LENEST 20 ED levonorgestrel/ethinylestradiol 100 microgram/20 microgram tablet blister composite pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

ethinylestradiol, Quantity: 0.02 mg; levonorgestrel, Quantity: 0.1 mg

Verfügbar ab:

Alphapharm Pty Ltd

INN (Internationale Bezeichnung):

ethinylestradiol,Levonorgestrel

Darreichungsform:

Tablet

Zusammensetzung:

Excipient Ingredients: povidone; croscarmellose sodium; iron oxide yellow; magnesium stearate; brilliant blue FCF aluminium lake; microcrystalline cellulose; lactose monohydrate

Verabreichungsweg:

Oral

Einheiten im Paket:

4 x 28 (21 active and 7 placebo), 2 x 28 (21 active and 7 placebo), 3 x 28 (21 active and 7 placebo), 1 x 28 (21 active and 7 placebo)

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Lenest 20 ED is indicated for the prevention of pregnancy.

Produktbesonderheiten:

Visual Identification: Round, green, uncoated flat tablets debossed 471 on one side and other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2014-11-21

Gebrauchsinformation

LENEST 20 ED
_contains the active ingredients levonorgestrel and ethinylestradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LENEST 20 ED. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LENEST 20 ED
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS, OR ARE
UNSURE ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST FOR
MORE ADVICE.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT LENEST 20 ED
IS USED FOR
LENEST 20 ED is a combined oral
contraceptive, commonly known as
'birth control pill' or 'the Pill'.
LENEST 20 ED is used to prevent
pregnancy.
You may also experience the
following benefits:
•
more regular and lighter periods –
potentially resulting in a decrease
in anaemia (iron deficiency)
•
a decrease in period pain.
Some conditions such as pelvic
inflammatory disease, ovarian cysts,
ectopic pregnancy (where the foetus
is carried outside of your womb),
lumpy breasts, acne and cancer of the
uterus (womb) and ovaries may be
less common in women taking the
Pill.
When taken correctly, LENEST 20
ED prevents you from becoming
pregnant in several ways, including:
•
Inhibiting ovulation (egg release)
•
changing the cervical mucus
consistency, making it more
difficult for the sperm to reach
the egg
•
changing the lining of the uterus,
making it less suitable for
implantation.
When the Pill is taken by women
under close observation in clinical
trials, it is more than 99% effective in
preventing pregnancy. However, in
real life the Pill is around 92%
effective. This is because pills might
have been missed, may have been
taken with medicines that interfere
with their effectiveness, or may not
be absorbed due to vomiting or
diarrhoea.
Like all oral contraceptives,
LENEST 20 ED is intended to
prevent pregnancy. It does not
protect against HIV infection

Fachinformation

AUSTRALIAN PRODUCT INFORMATION
LENEST 20 ED
_Levonorgestrel/ethinylestradiol tablets _
1
NAME OF THE MEDICINE
Levonorgestrel/ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pink active tablet contains levonorgestrel 100 μg and
ethinylestradiol 20 μg as the active ingredients.
Excipients of known effect: lactose monohydrate (present in both pink
active tablet and green placebo tablet).
For the full list of excipients see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
LENEST 20 ED is a combined oral contraceptive (COC) tablet containing
the synthetic progestogen
levonorgestrel and the synthetic estrogen ethinylestradiol.
The pink active tablets are round, pink, uncoated flat tablets
debossed ‘405’ on one side and the other side is
plain.
The green placebo tablets are round, green, uncoated flat tablets
debossed ‘471’ on one side and the other side
is plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LENEST 20 ED is indicated for the prevention of pregnancy.
4.2
DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE LENEST 20 ED
Combined oral contraceptives (COC), when taken correctly, have a
failure rate of approximately 1% per year.
The failure rate may increase when pills are missed or taken
incorrectly.
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 for 28 consecutive
days, starting with a pink active tablet marked with the corresponding
day of the week from the green area of
the LENEST 20 ED 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 green placebo tablets (last row) and
may not have finished before the next pack is started.
HOW TO START LENEST 20 ED
No Preceding Hormonal Contraceptive Use (in the past month)
Tablet-taking must start on day 1 of the woman’s natural cycle (i.e.
the first day of her menstrual blee