DUROGESIC D-TRANS 25 MICROGRAMS/HR TRANSDERMAL PATCH

6

Contents of the pack and other information

S642-5 LEAFLET Durogesic 20170425

PACKAGE LEAFLET: INFORMATION FOR THE USER
What Durogesic DTrans Patches contain




Each Durogesic D-Trans 50 micrograms /hr Transdermal Patch
contains 8.4 mg of fentanyl and gives a dose of 50 micrograms
of fentanyl every hour.



Each Durogesic D-Trans 75 micrograms /hr Transdermal Patch
contains 12.6mg of fentanyl and gives a dose of 75 micrograms
of fentanyl every hour.



Each Durogesic D-Trans 100 micrograms /hr Transdermal
Patch contains 16.8 mg of fentanyl and gives a dose of 100
micrograms of fentanyl every hour.



DUROGESIC® D-TRANS® 25 micrograms/hr
TRANSDERMAL PATCH
DUROGESIC® D-TRANS® 50 micrograms /hr
TRANSDERMAL PATCH
DUROGESIC® D-TRANS® 75 micrograms /hr
TRANSDERMAL PATCH
DUROGESIC® D-TRANS® 100 micrograms /hr
TRANSDERMAL PATCH
(fentanyl)

Each Durogesic D-Trans 25 micrograms/hr Transdermal Patch
contains 4.2 mg of fentanyl and gives a dose of 25 micrograms
of fentanyl every hour.

Durogesic D-Trans Patches also contains the following inactive
ingredients: polyacrylate adhesive, polyethylene
terephthalate/ethyl vinyl acetate film, red/ green/ blue/ grey
printing ink and siliconised polyester film.

What Durogesic DTrans Patches look like and contents of the
pack
Durogesic D-Trans 25 micrograms/hr Transdermal Patch is clear
plastic rectangular transdermal patch is printed ‘Durogesic 25μg
fentanyl/h’ in pink. The active surface area of each patch is
10.5cm2.
Durogesic D-Trans 50 micrograms/hr Transdermal Patch is clear
plastic rectangular transdermal patch is printed ‘Durogesic 50μg
fentanyl/h’ in green. The active surface area of each patch is
21.0cm2.
Durogesic D-Trans 75 micrograms/hr Transdermal Patch is clear
plastic rectangular transdermal patch is printed ‘Durogesic 75μg
fentanyl/h’ in blue. The active surface area of each patch is
31.5cm2.
Durogesic D-Trans 100 micrograms/hr Transdermal Patch is clear
plastic rectangular transdermal patch is printed ‘Durogesic 100μg
fentanyl/h’ in grey. The active surface area of each patch is
42.0cm2.
Durogesic D-Trans Patches are available in packs of 5 patches for
all strengths.

Important things you need to know about Durogesic DTrans
transdermal patches

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 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)



Take the patch off

If your breathing becomes shallow and weak take the patch off
and seek medical help



Call a doctor, or go to your nearest hospital straight away



Keep the person moving and talking as much as possible



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.

3

How to use Durogesic DTrans

4

Possible side effects

5

How to store Durogesic DTrans

6

Contents of the pack and other information

PL. 19488/0643 Durogesic D-Trans 50 micrograms/hr Transdermal
Patch

1

What Durogesic DTrans is and what it is used for

PL. 19488/0644 Durogesic D-Trans 75 micrograms/hr Transdermal
Patch

The name of your medicine is Durogesic DTrans
The patches help relieve pain that is very bad and long-lasting:


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.

Leaflet revision date: 25 April 2017

Durogesic DTrans contains a medicine called fentanyl.

Side effects and Durogesic DTrans


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

Durogesic® is a registered trade mark of Janssen-Cilag Ltd.



You have breathing difficulties, with slow or shallow breathing

D-Trans is a registered trade mark of Alza Corp, USA.

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.

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).

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 lifethreatening 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.

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:



It belongs to a group of strong painkillers called opioids.



S642-5 LEAFLET Durogesic 20170425

You have ever had a brain tumour



Patches must not be cut

What you need to know before you use Durogesic DTrans

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.





What Durogesic DTrans is and what it is used for

PL. 19488/0645 Durogesic D-Trans 100 micrograms/hr
Transdermal Patch

You have ever had problems with your heart, liver, kidneys, or
low blood pressure

Ensure that old patches are removed before applying a new
one

2

PL. 19488/0642 Durogesic D-Trans 25 micrograms/hr Transdermal
Patch

You have ever had problems with your lungs or breathing



These patches contain a strong pain killer

1

POM





What is in this leaflet

This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.

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:



Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

Take special care with Durogesic DTrans

Durogesic DTrans with antidepressants

Adults and Children:

How long will you use the patches for?



Stomach pain or indigestion

The risk of side effects increases if you are taking medicines such
as certain antidepressants.

Do not apply the patch on





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)



The same place twice in a row.

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.



Areas that you move a lot (joints), skin that is irritated or with
cuts.

Operations

Putting a patch on

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

Step 1: Preparing the skin





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

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

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)

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.



