Transdermal System
Fentanyl
Consumer Medicine Information
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WARNING
Limitations of use
DUROGESIC 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
DUROGESIC 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
DUROGESIC 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 DUROGESIC 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 DUROGESIC 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 DUROGESIC.
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What is in this leaflet
This leaflet answers some common questions about DUROGESIC 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
DUROGESIC against the benefits this medicine is expected to have for you.
If you have any concerns about using DUROGESIC, ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What DUROGESIC is used for
DUROGESIC 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. DUROGESIC is only used in
people who have previously been using other opioid-based pain relief. DUROGESIC is
not used to treat pain that you only have once in a while.
DUROGESIC patches contain 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 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.
Before you use DUROGESIC
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.
DUROGESIC may become habit-forming causing mental and physical dependence. If abused,
it may become less able to reduce pain.
DUROGESIC patches may be retrieved and abused or misused illegally. 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. A patch may be tempting
to a child. Accidental exposure or ingestion of used or unused DUROGESIC patches,
particularly in children, may result in breathing difficulties, with slow or shallow
breathing, that could lead to death. Improper use including DUROGESIC patches sticking
to another person can be life-threatening.
DUROGESIC can cause sleep apnoea (stopping breathing from time to time while sleeping)
which can lead to low levels of oxygen in the blood. Tell your doctor if you have
a history of sleep apnoea or if anyone notices you stop breathing from time to time
whilst sleeping.
Tolerance
As with all opioid analgesics, DUROGESIC may lead to tolerance with continued use.
Tolerance means that the effect of the medicine may decrease and more is needed to
produce the same effect. Therefore, it is possible your doctor will prescribe a higher
dose of DUROGESIC after some time to produce the same result.
Dependence and withdrawal
As with all other opioids, your body may become used to you taking DUROGESIC after
several days to weeks of continued use resulting in physical dependence. Physical
dependence means that you may experience withdrawal symptoms if you stop taking DUROGESIC
suddenly. Some examples of withdrawal symptoms include feeling uneasy and unwell,
restless, agitated, anxious, increased pain, sweating, chills, weakness, stomach cramps,
problems sleeping, nausea, vomiting, diarrhoea, increased blood pressure, fast breathing
and fast heartbeat.
DUROGESIC must be stopped by decreasing the dose gradually. Your doctor will tell
you how to do this, and will regularly monitor and support any increase in pain or
withdrawal symptoms.
Increased sensitivity to pain
Rarely, increasing the dose of this medicine can make you more sensitive to pain.
If this happens, you need to speak to your doctor about your treatment.
When you must not use it
Do not use DUROGESIC
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 any lung condition or breathing difficulties
if you have not used any opioid analgesics in the past. This is because you may be
more likely to experience some of the side effects.
Do not use DUROGESIC if the packaging is torn or shows signs of tampering. Do not
use DUROGESIC beyond the expiry date (month and year) printed on the pack.
Before you start to use it
You must tell your doctor if you
are pregnant or planning to become pregnant
are breast feeding or wish to breastfeed
have or have ever had problems with your liver or kidney
have or have ever had problems with your lungs or breathing difficulties
have sleep apnoea or if anyone notices you stop breathing from time to time while
sleeping
have or have ever had problems with your heart
have or have ever had a brain tumour or head injuries
have problems with your stomach or intestines such as bowel blockage
have problems with your immune system or medical conditions which lower your resistance
to diseases.
If you have not told your doctor or pharmacist about any of the above, tell them before
you start using or are given DUROGESIC.
Tell your doctor if you (or a family member) have ever abused or been dependent on
alcohol, prescription medicines, or illegal drugs or have a mental illness.
Your doctor will advise you whether or not to use DUROGESIC or if you need to adjust
the dose or adapt your treatment.
Children
DUROGESIC should not be used in children under 12 years of age or in adolescents under
18 years of age who weigh less than 50 kg.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines
you can buy without a prescription from a pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
medicines that slow down your central nervous system, for example:
medicines that makes you sleepy, reduce anxiety such as sedatives, hypnotics, sleeping
tablets, tranquillisers (benzodiazepines)
other opioid medicines
medicines used for surgery (anesthetics) and muscle relaxants
antihistamines or allergy medicine that makes you drowsy
gabapentinoid medicines used to treat epilepsy or nerve pain such as gabapentin and
pregabalin
alcohol, cannabis or some illegal drugs.
