FENTANYL SANDOZ fentanyl 50 micrograms/hour transdermal drug delivery system sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl, Quantity: 8.4 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:

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

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 50 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:

Registered

Authorization date:

2009-12-22

Patient Information leaflet

Fentanyl Sandoz
®
1
FENTANYL SANDOZ
®
_fentanyl transdermal patches _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Fentanyl Sandoz.
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 taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FENTANYL
SANDOZ IS USED
FOR
Fentanyl Sandoz 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.
Fentanyl Sandoz is only used in
people who have previously been
using other opioid-based pain relief.
Fentanyl Sandoz is not used to treat
pain that you only have once in a
while.
It contains the active ingredient
fentanyl. Fentanyl belongs to a group
of medicines called opioid
analgesics.
It works by blocking the nerves that
recognise pain messages from the
body.
Each patch is applied onto 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine may be addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
FENTANYL SANDOZ
_WARNING _
Opioids can be abused and misused,
and you are at risk for opioid
addiction, even if you take your dose
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.
HAZARDOUS AND HARMFUL USE
Fen

Summary of Product characteristics

200910-Fentanyl Sandoz-pi
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
FENTANYL SANDOZ
® (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.
Fentanyl Sandoz 12 µg/h transdermal patch – surface area of 5.25 cm
2
Fentanyl Sandoz 25 µg/h transdermal patch – surface area of 10.5 cm
2
Fentanyl Sandoz 37 µg/h transdermal patch* – surface area of 15.75
cm
2
Fentanyl Sandoz 50 µg/h transdermal patch – surface area of 21 cm
2
Fentanyl Sandoz 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, Fentanyl
Sandoz 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 _
Fentanyl 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 Fentanyl
Sandoz. 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 u