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DUROGESIC DTRANS 12MICROGRAM/HR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Durogesic® DTrans® 12microgram/hr
Transdermal Patch

Warning and precaution


(fentanyl)

Important things you need to know about
Durogesic DTrans transdermal patches







These patches contain a strong pain killer
Ensure that old patches are removed before applying a
new one
Patches must not be cut
Do not expose the patches to a heat source (such as a
hot water bottle)
If you develop a fever tell your doctor immediately
Follow the dosage instructions carefully and only
change your patch every 3 days (72 hours) • If your
breathing becomes shallow and weak take the patch off
and seek medical help

The rest of this leaflet includes more detail and other
important information on the safe and effective use of
this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor,
nurse or pharmacist
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours
• If you get side effects and they become serious or if
you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist
Please note that this leaflet also contains information about
other strengths Durogesic DTrans 12, 25, 75, 100mcg/hr
Transdermal patch.
In this leaflet
1. What Durogesic DTrans patches are and what they
are used for
2. Before you use Durogesic DTrans patches
3. How to use Durogesic DTrans patches
4. Possible side effects
5. How to store Durogesic DTrans patches
6. Further information

1. What Durogesic DTrans patches are and what
they are used for
The name of your medicine is Durogesic DTrans
transdermal patch. It is called ‘Durogesic DTrans patch’ or
just ‘patch’ in this leaflet.
The patches help relieve pain that is very bad and longlasting. Durogesic DTrans patch contains a medicine called
fentanyl. It belongs to a group of strong painkillers called
opioids. The patches come in five strengths (see section 6
overleaf). The medicine passes slowly into your body
through your skin.

2. Before you use Durogesic DTrans patches
Durogesic DTrans patches can be used in children aged 2
to 16 years who have previously used opioid painkillers. If
the patches have been prescribed for your child, the ‘you’
stated everywhere below should be read as ‘your child’.
Do not use Durogesic DTrans patches if:
• You are allergic to fentanyl, Durogesic or anything in
Durogesic DTrans patches (listed in section 6 overleaf)
• You have pain which lasts only for a short period
• Your child who is in pain is under 2 years old
• Your child has not been treated with strong painkillers
such as morphine Do not use this medicine if any of the
above applies to you or your child. If you are not sure,
talk to your doctor or pharmacist before using
Durogesic DTrans patches.



Durogesic DTrans is a medicinal product that could be
life-threatening to children, even if the patches have
been used. Bear in mind that a sticky patch could be
tempting to a child and in some cases may lead to a
fatal outcome.
Durogesic DTrans can have life-threatening side
effects in persons who are not using prescribed opioid
medicines on a regular basis.

