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YAZ
®
Flex
_ethinyloestradiol (as betadex clathrate) and drospirenone _
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,
fibrocystic breast changes and
cancer of the uterus (womb),
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
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1301 YAZ FLEX Pl
1
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).
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
-pregna-1,3,5(10)-trien-20-yne-3,
17
–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
CAS No: 57-63-6
The chemical name for drospirenone is 6
, 7
,15
, 16
-Dimethylene-3-oxo-17
-pregn-4-
ene-21, 17-carbolactone and
has the following structural formula:
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
1301 YAZ FLEX Pl
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.
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 practically insoluble in hexane and water.
Each YAZ Flex tablet contains drospirenone 3 mg and
ethinyloestradiol (as betadex
clathrate) 20
g and the excipients: lactose, maize
starch, magnesium stearate,
hypromellose, purified talc, titanium dioxide and
iron oxide red.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
The contr
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