FEMME-TAB ED 30/150 150mcg ethinylestradiol 30mcg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

ethinylestradiol,Levonorgestrel

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: titanium dioxide; iron oxide red; Gelatin; maize starch; macrogol 4000; magnesium stearate; hypromellose; lactose monohydrate

Administration route:

Oral

Units in package:

4x28 tablets (112 tablets), 3 x 28 Tablets, 1 x 28 Tablets sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ORAL CONTRACEPTION

Product summary:

Visual Identification: red-brown round convex 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:

Registered

Authorization date:

2012-01-10

Patient Information leaflet

FEMME-TAB ED 30/150
LEVONORGESTREL 150 ΜG AND ETHINYLOESTRADIOL 30 ΜG TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Femme-Tab ED
30/150. It will
advise you about how to take Femme-Tab ED 30/150 properly and when to
tell your
doctor about health-related conditions. If you have any questions or
need more
advice, ask your doctor, professional health care provider or
pharmacist.
WHAT IS FEMME-TAB ED 30/150 USED FOR AND HOW DOES IT WORK
Femme-Tab ED 30/150 is a combined oral contraceptive (often called
"the Pill")
consisting of 21 yellow to brownish active tablets and 7 red-brown
inactive (placebo)
tablets. Each round yellow to brownish film-coated tablet contains a
small amount of
two
different
female
hormones.
These
are
levonorgestrel
(a
progestogen)
and
ethinyloestradiol (an oestrogen). Because of the small amount of
hormones, Femme-
Tab
ED
30/150
is
considered
to
be
a
low-dose
combined
oral
contraceptive
preparation. The red-brown inactive tablets do not contain any active
ingredients.
_HOW DOES FEMME-TAB ED 30/150 WORK?_
_ _
Combined oral contraceptive Pills, such as Femme-Tab ED 30/150,
provide one of
the
most
effective
reversible
methods
of
contraception
known.
Usually,
when
Femme-Tab ED 30/150 is taken according to the instructions, the egg
cells (normally
released by the ovary each month) are prevented from maturing to the
point where
they can be fertilised. In addition, the cervical mucus remains thick,
so it is more
difficult for a man's sperm to enter the womb. Also, the lining of the
womb is not
prepared sufficiently for a fertilised egg to grow in.
_WHAT IS FEMME-TAB ED 30/150 USED FOR?_
_ _
Femme-Tab ED 30/150 is used to prevent pregnancy. Combined oral
contraceptives
are a very effective method of birth control. When taken correctly
(without missing
tablets) the chance of becoming pregnant is very low (approximately 1%
per year).
The failure rate may increase when tablets are missed or taken
incorrectly.
Like other combined oral contraceptive pills, Femme-T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
FEMME-TAB ED 30/150 (LEVONORGESTREL/ETHINYLESTRADIOL)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femme-Tab ED 30/150 is a combined oral contraceptive (COC) tablet
containing the
synthetic progestogen levonorgestrel and the synthetic estrogen,
ethinylestradiol.
Each round brownish active tablet contains ethinylestradiol 30 µg and
levonorgestrel 150
µg.
Excipients with known effect: lactose
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Film-coated tablet
Femme-Tab ED 30/150 tablets are available in blister packs. Each
blister contains 28
tablets consisting of 21 brownish round convex active tablets,
followed by 7 red-brown
round convex placebo tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Femme-Tab ED 30/150 is used for oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives, such as Femme-Tab ED 30/150, when taken
correctly,
have a failure rate of approximately 1% per year. The failure rate may
increase when pills
are missed or taken incorrectly.
HOW TO TAKE FEMME-TAB ED 30/150
One tablet is to be taken daily. The tablets must be taken in the
order directed on the
package every day at about the same time with some liquid as needed.
Daily tablet taking
should be continuous for 28 consecutive days, starting with a tablet
corresponding to that
day of the week from the red section of the Femme-Tab ED 30/150 pack.
If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday,
her first tablet
is a red-brown placebo one, while if she starts on a Saturday or
Sunday her first tablet
will be a yellow to brownish active one. Thereafter, one tablet is
taken daily, following the
arrows marked on the pack, until all tablets have been taken. Each
subsequent pack is
started the day after the last tablet of the previous pack. Withdrawal
bleeding usually
2
starts on days 2 to 3 after starting the red-brown placebo tablets an