LOGYNON ED tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levonorgestrel, Quantity: 0.05 mg; ethinylestradiol, Quantity: 0.03 mg

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

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

Administration route:

Oral

Units in package:

1 x 28 tablets, 4 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral contraception.

Product summary:

Visual Identification: White, biconvex, round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1992-06-18

Patient Information leaflet

Logynon
®
ED CMI XV1.0
1
LOGYNON
®
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 LOGYNON ED?
Logynon ED contains the active ingredients ethinylestradiol and
levonorgestrel. Logynon ED is used to prevent pregnancy.
For more information, see Section 1. Why am I using Logynon ED?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LOGYNON ED?
Do not use if you have ever had an allergic reaction to Logynon 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
Logynon ED?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Logynon 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 LOGYNON ED?
•
Take one tablet daily at about the same time every day. You must take
Logynon 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 Logynon ED?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LOGYNON ED?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Logynon 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
SHOULD NOT DO
•
Do not take Logynon ED to treat any other conditions, unless your
doctor tells you to.
•
Do not give yo

Summary of Product characteristics

LOGYNON ED PI XV1.0; CCDS 14
1
AUSTRALIAN PRODUCT INFORMATION
LOGYNON
 ED (ETHINYLESTRADIOL, LEVONORGESTREL)
TABLET
1
NAME OF THE MEDICINE
Ethinylestradiol
Levonorgestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LOGYNON
ED
is
a
cycle-adapted
combined
estrogen-progestogen
oral
contraceptive
containing
the
synthetic
estrogen,
ethinylestradiol
and
the
synthetic
progestogen,
levonorgestrel.
Each light brown active tablet contains 30 µg of ethinylestradiol and
50 µg of levonorgestrel.
Each white active tablet contains 40 µg of ethinylestradiol and 75
µg of levonorgestrel.
Each ochre active tablet contains 30 µg of ethinylestradiol and 125
µg of levonorgestrel.
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.
Each blister pack contains 6 round light brown coated tablets each
containing 30 µg
ethinylestradiol and 50 µg levonorgestrel followed by 5 small round
white coated tablets each
containing 40 µg ethinylestradiol and 75 µg levonorgestrel followed
by 10 round ochre coated
tablets each containing 30 µg ethinylestradiol and 125 µg
levonorgestrel followed by 7 large
round white placebo tablets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oral contraception.
4.2
D
OSE AND METHOD OF ADMINISTRATION
HOW TO TAKE LOGYNON 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.
LOGYNON ED PI XV1.0; CCDS 14
2
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 LOGYNON ED pack.
If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday,
her first tablet is a
large white placebo one, while if she starts on a Saturday or Sunday
her