APO-FENTANYL fentanyl 12 micrograms/hour transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl, Quantity: 2.1 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Fentanyl

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate; vinyl acetate; 2,2'-azobisisobutyronitrile; 2-hydroxyethyl acrylate

Administration route:

Transdermal

Units in package:

10, 2, 5, 8, 4, 7, 1, 3

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

For the management of pain associated with cancer, palliative cancer and other conditions in patients 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 - severe enough to require daily, continuous long term opioid treatment. Not for use in opioid-naive patients.

Product summary:

Visual Identification: Dull, homogenous, rectangular transdermal drug delivery system on release liner, imprint on backing foil 'fentanyl 12 microgram/h'; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-12-22

Patient Information leaflet

APO-Fentanyl
1
APO-FENTANYL
_fentanyl transdermal patches _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about APO-Fentanyl
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 APO-Fentanyl
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING APO-FENTANYL, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT APO-
FENTANYL IS USED
FOR
APO-Fentanyl is used for the long-
term management of pain that is
severe enough to require daily
around-the-clock pain relievers,
when other treatment options are not
able to effectively manage your pain
or you cannot tolerate them.
APO-Fentanyl is only used in people
who have previously been using
other opioid-based pain relief. APO-
Fentanyl is not used to treat pain that
you only have once in a while.
APO-Fentanyl patches contains a
medicine call fentanyl. This strong
pain reliever belongs to a group of
medicines known as opioid
analgesics. Fentanyl relieves pain by
blocking the nerves that recognise
pain messages from the body.
Each patch is applied on the skin
every three days (72 hours). The
patch releases a continuous amount
of fentanyl that is absorbed through
the skin in contact with the patch.
Your doctor may have prescribed
APO-Fentanyl for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
APO-FENTANYL
_WARNING _
Opioids can be abused and misused,
and you are at risk for opioid
addiction, even if you take your dose
as prescribed. Opioid addiction,
abuse and misuse can lead to
overdose and death.
WARNING
LIMITATIONS OF USE
Fentanyl Sandoz should only be used when your doctor decides that
other treatment options are not able to effectively
manage your pain or you cannot tolerate them.
HA

Summary of Product characteristics

200910-APO-Fentanyl-pi
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
APO-FENTANYL (FENTANYL) TRANSDERMAL DRUG DELIVERY
SYSTEM
1
NAME OF THE MEDICINE
Fentanyl
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
It is available in six different strengths delivering fentanyl 12, 25,
37, 50, 75 or 100
micrograms/hour to the systemic circulation. The amount of fentanyl
released from each patch
per hour is proportional to the surface area. The composition per unit
area of all patches is
identical.
APO-Fentanyl 12 µg/h transdermal patch – surface area of 5.25 cm
2
APO-Fentanyl 25 µg/h transdermal patch – surface area of 10.5 cm
2
APO-Fentanyl 37 µg/h transdermal patch* – surface area of 15.75 cm
2
APO-Fentanyl 50 µg/h transdermal patch – surface area of 21 cm
2
APO-Fentanyl 75 µg/h transdermal patch – surface area of 31.5 cm
2
WARNINGS
_LIMITATION OF USE _
Because of the risks associated with the use of opioids, APO-Fentanyl
should only be used
in
patients
for
whom
other
treatment
options,
including
non-opioid
analgesics,
are
ineffective, not tolerated or otherwise adequate to provide
appropriate management of pain
(see Section 4.4 Special warnings and precautions for use).
_HAZARDOUS AND HARMFUL USE _
APO-Fentanyl 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 APO-
Fentanyl. 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