contains the active ingredient fentanyl
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about DENPAX. It does not contain all the available information. It does not
take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking DENPAX against the benefits they expect
it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What DENPAX is used for
DENPAX is used to relieve chronic or long-lasting pain, which requires strong painkillers.
DENPAX transdermal 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 recognize pain messages from the body.
Each transdermal patch is applied onto the skin every 72 hours (3 days). The transdermal patch releases a continuous amount
of fentanyl that is absorbed through the skin in contact with the transdermal patch.
Your doctor may have prescribed DENPAX for another reason. Ask your doctor if you have any questions about why this medicine
has been prescribed for you.
DENPAX transdermal patches may be retrieved and abused by addicts. Please ensure that used transdermal patches are concealed
and disposed of carefully. Return unused transdermal patches to the pharmacy (see Disposal at the end of this leaflet).
Keep used and unused transdermal patches where children cannot reach them.
Before you use DENPAX
When you must not use it
You should not use DENPAX 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
for acute pain or pain following surgery.
for mild or intermittent pain.
other than 12 micrograms/hour transdermal patch if you have never had opioid analgesics for pain relief.
Do not use DENPAX if the packaging is torn or shows signs of tampering. Do not use DENPAX beyond the expiry date (month and
year) printed on the pack.
Before you start to take it
You must tell your doctor if you:
are pregnant or planning to become pregnant.
are breast feeding or wish to breast feed.
have or have ever had liver or kidney disease.
have or have ever had lung disease.
have or have ever had heart disorders.
have or have ever had brain lesions or head injuries.
have medical conditions which lower your resistance to diseases.
You must tell your doctor if you have not used any opioid analgesics in the past, unless you are being treated for cancer
pain. This is because you may be more likely to experience some of the side effects.
If you have not told your doctor or pharmacist about any of the above tell them before your start using or are given DENPAX.
Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines or illegal
Your doctor will advise you whether or not to use DENPAX or if you need to adjust the dose or adapt your treatment.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from
your pharmacy, supermarket or health food store.
In particular, tell your doctor or pharmacist if you are taking any of the following:
other strong analgesics used to manage pain such as morphine, codeine, methadone, oxycodone, pethidine or buprenorphine.
ritonavir or nelfinavir (used to treat AIDS). Do not take ritonavir or nelfinavir while using DENPAX, unless you are closely
monitored by a doctor.
antidepressant medicines belonging to the class monoamine oxidase inhibitors (MAOIs), selective serotonin re-uptake inhibitors
(SSRIs), or serotonin norepinephrine re-uptake inhibitors (SNRIs) including moclobemide, phenelzine sulfate and tranylcypromine
sulfate. Combination of these medicines with DENPAX may increase the risk of serotonin syndrome, a potentially life-threatening
certain medicines to treat depression such as nefazodone.
medicines used as sedatives, sleeping tablets, tranquillisers or muscle relaxants.
medicines used to treat mental illness or psychotic conditions and to relieve severe nausea and vomiting.
certain antibiotics used to treat infections such as clarithromycin and troleandomycin.
certain medicines to treat fungal infections such as ketoconazole and itraconazole.
medicines used as antihistamines that are sedating.
certain medicines that act on the heart and blood vessels such as calcium-channel blockers like verapamil and diltiazem.
certain medicines used to treat arrhythmias such as amiodarone.
DENPAX can increase the effect of drugs that are sedating or slow down your ability to react. A change in dose may be required
if DENPAX is used with these medicines.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effect on driving and operating machinery
DENPAX can affect your alertness and ability to drive and operate machinery. Do not drive or operate machinery until your
doctor says it is safe.
Effect of alcohol
Avoid alcohol when using DENPAX since their combined effects may cause drowsiness.
As with all opioid analgesics, DENPAX may lead to tolerance with continued use. Your doctor may, therefore, prescribe a higher
dose of DENPAX after some time to continue to give you pain relief.
How much to use
DENPAX is available in five different sizes. Your doctor will decide which transdermal patch, or combination of transdermal
patches, is suitable to control your pain.
Each transdermal patch is applied onto the skin and lasts for three days (72 hours).
After three days, remove the transdermal patch and apply a new transdermal patch to the skin at a different place.
