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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

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

Disponible depuis:

AFT Pharmaceuticals Pty Ltd

DCI (Dénomination commune internationale):

ethinylestradiol,Levonorgestrel

forme pharmaceutique:

Tablet, film coated

Composition:

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

Mode d'administration:

Oral

Unités en paquet:

1 x 21 Tablets sample pack, 3 x 21 Tablets, 4 x 21 tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

ORAL CONTRACEPTION

Descriptif du produit:

Visual Identification: white to off white 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

Statut de autorisation:

Registered

Date de l'autorisation:

2012-01-10

Notice patient

FEMME-TAB 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
20/100. It will
advise you about how to take Femme-Tab 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 20/100 USED FOR AND HOW DOES IT WORK
Femme-Tab
20/100
is
a
combined
oral
contraceptive
(often
called
"the
Pill")
consisting of 21 hormonal tablets. Each white to off white 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
20/100
is
considered
to
be
a
low-dose
combined
oral
contraceptive preparation.
_HOW DOES FEMME-TAB 20/100 WORK?_
_ _
Combined oral contraceptive pills, such as Femme-Tab 20/100, provide
one of the
most effective reversible methods of contraception known. Usually,
when Femme-
Tab 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 20/100 USED FOR?_
_ _
Femme-Tab 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-Tab 20/100 may
also have non-
contraceptive health benefits.
•
Your period may be lighter and shorter. As a result, the risk of
anemia may be
lower.
Your
period
pains
m

Résumé des caractéristiques du produit

1
AUSTRALIAN PRODUCT INFORMATION
FEMME-TAB 20/100 (LEVONORGESTREL/ETHINYLESTRADIOL)
FILM-COATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Femme-Tab
20/100
is
a
combined
oral
contraceptive
(COC)
tablet
containing
the
synthetic progestogen, levonorgestrel, and the synthetic estrogen,
ethinylestradiol.
Each 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 20/100 tablets are available in blister packs. Each blister
contains 21 white
to off-white round convex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Femme-Tab 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 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.
Tablet-taking is continuous
for 21 consecutive days. Start with a tablet marked with the
corresponding day of the
week. Thereafter, one tablet is taken daily, following the arrows
marked on the pack, until
all tablets are taken.
The woman should be instructed to have a tablet free break of one
week. Each subsequent
pack is to be started immediately following the 7-day break. During
the tablet free period
a withdrawal bleed usually occurs. This usually starts on day 2-3
after the last tablet and
may not have finished before the next pack is started.
2
HOW TO START FEMME-TAB 20/100
_No preceding hormonal contraceptive use (in the past month) _
Tablet taking should start on day 1 of the woman's natural cycle (i.e.
the first day of her
menstrual bleeding). Femme-Tab 20/100 is effective from the first day
of therapy if the
tablets ar