing 1mg oestradiol 
valerate and 2 white placebo tablets. Besi