Microgynon 20 ED

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ethinylestradiol 20ug; Levonorgestrel 100ug

Available from:

Bayer New Zealand Limited

INN (International Name):

Ethinylestradiol 20 µg

Dosage:

20µg/100µg

Pharmaceutical form:

Coated tablet

Composition:

Active: Ethinylestradiol 20ug Levonorgestrel 100ug Excipient: Calcium carbonate Glycerol Glycol montanate Iron oxide red Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc Purified water Starch Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone   Purified talc   Sucrose

Units in package:

Blister pack, PVC,sample, 'credit-card' pk, 28 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bayer AG

Therapeutic indications:

Oral contraception

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC,sample, 'credit-card' pk - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al foil, 'credit card' - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al foil,3x28'credit card' - 84 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1997-09-23

Patient Information leaflet

MICROGYNON
20 ED CMI VX1.0
1
MICROGYNON
® 20 ED
(MY
⋅
CROW
⋅
GUY
⋅
NON 20 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 20 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 20 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
20 ED IS USED FOR
Microgynon 20 ED is a combined
oral contraceptive, commonly
known as a ‘birth control pill’ or
‘the Pill’.
Microgynon 20 ED is used to
prevent pregnancy.
When taken correctly,
Microgynon 20 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
diarrhoea.
Like all oral contraceptives,
Microgynon 20 ED is intended to
prevent pregnancy. It does not
protect against HIV infection
(AIDS) and other sexually
transmitted infections.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
MICROGYNON 20 ED
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MICROGYNON 20
ED IF YOU

Summary of Product characteristics

MICROGYNON 20 ED DS VX1.0
1
NEW ZEALAND DATA SHEET
1.
MICROGYNON
® 20 ED
MICROGYNON 20 ED 20 micrograms ethinylestradiol and 100 micrograms
levonorgestrel tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One active tablet contains 20 micrograms ethinylestradiol and 100
micrograms
levonorgestrel.
Each pink active tablet contains 33 mg of lactose and each white
hormone-free tablet
contains 34 mg of lactose. Patients with rare hereditary problems of
galactose
intolerance, Lapp lactase deficiency or glucose-galactose
malabsorption who are on a
lactose free diet should take this amount into consideration.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sugar-coated tablets.
The active tablets are pink, 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 20 ED, when
taken
correctly, have a failure rate of approximately 1% per year. Failure
rate may increase
when pills are missed or taken incorrectly.
HOW TO TAKE MICROGYNON 20 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 20 ED
START WITH THE FIRST TABLET FROM THE GREEN SECTION MARKED WITH
THAT DAY OF THE WEEK, in accordance with one of the following:
MICROGYNON 20 ED DS VX1.0
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