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DUROGESIC DTRANS 12 MICROGRAMS PER HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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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.

S1316 LEAFLET Durogesic 20170425

PACKAGE LEAFLET: INFORMATION FOR THE USER

DUROGESIC® DTRANS® 12 micrograms per hour
TRANSDERMAL PATCH
(fentanyl)

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

Important things you need to know about Durogesic DTrans
transdermal patches

PL: 19488/1316



These patches contain a strong pain killer



Ensure that old patches are removed before applying a new
one

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.



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

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

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

Leaflet revision date: 25 April 2017

D-Trans is a registered trade mark of Alza Corp, USA.
S1316 LEAFLET Durogesic 20170425

Take special care with Durogesic DTrans
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.
Side effects and Durogesic DTrans


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:



Keep this leaflet. You may need to read it again



Take the patch off



If you have any further questions, ask your doctor, pharmacist
or nurse



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



Keep the person moving and talking as much as possible



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 a fever while using Durogesic DTrans, tell your doctor
- this may increase the amount of medicine that passes through
your skin

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.



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.

What is in this leaflet
1

What Durogesic DTrans is and what it is used for

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

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

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 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.

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.

Durogesic DTrans contains a medicine called fentanyl.

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.

It belongs to a group of strong painkillers called opioids.

In particular, tell your doctor or pharmacist if you are taking:

2



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).

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 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 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.

Adults and Children:

How long will you use the patches for?



Stomach pain or indigestion

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.



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
Operations

Step 1: Preparing the skin

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



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



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

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

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.

Step 2: Open the sachet

If you forget to change your patch



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)

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.


Driving and using machines

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

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



Your child’s upper back



Constricted pupils (miosis)



Stopping breathing from time to time (apnoea)

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

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.



Grasp both sides of the opened sachet and pull apart



Take the patch out and use straight away



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



Keep the empty sachet to dispose of the used patch later



Use each patch once only



It is an offence to drive if this medicine affects your ability to
drive.



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

If you want to stop using the patches


Talk to your doctor before you stop using these patches



However, you would not be committing an offence if:



Inspect the patch for any damage



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



The medicine has been prescribed to treat a medical or
dental problem and



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



You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and



Never divide or cut the patch



It was not affecting your ability to drive safely

Step 3: Peel and press

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.

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



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

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:

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

More about using Durogesic DTrans

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)



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

Step 5: Wash

Possible side effects

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.


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

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



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.)

Change your patch on

Monday

Thursday

Tuesday

Friday



The patches are waterproof

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

Wednesday

Saturday



Nausea, vomiting, constipation

Sunday

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



Thursday

Feeling sleepy (somnolence)

Friday

Monday



Feeling dizzy

Saturday

Tuesday

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




Headache

Sunday

Wednesday

Where to apply the patch
Adults


The following side effects have also been reported

Everyday activities while using the patches





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

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.



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



If the patch becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

Where you should keep the patches


Keep all patches (used and unused) out of the sight and reach
of children. This medicinal product does not require any other
special storage conditions.

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

Contents of the pack and other information

Loss of appetite



Difficulty sleeping



Depression





Feeling anxious or confused



Seeing, feeling, hearing, or smelling things that are not there
(hallucinations)

Durogesic DTrans patches also contain the following inactive
ingredients: polyacrylate adhesive, polyethylene terephthalate/
ethyl vinyl acetate copolymer, orange printing ink and
siliconised polyester film.



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



Muscle tremors or spasms



Your doctor may give you other painkillers as well for the first
day or so



Unusual feeling in the skin, such as tingling or crawling feelings
(paraesthesia)



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



Spinning sensation (vertigo)



Heart beat feels fast or uneven (palpitations, tachycardia)



High blood pressure



Being short of breath (dyspnoea)



Diarrhoea



Dry mouth

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



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.



How to store Durogesic DTrans

Durogesic DTrans patches contain 2.1mg of fentanyl and gives
a dose of 12 micrograms of fentanyl every hour. The active
surface area of Durogesic Durogesic Dtrans Patches is
5.25cm2.



A higher dose patch has been put on

5



How quickly will the patches work?



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

What Durogesic DTrans Patches contains

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

The first patch has been put on

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.

Allergic reaction





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



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

Watch your child very closely for 48 hours after:

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.

Common (may affect up to 1 in 10 people)





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

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

Apply your patch on



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.

Reporting of side effects

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





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

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

Using and changing the patches

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

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

4

Step 4: Disposing of the patch





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



Uncommon (may affect up to 1 in 100 people)

What Durogesic DTrans Patches looks like and contents of the
pack
Durogesic DTrans patches are rectangular shaped, clear patches
with a sticky back with 'Durogesic 12μg fentanyl/h' in orange
marked on the front. The patches are individually packed in a
pouch.
Durogesic DTrans Patches are available in packs of 5 patches.

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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