ELEANOR 150/30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

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

Fáanlegur frá:

Lupin Australia Pty Limited

INN (Alþjóðlegt nafn):

ethinylestradiol,Levonorgestrel

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: magnesium stearate; lactose monohydrate; maize starch; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400

Stjórnsýsluleið:

Oral

Einingar í pakka:

4 blisters x 28 tablets (21 active and 7 placebo in each blister), 2 blisters x 28 tablets (21 active and 7 placebo in each blister), 1 blister x 28 tablets (21 active and 7 placebo in each blister), 3 blisters x 28 tablets (21 active and 7 placebo in each blister)

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

ORAL CONTRACEPTION

Vörulýsing:

Visual Identification: White to Off-white, round shaped, biconvex film coated tablets, plain on both side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2014-02-03

Upplýsingar fylgiseðill

1
Eleanor 150/30 ED v1.0
Eleanor 150/30 ED
Contraceptive tablets for women
_Levonorgestrel and Ethinyloestradiol Tablet 150/30 _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Eleanor 150/30 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 Eleanor 150/30 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 ELEANOR 150/30
ED IS USED FOR
Eleanor 150/30 ED is a
combined oral
contraceptive, commonly
known as a ‘birth control
pill’ or ‘the Pill’.
Eleanor 150/30 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, fibrocystic
breast changes, acne and
cancer of the uterus (womb)
and ovaries may be less
common in women taking
the Pill.
When taken correctly, it
prevents you from
becoming pregnant in
several ways, including:

inhibiting the egg release
by stopping it maturing.

changing the cervical
mucus consistency,
making it more difficult
for the sperm to reach
the egg.
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, or
taken with medicines that
may interfere with their
effectiveness.
Like all oral contraceptives,
Eleanor 150/30 ED is
intended to prevent
pregnancy. It does not
protect against HIV
infection (AIDS) and other
sexually transmitted
diseases.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS

Vara einkenni

Eleanor 150/30 ED V2
Page 1 of 26
PRODUCT INFORMATION
ELEANOR 150/30 ED
NAME OF MEDICINE (LEVONORGESTREL/ETHINYLOESTRADIOL TABLET 150/30)
Eleanor 150/30 ED is a combined oral contraceptive (COC) tablet
containing the synthetic
progestogen levonorgestrel and the synthetic oestrogen
ethinyloestradiol.
PHYSICAL AND CHEMICAL CHARACTERISTICS
LEVONORGESTREL:
The chemical name for levonorgestrel is 13β-ethyl-17β-hydroxy-18,
19-dinor-17α-pregn-4-
en-20-yn-3-one and has the following structural formula:
Chemical Formula:
C
21
H
28
O
2
Molecular Weight:
312.45
CAS:
797-63-7
ETHINYLOESTRADIOL:
The chemical name for ethinyloestradiol is
19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17β-
diol and has the following structural formula
Chemical Formula:
C
20
H
24
O
2
Molecular Weight:
296.41
CAS:
57-63-6
Eleanor 150/30 ED V2
Page 2 of 26
DESCRIPTION
PHYSICAL AND CHEMICAL CHARACTERISTICS
Levonorgestrel is a white or almost white, crystalline powder.
Practically insoluble in
water; sparingly soluble in methylene chloride and slightly soluble in
ethanol (96%).
Ethinyloestradiol is a white or slightly yellowish-white crystalline
powder. It is
practically insoluble in water, soluble in chloroform and in ether,
freely soluble in
alcohol.
ACTIVE TABLET:
Yellow, round biconvex film coated tablets, debossed with ‘LE4’ on
one side and plain on
other side.
Each yellow film coated active tablet contains ethinyloestradiol 30
microgram and
levonorgestrel 150 microgram and the excipients: lactose anhydrous,
microcrystalline
cellulose, povidone, croscarmellose sodium, magnesium stearate,
hypromellose, macrogol
400, titanium dioxide and iron oxide yellow [E172].
PLACEBO TABLET:
White to off-white, round shaped, biconvex film coated tablets, plain
on both side.
Each white film coated tablet contains lactose, maize starch,
pregelatinised maize starch,
magnesium stearate, hypromellose, macrogol 400, titanium dioxide.
PHARMACOLOGY
PHARMACODYNAMICS
The contraceptive effect of COCs is based on the interaction of
various factors. The primary
mech