Taking these medicines with DUROGESIC may make you even more drowsy, slow down your
ability to react, have decrease awareness, breathing difficulties with slow or shallow
breathing, coma and death. A change in dose by your doctor may be required if DUROGESIC
is used with these medicines.
antidepressant medicines belonging to the class monoamine oxidase inhibitors (MAOIs).
DUROGESIC should not be used together with MAOIs as this may cause severe serotonin
syndrome which is a potentially life-threatening condition. Signs and symptoms can
include confusion, restlessness, fever, heavy sweating, fast or irregular heart rate,
diarrhoea, uncoordinated movement of limbs or eyes, uncontrollable jerking of muscles,
seizures and unconsciousness. Do not use DUROGESIC if you have taken an MAOI in the
last 14 days.
other antidepressant medicines belonging to the class selective serotonin re-uptake
inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic
antidepressants (TCAs) and nefazodone. Combination of these medicines with DUROGESIC
may increase the risk of serotonin syndrome.
medicines used to treat mental illness or psychotic conditions and to relieve severe
nausea and vomiting, such as phenothiazines.
certain antibiotics used to treat infections such as erythromycin, clarithromycin
and troleandomycin.
certain medicines to treat fungal infections such as fluconazole, ketoconazole, itraconazole
and voriconazole
ritonavir and nelfinavir (used to treat AIDS). Do not take ritonavir or nelfinavir
while using DUROGESIC, unless you are closely monitored by your doctor.
if taking rifampicin, carbamazepine, phenobarbital or phenytoin, careful monitoring
by your doctor and dose adjustment may be required.
Idelalisib (cancer treatment)
certain medicines that act on the heart and blood vessels such as calcium-channel
blockers like verapamil and diltiazem, nicardipine.
certain medicines used to treat arrhythmias such as amiodarone
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effect of alcohol
You must not drink alcohol while using DUROGESIC since their combined effect may cause
severe drowsiness, decreased awareness, breathing problems, coma and death.
Using DUROGESIC
How to use the patch
Adults
DUROGESIC is available in five different patches, each with a different size and strength.
Your doctor will decide which patch, or combination of patches, is suitable to control
your pain. The lowest effective strength should be used.
Using it for the first time
The first patch may take up to a day to take effect after it is applied onto the skin.
This is because fentanyl is slowly absorbed through the skin into the blood. Your
doctor may prescribe additional medicines to control the pain for the first day.
Using and changing the patches
Make a note of the day, date and time you apply a patch, to remind you when you need
to change your patch.
There is enough medicine in each patch to last 3 days (72 hours).
You should change your patch every third day, unless your doctor has told you differently.
If the patch comes off before 3 days, a new patch of the same strength should be applied
to a new spot of intact skin.
Always remove the old patch before applying a new one.
Always change your patch at the same time of day every 3 days (72 hours).
You should not use more than one patch at a time, unless your doctor authorises otherwise
(for example to obtain a dose that cannot be achieved with a single patch).
If you are using more than one patch, change all your patches at the same time.
The old patch should be removed before the new patch is applied.
Where to apply the patch
Apply the patch to non-irritated and non-irradiated skin on a flat surface of the
upper body or upper arms.
Do not apply the patch on:
the same place twice in a row
areas that you move a lot (joints)
skin that is red, burnt or damaged
hairy skin
Putting a patch on
Step 1: Preparing the skin
Hair at the application site (a hairless area is preferable) should be trimmed with
scissors (not shaved) prior to application. The skin should be healthy and undamaged.
Do not place the patch onto skin that is red, burnt or damaged.
If the site of DUROGESIC application needs to be cleaned before applying the patch,
this should be done with clear water. Do not use soaps, oils, or any other cleaners,
creams or moisturisers.
Make sure your skin is completely dry before the patch is applied. Do not stick a
patch on straight after a hot bath or shower. Patches should be inspected prior to
use.
Step 2: Open the pouch
DUROGESIC patch should be applied immediately upon removal from the sealed package.
To remove the patch from the protective pouch, locate the precut notch (indicated
by an arrow on the patch label) along the edge of the seal.
Fold the pouch at the notch, then carefully tear the pouch material.
Inspect the patch for any damage. Patches that are cut, divided, or damaged in any
way should not be used.
Further open the pouch along both sides, folding the pouch open like a book.
The clear plastic protective (release) liner for the patch is slit.
Fold the patch in the middle and remove each half of the liner separately.
Step 3: Peel and press
Avoid touching the adhesive side of the patch.
Apply the patch to the skin by applying light pressure with the palm of the hand for
about 30 seconds.
