YELENA drospirenone 3 mg and ethinylestradiol 30 microgram film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

drospirenone, Quantity: 3 mg; ethinylestradiol, Quantity: 30 microgram

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Drospirenone,ethinylestradiol

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: povidone; magnesium stearate; lactose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

4 x 28 tablets: 21 active with 7 placebo, 1 x 28 tablets: 21 active with 7 placebo, 3 x 28 tablets: 21 active with 7 placebo, 6 x 28 tablets: 21 active with 7 placebo, 2 x 28 tablets: 21 active with 7 placebo

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

indicated for use as an oral contraceptive

Product summary:

Visual Identification: Plain, round, white, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-05-03

Patient Information leaflet

YELENA
®
1
YELENA
®
_Contains the active ingredients drospirenone and ethinylestradiol _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about drospirenone and
ethinylestradiol. It does not contain
all the available information. It does
not take the place of talking to your
doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
YELENA
®
. It contains the active
ingredient drospirenone and
ethinylestradiol.
This medicine is a combined oral
contraceptive, commonly known as a
‘birth control pill’ or ‘the Pill’.
It is used to prevent pregnancy.
You may also experience the
following benefits:
•
improvement in symptoms like
bloating, swelling or weight gain
related to fluid retention
•
more regular and shorter, lighter
periods
•
a decrease in anaemia (iron
deficiency)
•
a decrease in period pain.
Some medical 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
oral contraceptives.
When the Pill is taken by women
under close observatio

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
YELENA
® (DROSPIRENONE AND ETHINYLESTRADIOL) FILM
COATED
TABLETS
1
NAME OF THE MEDICINE
Drospirenone and Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each yellow active tablet contains drospirenone 3 mg and
ethinylestradiol 30 μg.
EXCIPIENTS WITH KNOWN EFFECT
Active tablet: Lactose monohydrate
Placebo tablet: Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
YELENA
®
Active tablet: Plain, round, yellow, film coated tablet.
Placebo tablet: Plain, round, white, film coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is indicated for use as an oral contraceptive.
4.2
DOSE AND METHOD OF ADMINISTRATION
YELENA
®
is intended for oral administration.
DOSAGE
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.
2
HOW TO START THIS MEDICINE
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 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 and no additional
methods of contraception
are required.
Starting on day 2 - 5 of the menstrual cycle is allowed, but during
the first 7 days of the first
cycle a barrier method is recommended in addition to tablet-taking.
Cha