Patch sticking to another person
The patch should be used only on the skin of the person for
whom it has been prescribed. Cases have been reported
where a patch was accidentally stuck to a family member
while in close physical contact or sharing the same bed as
the patch wearer. A patch sticking to another person
(particularly a child) may result in an overdose. In case the
patch sticks to the skin of another person, take the patch off
immediately and seek medical attention. See also section 3
below.
Take special care with Durogesic DTrans patches
• Like some other strong painkillers, Durogesic DTrans
patches may make you unusually drowsy, and breathe
more slowly or weakly. Very rarely these breathing
difficulties can be life threatening or even fatal in
people who have not used strong morphine-related
painkillers (like Durogesic DTrans) or morphine before.
If you, or your partner or carer, notice that you or your
child are breathing much more slowly or weakly then:
- Take the patch off
- Call a doctor, or go to your nearest hospital, straight
away - Keep moving and talking as much as possible
• If you develop a fever while wearing Durogesic DTrans
patches, tell your doctor as this may affect the way the
medicine passes through your skin
• Don’t expose the patch to direct heat such as heating
pads, electric blankets, hot-water bottles, heated
water beds, heat or tanning lamps, intensive sun
bathing, prolonged hot baths, saunas or hot whirlpool
spa baths. These may affect the way the medicine is
absorbed through the skin
• Check with your doctor or pharmacist before using this
medicine if you have ever had:
- Problems with your lungs or breathing
- Problems with your heart or blood pressure and blood
volume, liver or kidneys
- Brain tumours
- Persistent headaches or a head injury Your doctor
might need to check you more closely.
• If you are very ill, very thin or elderly, you may be more
sensitive to the effects of the patches
• If you suffer from a condition in which muscles become
weak and tire easily, known as myasthenia gravis, talk
to your doctor or pharmacist before using Durogesic
DTrans patches.
• Like many other strong painkillers, repeated use of the
patches may make you become tolerant to the
medicine or become dependent on it
• Tell your doctor if you have ever abused or been
dependent on alcohol, prescription medicines or illegal
drugs
• Durogesic DTrans may cause constipation, talk to your
doctor or pharmacist for advice on how to prevent
constipation.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before using Durogesic DTrans
patches.
Other makes of patch
There are other makes of fentanyl transdermal patch
available, but they are not all the same. If your patch looks
different from one you have used before you should check
with your doctor or pharmacist before using it.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines that you buy without a prescription or herbal
medicines. You should also tell your pharmacist that you
are using Durogesic DTrans patches if you buy any
medicines from your pharmacy.
In particular, tell your doctor or pharmacist if you are taking:
• Other medicines for pain, such as other opioid
painkillers (buprenorphine, nalbuphine or pentazocine)
• Medicines for helping you sleep
• Medicines to help you calm down (tranquillisers) and
medicines for mental conditions
• Medicines for relaxing your muscles
• Some medicines used to treat depression (such as
citalopram, duloxetine escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline, venlafaxine)
• Some medicines used to treat depression (called
MAOIs) You should not take Durogesic DTrans within
14 days of stopping these medicines.
• Nefazodone a medicine used to treat depression
• Some antihistamines (especially ones that make you
sleepy)
• Some antibiotics used to treat infection, such as
erythromycin, clarithromycin or troleandomycin
• Medicines used to treat fungal infection, such as
itraconazole, ketoconazole, fluconazole or voriconazole

Medicines used to treat HIV infection, such as ritonavir
or nelfinavir
• Medicines used to treat an irregular heart beat, such as
amiodarone, diltiazem or verapamil
• Rifampicin (for treatment of TB)
• Some medicines used to treat epilepsy (such as
carbamazepine, phenobarbital or phenytoin)
Your doctor will know which medicines are safe to take with
Durogesic DTrans patches. You may need to be closely
monitored if you are taking some of the types of medicines
listed above or if you stop taking some of the types of
medicines listed above, as this may affect the strength of
Durogesic DTrans you need. If you are not sure if any of
the above applies to you, talk to your doctor or pharmacist
before using Durogesic DTrans patches.
Operations or tests
If you think that you are going to have an anaesthetic, tell
your doctor or dentist that you are using Durogesic DTrans.
Using Durogesic DTrans patches and drinking alcohol
Do not drink alcohol unless you have talked to your doctor
first.
Durogesic DTrans patches can make you drowsy or
breathe more slowly. Drinking alcohol may make these
effects worse.
Pregnancy and breast-feeding
You must tell your doctor before using Durogesic DTrans
patches if you are pregnant, think you may be pregnant or
might become pregnant. Durogesic DTrans patches should
not be used during childbirth as the medication can affect
the breathing of the newborn child.
Do not breast-feed whilst using Durogesic DTrans patches.
You should not breast-feed for 3 days after removing your
Durogesic DTrans patch. This is because small amounts of
the medicine may pass into breast milk.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.
Driving and using machines
Durogesic DTrans patches can make you drowsy. If this
happens, do not drive or use any tools or machines.
This medicine can affect your ability to drive as it may make
you sleepy or dizzy.
• Do not drive while taking this medicine until you know
how it affects you.



