FEMME TAB ED 20/100 levonorgestrel 100mcg ethinylestradiol 20mcg film-coated blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

levonorgestrel, Quantity: 100 microgram; ethinylestradiol, Quantity: 20 microgram

から入手可能:

AFT Pharmaceuticals Pty Ltd

INN（国際名）:

ethinylestradiol,Levonorgestrel

医薬品形態:

Tablet, film coated

構図:

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

投与経路:

Oral

パッケージ内のユニット:

3 x 28 Tablets, 1 x 28 Tablets sample pack

処方タイプ:

(S4) Prescription Only Medicine

適応症:

ORAL CONTRACEPTION

製品概要:

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

認証ステータス:

Registered

承認日:

2012-01-10

情報リーフレット

FEMME-TAB ED 20/100
LEVONORGESTREL 100 ΜG AND ETHINYLOESTRADIOL 20 ΜG TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Femme-Tab ED
20/100. It will
advise you about how to take Femme-Tab ED 20/100 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 20/100 USED FOR AND HOW DOES IT WORK
Femme-Tab ED 20/100 is a combined oral contraceptive (often called
"the Pill")
consisting of 21 white to off white active tablets and 7 red-brown
inactive (placebo)
tablets. Each white to off white round 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
20/100
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 20/100 WORK?_
_ _
Combined oral contraceptive Pills, such as Femme-Tab ED 20/100,
provide one of
the
most
effective
reversible
methods
of
contraception
known.
Usually,
when
Femme-Tab ED 20/100 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 20/100 USED FOR?_
_ _
Femme-Tab ED 20/100 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

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION
FEMME-TAB ED 20/100 (LEVONORGESTREL/ETHINYLESTRADIOL)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femme-Tab ED 20/100 is a combined oral contraceptive (COC) tablet
containing the
synthetic progestogen, levonorgestrel, and the synthetic estrogen,
ethinylestradiol.
Each
round
white
to
off-white
active
tablet
contains
ethinylestradiol
20
μg
and
levonorgestrel 100 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 20/100 tablets are available in blister packs. Each
blister contains 28
tablets consisting of 21 white to off-white round convex active
tablets, followed by 7 red-
brown round convex placebo tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Femme-Tab ED 20/100 is used for oral contraception.
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.
HOW TO TAKE FEMME-TAB ED 20/100
One tablet is to be taken daily. 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 white to
off-white active tablet
marked with the corresponding day of the week from the red area of the
Femme-Tab ED
20/100 pack. Each subsequent pack is to be started the day after the
last tablet of the
previous pack. A withdrawal bleed usually starts on day 2 to 3 after
starting the red-
brown placebo tablets and may not have finished before the next pack
is started.
2
HOW TO START FEMME-TAB ED 20/100
_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). If started on day 1 in this way, protect