FENPATCH 25 fentanyl 25 mcg/hr transdermal patch pouch

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fentanyl, Quantity: 4.125 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Fentanyl

Pharmaceutical form:

Drug delivery system, transdermal

Composition:

Excipient Ingredients: polyethylene terephthalate; titanium dioxide; polypropylene; 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: Fenpatch 25 is a rectangular, round cornered, transparent and colourless patch with 7.5 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:

Registered

Authorization date:

2009-07-07

Patient Information leaflet

________________________________________________________________________________
Fenpatch CMI 110520
Page 1 of 6
FENPATCH® TRANSDERMAL DRUG DELIVERY SYSTEM
_ _
_contains the active ingredient fentanyl _
CONSUMER MEDICINE INFORMATION
_ _
WARNING
LIMITATIONS OF USE
FENPATCH 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
FENPATCH poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will
monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
FENPATCH can cause life-threatening or fatal breathing difficulties
(slow, shallow, unusual or no breathing) even
when used as recommended. These problems can occur at any time during
use but the risk is higher when first
starting FENPATCH and after a dose increase, if you are older, or have
an existing problem with your lungs. Your
doctor will monitor you and change the dose as appropriate.
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING ALCOHOL
Using FENPATCH with other medicines that can make you feel drowsy such
as sleeping tablets (e.g.
benzodiazepines), other pain relievers, antihistamines,
antidepressants, antipsychotics, gabapentinoids (e.g.
gabapentin and pregabalin), cannabis and alcohol may result in severe
drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will minimise the dose
and duration of use; and monitor you
for signs and symptoms of breathing difficulties and sedation. You
must not drink alcohol while using FENPATCH.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FENPATCH. 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 FENPATCH
against the benefits this medicine
is expected to have for you.
If you have any concer

Summary of Product characteristics

Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION - FENPATCH
® (FENTANYL)
TRANSDERMAL DRUG DELIVERY SYSTEM
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Fenpatch
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 _
Fenpatch 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 Fenpatch.
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 Fenpatch.
1.
NAME OF THE MEDICINE
Fentanyl
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fenpatch is available in five different strengths delivering 12, 25,
50, 75 or 100
microgram/hour of fentanyl to the systemic circulation.
FENPATCH 12
– Each transdermal patch with 3.75 cm
2
active surface area contains