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DUROGESIC DTRANS 12 MCG/HR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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Package leaflet: Information for the user

12 micrograms/hour
transdermal patch
25 micrograms/hour
transdermal patch
50 micrograms/hour
transdermal patch
75 micrograms/hour
transdermal patch
100 micrograms/hour
transdermal patch
Fentanyl
Durogesic and DTrans are registered trademarks

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

Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor,
pharmacist or nurse
• This medicine has been prescribed for you (or your
child) only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as
yours
• If you get side effects talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed
in this leaflet. See section 4.

What is in this leaflet
1 What Durogesic DTrans is and what it is used for
© J-C 2016
GB - AW_118494

2 What you need to know before you use

Durogesic DTrans

3 How to use Durogesic DTrans
4 Possible side effects
5 How to store Durogesic DTrans
6 Contents of the pack and other information

1 What Durogesic DTrans is and
what it is used for
The name of your medicine is Durogesic DTrans
The patches help relieve pain that is very bad and longlasting:
• in adults who need continuous pain treatment
• in children above 2 years of age who are already using
opioid medication and who need continuous pain
treatment.
Durogesic DTrans contains a medicine called fentanyl.
It belongs to a group of strong painkillers called opioids.

2 What you need to know before
you use Durogesic DTrans
Do not use Durogesic DTrans if:

• You are allergic to fentanyl or any of the other
ingredients of this medicine (listed in section 6)
• You have pain which lasts only for a short period, such
as sudden pain or pain after having an operation
• You have breathing difficulties, with slow or shallow
breathing
Do not use this medicine if any of the above apply to you
or your child. If you are not sure, talk to your doctor or
pharmacist before using Durogesic DTrans.

Warnings and precautions
• Durogesic DTrans can have life-threatening side
effects in people who are not already regulary using
prescribed opioid medicines.
• Durogesic DTrans is a medicine that could be
life-threatening to children, even if the patches have
been used. Bear in mind that a sticky patch (unused
or used) could be tempting to a child and if it sticks
to a child’s skin or they put it in their mouth, the result
may be fatal.

Patch sticking to another person

The patch should be used only on the skin of the person
for whom it has been prescribed. There have been
reports of patches accidentally sticking to a family
member while in close physical contact or sharing the
same bed as the person wearing the patch. A patch
accidently sticking to another person (particularly a
child) can cause the medicine in the patch to go through
the skin of the other person and cause serious side
effects such as breathing difficulties, with slow or shallow
breathing which may be fatal. In case the patch sticks to
the skin of another person, take the patch off right away
and get medical attention.

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Take special care with Durogesic DTrans

Durogesic DTrans and alcohol

Talk to your doctor or pharmacist before using this
medicine if any of the following apply to you - your doctor
may need to check you more closely if:
• You have ever had problems with your lungs or
breathing
• You have ever had problems with your heart, liver,
kidneys, or low blood pressure
• You have ever had a brain tumour
• You have ever had persistent headaches or a head
injury
• You are elderly - you may be more sensitive to the
effects of this medicine.
• You have a condition called ‘myasthenia gravis’ in
which muscles become weak and tire easily.
• You have ever abused or been dependent on alcohol,
prescription medicines or illegal drugs.
If any of the above apply to you (or you are not sure),
talk to your doctor or pharmacist before using
Durogesic DTrans.

Do not drink alcohol while using Durogesic DTrans
unless you have talked to your doctor first.

Side effects and Durogesic DTrans

Driving and using machines

• Durogesic DTrans may make you unusually drowsy,
and make your breathing more slow or shallow.
Very rarely these breathing problems 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 the person wearing
the patch is unusually drowsy, with slow or shallow
breathing:
- Take the patch off
- Call a doctor, or go to your nearest hospital straight
away
- Keep the person moving and talking as much as
possible
• If you get a fever while using Durogesic DTrans,
tell your doctor - this may increase the amount of
medicine that passes through your skin
• Durogesic DTrans may cause constipation, talk to your
doctor or pharmacist for advice on how to prevent or
relieve constipation.
• Repeated, long term use of the patches may make the
medicine less effective (you become ‘tolerant’ to it) or
you may become dependent on it.
See section 4 for a full list of possible side effects.
When you are wearing the patch do not expose it to
direct heat such as heating pads, electric blankets,
hot-water bottles, heated water beds or heat or tanning
lamps. Do not sunbathe, have long hot baths or saunas
or use hot whirlpool spa baths. If you do, you may
increase the amount of medicine you get from the patch.

