NORLEVO-1 levonorgestrel 1.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levonorgestrel, Quantity: 1.5 mg

Available from:

Orion Laboratories Pty Ltd T/A Perrigo Australia

INN (International Name):

Levonorgestrel

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: magnesium stearate; maize starch; colloidal anhydrous silica; lactose monohydrate; povidone

Administration route:

Oral

Units in package:

1 tablet

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: White, round, biconvex tablet engraved with code NL 1.5 on one face; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2009-10-27

Patient Information leaflet

NORLEVO
®
-1
1
NORLEVO
®
-1
_levonorgestrel 1.5 mg tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NorLevo-1.
It does not contain all the available
information. It does not take the
place of talking to your doctor,
pharmacist, nurse or family planning
clinic.
All medicines have risks and
benefits. Your doctor, pharmacist,
nurse or family planning clinic have
weighed the risk of you taking this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, PHARMACIST, NURSE OR
FAMILY PLANNING CLINIC.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT NORLEVO-1 IS
USED FOR AND HOW IT
WORKS
NorLevo-1 is an oral emergency
contraceptive indicated for use within
72 hours of unprotected intercourse.
It is not intended as a regular method
of contraception.
It contains the active ingredient
levonorgestrel.
NorLevo-1 must be taken as soon as
possible, preferably within 12 hours
and no later than within 72 hours of
unprotected intercourse. It has been
estimated that NorLevo-1 will
prevent 85% of expected pregnancies
if taken within 72 hours. The sooner
you take NorLevo-1, the more likely
it is that it will work.
NorLevo-1 is thought to work by:
•
stopping your ovaries from
releasing an egg
•
preventing sperm from fertilising
any eggs you may have already
released
•
stopping a fertilised egg from
attaching itself to your womb
lining.
Therefore, NorLevo-1 stops a
pregnancy before it is established. It
does not work if you are already
pregnant.
NorLevo-1 does not protect against
sexually transmitted diseases.
BEFORE YOU TAKE
NORLEVO-1
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:
•
you are allergic to the active
ingredient or any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
you are pregnant or think you
may be pregnant
•
you have previously had
unprotected intercourse more than
72 hours earlier in the sam

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION –
NORLEVO-1 LEVONORGESTREL 1.5 MG TABLET
[vA01, Jan 2020]
Page 1 of 10
1
NAME OF THE MEDICINE
Levonorgestrel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NorLevo-1 contains 1.5 mg of levonorgestrel as active ingredient.
List of excipients with known effect: lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
NorLevo-1 is a white, round, biconvex tablet engraved with code ‘NL
1.5’ on one face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
NorLevo-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
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
One tablet should be taken. The efficacy of the method is higher the
sooner after the
unprotected intercourse the treatment is initiated. Therefore, the
tablet must be taken as
soon as possible, preferably within 12 hours, after the unprotected
intercourse and no longer
than 72 hours (3 days) after the intercourse.
If the patient vomits within two hours of taking the tablet, she
should return to her
pharmacist, doctor or clinic where another tablet may be given.
NorLevo-1 can be used at any time during the menstrual cycle unless
menstrual bleeding is
overdue.
Women who have used enzyme-inducing drugs during the last 4 weeks and
need emergency
contraception are recommended to use a non-hormonal method, e.g.
copper intrauterine
device (Cu-IUD), or take a double dose of NorLevo-1 (i.e. 2 tablets
taken together) if unable
or unwilling to use the non-hormonal method.
NorLevo
®
-1 levonorgestrel 1.5 mg tablet
[vA01, Jan 2020]
Page 2 of 10
CHILDREN
NorLevo-1 is not recommended in children. Only limited data are
available in young women
of childbearing potential aged 14 to 16 years. No data are available
about use in young
women aged less than 14 years or in children.
4.3