MICROLEVLEN ED tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

Excipient Ingredients: calcium carbonate; maize starch; povidone; glycol montanate; lactose monohydrate; macrogol 6000; magnesium stearate; sucrose; purified talc

Administration route:

Oral

Units in package:

4 x 28 tablets, 3 x 28 tablets, 1 x 28 tablets, 2 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Microlevlen ED is indicated for the prevention of pregnancy.

Product summary:

Visual Identification: White, lustrous, coated biconvex tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-11-17

Patient Information leaflet

1802 MICROLEVLEN
ED CMI
1
MICROLEVLEN
® ED
(MY
⋅
CROW
⋅
LEV
⋅
LEN EE
⋅
DEE)
Contraceptive tablets for women
_ethinyloestradiol and levonorgestrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Microlevlen 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 Microlevlen
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 MICROLEVLEN
ED IS USED FOR
Microlevlen ED is a combined oral
contraceptive, commonly known as
a ‘birth control pill’ or ‘the Pill’.
Microlevlen 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, Microlevlen
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

Summary of Product characteristics

1801 Microlevlen ED PI
1
PRODUCT INFORMATION
MICROLEVLEN
 ED
NAME OF THE MEDICINE
MICROLEVLEN ED is a combined oral contraceptive (COC) tablet
containing the synthetic
oestrogen, ethinyloestradiol and the synthetic progestogen,
levonorgestrel.
The chemical name for ethinyloestradiol is 19-nor-17
α
-pregna-1,3,5(10)-trien-20-yne-3,
17
β
-diol and has the following structural formula:
C
H
3
OH
C
CH
O
H
H
H
H
Chemical Formula: C
20
H
24
O
2
Molecular Weight: 296.41
Melting Point: 181 – 185°C
CAS No: 57-63-6
The chemical name for levonorgestrel is 13
β
-ethyl-17
β
-hydroxy-18, 19-dinor-17
α
-pregn-4-
en-20-yn-3-one and has the following structural formula:
H
OH
C
CH
O
H
H
H
Chemical Formula: C
21
H
28
O
2
Molecular Weight: 312.45
Melting Point: 232 – 239°C
CAS No: 797-63-7
DESCRIPTION
Ethinyloestradiol is a white to creamy white, odourless, crystalline
powder. It is practically
insoluble in water and soluble in alcohol, chloroform, ether,
vegetable oils and aqueous
solutions of alkali hydroxides.
1801 Microlevlen ED PI
2
Levonorgestrel is a white or almost white, odourless or almost
odourless, crystalline powder.
Practically insoluble in water; slightly soluble in alcohol, acetone
and ether; soluble in
chloroform; sparingly soluble in methylene chloride.
Each pink active tablet contains ethinyloestradiol 20
µ
g and levonorgestrel 100
µ
g and the
excipients: calcium carbonate, glycerol, glycol montanate, iron oxide
red, iron oxide yellow,
lactose, macrogol 6000, magnesium stearate, maize starch, povidone,
pregelatinised starch,
purified talc, sucrose and titanium dioxide.
Each white placebo tablet contains calcium carbonate, glycol
montanate, lactose, macrogol
6000, magnesium stearate, maize starch, povidone, purified talc and
sucrose.
PHARMACOLOGY
The hormonal components of MICROLEVLEN ED inhibit ovulation by
suppressing
gonadotrophin release. Secondary mechanisms which may contribute to
the effectiveness of
MICROLEVLEN ED as a contraceptive include changes in the cervical
mucus (which
increase the di