MADELINE desogestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

desogestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram

MAH:

Arrotex Pharmaceuticals Pty Ltd

INN:

Desogestrel,ethinylestradiol

pharmaceutical_form:

Tablet

composition:

Excipient Ingredients: povidone; titanium dioxide; magnesium stearate; maize starch; hypromellose; polysorbate 80; triacetin; indigo carmine aluminium lake; colloidal anhydrous silica; iron oxide yellow; lactose monohydrate

administration_route:

Oral

units_in_package:

21 active tablets + 7 placebo tablets

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

ORAL CONTRACEPTION

leaflet_short:

Visual Identification: Round, biconvex, plain, green, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Licence status A

authorization_date:

2013-09-23

PIL

MADELINE
®
1
MADELINE
®
_Ethinylestradiol and Desogestrel _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS INFORMATION CAREFULLY
BEFORE YOU START TAKING MADELINE
TABLETS.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Madeline. It contains the active
ingredients desogestrel and
ethinylestradiol.
It 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:
•
more regular periods, lighter
bleeding
•
a decrease in the occurrence of
anaemia (iron deficiency)
•
a decrease in period pain.
There is also evidence that some
medical conditions such as benign
breast disease, ovarian cysts, pelvic
inflammatory disease (pelvic
infections), ectopic pregnancy
(pregnancy in which the embryo
implants outside of the womb) and
cancer of the endometrium (lining of
the womb) and ovaries may be less
common in women using combined
oral contraceptives containing 50
micrograms of ethinylestradiol (high-
dose Pills). This may also be the case
for low-dose Pills but so far this has
only been confirmed for endometrial
and ovarian cancer.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
When taken correctly, this medicine
prevents pregnancy in two ways:
•
it inhibits the

SPC

1
AUSTRALIAN PRODUCT INFORMATION
MADELINE
®
(DESOGESTREL AND ETHINYLESTRADIOL) FILM-COATED
TABLETS
1
NAME OF THE MEDICINE
Desogestrel and Ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MADELINE
is
a
combined
oral
contraceptive
(COC)
tablet
containing
the
synthetic
progestogen, desogestrel and the synthetic estrogen, ethinylestradiol.
Each white active tablet contains 150 µg desogestrel and 30 µg
ethinylestradiol.
EXCIPIENTS WITH KNOWN EFFECT
Active tablets
Lactose monohydrate, d-alpha-tocopherol.
Placebo tablets
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
MADELINE is available in blister packs. Each blister contains 28
tablets consisting of 21 active
tablets and 7 placebo tablets.
Active tablet: Round, biconvex, white, film-coated tablets with
“MI” debossed on one side, and
“7” debossed on the other.
Placebo tablet: Round, biconvex, plain, green, film coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
MADELINE is intended for oral administration.
DOSAGE
HOW TO TAKE THIS MEDICINE
One tablet is to be taken daily. The tablets must be taken in the
order directed on the package
at about the same time each day, with some liquid as needed. Daily
tablet taking should be
continuous, starting with the tablet marked with the corresponding day
from the blue zone.
Each subsequent pack is to be started immediately following the last
placebo (green) tablet.
2
During the placebo days a withdrawal bleed usually occurs. This
usually starts on day 2-3 after
the last active (white) tablet and may not have finished before the
next pack is started.
HOW TO START THIS MEDICINE
The tablets are taken starting with the tablet marked with the
corresponding day from the blue
zone of the pack. This way, the woman will virtually always have a
menstruation-free weekend.
_• _
_No preceding hormonal contraceptive use (in the past month) _
Tablet-taking has to start on day 1 of the