Loss of contractions of the gut (ileus)



Itchy skin rash (eczema), allergic reaction or other skin
disorders where the patch is placed

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.



Flu-like illness



Feeling of body temperature change



Fever

If a patch falls off



Muscle twitching





Difficulty getting and keeping an erection (impotence) or
problems having sex

If you use too many patches or the wrong strength patch



If you need to clean the skin, just use cold water



If you have stuck on too many patches or the wrong strength patch,
take the patches off and contact a doctor straight away.

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

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.

Pregnancy and breastfeeding

Step 2: Open the sachet

If you forget to change your patch

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.



Each patch is sealed in its own sachet





Tear or cut open the sachet at the notch, shown by the arrow

Durogesic DTrans should not be used during pregnancy unless you
have discussed this with your doctor.



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)

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.



Driving and using machines
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



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

How to use Durogesic DTrans

If you have been using them for some time your body may have
got used to them. Stopping suddenly may make you feel unwell





Never divide or cut the patch

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

There have been reports also of newborn infants experiencing
withdrawal effects after their mothers have used Durogesic DTrans
for a long time during pregnancy.

Step 3: Peel and press




There is enough medicine in each patch to last 3 days (72
hours).



As soon as you take a patch off, fold it firmly in half so that the
sticky side sticks to itself



You should change your patch every third day, unless your
doctor has told you differently.



Put it back in its original sachet and dispose of the sachet as
instructed by your pharmacist



Always remove the old patch before applying a new one.



Keep used patches out of sight and reach of children



Always change your patch at the same time of day every 3
Days (72 hours).



even used patches contain some medicine which may
harm children and may even be fatal

4



Always wash your hands after you have handled the patch
using clean water only

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.




Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin.

Where should I keep Durogesic D-Trans Patches?

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.)

Everyday activities while using the patches


The patches are waterproof

Wednesday

Saturday



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



Nausea, vomiting, constipation

You can also swim while wearing the patch, but:



Feeling sleepy (somnolence)



Feeling dizzy



Headache

Tuesday

Sunday

Wednesday

Adults





Apply the patch on a flat part of your upper body or arm (not
over a joint).
Children



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.

Always apply the patch to the upper back to make it difficult for
your child to reach it or take it off.

How quickly will the patches work?



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.

It may take some time for your first patch to have its maximum
effect.





Watch your child very closely for 48 hours after:

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



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.

How long to keep Durogesic DTrans Patches for

If your doctor has told you that you no longer need to use
Durogesic D-Trans Patches then you must take any unused
patches to your pharmacy.

Friday

Saturday

How to store Durogesic DTrans



Thursday

Sunday

5

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)

Monday

Monday

By reporting side effects you can help provide more information on
the safety of this medicine.

Once the pouch is opened the patch must be used straight
away. Do not use Durogesic D-Trans Patches after the expiry
date on the pouch. The expiry date refers to the last day of that
month. If they are out of date then take them to your pharmacy.

Tuesday

Friday

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.





More about using Durogesic DTrans

Reporting of side effects

Feeling unusually drowsy, breathing that is more slow or
shallow than expected.

These may be signs of a severe allergic reaction. (frequency
cannot be estimated from the available data.)

Step 5: Wash

The following table shows you when to change your patch:

Where to apply the patch



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

Make sure that the patch will be covered by loose clothing and
not stuck under a tight or elasticated band

Step 4: Disposing of the patch

Thursday

Repeated use of the patches may make the medicine become less
effective (you become ‘tolerant’ to it) or become dependent on it.



Using and changing the patches



If your patches keep falling off, talk to your doctor, pharmacist
or nurse

Do not use the patch if it has been divided, cut or looks
damaged

Hold for at least 30 seconds. Make sure it sticks well, especially
the edges



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.

Inspect the patch for any damage



Change your patch on

Constricted pupils (miosis)





Remove the other part of the backing and press the whole
patch onto the skin with the palm of your hand

Apply your patch on



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







Your child’s upper back

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.

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.

Make a note of the day, date and time you apply a patch, to
remind you when you need to change your patch.

Rare side effects (may affect up to 1 in 1000 people)



Talk to your doctor before you stop using these patches

Press this sticky part of the patch onto the skin



Your upper body or arm





If you are using more than one patch, change all your patches
at the same time.



Do not take the patch out of its sachet until you are ready to use
it



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

Always use this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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:

If you want to stop using the patches







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




Uncommon (may affect up to 1 in 100 people)


Make sure your skin is completely dry, clean and cool before
you put the patch on

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

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.

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

The following side effects have also been reported



What do I do with my used Durogesic D-Trans Patches?


Always keep used and unused patches safely out of the sight
and reach of children.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine shows any signs of deterioration, you should
seek the advice of your pharmacist who will tell you what to do.

Very common (may affect more than 1 in 10 people)

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

Like all medicines, you should always keep used and unused
Durogesic D-Trans Patches safely out of the sight and reach of
children. Keep Durogesic D-Trans Patches dry. Store in the
original package.

Handling the patch
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 pouch and putting the pouch in
the bin with your household rubbish. Accidental exposure to used
and unused patches particularly in children may be fatal.