You should not use more than one transdermal patch at a time, unless your doctor authorizes otherwise (for example to obtain
a dose that cannot be achieved with a single transdermal patch). The old transdermal patch should be removed before the new
transdermal patch is applied.
DENPAX should not be used in children under 12 years of age or in adolescents under 18 years of age who weigh less than 50
Using it for the first time
The first transdermal 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.
Applying the transdermal patch
1.Find an intact and hairless spot of skin on the upper part of your body or on your upper arm. This skin should be healthy
and undamaged. Do not place the transdermal patch onto skin that is red, burnt or damaged. Do not stick a patch on straight
after a hot bath or shower.
2.Trim any excess hair with scissors. Do not shave the hair off since this may affect the skin. If you need to wash the skin
before applying the transdermal patch, use clean cold water only. Do not use soap, oils or lotions. The skin should be completely
dry and cool before applying the transdermal patch.
3.To open the pouch, locate the pre-cut notch indicated by the scissors. Make a small cut and fold at the notch. Carefully tear
the pouch along the edge and then fully open the pouch by folding it open like a book.
4.Remove the DENPAX transdermal patch from the sealed pouch.
Do not apply the transdermal patch if it looks damaged in any way. Never cut or divide the transdermal patch. Do not use a
transdermal patch that has been divided, cut, or damaged in any way.
5.Each DENPAX transdermal patch has a clear plastic protective (release) liner that can be peeled off in two pieces. After folding
the transdermal patch in the middle, peel off each part of the protective liner separately.
Avoid touching the adhesive side of the transdermal patch.
6.Apply the transdermal patch to the skin and press with the palm of the hand for about 30 seconds. Make sure all of the transdermal
patch is in contact with skin and the corners are stuck tightly.
7.Wash hands after applying or removing the transdermal patch.
You can now leave the transdermal patch on for three days (72 hours). You may have a bath, shower or swim.
If you do have a shower or bath whilst wearing your patch be careful that the water is not too hot and do not soak in a hot
bath for a long time.
Always write the date and time you applied the transdermal patch on the pack. It will help you to use DENPAX correctly and
remember when the next transdermal patch is due.
Your doctor may prescribe additional pain relievers to control occasional outbreaks of pain.
Changing the transdermal patch
1.After three days (72 hours), remove the transdermal patch.
2.Fold the used transdermal patch in half so that the adhesive side sticks to itself. Wrap the folded transdermal patch and
carefully dispose of it in the garbage.
3.Apply a new transdermal patch straight away to a different area of the skin, following the steps under "Using DENPAX - Applying
the transdermal patch."
If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.
If your pain continues, see your doctor who may prescribe additional medicines to help control the pain or change the dose
of DENPAX. Your doctor may advise you initially to change the patch every 48 hours instead of every 72 hours to achieve adequate
If you forget to use it
If you forget to apply a transdermal patch, and are not sure what to do, check with your doctor or pharmacist.
If you have trouble remembering when to apply each transdermal patch, ask your pharmacist for some hints.
If you receive too much (overdose)
The most important sign of overdose is difficulty in breathing. If a person using DENPAX has abnormally slow or weak breathing,
remove the transdermal patch. Keep the person awake by talking to them or gently shaking them every now and then.
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and
Emergency at the nearest hospital, if you think you or anyone else may have taken too much DENPAX. Do this even if there are
no signs of discomfort or poisoning.
You or the person may need urgent medical attention.
Keep the number of these facilities handy.
Information for the doctor in case of overdose: inject with naloxone and transfer patient to hospital.
Please refer to full Product Information for details on appropriate management of overdose.
While you are using DENPAX
Things you must do
Always follow your doctor's instructions carefully.
Tell your doctor if you become pregnant while using DENPAX.
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 DENPAX transdermal 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 DENPAX dose.
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are using DENPAX.
Things you must not do
Do not expose the transdermal 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 DENPAX. Direct exposure
to such heat may cause an increase in the amount of fentanyl absorbed by the skin, resulting in possible overdose and death.
Whilst wearing your patch you can go outside in the sun but you must cover the patch with clothing on hot sunny days.
Do not use DENPAX to treat any other complaint unless your doctor says so.
