LENEST 30 ED levonorgestrel/ ethinylestradiol 150 micrograms/30 micrograms tablet composite pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Alphapharm Pty Ltd

INN (International Name):

ethinylestradiol,Levonorgestrel

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; iron oxide yellow; brilliant blue FCF aluminium lake; polacrilin potassium; magnesium stearate

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ORAL CONTRACEPTION

Product summary:

Visual Identification: Green coloured, uncoated, round, biconvex tablets debossed '274' on side side and other side plain; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-11-03

Patient Information leaflet

LENEST 30 ED
_contains levonorgestrel and ethinylestradiol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LENEST 30 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 risks and
benefits. Your doctor has weighed
the risks of you taking LENEST 30
ED against the benefits they expect it
will have 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 THE MEDICINE.
You may need to read it again.
WHAT LENEST 30 ED
IS USED FOR
LENEST 30 ED is a combined oral
contraceptive, commonly known as a
'birth control pill' or 'the Pill'.
LENEST 30 ED is used to prevent
pregnancy.
You may also experience the
following benefits:
•
more regular, shorter and lighter
periods
•
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 30
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
be 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 30 ED is intended to
prevent pregnancy. It does not
protect against HIV infection (AIDS)
and other sexually tr

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LENEST 30 ED
_Levonorgestrel/ethinylestradiol tablets _
1
NAME OF THE MEDICINE
Levonorgestrel/ethinylestradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white to off white active tablet contains ethinylestradiol 30 µg
and levonorgestrel 150 µg as the active
ingredients.
Excipients of known effect: lactose monohydrate (present in both white
to off white active tablet and green
placebo tablet)
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
LENEST 30 ED is a combined oral contraceptive (COC) tablet containing
the synthetic progestogen
levonorgestrel and the synthetic estrogen ethinylestradiol.
The white to off white active tablet is white to off white, uncoated,
biconvex tablet debossed with ‘711’ on
one side and the other side is plain.
The green is uncoated, round, biconvex tablets debossed ‘274’ on
one side and the other is side plain.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE LENEST 30 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 every day, 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 LENEST 30 ED
pack.
If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday,
her first tablet is a green placebo
one, while if she starts on a Saturday or Sunday her first tablet will
be a white to off white 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
starts on days 2 to