VALETTE

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Ethinyloestradiol; Dienogest

Available from:

Bayer Australia Ltd

Class:

Medicine Registered

Patient Information leaflet

121119ValetteAUCMI 
1
VALETTE
® 
(VAL·ETTE)

Contraceptive tablets for women

_ethinyloestradiol and dienogest _
Consumer Medicine Information 

WHAT IS IN THIS 
LEAFLET 

This leaflet answers some 
common questions about 
Valette. 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 
Valette 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 VALETTE IS 
USED FOR 

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

Valette is used to prevent 
pregnancy.  

It is also used to treat mild to 
moderate acne in women 
seeking oral contraception.  

You may also experience the 
following benefits: 
  more regular, shorter and 
lighter periods  
  a decrease in anaemia (iron 
deficiency) 
  a decrease in period pain 
  reduction of greasiness in 
skin and hair. 

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 oral 
contraceptives.  

When taken correctly, it prevents 
you from becoming pregnant in 
several ways, including: 
  inhibiting the egg release by 
stopping it maturing 
  changing the cervical mucus 
consistency, making it more 
difficult for the sperm to 
reach the egg 

When the Pill is taken by women 
under close observation in 
clinical trials, it is more than 
99% effective in preventing 
pregnancy. However, in real life 
the Pill is around 92% effective. 
This is because pills m

Summary of Product characteristics

 
1105 Valette PI  
1
PRODUCT INFORMATION 

VALETTE
®

NAME OF THE MEDICINE 

Valette is a combined oral contraceptive (COC) preparation containing
the synthetic 
progestogen, dienogest and the synthetic oestrogen, ethinyloestradiol
as the active 
substances.  

Ethinyloestradiol is an oestrogen. Chemically, ethinyloestradiol is
19-nor-17
α-pregna-
1,3,5(10)-trien-20-yne-3, 17
β–diol and has the following structural formula: 

C
H
3
OH
C
CH
O
H
H
H
H

Chemical Formula: C
20
 H
24
 O
2

Molecular Weight:  296.41 
Melting Point: 181-185
o
C 
CAS No: 57-63-6 

Dienogest is a progestogen.  The chemical name for dienogest is 17
α-cyanomethyl-17β-
hydroxy-estra-4,9(10)-dien-3-one and has the following structural
formula:    

OH
CH
3
O
H
H
C
N

Chemical formula C
20
H
25
NO
2  
Molecular weight 311.42 
Melting point: 210-218
o
C 
CAS No.: 65928-58-7 

DESCRIPTION 

1105 Valette PI  
2
Ethinyloestradiol is a white to creamy white, odourless, crystalline
powder. It is insoluble 
in water and soluble in alcohol, chloroform, ether, vegetable oils,
and aqueous solutions 
of alkali hydroxides. 

Dienogest is a white to pale yellow crystalline powder: odourless;
practically insoluble in 
water, sparingly soluble in ethanol and acetone, soluble
in chloroform. 

Each small white active tablet contains dienogest 2 mg,
ethinyloestradiol 30 
μg and the 
excipients: lactose, maize starch, magnesium stearate, sucrose,
liquid glucose, calcium 
carbonate, povidone, macrogol 35000, carnauba wax, maltodextrin and
titanium dioxide. 

Each brown inactive tablet contains lactose, maize starch, purified
talc, magnesium 
stearate, povidone, sucrose, macrogol 6000, calcium carbonate,
titanium dioxide, 
glycerol, ferric oxide, glycol montanate. 

PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
The contraceptive effect of combined oral contraceptives (COCs) is
based on the 
interaction of various factors. The primary mechanisms are
in