DUROGESIC D-TRANS 25 MICROGRAMS/HR TRANSDERMAL PATCH

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.

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.





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 If they are out of date then take them to your pharmacy.
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.

Where should I keep Durogesic D-Trans Patches?


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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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)

Manufacturer
This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
POM
PL. 19488/0642 Durogesic D-Trans 25 micrograms/hr Transdermal
Patch
PL. 19488/0643 Durogesic D-Trans 50 micrograms/hr Transdermal
Patch
PL. 19488/0644 Durogesic D-Trans 75 micrograms/hr Transdermal
Patch
PL. 19488/0645 Durogesic D-Trans 100 micrograms/hr
Transdermal Patch

5. How to store Durogesic DTrans patches
How long to keep Durogesic DTrans Patches for

S642-5 LEAFLET Durogesic 20160627

Leaflet revision date: 27 June 2016
Durogesic® is a registered trade mark of Janssen-Cilag Ltd.
D-Trans is a registered trade mark of Alza Corp, USA.
For information in large print, tape, CD or Braille, telephone
02087997607.
S642-5 LEAFLET Durogesic 20160627

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


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.

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.
6. Further information
What Durogesic DTrans Patches contain






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.
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 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.

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
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 long-lasting.
Durogesic DTrans patch contains a medicine called fentanyl. It
belongs to a group of strong painkillers called opioids. The patches
come in five strengths. The medicine passes slowly into your body
through your skin.

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)



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.

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

Warning and precaution



Medicines used to treat HIV infection, such as ritonavir or
nelfinavir

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



Durogesic DTrans is a medicinal product that could be lifethreatening 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.



Medicines used to treat an irregular heart beat, such as
amiodarone, diltiazem or verapamil



Rifampicin (for treatment of TB)



Durogesic DTrans can have life-threatening side effects in
persons who are not using prescribed opioid medicines on a
regular basis.



Some medicines used to treat epilepsy (such as
carbamazepine, phenobarbital or phenytoin)

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.

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

Putting a patch on

If a patch sticks to another person (See also section 2 above)

Feeling nervous, worried or depressed

Step 1: Preparing the skin





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.

Only use the patch on the skin of the person who it was
prescribed for





Confusion, hallucinations (seeing, feeling or hearing things that
are not there)

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



Sensation of pins and needles, shaking, feeling giddy



Muscle spasms

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.



Stomach ache, indigestion, difficulty passing urine



Diarrhoea



Feeling cold, excessive sweating

How long will you use the patches for?



General feelings of discomfort, tiredness, weakness

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.



Swelling of hands, ankles or feet



Itchy skin, rashes or redness of the skin

Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant or breast-feeding.



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

Driving and using machines



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

Durogesic DTrans patches can make you drowsy. If this happens,
do not drive or use any tools or machines.



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)

This medicine can affect your ability to drive as it may make you
sleepy or dizzy.


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



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



Inspect the patch for any damage

Everyday activities while using the patches



Muscle twitching



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



The patches are waterproof



Fever, body temperature changes



You can shower or bathe while wearing a patch, but do not
scrub the patch itself



Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering)



If your doctor agrees, you can exercise or play sport while
wearing the patch



You can also swim while wearing the patch, but:

Rare side effects (probably affecting fewer than 1 in 1,000
people):



Don’t use hot whirlpool spa baths



Tiny pupils



Don’t put a tight or elasticated band over the patch



Incomplete obstruction of the small or large intestine



Never divide or cut the patch



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



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



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



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



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



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

Don’t expose the patch to direct heat such as heating pads, hotwater 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.

Step 4: Disposing of the patch

4. Possible side effects



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

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.

Apply your patch on

Change your patch at
the same time on



Put it back in its original pouch and put the pouch in the bin with
your household rubbish

Monday

Thursday



Tuesday

Friday

Wednesday

Saturday

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

Thursday

Sunday

Friday

Monday

Step 5: Wash

Saturday

Tuesday



Sunday

Wednesday
How quickly will the patches work?




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

Wash your hands afterwards with clean water

More about using Durogesic DTrans patches

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

Bluish colouration of the skin



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

Press this sticky part of the patch onto the skin









 Apply the patch on a flat part of your upper body or arm
Children

Blurred vision

Use each patch once only

Always remove the old patch before applying a new one

Adults

Decreased feeling of sensitivity, especially in the skin







Where to apply the patch

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

Low blood pressure



Keep the empty pouch to dispose of the used patch later

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

The following table shows you which day of the week to change
your patch:



Slow heart rate









Talk to your doctor before you stop using these patches

Flu-like symptoms



Take the patch out and use straight away

Step 3: Peel and press

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



If increasing the strength of the patch does not help, your doctor
may stop the patches

Uncommon (affects fewer than 1 in 100 people):

Grasp both sides of the opened pouch and pull apart



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

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)



3. How to use Durogesic DTrans patches





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.

If a patch accidentally sticks to another person, take it off
straight away and seek immediate medical attention

If your pain gets worse



Do not drive while taking this medicine until you know how it
affects you.







It may take up to a day before your first patch is working
completely

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



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

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 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):



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



If you forget to change your patch



Confusion

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





Sensation of pins and needles

Very common (affects more than 1 in 10 people):



Tiny pupils



Feeling sick (nausea) or being sick (vomiting), constipation



Feeling giddy



Dizziness, drowsiness or not being able to sleep





Headache

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.





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



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


You should allow several days to pass before you put a new
patch on the same area of skin

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

The following side effects have also been reported

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

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.