Norspan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Buprenorphine

Available from:

Mundipharma Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

NORSPAN
®

_TRANSDERMAL DRUG DELIVERY SYSTEM_
_Buprenorphine (boo-pree-nor-feen)_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NORSPAN
Transdermal Drug Delivery System
("patches").
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NORSPAN
PATCHES ARE USED FOR
NORSPAN patches contain
buprenorphine. Buprenorphine
belongs to a group of medicines
called opioid analgesics.
NORSPAN patches are used to
relieve moderate to severe pain.
Opioid analgesics such as
buprenorphine have been used to
treat pain for many years. Your
doctor, however, may prescribe it for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
NORSPAN patches act through the
skin. After application,
buprenorphine passes through the
skin into the blood. Each patch can
be worn for seven days. They should
not be used for acute pain.
As with all strong painkillers, your
body may become used to you using
buprenorphine patches. Using them
may result in physical dependence.
Physical dependence means that you
may experience withdrawal
symptoms if you stop using
buprenorphine suddenly, so it is
important to use it exactly as directed
by your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU USE
NORSPAN PATCHES
_WHEN YOU MUST NOT USE_
_THEM_
DO NOT USE NORSPAN PATCHES IF
YOU:
•
suffer from difficult or shallow
breathing such as acute asthma,
impaired lung function or chronic
bronchitis
•
have confusion and shaking due
to stopping drinking alcohol
•
have just had an operation or are
about to have surgery on your
spine for pain relie

Summary of Product characteristics

NORSPAN
®
 transdermal patch PI (Orbis RA-0027 Mar 13)   

Supersedes mfpnorsp10712 
mfpnorsp10313      

Page 1 of 16

PRODUCT INFORMATION 

NORSPAN
® 
TRANSDERMAL DRUG DELIVERY SYSTEM 
5, 10 AND 20 MICROGRAMS PER HOUR 

NAME OF THE MEDICINE 
Buprenorphine base (active). 

The  structural formula is: 

CAS Registry Number: 52485-79-7 

The  inactive  ingredients  in  NORSPAN

transdermal  drug  delivery  system  (patch)  are 
levulinic  acid,  oleyl  oleate,  povidone,  Duro  Tak  387-2051,  Duro  Tak  387-2054  and 
polyethylene terephthalate. 

DESCRIPTION 
Buprenorphine is a white or  almost white powder and is very slightly soluble in water, freely 
soluble  in  acetone,  soluble  in  methanol  and  ether  and  slightly  soluble  in  cyclohexane.   The 
pKa  is  8.5.  The  chemical  name  of  buprenorphine  is  (2S)-2-[17-(cyclopropylmethyl)-4, 5α- 
epoxy-3-hydroxy-6-methoxy-6α,  14-ethano-14α-morphinan-7α-yl]-3,  3-dimethylbutan-2-ol. 
The  molecular  weight  is  467.6  and  the  empirical  formula  is  C
29
H
41
NO
4
.     

NORSPAN

patches  are  either  a  rectangular  (10  micrograms  per  hour),  or  square  (5  and 20 
micrograms  per  hour),  beige-coloured,  matrix  patch  with  rounded  corners,  marked  with  the 
trade  name  and  consisting  of  a  protective  liner  and  functional  layers.   Proceeding  from  the 
outer surface towards the surface adhering to the skin, the layers are (1) a beige-coloured web 
backing  layer  of  polyester  material;  (2)  an  adhesive  matrix  rim  without buprenorphine; (3)  a 
separating  foil  over  the  adhesive  matrix;  (4)  the  buprenorphine-containing adhesive  matrix; 
and (