Make sure the entire patch is in contact with skin, the corners and the edges of the
patch are adhering properly.
Then wash hands with clean water.
Step 4: Disposing of the patch
As soon as you take a patch off, fold it firmly in half so that the sticky side sticks
to itself.
Put it back in its original sachet and dispose of the sachet as instructed by your
pharmacist.
Unused patches should be returned to the pharmacy.
Keep used patches out of sight and reach of children – even used patches contain some
medicine which may harm children and may even be fatal.
Step 5: Wash
Always wash your hands after you have handled the patch using clean water only.
If you do not understand the instructions provided with this medicine, ask your doctor
or pharmacist for help.
Children
DUROGESIC should not be used in children under 12 years of age or in adolescents under
18 years of age who weigh less than 50 kg.
If you forget to use it
If you forget to apply a patch, and are not sure what to do, check with your doctor
or pharmacist.
If you have trouble remembering when to apply each patch, ask your pharmacist for
some hints.
If you receive too much (overdose)
Immediately remove the patch(es) and phone triple zero (000) for an ambulance. Keep
the person awake by talking to them or gently shaking them every now and then.
Also, phone the Poisons Information Centre for advice, or go to the Emergency Department
at your nearest hospital if you think you or anyone else may have used too much DUROGESIC.
Do this even if there are no signs of discomfort or poisoning. The person may need
urgent medical attention.
Poisons Information Centre telephone number:
Australia: 13 11 26
Keep this telephone number handy.
You should also follow the above steps if someone other than you have accidentally
used DUROGESIC that was prescribed for you. If someone takes an overdose they may
experience one or more of the following symptoms:
Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heart beat
Nausea or vomiting
Convulsions or fits
When seeking medical attention, take this leaflet and remaining medicine with you
to show the doctor. Also tell them about any other medicines or alcohol which have
been taken.
While you are using DUROGESIC
Things you must do
Always follow your doctor's instructions carefully.
If you are pregnant or plan to become pregnant, you should inform your doctor, who
will decide whether you may use DUROGESIC. DUROGESIC should not be used during childbirth
as the medicine can slow the breathing of the newborn child. Prolonged use of DUROGESIC
during pregnancy can cause withdrawal symptoms in your newborn baby that could be
life-threatening if not recognized and treated. If you are breast feeding, you should
not use DUROGESIC since it may be present in your milk. See your doctor.
If your pain continues or returns, see your doctor. You may need additional medicines
to control the pain or a change in the strength of the DUROGESIC patch.
Tell your doctor if you develop a fever. At high temperatures, the amount of fentanyl
absorbed by the skin increases. Your doctor may need to adjust your DUROGESIC dose
If you are about to start taking a new medicine, tell your doctor and pharmacist that
you are using DUROGESIC.
Things you must not do
DO NOT expose the patch to direct heat from electric blankets, heat pads, heated water
beds, heat or tanning lamps, intensive sunbathing, hot water bottles, long hot baths,
saunas or hot spa baths while you are using DUROGESIC. Direct exposure to such heat
may cause an increase in the amount of fentanyl absorbed by the skin, resulting in
possible overdose and death.
Do not give the patches to anyone else, even if their symptoms seem similar to yours
as they could die from taking it.
Do not stop using DUROGESIC unless your doctor advises you to do so. If you have been
using DUROGESIC for a long period of time but stop using it suddenly without your
doctor's advice, you may experience withdrawal symptoms such as:
trouble sleeping, nervousness, restlessness, agitation or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
Seek your doctor's advice if you experience these symptoms.
Do not cut, break, chew, crush, dissolve, snort or inject DUROGESIC.
This can result in serious side effects and death.
Things to be careful of
If the patch accidentally sticks to another person (for example a family member sharing
the same bed) or is accidentally swallowed (for example by a child), remove the patch
and phone triple zero (000). Do this even if there are no signs of discomfort or drowsiness.
DUROGESIC can affect your alertness and ability to drive and operate machinery. Do
not drive or operate machinery until you know how this medicine affects you.
Different brands of fentanyl patches may vary in size, shape, colour or adhesiveness.
DO NOT switch brands of fentanyl patches unless your doctor and pharmacist authorise
it.
