Microgynon 50 ED tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levonorgestrel, Quantity: 125 microgram; ethinylestradiol, Quantity: 50 microgram

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

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

Administration route:

Oral

Units in package:

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

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ORAL CONTRACEPTION

Product summary:

Visual Identification: White round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-19

Patient Information leaflet

2003 MICROGYNON 50 ED CMI
1
MICROGYNON
® 50 ED
(MY
⋅
CROW
⋅
GUY
⋅
NON 50 EE
⋅
DEE)
Contraceptive tablets for women
_ethinylestradiol and levonorgestrel_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Microgynon 50 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
Microgynon 50 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 MICROGYNON
50 ED IS USED FOR
Microgynon 50 ED is a
combined oral contraceptive,
commonly known as a ‘birth
control pill’ or ‘the Pill’.
Microgynon 50 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,
Microgynon 50 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 d

Summary of Product characteristics

200311 MICROGYNON 50 ED PI
1
Australian Product Information
MICROGYNON
 50 ED (ETHINYLESTRADIOL, LEVONORGESTREL)
TABLET
1
NAME OF THE MEDICINE
Ethinylestradiol and levonorgestrel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MICROGYNON 50 ED is a combined oral contraceptive (COC) tablet
containing the
synthetic estrogen, ethinylestradiol and the synthetic progestogen,
levonorgestrel.
Each ochre active tablet contains ethinylestradiol 50 µg and
levonorgestrel 125 µg
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
Tablet, sugar coated
MICROGYNON 50 ED tablets are available in blister packs. Each blister
pack contains 28
tablets consisting of 21 round ochre active tablets followed by 7
round white placebo tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oral contraception.
4.2
D
OSE AND METHOD OF ADMINISTRATION
H
OW TO
T
AKE
MICROGYNON
50
ED
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 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 MICROGYNON 50 ED pack.
200311 MICROGYNON 50 ED PI
2
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 an
ochre 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.
H
OW TO
S
T