Levonelle-1

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Levonorgestrel 1.5mg

Available from:

CARSL Consulting

INN (International Name):

Levonorgestrel 1.5 mg

Dosage:

1.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Levonorgestrel 1.5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Maize starch Potato starch Purified talc

Units in package:

Blister pack, Aluminium/PVC, 1 tablet

Class:

Restricted

Prescription type:

Restricted

Manufactured by:

Gedeon Richter Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, Aluminium/PVC - 1 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2004-05-11

Patient Information leaflet

LEVONELLE-1 CMI 

1 
CONSUMER MEDICINE INFORMATION 
LEVONELLE-1 
_LEVONORGESTREL 1.5 MG TABLET _
READ THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE. 
• 
Keep this leaflet. You may need to read it again.  
• 
If you have further questions, please ask your doctor, nurse,
pharmacist or 
family planning clinic.  
• 
This medicine has been prescribed for you personally and you should
not 
pass it on to others.  
WHAT IS LEVONELLE-1 USED FOR AND HOW DOES IT WORK 
LEVONELLE-1 is an emergency contraceptive that can be used after 
unprotected sex or where a contraceptive method has failed. This type
of 
contraception is often called "the morning-after pill". 
Each pack of LEVONELLE-1 contains a complete treatment which is one
round, 
white tablet. This tablet contains 1.5 milligrams of levonorgestrel,
which is the 
active ingredient. 
LEVONELLE-1 also contains the inactive ingredients: potato starch,
maize 
starch, colloidal silica anhydrous, magnesium stearate, talc and
lactose 
monohydrate. 
HOW DOES LEVONELLE-1 WORK? 
LEVONELLE-1 prevents about 84% of expected pregnancies when the tablet
is 
taken within 72 hours (3 days) of unprotected sex. LEVONELLE-1 will
not 
prevent a pregnancy in every instance, but the tablet is more
effective the sooner 
it is taken after unprotected sex. It is better to take it within 12
hours rather than 
delay until the third day. LEVONELLE-1 is thought to work by: 
• 
Stopping your ovaries from releasing an egg;  
• 
Preventing sperm from fertilising any egg you may have already
released; 
or  
• 
Stopping a fertilised egg from attaching itself to your womb lining.

So LEVONELLE-1 stops a pregnancy before it is established. It does
not work if 
you are already pregnant.  
LEVONELLE-1 CMI 

2 
BEFORE YOU USE LEVONELLE-1 
If any of these apply to you, tell your doctor, nurse, or pharmacist
before you take 
LEVONELLE-1, as emergency contraception may not be suitable for you. 
DO NOT TAKE LEVONELLE-1 IF: 
• 
you are p

Summary of Product characteristics

1 
DATA SHEET 
LEVONELLE
®
-1 
_LEVONORGESTREL 1.5 MG TABLETS _
PRESENTATION 
Each round white tablet contains 1.5 mg of levonorgestrel. 
Do not halve tablet. Dose equivalence when the tablet is divided has
not been 
established. 
USES 
ACTIONS 
The precise mode of action of LEVONELLE-1 is not known. 
At the recommended regimen, levonorgestrel is thought to work
mainly by preventing 
ovulation and fertilisation if intercourse has taken place in the
preovulatory phase, when 
the likelihood of fertilisation is the highest. It may also
cause endometrial changes that 
discourage implantation. LEVONELLE-1 is not effective once the
process of implantation 
has begun. 
At the recommended regimen, levonorgestrel is not expected to
induce significant 
modification of blood clotting factors, and lipid and carbohydrate
metabolism. 
EFFICACY 
It was estimated from the results of an earlier clinical study
(Lancet, 1998; 352: 428-
433), that levonorgestrel, taken as two 750 microgram doses with a
12 hour interval, 
prevents 85% of expected pregnancies. Efficacy appears to decline
with time of start of 
treatment after intercourse (95% within 24 hours, 85% 24-48 hours,
58% if started 
between 48 and 72 hours). Efficacy after 72 hours is not known. 
Results from a recent clinical study (Lancet 2002; 360: 1803-1810)
showed that a 1500 
microgram single dose of LEVONELLE-1, when taken within 72 hours
of unprotected 
sex, prevented 84% of expected pregnancies. This was in comparison
with 79% of 
expected pregnancies when two 750 microgram tablets were taken 12
hours apart). 
It is therefore, recommended that the complete course of one tablet of
LEVONELLE-1 is 
taken as soon as possible (and no later than 72 hours)
after unprotected intercourse. 

2 
PHARMACOKINETICS 
Orally administered levonorgestrel is rapidly and almost completely
absorbed.  
The results of a pharmacokinetic study carried out with 15 healthy
women showed that 
following ingestion of one tablet of