Other medicines and Durogesic DTrans

Tell your doctor or pharmacist if you are taking, have
recently taken or might take 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 if you buy any
medicines from your pharmacy.
Your doctor will know which medicines are safe to take
with Durogesic DTrans. You may need to be closely
monitored if you are taking some of the types of
medicines listed below or if you stop taking some of the
types of medicines listed below, as this may affect the
strength of Durogesic DTrans you need.
In particular, tell your doctor or pharmacist if you are
taking:
• Other medicines for pain, such as other opioid
painkillers (such as buprenorphine, nalbuphine, or
pentazocine).
• Medicines for helping you sleep (such as temazepam,
zaleplon, or zolpidem).
• Medicines to help you calm down (tranquillisers, such
as alprazolam, clonazepam, diazepam, hydroxyzine, or
lorazepam) and medicines for mental conditions (antipsychotics, such as aripiprazole, haloperidol,
olanzapine, risperidone, or phenothiazines).
• Medicines for relaxing your muscles (such as
cyclobenzaprine or diazepam).
• Some medicines used to treat depression called
SSRIs or SNRIs (such as citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine, paroxetine,
sertraline, or venlafaxine). – see below for more
information
• Some medicines used to treat depression or Parkinson’s
disease called MAOIs (such as isocarboxazid,
phenelzine, selegiline, or tranylcypromine). You should
not take Durogesic DTrans within 14 days of stopping
these medicines. – see below for more information
• Some antihistamines, especially ones that make you
sleepy (such as chlorpheniramine, clemastine,
cyproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infection (such as
erythromycin or clarithromycin.
• Medicines used to treat fungal infection (such as
itraconazole, ketoconazole, fluconazole, or
voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat an irregular heart beat (such
as amiodarone, diltiazem, or verapamil).
• Medicines to treat tuberculosis (such as rifampicin).
• Some medicines used to treat epilepsy (such as
carbamazepine, phenobarbital, or phenytoin).
• Some medicines used to treat nausea or motion
sickness (such as phenothiazines).
• Some medicines used to treat heartburn or ulcers
(such as cimetidine).
• Some medicines used to treat angina (chest pain) or
high blood pressure (such as nicardipine).
• Some medicines used to treat cancer of the blood
(such as idelalisib).

Durogesic DTrans with antidepressants

The risk of side effects increases if you are taking
medicines such as certain antidepressants.
Durogesic DTrans may interact with these medicines
and you may experience changes to mental status such
as feeling agitated, seeing, feeling, hearing, or smelling
things that are not there (hallucinations) and other
effects such as changing blood pressure, fast heart beat,
high body temperature, overactive reflexes, lack of
coordination, muscle stiffness, nausea, vomitting and
diarrhoea.

Operations

If you think that you are going to receive anaesthesia
tell your doctor or dentist that you are using
Durogesic DTrans.

Durogesic DTrans can make you drowsy or breathe more
slowly. Drinking alcohol may make these effects worse.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Durogesic DTrans should not be used during pregnancy
unless you have discussed this with your doctor.
Durogesic DTrans should not be used during childbirth
as the medication can affect the breathing of the
newborn child.
Do not use Durogesic DTrans if you are breastfeeding.
You should not breastfeed for 3 days after removing your
Durogesic DTrans patch. This is because the medicine
may pass into breast milk.
Durogesic DTrans can affect your ability to drive and use
machines or tools as it may make you sleepy or dizzy. If
this happens, do not drive or use any tools or machines.
• 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
Always use this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
Your doctor will decide which strength of Durogesic DTrans
is most suitable for you, taking into account the severity
of your pain, your general condition and type of pain
treatment that you have received so far.

