情報リーフレット
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
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製品の特徴
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 (
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