DUTRAN 75 fentanyl 75 mcg/hr transdermal patch pouch

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl, Quantity: 12.375 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Fentanyl

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: titanium dioxide; polypropylene; polyethylene terephthalate; ethyl acetate; 2-ethylhexyl acrylate/2-hydroxyethyl acrylate/methyl acrylate copolymer; hexane

Administration route:

Transdermal

Units in package:

5 patches

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

For the management of pain associated with cancer, palliative care, 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-na?ve patients.

Product summary:

Visual Identification: Rectangular, round cornered, transparent and colourless patch with 22.5 cm2 active surface area contained in a protective pouch made from composite foil.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-08-28

Patient Information leaflet

DUTRAN CMI 050315
Page
1 of 5
DUTRAN TRANSDERMAL DRUG DELIVERY SYSTEM
_ contains the active ingredient fentanyl _
_ _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DUTRAN. 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 DUTRAN
against the benefits this medicine
is expected to have for you.
If you have any concerns about
using DUTRAN, ask your doctor
or pharmacist.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT DUTRAN IS USED
FOR
DUTRAN is used to relieve chronic
or long-lasting pain, which
requires strong painkillers.
DUTRAN contains a medicine
called 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 onto the skin
every 72 hours (3 days). The patch
releases a continuous amount of
fentanyl that is absorbed through
the skin in contact with the patch.
Your doctor may have prescribed
DUTRAN for another reason. Ask
your doctor if you have any
questions about why this medicine
has been prescribed for you.
_Warning _
_ _
DUTRAN PATCHES MAY BE
RETRIEVED AND ABUSED BY ADDICTS.
PLEASE ENSURE THAT USED PATCHES
ARE CONCEALED AND DISPOSED OF
CAREFULLY. RETURN UNUSED PATCHES
TO THE PHARMACY (SEE DISPOSAL AT
THE END OF THIS LEAFLET).
KEEP USED AND UNUSED PATCHES
WHERE CHILDREN CANNOT REACH
THEM.
BEFORE YOU USE DUTRAN
_When you must not use it _
_ _
Do not use DUTRAN
•
if you have an allergy to
fentanyl or any of the
ingredients. See Product
Description at the end of this
leaflet for a list of ingredients.
•
for acute pain or pain following
surgery
•
for mild or intermittent pain
•
at a starting dose greater than
25 micrograms/hour if you
have never had opioid
analgesics for pain relief.
Do not use DUTRAN if the
packaging is

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - DUTRAN
TM (FENTANYL)
TRANSDERMAL DRUG DELIVERY SYSTEM
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Dutran 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 _
Dutran 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 Dutran. 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 taking Dutran.
1.
NAME OF THE MEDICINE
Fentanyl
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dutran is available in five different strengths delivering fentanyl
12, 25, 50, 75 or 100
microgram/hour to the systemic circulation.
DUTRAN 12
– Each transdermal patch with 3.75 cm
2
active surface area contains 2.063 mg
fentanyl with a rele