It is an offence to drive if this medicine affects your
ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical
or dental problem and
- You have taken it according to the instructions given
by the prescriber or in the information provided with the
medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this medicine.

3. How to use Durogesic DTrans patches
Always use this medicine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.









Using and changing the patches
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
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)
If you are using more than one patch, change all your
patches at the same time
Make a note of the day, date and time you apply a
patch, to remind you when you need to change your
patch
The following table shows you which day of the week to
change your patch:
Apply your
patch on

Change your patch at
the same time on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper body or arm
Children
• Always apply the patch to the upper back to make it
difficult for your child to reach it or take it off

Every so often check that the patch remains stuck to
the skin

It is important that your child does not remove the
patch and put it in their mouth as this could be lifethreatening or even fatal

It may take some time before the patch becomes fully
effective. Therefore, your child might need additional
painkillers until the patches become effective. Your
doctor will advise you on this if it is needed

Children should be monitored very closely for 48 hours
after:
- The first patch has been put on
- A higher dose patch has been put on

For you or your child, do not apply the patch on:
• The same place twice in a row.
• Sensitive areas that you move a lot, skin with cuts,
spots or other skin blemishes
• Skin that is very hairy. If there is hair, do not shave it
(shaving irritates the skin). Instead, clip the hair as
close to the skin as possible
You should allow several days to pass before you put a
new patch on the same area of skin

Putting a patch on
Step 1: Preparing the skin
• Make sure your skin is completely dry, clean and cool
before you put the patch on
• If you need to clean the skin, just use cold water
• Do not use soap or any other cleansers, creams,
moisturisers, oils or talc before applying the patch
• Do not stick a patch on straight after a hot bath or
shower
Step 2: Open the pouch
• Each patch is sealed in its own pouch
• Tear or cut open the pouch at the notch, shown by the
arrow
• Gently tear or cut off the edge of the pouch completely
(if you use scissors, cut close to the sealed edge of the
pouch to avoid damaging the patch)
• Grasp both sides of the opened pouch and pull apart
• Take the patch out and use straight away
• Keep the empty pouch to dispose of the used patch
later
• Use each patch once only
• Do not take the patch out of its pouch until you are
ready to use it
• Inspect the patch for any damage
• Do not use the patch if it has been divided, cut or looks
damaged
• Never divide or cut the patch
Step 3: Peel and press
• Make sure that the patch will be covered by loose
clothing and not stuck under a tight or elasticated band
• Carefully peel one half of the shiny plastic backing
away from the centre of the patch. Try not to touch the
sticky side of the patch
• Press this sticky part of the patch onto the skin
• Remove the other part of the backing and press the
whole patch onto the skin with the palm of your hand
• Hold for at least 30 seconds. Make sure it sticks well,
especially the edges
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 pouch and put the pouch in the
bin with your household rubbish
• Even used patches contain some medicine which may
harm children and may be fatal, so keep your used
patches out of the sight and reach of children
Step 5: Wash
• Wash your hands afterwards with clean water

More about using Durogesic DTrans patches
How quickly will the patches work?
• It may take up to a day before your first patch is
working completely
• Your doctor may give you extra painkillers for the first
day or so
• After this, the patch should help to relieve pain
continuously so that you can stop taking other
painkillers. However, your doctor may still prescribe
extra painkillers from time to time

