B-PATCH buprenorphine 5 microgram/hour transdermal drug delivery system pouches

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine, Quantity: 5 mg

Available from:

AU Pharma Pty Ltd

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

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

Administration route:

Transdermal

Units in package:

2 patches

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

B-PATCH 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.,B-PATCH patches are not indicated for use in chronic non-cancer pain other than in exceptional circumstances. B-PATCH patches are not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Round edged rectangular patch, beige coloured backing web with active ingredient name & strength & transparent adhesive matrix with central matrix & release liner.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2021-11-11

Patient Information leaflet

_Consumer Medicine Information _
_ _
_AU Pharma Pty Ltd _
B-PATCH Patch
1
B-PATCH
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 B-PATCH PATCHES?
B-PATCH Transdermal Drug Delivery System ("patches") contain the
active ingredient buprenorphine. B-PATCH 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 B-PATCH patches?
in the full CMI.
2. WHAT SHOULD I KNOW BEFORE I USE B-PATCH 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
B-PATCH patches? in the full CMI.
3. WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with B-PATCH 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 B-PATCH 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 B-PATCH
patches? in the full CMI.
5. WHAT SHOULD I KNOW WHILE USING B-PATCH PATCHES?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using B-PATCH
patches.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to help
you relax, anything that contains alco

Summary of Product characteristics

Page | 1
AUSTRALIAN PRODUCT INFORMATION B-PATCH
(BUPRENORPHINE) TRANSDERMAL DRUG DELIVERY
SYSTEM (PATCH) (5, 10, 15 AND 20 MICROGRAMS PER HOUR)
1 NAME OF THE MEDICINE
Buprenorphine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
B-PATCH patch 5 micrograms/hr
Each square patch releases buprenorphine 5 micrograms per hour.
The area containing the active substance: 6.25 cm
2
Total buprenorphine content: 5 mg
B-PATCH patch 10 micrograms/hr
Each rectangular patch releases buprenorphine 10 micrograms per hour.
The area containing the active substance: 12.5 cm
2
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, buprenorphine
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
Buprenorphine 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
buprenorphine
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 t