PETIBELLE ethinylestradiol 30 microgram/ drospirenone 3 mg film coated tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

drospirenone,ethinylestradiol

Boleh didapati daripada:

Bayer Australia Ltd

INN (Nama Antarabangsa):

Drospirenone,ethinylestradiol

Status kebenaran:

Registered

Ciri produk

180925 PETIBELLE PI AUST R 178481
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
PETIBELLE
® (DROSPIRENONE & ETHINYLESTRADIOL) TABLET
1
NAME OF THE MEDICINE
PETIBELLE (drospirenone and ethinylestradiol)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each light yellow active tablet contains ethinylestradiol 30 µg and
drospirenone 3
mg.
Excipients with known effect:
Each light yellow active tablet contains 48.17 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 PETIBELLE active tablet is light yellow, round and marked on one
side with
the letters "DO" in a regular hexagon.
Each PETIBELLE placebo tablet is white, round and marked on one side
with the
letters “DP” in a regular hexagon.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PETIBELLE is indicated for use as an oral contraceptive.
4.2
DOSE AND METHOD OF ADMNISTRATION
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.
180925 PETIBELLE PI AUST R 178481
Page 2 of 27
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. Withdrawal bleeding 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 PETIBELLE
_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking has to start on Day 1 of the woman’s natural cycle
(i.e. the first day of
her menstrual bleeding). The women should be instructed to take a
light yellow
active tablet from the green section of the pack, corresponding to
that day of the
week. If started on Day 1 in this way, protection against pregnancy is
immediate