Norspan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Buprenorphine 10mg;  ;  

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Buprenorphine 10 mg

Dosage:

10 mg

Pharmaceutical form:

Transdermal patch

Composition:

Active: Buprenorphine 10mg     Excipient: Polyacrylate. Durotak 387.2054 and Durotak 387.2051 Levulinic acid Oleyl oleate Povidone

Units in package:

Sachet, laminate, 2 individual wrapped patches, 2 patches

Class:

Class C4 Controlled Drug

Prescription type:

Class C4 Controlled Drug

Manufactured by:

Janssen Pharmaceutica NV

Therapeutic indications:

Management of moderate to severe pain.

Product summary:

Package - Contents - Shelf Life: Sachet, laminate, 2 individual wrapped patches - 2 patches - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2006-03-17

Patient Information leaflet

NORSPAN
®
PATCH
1
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
should be worn for seven days.
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. Selling or
giving away NORSPAN is against
the law.
BEFORE YOU USE
NORSPAN PATCHES
_WHEN YOU MUST NOT USE _
_THEM _
DO NOT USE NORSPAN PATCHES IF
YOU:

have any breathing problems or
have a condition where your lung
function is severely impaired

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

Summary of Product characteristics

NEW ZEALAND DATA SHEET
NORSPAN® PATCH – NORSP010
Aug 2022
Page 1 of 21
NORSPAN® TRANSDERMAL PATCH
Buprenorphine
1
PRODUCT NAME
NORSPAN® 5mg Patch
NORSPAN® 10mg Patch
NORSPAN® 20mg Patch
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NORSPAN® patch 5
Each square patch releases buprenorphine 5 micrograms per hour over 7
days
The area containing the active substance: 6.25 cm
2
Total buprenorphine content: 5mg
NORSPAN® patch 10
Each rectangular patch releases buprenorphine 10 micrograms per hour
over 7 days
The area containing the active substance: 12.5 cm
2
Total buprenorphine content: 10mg
NORSPAN® patch 20
Each square patch releases buprenorphine 20 micrograms per hour over 7
days
The area containing the active substance: 25 cm
2
Total buprenorphine content: 20mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
NORSPAN®
patch is either rectangular (10 micrograms/hr) or square (5 and 20
micrograms/hr) 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
layer
(“foil”)
consisting
of
polyethylene terephthalate over the adhesive matrix; (4) the
buprenorphine-containing adhesive
matrix; and (5) a release liner. Before use the release liner covering
the adhesive layer is removed and
discarded.
FIGURE 1: Cross section drawing of NORSPAN® patch
NEW ZEALAND DATA SHEET
NORSPAN® PATCH – NORSP010
Aug 2022
Page 2 of 21
NORSPAN®
patch is available in three different strengths: 5 micrograms per
hour, 10 micrograms per
hour and 20 micrograms per hour. The composition of all three
strengths is identical except for patch
size. The proportion of buprenorphine in the adhesive matrix is the
same in each strength (10% by
weight). The amount of buprenorphine released from each system per
hour is proportio