Denpax

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Transdermal System

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 risks and benefits. 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 recognise pain messages from the body.
Each transdermal patch is applied onto the skin every three days (72 hours). The transdermal 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 DENPAX for another reason.

Warning

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 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 DENPAX after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
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 you 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 drugs.
Your doctor will advise you whether to use DENPAX or if you need to adjust the dose or adapt your treatment.
Children
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 kg.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor or pharmacist if you are taking any of the following:
other strong analgesics used to manage pain such as opioids and general anaesthetics
ritonavir or nelfinavir (used to treat AIDS). Do not take ritonavir or nelfinavir while using DENPAX, unless you are closely monitored by your doctor
rifampicin, carbamazepine, phenobarbital or phenytoin, careful monitoring by your doctor and dose adjustment may be required
antidepressant medicines belonging to the class monoamine oxidase inhibitors (MAOIs), selective serotonin re-uptake inhibitors (SSRIs) or serotonin norepinephrine re-uptake inhibitors (SNRIs). DENPAX should not be used in combination with these medicines. DENPAX should be initiated 14 days after stopping treatment with MAOIs. Combination of these medicines with DENPAX may increase the risk of serotonin syndrome, a potentially life-threatening condition
certain medicines to treat depression such as nefazodone
medicines that slow down your central nervous system (for example medicines that make you sleepy, reduce anxiety or decrease awareness, such as sedatives, hypnotics, sleeping tablets, tranquillisers, strong pain killers (opioids), medicines used for surgery (anaesthetics), muscle relaxants, allergy medicine that makes you drowsy, alcohol or some illegal drugs) Combination of these medicines with DENPAX may increase the sedative effect of these drugs or slow down your ability to react, breathing difficulties with slow or shallow breathing, coma and death. A change in dose by your doctor may be required if DENPAX is used with these medicines
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 clarithromycin and troleandomycin
certain medicines used to treat fungal infections such as ketoconazole and itraconazole
sedating antihistamines
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
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Effect of alcohol
Avoid alcohol when using DENPAX since their combined effects may cause drowsiness.

Tolerance

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.

Using DENPAX

How to use the patch

Adults
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 in a different place
You should not use more than one transdermal patch at a time, unless your doctor authorises 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.
Children
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 kg.

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. The 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 since this may affect the skin. If you need to wash the skin before applying the transdermal patch, use clean water only. Do not use soap, oils or lotions. The skin should be completely dry 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 the entire transdermal patch is in contact with the skin and the corners are stuck tightly

7. Wash your hands after applying or removing the transdermal patch

You can now leave the transdermal patch on the skin 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 two days (48 hours) instead of every three days (72 hours) to achieve adequate pain relief.

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 may need urgent medical attention.
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 accidentally adheres to another person (for example a 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.
DENPAX 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 transdermal patches may vary in size, shape, colour or adhesiveness.
Check with your doctor or pharmacist before switching brands.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DENPAX.
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 them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
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, 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
numbness; seizures or fits
involuntary muscle movements including muscle spasms
sweating or trouble urinating
sudden life threatening allergic reaction
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
skin rash (local redness and itch at the site of the transdermal patch is usually mild and resolves when the transdermal patch is removed)
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 DENPAX transdermal patch and tell your doctor immediately or go to Accident and Emergency 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 such as sexual dysfunction and withdrawal symptoms may also occur in some people. Tell your doctor if you notice any other effects.

After using DENPAX

Storage

Keep DENPAX transdermal patches in the sealed pouch until it is time to apply them.
If you take the transdermal patches out of the pouch they may not keep well.
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 it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep DENPAX transdermal patches 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.

Disposal

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, then wrap and dispose of carefully.
If your doctor tells you to stop using DENPAX or the transdermal patches have passed their expiry date, return the transdermal patches to your pharmacist.

Product description

What it looks like

DENPAX transdermal patches are rectangular, transparent transdermal patches imprinted with
"Fentanyl 12 µg/hr" in white for the 12 micrograms/hour strength
"Fentanyl 25 µg/hr" in white for the 25 micrograms/hour strength
"Fentanyl 50 µg/hr" in white for the 50 micrograms/hour strength
"Fentanyl 75 µg/hr" in white for the 75 micrograms/hour strength
"Fentanyl 100 µg/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.

Ingredients

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.

Manufacturer

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
www.mylan.com.au
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 n
September 2017.
DENPAX_cmi\Sep17/01