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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg

Available from:

Bayer Australia Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; purified talc; microcrystalline cellulose

Administration route:

Oral

Units in package:

6 x 28 tablets, 4 x 28 tablets, 3 x 28 tablets, 2 x 28 tablets, 1 x 28 tablets (sample pack), 1 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

YAZ is indicated for use as: - an oral contraceptive. - treatment of moderate acne vulgaris in women who seek oral contraception - treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome), see CLINICAL TRIALS.

Product summary:

Visual Identification: Small round white tablet debossed on one side with the letters "DP" in a regular hexagon.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2014-08-04

Patient Information leaflet

190726 Yaz CMI ANZ
1
YAZ
®
Contraceptive tablets for women
_drospirenone and ethinylestradiol (as betadex clathrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about YAZ. 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
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 IS USED
FOR
YAZ is a combined oral
contraceptive, commonly known
as a ‘birth control pill’ or ‘the
Pill’.
YAZ is used to prevent
pregnancy.
It is also used to treat moderate
acne and symptoms of
premenstrual dysphoric disorder
(PMDD) in women seeking oral
contraception.
You may also experience the
following benefits:
•
more regular and lighter periods
– potentially resulting in a
decrease in anaemia (iron
deficiency)
•
a decrease in period pain
•
improvement in symptoms like
bloating, swelling or weight
gain related to fluid retention
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
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.
YAZ has 24 active (hormone)
tablets and 4 inactive tablets,
rather than the traditional 21
active tablets and 7 inactive
tablets. This means that with
YAZ, you take the active
(hormone) tablets for three more
days. This helps your hormone
levels to stay even.
When the Pill is taken by women
under close observation in

Summary of Product characteristics

180925 YAZ Pl
Page 1 of 31
AUSTRALIAN PRODUCT INFORMATION
YAZ
®
(DROSPIRENONE & ETHINYLESTRADIOL) TABLET
1
NAME OF THE MEDICINE
YAZ (drospirenone and ethinylestradiol)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each light pink active tablet contains drospirenone 3 mg and
ethinylestradiol (as betadex
clathrate) 20
µ
g.
Excipients with known effect:
Each light pink active tablet contains 48.18 mg of lactose
monohydrate.
Each white placebo tablet contains 23.21 mg of lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each YAZ active tablet is light pink in colour, marked on one side
with the letters "DS" in
a regular hexagon.
Each YAZ placebo tablet is white in colour, marked on one side with
the letters "DP" in a
regular hexagon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
YAZ is indicated for use as:
•
an oral contraceptive.
•
treatment of moderate acne vulgaris in women who seek oral
contraception.
180925 YAZ Pl
Page 2 of 31
•
treatment of symptoms of premenstrual dysphoric disorder (PMDD) in
women who
have chosen oral contraceptives as their method of birth control. The
efficacy of
YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been
evaluated for
treatment of PMS (premenstrual syndrome). See Section 5.1
PHARMACODYNAMIC PROPERTIES – Clinical trials.
4.2
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately
1% per year. The failure rate may increase when pills are missed or
taken incorrectly.
Tablets must be taken in the order directed on the package every day
at about the same
time with some liquid as needed. Tablet taking is continuous. One
tablet is taken daily
for 28 consecutive days. Each subsequent pack is started the day after
the last tablet of
the previous pack. A withdrawal bleed usually starts on Day 2-3 after
starting the white
placebo tablets and may not have finished before the next pack is
started.
HOW TO START YAZ
_No preceding hormonal contr