Side Effects
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some side effects. Do not
be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
nausea, vomiting, constipation, dry mouth, diarrhoea, uncomfortable feeling in stomach
or belching after eating, indigestion, blockage in the bowel.
low blood pressure, headache, weakness or dizziness, high blood pressure, being less
alert or aware, or loss of consciousness.
blurred vision
sleepiness, confusion, hallucinations, euphoria, depression, loss of appetite, anxiety,
trouble sleeping, agitation, loss of memory, pins and needles.
stopping breathing from time to time whilst sleeping (sleep apnoea)
skin rash (local redness and itch at the site of the patch is usually mild and resolves
when the patch is removed).
thinning or redness where the patch has been on the skin; ulcer (sore) where the patch
has been on the skin
unusual tiredness or weakness, feeling of body temperature change; swelling of the
feet, ankles and hands.
Tell your doctor immediately if you notice any of the following as you may need urgent
medical care:
slow heartbeat.
fast heartbeat.
REMOVE the DUROGESIC patch and phone triple zero (000) or go to the Emergency Department
at your nearest hospital if the following happens:
breathing slows or weakens.
temporarily stopped breathing;
difficulty in breathing.
numbness; seizures or fits.
involuntary muscle movements including muscle spasms
sweating or trouble urinating
sudden life-threatening allergic reaction.
sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
breathing.
Make sure that you are with someone who can keep you awake by talking to you or gently
shaking you every now and then. The risk of breathing problems is higher if you:
have an existing lung condition
have a small physique
are an elderly patient
have kidney or liver disease
are given a high DUROGESIC dose
you have not used opioid pain relief before.
Your doctor will carefully select the most appropriate dose for you.
Nausea, vomiting, diarrhoea, anxiety and shivering may occur initially when you are
switched from other opioid analgesics to DUROGESIC or if therapy is stopped suddenly.
Tell your doctor if you experience any of these effects.
Other side effects not listed above such as sexual dysfunction and withdrawal symptoms
may also occur in some people. Tell your doctor if you notice any other effects.
After using DUROGESIC
Storage
Keep DUROGESIC patches in the sealed pouch until it is time to apply them.
Keep the patches in a dry place where temperature stays below 30°C.
Store this medicine securely, where other people cannot access it. It may harm people
who may take this medicine by accident, or intentionally when it has not been prescribed
for them.
Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half
metres (1.5 m) above the ground is a good place to store medicines.
Do not store DUROGESIC patches or any other medicine, in the bathroom or near a sink.
Do not leave medicines in the car or on window sills. Heat and dampness can destroy
some medicines.
Disposal
The contents of DUROGESIC patches may be retrieved and abused or misused illegally.
Fold used patches so that the adhesive side of the patch sticks to itself, then wrap
and dispose of it carefully.
If your doctor tells you to stop using DUROGESIC, or the patches have passed their
expiry date, return the patches to your pharmacist.
Product Description
What it looks like
DUROGESIC 12 micrograms/hour patches are rectangular shape with rounded corners, translucent
system with printed border and "Durogesic 12 mcg fentanyl/h" in orange ink.
DUROGESIC 25 micrograms/hour patches are rectangular shape with rounded corners, translucent
system with printed border and "Durogesic 25 mcg fentanyl/h" in red ink.
DUROGESIC 50 micrograms/hour patches are rectangular shape with rounded corners, translucent
system with printed border and "Durogesic 50 mcg fentanyl/h" in green ink.
DUROGESIC 75 micrograms/hour patches are rectangular shape with rounded corners, translucent
system with printed border and "Durogesic 75 mcg fentanyl/h" in blue ink.
DUROGESIC 100 micrograms/hour patches are rectangular shape with rounded corners,
translucent system with printed border and "Durogesic 100 mcg fentanyl/h" in grey
ink.
Each pack contains 5 patches.
They are available in five sizes. The number after the name DUROGESIC refers to the
amount of fentanyl in micrograms (one thousandth of a milligram) released by the patch
per hour.
DUROGESIC 12 micrograms/hour (AUST R 116828)
DUROGESIC 25 micrograms/hour (AUST R 112368)
DUROGESIC 50 micrograms/hour (AUST R 112369)
DUROGESIC 75 micrograms/hour (AUST R 112370)
DUROGESIC 100 micrograms/hour (AUST R 112371)
Ingredients
The patches contain the active ingredient fentanyl.
The patch is made of polyethylene terephalate, ethylene/VA copolymer and polyacrylate
adhesive Duro-Tak 87-4287.
Sponsor
Janssen-Cilag Pty Ltd
1-5 Khartoum Road
Macquarie Park NSW 2113 Australia
Telephone: 1800 226 334
This leaflet was prepared in February 2020.