YAZ FLEX ethinylestradiol (as betadex clathrate) 20 micrograms / drospirenone 3 mg tablet dispenser pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

drospirenone,ethinylestradiol

Available from:

Bayer Australia Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Authorization status:

Registered

Patient Information leaflet

1802 YAZ
Flex
CMI AU
1
YAZ
®
FLEX
_drospirenone and ethinyloestradiol (as betadex clathrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about YAZ
Flex. 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 YAZ Flex
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 YAZ FLEX IS
USED FOR
YAZ Flex is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
YAZ Flex is used to prevent
pregnancy.
It is also used to treat moderate
acne in women seeking oral
contraception.
You may also experience the
following benefits:
•
improvement in symptoms like
bloating, swelling or weight
gain related to fluid retention
•
fewer bleeding/spotting days
•
a decrease in anaemia (iron
deficiency)
•
a decrease in period pain.
Some conditions such as pelvic
inflammatory disease, ovarian
cysts, ectopic pregnancy (where
the foetus is carried outside of
your womb, lumpy breasts and
cancer of the uterus (womb), and
ovaries may be less common in
women taking the Pill.
When taken correctly, it prevents
you from becoming pregnant in
various 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 might be missed, or
taken with medicines that may
interfere with their effectiveness
or may not be absorbed due to
vomiting and diarrhoea.
Like all oral contraceptives, YAZ
Flex is intended to

Summary of Product characteristics

180130YAZ FLEX Pl
Page 1 of 25
PRODUCT INFORMATION
YAZ
®
FLEX
NAME OF THE MEDICINE
YAZ FLEX is a combined oral contraceptive (COC) tablet containing the
synthetic progestogen,
drospirenone and the synthetic oestrogen, ethinyloestradiol (as
betadex clathrate).
The chemical name for drospirenone is 6
β
, 7
β
, 15
β
, 16
β
-dimethylene-3-oxo-17
α
-pregn-4-ene-
21, 17-carbolactone and has the following structural formula:
O
O
CH
3
H
3
C
O
H
H
H
_ _
Ethinyloestradiol betadex-clathrate is an inclusion complex of the
compendially described
substances ethinyloestradiol and betadex and when dissolved in water
it dissociates into the
active moiety ethinyloestradiol and the ligand betadex.
The chemical name for 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
DESCRIPTION
Drospirenone is a white to off-white crystalline powder. It is freely
soluble in methylene chloride,
soluble in acetone, methanol, sparingly soluble in ethyl acetate and
ethanol 96% (v/v) and
practically insoluble in hexane and water.
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.
Each YAZ FLEX tablet contains drospirenone 3 mg and ethinyloestradiol
(as betadex clathrate)
20
µ
g and the excipients: lactose, maize starch, magnesium stearate,
hypromellose, purified
talc, titanium dioxide and iron oxide red.
Chemical formula: C
24
H
30
O
3
Molecular weight: 366.50
CAS No: 67392-87-4
Chemical Formula: C
20
H
24
O
2
Molecular Weight: 296.41
CAS No: 57-63-6
180130YAZ FLEX Pl
Page 2 of 25
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
The contraceptive effect of combined oral contraceptives is based on
the interaction of various
factors, the most important of which are seen as the inhibition of
ovulation and the changes in
the cervical secretion. As well as protection against pregnancy,
combined oral contracept