MICROLUT levonorgestrel 30 mcg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levonorgestrel, Quantity: 30 microgram

Available from:

Bayer Australia Ltd

Pharmaceutical form:

Tablet, sugar coated

Composition:

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

Administration route:

Oral

Units in package:

1 x 28 tablets, 4 x 28 tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ORAL CONTRACEPTION

Product summary:

Visual Identification: White round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-08-19

Patient Information leaflet

Microlut
®
XV1.0
1
MICROLUT
®
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 MICROLUT?
Microlut contains the active ingredient levonorgestrel. Microlut is
used to prevent pregnancy.
For more information, see Section 1. Why am I using Microlut?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MICROLUT?
Do not use if you have ever had an allergic reaction to Microlut 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
Microlut?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Microlut 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 MICROLUT?
•
Take one tablet daily at the same time every day. You must take
Microlut every day regardless of how often you have sex.
•
An interval of exactly 24 hours should be maintained between tablets.
This interval must not be exceeded by more than 3
hours.
•
Swallow the tablet whole with 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 Microlut? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MICROLUT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Microlut.
•
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 Microlut,
your doctor will tell you to
return for regular check-ups, including getting a Pap smear test.
THINGS YOU
SHOULD NOT DO
•
Do not take Microlut to treat any other conditions, unless yo

Summary of Product characteristics

Microlut PI XV1.0, CCDS 8
1
AUSTRALIAN PRODUCT INFORMATION –
MICROLUT
® (LEVONORGESTREL) TABLET
1
NAME OF THE MEDICINE
Levonorgestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Microlut tablet contains 0.03 mg 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 contains 28 small white tablets, each containing
levonorgestrel 0.03 mg.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Oral Contraception
4.2
D
OSE AND METHOD OF ADMINISTRATION
The dosage of Microlut is one tablet daily without any break, taken at
the same time each day
with some liquid as needed. Tablets must be taken in the order
directed on the package
throughout the 28 days without regard to bleeding. This means that
after the first pack has
been finished the next should be started without interruption. The
number of 28 tablets per
pack is not related to the menstrual cycle. The days of the week
printed on the pack provide
easy control of Microlut tablet taking.
The attempt should always be made to maintain an interval of exactly
24 hours between
tablets. This interval should by no means be exceeded by more than 3
hours.
If, for example, the patient chooses 7 a.m. as the time for taking her
tablets, she should try to
always take them at this time. Whenever this is impossible, the tablet
must be taken by 10
a.m. at the very latest, otherwise protection against conception may
decline. The greatest
possible reliability of Microlut can be assured only by adhering as
closely as possible to the
24-hour-intervals.
HOW TO START MICROLUT
No preceding hormonal contraceptive use (in the past month)
Tablet taking has to start on the first day of the menstrual bleeding.
Microlut PI XV1.0, CCDS 8
2
Changing from a combined oral contraceptive (COC)
The woman should start with Microlut immediately on the day after the
last active tablet of her
previous COC and omit the pill-free interval of this COC.
Changing from ano