BUPRENORPHINE SANDOZ buprenorphine 20 micrograms/hour transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

buprenorphine, Quantity: 20 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Buprenorphine

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: povidone; oleyl oleate; polyethylene; levulinic acid; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; butyl acrylate; acrylic acid; 2,2'-azobisisobutyronitrile; aluminium acetylacetonate; heptane; acrylates copolymer; ethylene distearamide; adipic acid/1,4-butanediol/MDI copolymer; pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate

Administration route:

Transdermal

Units in package:

2, 1, 4

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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

Product summary:

Visual Identification: Rectangular transdermal patch with rounded edges having transparent release liner on bottom side and pale yellowish-brown adhesive foil imprinted (in black ink) with "Buprenorphinum 20 micrograms/h" on upper side; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-06-16

Patient Information leaflet

Buprenorphine Sandoz®
1
BUPRENORPHINE SANDOZ® 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 BUPRENORPHINE SANDOZ?
Buprenorphine Sandoz Transdermal Drug Delivery System (“patches”)
contains the active ingredient buprenorphine.
Buprenorphine Sandoz 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 Buprenorphine
Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BUPRENORPHINE SANDOZ?
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
Buprenorphine Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Buprenorphine Sandoz 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 BUPRENORPHINE SANDOZ?
•
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
Buprenorphine Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BUPRENORPHINE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using
Buprenorphine Sandoz.
•
Tell your doctor or pharmacist if you are taking any other medicines
that you use to h

Summary of Product characteristics

210329-Buprenorphine Sandoz-pi
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION
BUPRENORPHINE SANDOZ (BUPRENORPHINE BASE) TRANSDERMAL
DRUG DELIVERY SYSTEM
1.
NAME OF THE MEDICINE
Buprenorphine base
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buprenorphine Sandoz is a buprenorphine matrix transdermal drug
delivery system (patch) and
is 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
micrograms per hour and 40
micrograms per hour. The composition of all seven strengths is
identical except for patch size.
The proportion of buprenorphine in the adhesive matrix is the same in
each strength. The
amount of buprenorphine released from each system per hour is
proportional to the surface area
of the patch. The skin is the limiting barrier to diffusion from the
system into the bloodstream.
_Buprenorphine Sandoz 5 micrograms/h _
WARNINGS
_LIMITATIONS OF USE_
Because of the risks associated with the use of opioids, Buprenorphine
Sandoz 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 Sandoz poses 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
Sandoz.
Be
aware
of
situations
which
increase
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