LEVONORGESTREL-1 GH levonorgestrel 1.5mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
20-11-2013
Summary of Product characteristics
(SPC)
20-11-2013
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
levonorgestrel, Quantity: 1.5 mg
Available from:
Lupin Australia Pty Limited
INN (International Name):
Levonorgestrel
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; povidone; colloidal anhydrous silica
Administration route:
Oral
Units in package:
1's blister in carton
Prescription type:
(S3) Pharmacist Only Medicine
Therapeutic indications:
Emergency contraception within 72 hours of unprotected intercourse.
Product summary:
Visual Identification: White to off-white round shaped, tablets debossed with ?LV1" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-11-20
Patient Information leaflet
Levonorgestrel-1 GH v3
1
LEVONORGESTREL-1 GH
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 LEVONORGESTREL-1 GH?
Levonorgestrel-1 GH contains the active ingredient levonorgestrel.
Levonorgestrel-1 GH is used as an emergency
contraceptive.
For more information, see Section 1. Why am I using Levonorgestrel-1
GH? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEVONORGESTREL-1 GH?
Do not use if you have ever had an allergic reaction to
Levonorgestrel-1 GH 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
Levonorgestrel-1 GH? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Levonorgestrel-1 GH 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 LEVONORGESTREL-1 GH?
•
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
Levonorgestrel-1 GH? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEVONORGESTREL-1 GH?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Levonorgestrel-1 GH.
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 after
using Levonorgestrel-1 GH.
DRINKING
ALCOHOL
•
Tell your doctor or pharmacist if you drink alcohol.
LOOKING AFTER
YOUR MEDICINE
•
Store the medicine in a cool d
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – LEVONORGESTREL-1 GH
(LEVONORGESTREL) UNCOATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel-1 GH tablet contains 1.5 mg of levonorgestrel.
List of excipients with known effect: lactose monohydrate (see SECTION
4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE - EXCIPIENTS).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Levonorgestrel-1 GH is a white to off-white, round shaped tablet
debossed with ‘LV1’ on one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levonorgestrel 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.
Levonorgestrel can be used at any time during the menstrual cycle
unless menstrual bleeding is overdue.
Levonorgestrel-1 GH v5.0
Page 2 of 13
(levonorgestrel) uncoated tablet
Children
Levonorgestrel 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.
Levonorgestrel should not be given to pregnant women. If menstrual
Read the complete document