Do not give the transdermal patches to anyone else, even if their symptoms seem similar to yours.
Do not stop using DENPAX unless your doctor advises you to do so. If you have been using DENPAX for a long period of time
but stop using it suddenly without your doctor's advice, you may experience withdrawal symptoms (such as nausea, vomiting,
diarrhoea, anxiety and shivering). Seek your doctor's advice if you experience these symptoms.
Things to be careful of
If the transdermal patch accidently adheres to another person (for example, family member sharing the same bed), remove the
transdermal patch and contact your doctor. Do this even if there are no signs of discomfort or drowsiness.
Check with your doctor or pharmacist before switching brands.
Different brands of fentanyl transdermal patches may vary in size, shape, colour or adhesiveness.
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 of the side effects. Do not be alarmed by this list of possible side effects. You may not experience any of
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
nausea, vomiting, constipation, dry mouth, diarrhoea, uncomfortable feeling in the stomach or belching after eating, indigestion,
blockage in the bowel.
low blood pressure, headache, weakness or dizziness, high blood pressure, any changes to your level of consciousness.
sleepiness, confusion, hallucinations, euphoria, depression, loss of appetite, anxiety, trouble sleeping, agitation, loss
of memory, pins and needles.
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.
skin rash (local redness and itch at the site of the transdermal patch is usually mild and resolves when the transdermal patch
unusual tiredness or weakness, feeling of body temperature change.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
slow heart beat
fast heart beat.
REMOVE the DENPAX transdermal patch and tell your doctor immediately or go to the Emergency Department at your nearest hospital
if the following happens:
breathing slows or weakens
temporarily stopped breathing
difficulty in 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.
Nausea, vomiting, diarrhoea, anxiety and shivering may occur initially when you are switched from other opioid analgesics
to DENPAX or if therapy is stopped suddenly. Tell your doctor if you experience any of these effects.
Medicines like DENPAX can lead to addiction. This is unlikely when DENPAX is used correctly.
Other side effects not listed above, sexual dysfunction and withdrawal symptoms may also occur in some people. Tell your doctor
if you notice any other effects.
After using DENPAX
Keep DENPAX transdermal patches in the sealed pouch until it is time to apply them.
Keep DENPAX transdermal patches where young 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.
Keep the transdermal patches in a dry place where the temperature stays below 25°C.
Do not store DENPAX transdermal 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.
The contents of DENPAX transdermal patches may be retrieved and abused by addicts.
Fold used transdermal patches so that the adhesive side of the transdermal patch sticks to itself, wrap and dispose of carefully
in the garbage.
If your doctor tells you to stop using DENPAX or your transdermal patches have passed their expiry date, return the transdermal
patches to your pharmacist.
What it looks like
DENPAX transdermal patches are rectangular, transparent transdermal patches imprinted with
"Fentanyl 12 mcg/hr" in white for the 12 micrograms/hour strength.
"Fentanyl 25 mcg/hr" in white for the 25 micrograms/hour strength.
"Fentanyl 50 mcg/hr" in white for the 50 micrograms/hour strength.
"Fentanyl 75 mcg/hr" in white for the 75 micrograms/hour strength.
"Fentanyl 100 mcg/hr" in white for the 100 micrograms/hour strength.
Each pack contains five (5) transdermal patches.
They are available in five (5) sizes. The number beneath the name DENPAX refers to the amount of fentanyl in micrograms (one
thousandth of a milligram) released by the transdermal patch per hour.
The transdermal patches contain the active ingredient fentanyl.
The transdermal patch is made of a silicon adhesive, dimethicone 360, polyolefin film, white ink and a fluorocarbon-coated
polyester release liner.
DENPAX is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian registration numbers:
DENPAX fentanyl transdermal patch 12 micrograms/hour
(AUST R 163066)
DENPAX fentanyl transdermal patch 25 micrograms/hour
(AUST R 163068)
DENPAX fentanyl transdermal patch 50 micrograms/hour
(AUST R 163064)
DENPAX fentanyl transdermal patch 75 micrograms/hour
(AUST R 163065)
DENPAX fentanyl transdermal patch 100 micrograms/hour
(AUST R 163067)
This leaflet was prepared on
16 September 2016.