MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
08-02-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
levonorgestrel, Quantity: 100 microgram; ethinylestradiol, Quantity: 20 microgram
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
ethinylestradiol,Levonorgestrel
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: povidone; lactose; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Administration route:
Oral
Units in package:
3 x 28, 1 x 28, 4 x 28 tablets
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Oral contraception.
Product summary:
Visual Identification: Plain, round, white tablet.; Container Type: Blister Pack; 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
® 20 ED
TABLETS
_Each blister pack contains: 21 pink (active) tablets each containing
20 micrograms ethinylestradiol and_
_100 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 20 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 20 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 you
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
MICRONELLE
® 20 ED (LEVONORGESTREL AND
ETHINYLESTRADIOL) TABLETS
1
NAME OF THE MEDICINE
Levonorgestrel and ethinylestradiol.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MICRONELLE 20 ED is a combined oral contraceptive tablet containing
the synthetic
progestogen, levonorgestrel and the synthetic estrogen,
ethinylestradiol.
Each pink active tablet in Micronelle 20 ED contains ethinylestradiol
20 μg and levonorgestrel
100 μg.
EXCIPIENTS WITH KNOWN EFFECT
Pink active tablet in Micronelle 20 ED: Lactose monohydrate
White placebo tablet in Micronelle 20 ED: Lactose
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Active tablet: Plain, round, pink film-coated tablet.
Placebo tablet: Plain, round, white film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
Micronelle
®
20 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 package
at about the same time each day, with some liquid as needed. Daily
tablet taking should be
continuous for 28 consecutive days, starting with a pink active tablet
marked with the
corresponding day of the week from the green area of the Micronelle 20
ED pack. Each
subsequent pack is to be started the day after the last tablet of the
previous pack. A withdrawal
bleed 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.
HOW TO START MICRONELLE
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her
menstrual bleeding). If started on day 1 in this way, protection
against pregnancy is immediate
and no add
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