Microgynon 50 ED

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ethinylestradiol 0.05mg; Levonorgestrel 0.125mg

Available from:

Bayer New Zealand Limited

INN (International Name):

Ethinylestradiol 0.05 mg

Pharmaceutical form:

Tablet

Composition:

Active: Ethinylestradiol 0.05mg Levonorgestrel 0.125mg Excipient: Calcium carbonate Glycerol Wax E Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone as Polyvidone 25,000   Purified talc   Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose

Units in package:

Blister pack, 3 x 28, 84 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Oral contraception

Product summary:

Package - Contents - Shelf Life: Blister pack, 3 x 28 - 84 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1974-03-14

Patient Information leaflet

1805 NZ MICROGYNON
50 ED CMI
1
MICROGYNON
® 50 ED
(MY
⋅
CROW
⋅
GUY
⋅
NON 50 EE
⋅
DEE)
Contraceptive tablets for women
_ethinyloestradiol 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

Summary of Product characteristics

180424 Microgynon 50 ED DS
1
DATA SHEET
1.
MICROGYNON
® 50 ED
Microgynon 50 ED 50 micrograms ethinylestradiol and 125 micrograms
levonorgestrel tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One active tablet contains 50 micrograms ethinylestradiol and 125
micrograms
levonorgestrel. Each blister pack contains 21 active tablets and 7
hormone-free
tablets.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sugar-coated tablets.
The active tablets are ochre, biconvex, round and 5.7mm in diameter.
The hormone-
free tablets are white, biconvex, round and 6.8mm in diameter.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oral contraception.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Combined oral contraceptives (COCs), such as Microgynon 50 ED, when
taken
correctly, have a failure rate of approximately 1% per year. The
failure rate may
increase when pills are missed or taken incorrectly.
_HOW TO TAKE MICROGYNON 50 ED _
Tablets must be taken in the order directed on the package every day
at about the
same time with some water as needed. Tablet-taking is continuous
following the
directional arrows. One tablet is to be taken daily for 28 consecutive
days. Each
subsequent pack is started the day after the last tablet of the
previous pack.
Withdrawal bleeding usually starts on day 2 - 3 after starting the
white hormone-free
tablets and may not have finished before the next pack is started.
_HOW TO START MICROGYNON 50 ED _
START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH
THAT DAY OF THE WEEK, in accordance with one of the following:
180424 Microgynon 50 ED DS
2
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). Starting on days 2 - 5 of the menstrual cycle
is allowed, but
during the first cycle an additional barrier contraceptive method is
recommended for
the first 7 days of tablet-taking.
Changing from another combined oral contraceptive (COC), vaginal ring
o