If you forget to change your patch
• If you forget, change your patch as soon as you
remember and make a note of the day and time.
Change the patch again after 3 days (72 hours) as
usual
• If you are very late changing your patch, you should
talk to your doctor because you might need some extra
painkillers, but do not apply an extra patch
If you use too many patches or the wrong strength
patch
If you have stuck on too many patches or the wrong
strength patch, take the patches off and contact a doctor or
the nearest hospital straight away.
Signs of overdose include trouble breathing or shallow
breathing, tiredness, extreme sleepiness, being unable to
think clearly, walk or talk normally and feeling faint, dizzy or
confused.
If a patch falls off
• If a patch falls off before it needs changing, stick a new
one on straight away and make a note of the day and
time. Use a new area of skin on:
- Your upper body or arm
- Your child’s upper back
• Leave another 3 days (72 hours) before changing the
new patch as usual
• If your patches keep falling off, talk to your doctor,
nurse or pharmacist
If a patch sticks to another person (See also section 2
above)
• Only use the patch on the skin of the person who it was
prescribed for
• Make sure the patch does not get rubbed off and stick
to your partner or child, especially while sharing a bed
or in close contact
• If a patch accidentally sticks to another person, take it
off straight away and seek immediate medical attention
How long will you use the patches for?
Durogesic DTrans patches are for long-term pain. Your
doctor will be able to tell you how long you can expect to
use the patches.
If your pain gets worse
• If your pain gets worse while you are using these
patches, your doctor may try a higher strength patch, or
give you extra painkillers (or both)
• If increasing the strength of the patch does not help,
your doctor may stop the patches
If you want to stop using the patches
• Talk to your doctor before you stop using these patches
• If you have been using them for some time your body
may have got used to them. Stopping suddenly may
make you feel unwell
• If you stop using the patches, don’t start again without
asking your doctor first. You might need a different
patch strength when you restart
Everyday activities while using the patches
• The patches are waterproof
• You can shower or bathe while wearing a patch, but do
not scrub the patch itself
• If your doctor agrees, you can exercise or play sport
while wearing the patch
• You can also swim while wearing the patch, but: - Don’t
use hot whirlpool spa baths - Don’t put a tight or
elasticated band over the patch
• Don’t expose the patch to direct heat such as heating
pads, hot-water bottles, electric blankets, heated water
beds, heat or tanning lamps, intensive sun bathing,
prolonged hot baths or saunas. These may affect the
way the medicine is absorbed through the skin
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Durogesic DTrans patches can cause
side effects, although not everybody gets them.

Take the patch off and tell your doctor, or go to your
nearest hospital, straight away if you notice or
suspect any of the following. You may need urgent
medical treatment.







Feeling unusually drowsy, breathing more slowly or
weakly than expected. Very rarely these breathing
difficulties can be life-threatening or even fatal,
especially in people who have not used strong opioid
painkillers (like Durogesic DTrans or morphine) before.
If you, or your partner or carer, notice that you or your
child are breathing much more slowly or weakly, follow
the guidance above and keep moving and talking as
much as possible
Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin. These may be
signs of a severe allergic reaction. This only happens in
a small number of people
Convulsions, fits or seizures. This affects fewer than 1
in 100 people
Reduced consciousness or loss of consciousness.
These affect fewer than 1 in 100 people

The following side effects have also been reported
Very common (affects more than 1 in 10 people):
• Feeling sick (nausea) or being sick (vomiting),
constipation
• Dizziness, drowsiness or not being able to sleep
• Headache
Common (affects fewer than 1 in 10 people):
• Allergic reaction
• Awareness of unusual heart beats (also called
palpitations), fast heart rate
• High blood pressure
• Loss of appetite or dry mouth
• Feeling nervous, worried or depressed
• Confusion, hallucinations (seeing, feeling or hearing
things that are not there)
• Sensation of pins and needles, shaking, feeling giddy
• Muscle spasms
• Stomach ache, indigestion, difficulty passing urine
• Diarrhoea
• Feeling cold, excessive sweating
• General feelings of discomfort, tiredness, weakness
• Swelling of hands, ankles or feet
• Itchy skin, rashes or redness of the skin
Uncommon (affects fewer than 1 in 100 people):
• Flu-like symptoms
• Slow heart rate
• Low blood pressure
• Decreased feeling of sensitivity, especially in the skin
• Blurred vision
• Bluish colouration of the skin
• Feeling agitated, disorientated, excited or unusually
carefree
• Loss of memory
• Eczema and/or other skin disorders including dermatitis
where the patch is placed
• Disorders of sexual function
• Complete obstruction of the intestine
• Muscle twitching
• Fever, body temperature changes
• Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering)
Rare side effects (probably affecting fewer than 1 in
1,000 people):
• Tiny pupils
• Incomplete obstruction of the small or large intestine

