NORSPAN buprenorphine 15 micrograms/h transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

28-01-2021

Summary of Product characteristics (SPC)

28-01-2021

Public Assessment Report (PAR)

23-11-2017

Active ingredient:

buprenorphine, Quantity: 15 mg

Available from:

Mundipharma Pty Ltd

INN (International Name):

Buprenorphine

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: levulinic acid; oleyl oleate; povidone; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; heptane; aluminium acetylacetonate

Administration route:

Transdermal

Units in package:

2 patches

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

NORSPAN patches are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. NORSPAN patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. NORSPAN patches are not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Beige coloured rectangular patch with rounded corners on an aluminised rigid removable protective layer. The trade name and the strength is printed on the patch.; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-11-28

Patient Information leaflet

NORSPAN® Patch
1
NORSPAN
® TRANSDERMAL DRUG DELIVERY SYSTEM
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING NORSPAN PATCHES?
NORSPAN Transdermal Drug Delivery System ("patches") contain the
active ingredient buprenorphine. NORSPAN patches are
used for the management of pain severe enough to require daily,
long-term opioid treatment and for which other forms of
treatment have failed or are otherwise inappropriate to provide
sufficient management of pain.
For more information, see Section 1. Why am I using NORSPAN patches?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NORSPAN PATCHES?
Do not use if you have ever had an allergic reaction to buprenorphine
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
NORSPAN patches? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NORSPAN patches and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NORSPAN PATCHES?
•
Your doctor will tell you exactly how much to take.
•
Follow the instructions given to you by your doctor or your
pharmacist.
More instructions can be found in Section 4. How do I use NORSPAN
patches? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NORSPAN PATCHES?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using NORSPAN
patches.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help you relax,
anything that contains alcohol (like cough syrup) or other medicines
that treat

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Summary of Product characteristics

NORSPAN
®
PATCH
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION – NORSPAN
®
(BUPRENORPHINE) TRANSDERMAL DRUG DELIVERY SYSTEM
(PATCH)
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, NORSPAN
patches should only be used in
patients for whom other treatment options, including non-opioid
analgesics, are ineffective, not
tolerated or otherwise inadequate to provide appropriate management of
pain (see Section 4.4
Special warnings and precautions for use).
_HAZARDOUS AND HARMFUL USE _
NORSPAN patches pose risks of hazardous and harmful use which can lead
to overdose and
death. Assess the patient’s risk of hazardous and harmful use before
prescribing and monitor
the patient regularly during treatment (see Section 4.4. Special
warnings and precautions for
use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of NORSPAN
patches. Be aware of situations which increase the risk of respiratory
depression, modify dosing
in patients at risk and monitor patients closely, especially on
initiation or following a dose
increase (see section 4.4 Special warnings and precautions for use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, _
_INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants,
including alcohol, may result in profound sedation, respiratory
depression, coma, and death.
Limit dosages and durations to the minimum required; and monitor
patients for signs and
symptoms of respiratory depression and sedation. Caution patients not
to drink alcohol while
using NORSPAN patches.
1
NAME OF THE MEDICINE
Buprenorphine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NORSPAN patches are available in seven strengths: 5 micrograms per
hour, 10 micrograms per
hour, 15 micrograms per hour, 20 micrograms per hour, 25 micrograms
per hour, 30
micr

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