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 when to change your
patch:
Apply
your patch on

Change
your patch on

Monday

Ö

Thursday

Tuesday

Ö

Friday

Wednesday

Ö

Saturday

Thursday

Ö

Sunday

Friday

Ö

Monday

Saturday

Ö

Tuesday

Sunday

Ö

Wednesday

Where to apply the patch

Adults
• Apply the patch on a flat part of your upper body or
arm (not over a joint).
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 life
threatening or even fatal.
• Watch your child very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on
• It may take some time for the patch to have its
maximum effect. Therefore, your child might need to
use other painkillers as well until the patches become
effective. Your doctor will talk to you about this.
Adults and Children:
Do not apply the patch on
• The same place twice in a row.
• Areas that you move a lot (joints), skin that is irritated
or with cuts.
• 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.

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 sachet
• Each patch is sealed in its own sachet
• Tear or cut open the sachet at the notch, shown by the
arrow
• Gently tear or cut off the edge of the sachet completely
(if you use scissors, cut close to the sealed edge of the
sachet to avoid damaging the patch)

• Grasp both sides of the opened sachet and pull apart
• Take the patch out and use straight away
• Keep the empty sachet to dispose of the used patch
later
• Use each patch once only
• Do not take the patch out of its sachet 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 sachet and dispose of the
sachet as instructed by your pharmacist
• 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

More about using Durogesic DTrans
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
• While you are wearing the patch do not expose it to
direct heat such as heating pads, electric blankets,
hot-water bottles, heated water beds, heat or tanning
lamps. Do no sunbathe, have long hot baths or saunas.
If you do, you may increase the amount of medicine
you get from the patch.

How quickly will the patches work?

• It may take some time for your first patch to have its
maximum effect.
• Your doctor may give you other painkillers as well 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

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 additional painkillers (or both)
• If increasing the strength of the patch does not help,
your doctor may decide to stop the use of the patches

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
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 you forget to change your patch

• If you forget, change your patch as soon as you
remember and make 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 a patch falls off

• If a patch falls off before it needs changing, stick a new
one on straight away and make note of the day and
time. Use a new area of skin on:
- Your upper body or arm
- Your child’s upper back
• Let your doctor know this has happened and leave the
patch on for another 3 days (72 hours) or as directed
by your doctor, before changing the new patch as
usual
• If your patches keep falling off, talk to your doctor,
pharmacist or nurse

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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
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

If you or your partner, or carer, notice any
of the following about the person wearing
the patch, take the patch off and call a
doctor, or go to your nearest hospital,
straight away. You may need urgent medical
treatment.
• Feeling unusually drowsy, breathing that is more slow
or shallow than expected.
Follow the advice above and keep the person who
was wearing the patch moving and talking as much
as possible. 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.
(Uncommon, this may affect up to 1 in 100 people)

• Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin.
These may be signs of a severe allergic reaction.
(frequency cannot be estimated from the available data.)
• Fits (seizures). (Uncommon, this may affect up to 1 in
100 people.)
• Reduced consciousness or loss of consciousness.
(Uncommon, these may affect up to 1 in 100 people.)

The following side effects have also been
reported
Very common (may affect more than 1 in 10 people)
• Nausea, vomiting, constipation
• Feeling sleepy (somnolence)
• Feeling dizzy
• Headache
Common (may affect up to 1 in 10 people)
• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, hearing, or smelling things that are not
there (hallucinations)
• Muscle tremors or spasms
• Unusual feeling in the skin, such as tingling or crawling
feelings (paraesthesia)
• Spinning sensation (vertigo)
• Heart beat feels fast or uneven (palpitations,
tachycardia)
• High blood pressure
• Being short of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, skin rash or redness of the skin
• Being unable to pass urine or empty bladder
completely
• Feeling very tired, weak or generally unwell
• Feeling cold
• Swollen hands, ankles or feet (peripheral oedema)
Uncommon (may affect up to 1 in 100 people)
• Feeling agitated or disoriented
• Feeling extremely happy (euphoria)
• Decreased feeling or sensitivity, especially in the skin
(hypoaesthesia)
• Loss of memory
• Blurred vision
• Slow heart beat (bradycardia) or low blood pressure
• Blue colour to the skin caused by low oxygen in the
blood (cyanosis)
• Loss of contractions of the gut (ileus)
• Itchy skin rash (eczema), allergic reaction or other skin
disorders where the patch is placed
• Flu-like illness
• Feeling of body temperature change
• Fever
• Muscle twitching
• Difficulty getting and keeping an erection (impotence)
or problems having sex
Rare side effects (may affect up to 1 in 1000
people)
• Constricted pupils (miosis)
• Stopping breathing from time to time (apnoea)
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.
Repeated use of the patches may make the medicine
become less effective (you become ‘tolerant’ to it) or
become dependent on it.
If you switch from a different painkiller to Durogesic DTrans
or if you suddenly stop using Durogesic DTrans, you may
notice withdrawal effects such as sickness, feeling sick,
diarrhoea, anxiety or shivering. Tell your doctor if you
notice any of these effects.
There have been reports also of newborn infants
experiencing withdrawal effects after their mothers have
used Durogesic DTrans for a long time during pregnancy.