The following side effects have been reported
during clinical trials in children (up to 18 years of
age):
Very common side effects (probably affecting more
than 1 in 10 people):
• Headache
• Feeling or being sick
• Constipation, diarrhoea
• Itching
Common side effects (probably affecting up to 1 in 10
people):
• Allergic reaction
• Loss of appetite, stomach pain
• Not being able to sleep, drowsiness, tiredness, feeling
weak
• Feeling worried or depressed, hallucinations (seeing,
feeling or hearing things that are not there), dizziness
• Shaking, decreased feeling or sensitivity, especially in
the skin • Dry mouth
• Rash, excessive sweating, redness of the skin
• Muscle spasms
• Difficulty passing urine
• Swelling of hands, ankles or feet
• Skin reactions where the patch is placed
Uncommon side effects (probably affecting fewer than
1 in 100 people):
• Confusion
• Sensation of pins and needles
• Tiny pupils
• Feeling giddy
• Bluish colouration of the skin, eczema and/or other skin
disorders including dermatitis where the patch is placed
• Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering), flu-like symptoms.
If you get any of these side effects, tell your doctor, nurse
or pharmacist. Skin rashes, itching or sweating (affects less
than 1 in 10 people). You may notice rashes, redness or
slight itching of the skin at the site of the patch. This is
usually mild and disappears after you have removed the
patch. If it does not, or if the patch irritates your skin badly,
tell your doctor.
There have been reports of newborn infants experiencing
withdrawal effects after their mothers have used Durogesic
DTrans for a long time during pregnancy.
Like many other strong painkillers, repeated use of the
patches may make you become tolerant to the medicine or
become dependent on it. If you get any of these side
effects, tell your doctor, nurse or pharmacist.
If you switch from a different painkiller to Durogesic DTrans
patches, you may notice effects such as sickness, feeling
sick, diarrhoea, anxiety or shivering. Tell your doctor if you
notice any of these effects.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By
reporting side effects you can help provide more
information on the safety of this medicine

5. How to store Durogesic DTrans patches.
How long to keep Durogesic DTrans patches for
Do not use the patches after the expiry date which is stated
on the carton /sachet label after ‘Exp’. The expiry date
refers to the last day of that month. If the patches are out
dated, take them to your pharmacy.
If your doctor has told you that you no longer need to use
the patches, take any unused patches to your pharmacy.

Where you should keep the patches
Keep out of the sight and reach of children.
Store in the original package. Ensure that the sachets with
transdermal systems are kept together and intact.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further Information
What Durogesic D Transpatch contains
The active substance is fentanyl.
Each transdermal patch contains 2.1mg fentanyl
(absorption rate approx 12micrograms/hour; active surface
2
area 5.25cm ). The other components are Polyethylene
terephthalate / ethylene vinyl acetate , duro-Tak 87-4287,
siliconised polyester film and printing ink orange
What Durogesic D Trans patch looks like and contents
of the pack
Each patch is rectangular shaped patch with rounded
corners, translucent system marked Durogesic 12 μg
fentanyl/h in orange printing ink. It comes in packs
containing 5 patches.
Manufactured by:
Janssen Pharmaceutica, N.V. Turnhoutseweg 30, 2340
Beerse Belgium
Procured from within the EU and repackaged by the
Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

®

Durogesic DTrans 12mcg/hr Transdermal Patch
CD

PL No: 18799/2302
Leaflet date: 13.12.2014

POM

Durogesic and DTrans are registered trademarks of
Janssen Cilag

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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