BROOKLYNN drospirenone/ethinyloestradiol 3 mg/30 microgram tablet blister composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

drospirenone, Quantity: 3 mg; ethinylestradiol, Quantity: 0.03 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; magnesium stearate; polacrilin potassium

Administration route:

Oral

Units in package:

1 x 28 Tablets (21 active and 7 placebo), 2 x 28 Tablets (21 active and 7 placebo), 4 x 28 Tablets (21 active and 7 placebo), 3 x 28 Tablets (21 active and 7 placebo)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DROSPIRENONE/ETHINYLOESTRADIOL-ALPHAPHARM 3/30 is indicated for use as an oral contraceptive.

Product summary:

Visual Identification: Round, white to off white, uncoated biconvex tablets with 303 debossed on one side and other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-05-24

Patient Information leaflet

BROOKLYNN
_contains drospirenone 3 mg and ethinylestradiol 30 micrograms_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BROOKLYNN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking BROOKLYNN
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT BROOKLYNN IS
USED FOR
BROOKLYNN is a combined oral
contraceptive, commonly known as a
‘birth control pill’ or ‘the Pill’.
BROOKLYNN is used to prevent
pregnancy.
BROOKLYNN contains
drospirenone which has
antiandrogenic properties and may be
of some benefit in androgen-related
acne, skin conditions or greasy hair.
You may also experience the
following benefits:
improvement in symptoms like
bloating, swelling or weight gain
related to fluid retention
more regular, shorter and lighter
periods
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) and ovaries are 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
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.
Like all oral contraceptives,
BROOKLYNN is intended to
prevent pregnancy. It does not
protect against HIV infection (AIDS)
and other sexually

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BROOKLYNN
_Drospirenone/ethinylestradiol _
1
NAME OF THE MEDICINE
Drospirenone/Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg of drospirenone and 30 micrograms of
ethinylestradiol as the active ingredient.
Excipients with known effect: lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
BROOKLYNN active tablet: round, light brown, uncoated biconvex tablet
with ‘156’ debossed on one side
and other side plain.
BROOKLYNN placebo tablet: round, white to off white, uncoated biconvex
tablets with ‘303’ debossed on
one side and other side plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BROOKLYNN is indicated for use as an oral contraceptive.
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.
Withdrawal bleeding usually starts on day 2-
3 after starting the white placebo tablets (last row) and may not have
finished before the next pack is started.
HOW TO START BROOKLYNN
•
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 brown active
tablet from the orange section
of the pack, corresponding to that day of the week. If started on day
1 in this way, protection against
pregnancy is immediate and no additional methods of contraception are
required.
Starting on days 2-5 of the menstrual cycle is allowed, but during the
first cycle a barrier method is
recommended in addition for the fi