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
Where you should keep the patches

Keep all patches (used and unused) out of the sight and
reach of children.

This medicinal product is authorised in
the Member States of the EEA under the
following names:
Durogesic

Do not use Durogesic DTrans after the expiry date which
is stated on the carton and sachet. The expiry date
refers to the last date of that month. If the patches are
out of date, take them to your pharmacy.

Austria, Belgium, Croatia,
Cyprus, Czech Republic,
Denmark, Finland, France,
Greece, Hungary, Iceland,
Italy, Luxembourg,
Netherlands, Norway, Poland,
Portugal, Slovenia, Sweden

If your doctor has told you that you no longer need to use
the patches, take any unused patches to your pharmacy.

Germany

Durogesic SMAT

Ireland, Malta, United Kingdom Durogesic DTrans

How to dispose of used patches or patches
you no longer use

Spain

How long to keep Durogesic DTrans for

A used or unused patch accidentally sticking to another
person, especially a child, may be fatal.

Used patches should be folded firmly in half so that the
sticky side of the patch sticks to itself. Then they should
be safely discarded by putting them back into the original
sachet and stored out of sight and reach of other people,
especially children, until safely disposed. Ask your
pharmacist how to throw away medicines you no longer
use.
Do not throw away any medicines via wastewater or
household waste. These measures will help protect the
environment.

6 Contents of the pack and other
information
What Durogesic DTrans contains
The active substance in Durogesic DTrans patches is
fentanyl.
The patches come in 5 different strengths (see table
below).
Name of
patch

Durogesic
DTrans 12
micrograms/
hour
transdermal
patch
Durogesic
DTrans 25
micrograms/
hour
transdermal
patch
Durogesic
DTrans 50
micrograms/
hour
transdermal
patch
Durogesic
DTrans 75
micrograms/
hour
transdermal
patch
Durogesic
DTrans 100
micrograms/
hour
transdermal
patch

Each
Each patch Active
patch
gives a dose surface
contains: of:
area of
each patch
is:
2.1
12
5.25
milligrams micrograms square
(mg) of
(mcg) of
centimetres
fentanyl
fentanyl per (cm2)
hour
4.2 mg
fentanyl

25 mcg per
hour

10.5 cm2

8.4 mg
fentanyl

50 mcg per
hour

21 cm2

12.6 mg
fentanyl

75 mcg per
hour

31.5 cm2

16.8 mg
fentanyl

100 mcg per
hour

42 cm2

The other ingredients in the patch are:
• Polyester/ethyl vinyl acetate
• Polyacrylate adhesive
• Siliconised polyester film which is removed before use
Each patch is identified using a different colour of
printing ink:
• Durogesic DTrans 12 micrograms/hour transdermal
patch: Orange
• Durogesic DTrans 25 micrograms/hour transdermal
patch: Red
• Durogesic DTrans 50 micrograms/hour transdermal
patch: Green
• Durogesic DTrans 75 micrograms/hour transdermal
patch: Blue
• Durogesic DTrans 100 micrograms/hour transdermal
patch: Grey

What Durogesic DTrans looks like and
contents of the pack

Durogesic DTrans is a translucent rectangular patch with
rounded corners, marked with the product name,
strength and a border in coloured ink. The patch has a
sticky back so that it can be stuck onto the skin.
The patches come in individually wrapped heat-sealed
(acrylonitrile film) pouches, and usually come in cartons
containing five patches, but your doctor will have
prescribed the number and strength of patches which is
best for you.
Marketing Authorization Holder Manufacturer
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire HP12 4EG, UK
Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium

Durogesic Matrix

For information in large print,
tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in October 2016.

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Expand Transcript

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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