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

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

drospirenone,ethinylestradiol

Доступна с:

Bayer Australia Ltd

ИНН (Международная Имя):

Drospirenone,ethinylestradiol

Статус Авторизация:

Registered

Характеристики продукта

180925 YAZ Pl 133649
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

g.
Excipients with known effect:
Each light pink active tablet contains 48.18 mg of lactose
monohydrate.
Each white placebo tablet contains 52.14 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 133649
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
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