MICRONELLE 30 ED levonorgestrel 150 microgram and ethinylestradiol 30 microgram film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

ethinylestradiol,Levonorgestrel

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; lactose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

4 x 28, 1 x 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral contraception.

Product summary:

Visual Identification: Plain, round, white tablet.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-31

Patient Information leaflet

MICRONELLE
® 30 ED
TABLETS
_Each blister pack contains: 21 yellow (active) tablets each
containing 30 micrograms ethinylestradiol and_
_150 micrograms levonorgestrel; 7 white placebo (inactive) tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about Micronelle 30 ED. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Micronelle 30 ED. It contains the
active ingredients levonorgestrel and
ethinylestradiol.
It is a combined oral contraceptive,
commonly known as a 'birth control
pill' or 'the Pill'.
It is used to prevent pregnancy.
You may also experience the
following benefits:
•
more regular periods, 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.
This medicine must only be used
after a female's first period has
occurred and should not be used after
menopause.
Ask your doctor if yo

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
MICRONELLE
® 30 ED
(LEVONORGESTREL AND ETHINYLESTRADIOL) TABLETS
1
NAME OF THE MEDICINE
Levonorgestrel and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MICRONELLE 30 ED is a combined oral contraceptive tablet containing
the synthetic
progesterone, levonorgestrel and the synthetic estrogen,
ethinylestradiol.
Each
yellow
active
tablet
in
Micronelle
30
ED
contains
ethinylestradiol
30
μg
and
levonorgestrel 150 μg.
EXCIPIENTS WITH KNOWN EFFECT
Yellow active tablet in Micronelle 30 ED: Lactose monohydrate
White placebo tablet in Micronelle 30 ED: Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Active tablet: Plain, round, yellow film-coated tablet.
Placebo tablet: Plain, round, white film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
Micronelle
®
30 ED tablets are intended for oral administration.
DOSAGE
HOW TO TAKE MICRONELLE
COCs, 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 packaging
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 pack.
If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday,
her first tablet is a
white placebo one, while if she starts on a Saturday or Sunday her
first tablet will be a yellow
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 day 2 to 3 after
starting the white placebo
tablets (last row) and may not have finished before the next pack is
started.