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DUROGESIC DTRANS 12 MICROGRAMS/HR TRANSDERMAL PATCH
Active substance(s): FENTANYL / FENTANYL / FENTANYL
Package leaflet: Information for the user
12 micrograms/hr Transdermal Patch
25 micrograms/hr Transdermal Patch
50 micrograms/hr Transdermal Patch
75 micrograms/hr Transdermal Patch
100 micrograms/hr Transdermal Patch
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
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
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
What Durogesic DTrans is and what it is used for
What you need to know before you use Durogesic DTrans
How to use Durogesic DTrans
Possible side effects
How to store Durogesic DTrans
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 12 micrograms/hr transdermal
patch, Durogesic DTrans 25 micrograms/hr transdermal patch, Durogesic DTrans
50 micrograms/hr transdermal patch, Durogesic DTrans 75 micrograms/hr
transdermal patch or Durogesic DTrans 100 micrograms/hr transdermal patch. It is
called ‘Durogesic DTrans’ or just ‘patch’ in this leaflet.
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.
Durogesic DTrans contains a medicine called fentanyl. It belongs to
a group of strong painkillers called opioids.
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 (anti-psychotics, 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
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,
Some medicines used to treat nausea or motion sickness (such as
Some medicines used to treat heartburn or ulcers (such as cimetidine).
Some medicines used to treat angina (chest pain) or high blood pressure (such
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
If you think that you are going to receive anaesthesia tell your doctor or dentist
that you are using
Durogesic DTrans and alcohol
Do not drink alcohol while using Durogesic DTrans unless you have talked to your
Durogesic DTrans can make you drowsy or breathe more slowly. Drinking alcohol
may make these effects worse.
Pregnancy and breastfeeding
Where to apply the patch
• Apply the patch on a flat part of your upper body or arm (not over a joint).
• 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
• 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
• 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
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.
Step 5: Wash
• Always wash your hands after you have handled the patch using clean water
2 What you need to know before you use Durogesic
Durogesic DTrans should not be used during pregnancy unless you have
discussed this with your doctor.
More about using Durogesic DTrans
Do not use Durogesic DTrans if:
Durogesic DTrans should not be used during childbirth as the medication can
affect the breathing of the newborn child.
Everyday activities while using the patches
• 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.
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
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 lifethreatening 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
- 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.
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
• 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.
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
3 How to use Durogesic DTrans
higher strength patch, or give you additional painkillers (or both)
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
• 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
• 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
• If your patches keep falling off, talk to your doctor, pharmacist or nurse
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
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
gives a dose of:
2.1 milligrams (mg) 12 micrograms (mcg)
of fentanyl per hour
4.2 mg fentanyl
8.4 mg fentanyl
12.6 mg fentanyl
16.8 mg fentanyl
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
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
Common (may affect up to 1 in 10 people)
• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• 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)
• 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
• 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
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
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.
How long to keep Durogesic DTrans for
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.
If your doctor has told you that you no longer need to use the patches, take any
unused patches to your pharmacy.
How to dispose of used patches or patches you no longer use
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.
The other ingredients in the patch are:
• Polyethylene terephthalate/ethyl vinyl acetate laminate
• 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/hr transdermal patch: Durogesic 12 μg
fentanyl/h in orange printing ink
• Durogesic DTrans 25 micrograms/hr transdermal patch: Durogesic 25 μg
fentanyl/h in red printing ink
• Durogesic DTrans 50 micrograms/hr transdermal patch: Durogesic 50 μg
fentanyl/h in green printing ink
• Durogesic DTrans 75 micrograms/hr transdermal patch: Durogesic 75 μg
fentanyl/h in blue printing ink
• Durogesic DTrans 100 micrograms/hr transdermal patch: Durogesic 100 μg
fentanyl/h in grey printing ink
What Durogesic DTrans looks like and contents of the pack
Each patch is a rectangular shaped, clear patch with a sticky back.
The patches come in individually wrapped heat-sealed (acrylonitrile film) pouches
and come in cartons containing five patches, but your doctor will have prescribed
the number and strength of patches which is best for you.
Product Licence Holder and Manufacturer
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager
Ginova UK Ltd, both at St James’ House, 8 Overcliffe, Gravesend, Kent, DA11
Manufactured by Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse,
Durogesic DTrans 12 micrograms/hr Transdermal Patches
PL No: 18067/0421
Durogesic DTrans 25 micrograms/hr Transdermal Patches
PL No: 18067/0422
Durogesic DTrans 50 micrograms/hr Transdermal Patches
PL No: 18067/0423
Durogesic DTrans 75 micrograms/hr Transdermal Patches
PL No: 18067/0424
Durogesic DTrans 100 micrograms/hr Transdermal Patches
PL No: 18067/0425
This leaflet was last revised on 7th April 2017.
To request a copy of this leaflet in Braille,
large print or audio, please call
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.