DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS 3 mg/30 micrograms drospirenone/ethinylestradiol 3 mg/30 micrograms tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

drospirenone, Quantity: 3 mg; ethinylestradiol, Quantity: 30 microgram

Available from:

Lupin Australia Pty Limited

INN (International Name):

Drospirenone,ethinylestradiol

Pharmaceutical form:

Tablet

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For use as an oral contraceptive

Product summary:

Visual Identification: White to off-white coloured, round, biconvex, film coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-01-20

Patient Information leaflet

_Draft v0.1, 26 July 2011 _
DROSPIRENONE/ ETHINYLOESTRADIOL-GH CMI
Page 1 of 13
DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS
3 MG/ 30 ΜG
Contraceptive tablets for women
_drospirenone and ethinyloestradiol _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Drospirenone/
Ethinyloestradiol-GH . 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
Drospirenone/ Ethinyloestradiol-GH 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 DROSPIRENONE/ ETHINYLOESTRADIOL-GH IS USED FOR
Drospirenone/ Ethinyloestradiol-GH is a combined oral contraceptive,
commonly known as a
‘birth control pill’ or ‘the Pill’.
Drospirenone/ Ethinyloestradiol-GH is used to prevent pregnancy.
Drospirenone/
Ethinyloestradiol-GH
contains
drospirenone
which
has
antiandrogenic
properties and may be of some benefit in androgen-related acne, skin
conditions or greasy
hair.
You may also experience the following benefits:
• improvement in symptoms like bloating, swelling or weight gain
related to fluid retention
• more regular and shorter periods and a decrease in the amount of
blood you lose each
month
• a decrease in anaemia (iron deficiency)
• a decrease in period pain.
_Draft v0.1, 26 July 2011 _
DROSPIRENONE/ ETHINYLOESTRADIOL-GH CMI
Page 2 of 13
Some medical conditions such as pelvic inflammatory
disease, ovarian cysts, ectopic
pregnancy and disorders of the uterus (womb), ovaries and breast are
less common in
women taking oral contraceptives.
When taken correctly, it prevents you from becoming pregnant in
several ways:
• inhibiting the egg release by stopping it maturing
• changing the cervical mucus consistency, making it more diff

Summary of Product characteristics

_ _
DROSPIRENONE/ ETHINYLOESTRADIOL-GH PI_v2
Page 1 of 32
PRODUCT INFORMATION
DROSPIRENONE/ ETHINYLOESTRADIOL-GH TABLETS
(3 MG/30 ΜG)
NAME OF THE MEDICINE
Drospirenone/ Ethinyloestradiol-GH is a combined oral contraceptive
tablet containing
the synthetic progestogen, drospirenone and the synthetic oestrogen,
ethinyloestradiol.
Ethinyloestradiol is an oestrogen. Chemically, 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 No: 57-63-6
Drospirenone is a progestogen. The chemical name for drospirenone is
3-0xo-6α, 7α,
15α, 16α-tetrahydro-3'
_H,3"H-_
dicydopropa[6,7:15,16]-17α-pregn-4-en-21,17-carbolactone
and has the following structural formula:
Chemical formula: C
24
H
30
O
3
Molecular weight: 366.50
_ _
DROSPIRENONE/ ETHINYLOESTRADIOL-GH PI_v2
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CAS No: 67392-87-4
DESCRIPTION
Ethinyloestradiol
is
a
white
or
slightly
yellowish-white,
crystalline
powder.
It
is
practically insoluble in water, freely soluble in ethanol (96 per
cent). It dissolves in dilute
alkaline solutions.
Drospirenone is a white to off-white crystalline powder. It is freely
soluble in methylene
chloride, soluble in acetone, methanol, sparingly soluble in
ethylacetate and ethanol 96%
(v/v) and practically insoluble in hexane and water.
Each yellow active tablet contains drospirenone 3 mg and
ethinyloestradiol 30 μg and the
excipients: lactose, maize starch, pregelatinised maize starch,
magnesium stearate and
Opadry Complete Film Coating System 03F82726 Yellow (containing
hypromellose,
macrogol 6000, purified talc, titanium dioxide and iron oxide yellow).
Each white inactive tablet contains lactose, maize starch,
pregelatinised maize starch,
magnesium
stearate
and
Opadry
Complete
Film
Coating
System
03B28796
White
(containing hypromellose, macrogol 400 and titanium dioxide).
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
The contraceptive effect of combined oral contraceptives is based on
the interaction of