LEVLEN ED tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol, Quantity: 30 microgram; levonorgestrel, Quantity: 150 microgram

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

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

Administration route:

Oral

Units in package:

4 x 28 tablets, 1 x 28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the control of conception.

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

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

Summary of Product characteristics

200311 LEVLEN ED PI
1
Australian Product Information
LEVLEN
 ED (ETHINYLESTRADIOL, LEVONORGESTREL) TABLET
1
NAME OF THE MEDICINE
Ethinylestradiol and levonorgestrel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LEVLEN ED is a combined oral contraceptive (COC) tablet containing the
synthetic
estrogen, ethinylestradiol and the synthetic progestogen,
levonorgestrel.
Each beige active tablet contains ethinylestradiol 30 µg and
levonorgestrel 150 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
LEVLEN ED tablets are available in blister packs. Each blister pack
contains 28 tablets
consisting of 21 round beige 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
HOW TO TAKE LEVLEN 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 LEVLEN ED pack.
200311 LEVLEN 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 a
beige 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.
HOW TO START LEVLEN ED
_NO PRECEDING HORMONAL CONTRACEPTIVE USE