BROOKE drospirenone/ethinyloestradiol 3 mg/20 microgram tablet blister composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 0.02 mg; drospirenone, Quantity: 3 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: polacrilin potassium; magnesium stearate; lactose monohydrate

Administration route:

Oral

Units in package:

1 x 28 tablets (24 active and 4 placebo), 4 x 28 tablets (24 active and 4 placebo), 6 x 28 tablets (24 active and 4 placebo), 2 x 28 tablets (24 active and 4 placebo), 3 x 28 tablets (24 active and 4 placebo)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

DROSPIRENONE/ETHINYLOESTRADIOL-ALPHAPHARM 3/20 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 drospirenone 3 mg/ethinyloestradiol 20 ?g tablets for PMDD was not assessed beyond 3 cycles. Drospirenone 3 mg/ethinyloestradiol 20 ?g tablets has not been evaluated for treatment of PMS (premenstrual syndrome) (see CLINICAL TRIALS).

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

BROOKE
_contains drospirenone 3 mg and ethinylestradiol 20 micrograms_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BROOKE.
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 BROOKE 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 BROOKE IS
USED FOR
BROOKE is a combined oral
contraceptive, commonly known as a
'birth control pill' or 'the Pill'.
BROOKE is used to prevent
pregnancy.
It is also used to treat moderate acne
in women seeking oral contraception
and to treat symptoms of
premenstrual dysphoric disorder
(PMDD).
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
•
improvement in symptoms like
bloating, swelling or weight gain
related to fluid retention.
Some conditions such as pelvic
inflammatory disease, ovarian cysts,
ectopic pregnancy, fibrocystic breast
changes 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.
BROOKE has 24 active (hormone)
tablets and 4 inactive tablets, rather
than the traditional 21 active tablets
and 7 inactive tablets. This means
that with BROOKE, 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 clinical
trials, it is more t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BROOKE
_Drospirenone/ethinylestradiol _
1
NAME OF THE MEDICINE
Drospirenone / Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3 mg of drospirenone and 20 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
BROOKE ACTIVE TABLET: round, light pink, uncoated biconvex tablet with
‘420’ debossed on one side
and other side plain.
BROOKE PLACEBO TABLET: round, white to off-white, uncoated biconvex
tablet with ‘303’ debossed on
one side and other side plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BROOKE 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
drospirenone 3 mg/ethinylestradiol 20
micrograms tablets for PMDD was not assessed beyond 3 cycles.
Drospirenone 3 mg/ethinylestradiol
20 micrograms tablets 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 placebo tablets (white tablets in the last row) and
may not have finished before the next pack
is started.
HOW TO START BROOKE
•
NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MO