MICROGYNON 20 ED tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levonorgestrel, Quantity: 100 microgram; ethinylestradiol, Quantity: 20 microgram

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Microgynon 20 ED is indicated for the prevention of pregnancy.

Product summary:

Visual Identification: White, lustrous, biconvex tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-11-16

Patient Information leaflet

MICROGYNON
®
20 ED CMI XV1.0
1
MICROGYNON® 20 ED
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MICROGYNON® 20 ED?
MICROGYNON® 20 ED contains the active ingredients ethinylestradiol
and levonorgestrel. MICROGYNON® 20 ED is used to
prevent pregnancy. For more information, see Section 1. Why am I using
MICROGYNON® 20 ED? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MICROGYNON® 20 ED?
Do not use if you have ever had an allergic reaction to MICROGYNON®
20 ED or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
MICROGYNON® 20 ED?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MICROGYNON® 20 ED and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE MICROGYNON® 20 ED?
•
Take one tablet daily at about the same time every day.
•
You must take MICROGYNON® 20 ED every day regardless of how often you
have sex.
•
Swallow the tablet whole with a full glass of water. It does not
matter if you take it before or after food.
More instructions can be found in Section 4. How do I use MICROGYNON®
20 ED?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MICROGYNON® 20 ED?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MICROGYNON® 20 ED.
•
If you are about to have any blood tests, tell your doctor that you
are taking this medicine. It may
interfere with the results of some tests.
•
Have regular check-ups with your doctor. When you are taking the Pill,
your doctor will tell you to
return for regular check-ups, including getting a Cervical Screening
Test.
THINGS YOU
SHOU

Summary of Product characteristics

200311 MICROGYNON 20 ED PI
1
Australian Product Information
MICROGYNON
 20 ED (ETHINYLESTRADIOL, LEVONORGESTREL)
TABLET
1
NAME OF THE MEDICINE
Ethinylestradiol and levonorgestrel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
MICROGYNON 20 ED is a combined oral contraceptive (COC) tablet
containing the
synthetic estrogen, ethinylestradiol and the synthetic progestogen,
levonorgestrel.
Each pink active tablet contains ethinylestradiol 20
µ
g and levonorgestrel 100
µ
g
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 20 ED tablets are available in blister packs. Each blister
contains 28 tablets
consisting of 21 small round pink active tablets, followed by 7 large
round white placebo
tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MICROGYNON 20 ED is indicated for the prevention of pregnancy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
HOW TO TAKE MICROGYNON 20 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 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
MICROGYNON 20 ED pack.
200311 MICROGYNON 20 ED PI
2
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 MICROGYNON 20 ED
_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
agai