POSTINOR-1 levonorgestrel 1.5mg tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

levonorgestrel, Quantity: 1.5 mg

Saatavilla:

Gedeon Richter Australia Pty Ltd

INN (Kansainvälinen yleisnimi):

Levonorgestrel

Lääkemuoto:

Tablet, uncoated

Koostumus:

Excipient Ingredients: potato starch; maize starch; purified talc; lactose monohydrate; colloidal anhydrous silica; magnesium stearate

Antoreitti:

Oral

Kpl paketissa:

One tablet in a blister pack in a carton

Prescription tyyppi:

(S3) Pharmacist Only Medicine

Käyttöaiheet:

Emergency contraception within 72 hours of unprotected intercourse.

Tuoteyhteenveto:

Visual Identification: Almost white, flat, rimmed tablet with an impressed mark of "GOO" on one side; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2008-01-16

Pakkausseloste

POSTINOR-1_A110521
POSTINOR-1
________________________________________________________________________________________________________
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 Postinor-1?
Postinor-1 contains the active ingredient levonorgestrel. Postinor-1
is used as an emergency contraceptive.
For more information, see Section 1. Why am I using Postinor-1? In the
full CMI.
2. What should I know before I use Postinor-1?
Do not use if you have ever had an allergic reaction to Postinor-1 or
any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist 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
Postinor-1?. in the full CMI
3. What if I am taking other medicines?
Some medicines may interfere with Postinor-1 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 Postinor-1?
•
Take one tablet as soon as possible, preferably within 12 hours and no
later than 72 hours (3 days) after you have had
unprotected sex.
More instructions can be found in Section 4. How do I use Postinor-1?.
in the full CMI.
5. What should I know while using Postinor-1?
Things you
should do
•
Remind any doctor, dentist or pharmacist you visit that you are using
Postinor-1
Things you
should not do
•
Do not this medicine if you had unprotected intercourse more than 72
hours earlier in the same menstrual
cycle
•
Do not use this medicine if you are pregnant
Driving or
using
machines
•
Do not drive or operate machinery if you feel drowsy or dizzy using
Postinor-1
Drinking
alcohol
•
Tell your doctor or pharmacist if you drink a

Valmisteyhteenveto

GEDEON RICHTER
AUST R 149269
1 of 14
AUSTRALIAN PRODUCT INFORMATION
POSTINOR- 1 (LEVONORGESTREL) TABLET
1.
NAME OF THE MEDICINE
Levonorgestrel
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
POSTINOR-1 tablet contains 1.5 mg of levonorgestrel.
Excipients with known effect: lactose monohydrate (
See Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR UE – Excipients.)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Almost white, flat rimmed tablet of about 8 mm in diameter, with an
impressed mark of
“GOO” on one side.
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
POSTINOR-1 is an oral emergency contraceptive indicated for use within
72 hours of
unprotected intercourse. It should be used only as an emergency
measure.
Women who present for repeated courses of emergency contraception
should be advised to
consider long-term methods of contraception.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
One 1.5 mg tablet to be taken as soon as possible (and not later than
72 hours) after
unprotected intercourse.
The highest efficacy is achieved if the tablet is taken as early as
possible. Therefore treatment
should not be delayed as efficacy declines with time.
If the patient vomits within two hours of taking the tablet, she
should return to her
pharmacist, doctor or clinic where an additional tablet may be given.
POSTINOR-1 can be used at any time during the menstrual cycle unless
menstrual bleeding is
overdue.
GEDEON RICHTER
AUST R 149269
2 of 14
Children: POSTINOR-1 is not recommended in children.
Only limited data are available in young women of child-bearing
potential aged 14-16 years.
No data are available about use in young women aged less than 14 years
or children.
METHOD OF ADMINISTRATION
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1 List
of excipients.
POSTINOR-1 should not be given to pregnant women. If menstrual
bleeding is overdue, if
the last menstrual period was abnormal in timing or ch