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DUROGESIC DTRANS 12MICROGRAMS/HR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Durogesic® DTrans®
12 micrograms/hr transdermal patch
Durogesic® DTrans®
25 micrograms/hr transdermal patch
(fentanyl)
Important things you need to know about Durogesic DTrans
transdermal patches





These patches contain a strong pain killer
Ensure that old patches are removed before applying a new one
Patches must not be cut
Do not expose the patches to a heat source (such as a hot water
bottle)
 If you develop a fever tell your doctor immediately
 Follow the dosage instructions carefully and only change your patch
every 3 days (72 hours)
 If your breathing becomes shallow and weak take the patch off and
seek medical help
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you (or your child) only. Do not
pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
 If you get side effects talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
 The name of this medicine is Durogesic DTrans 12 micrograms/hr
transdermal patch or Durogesic DTrans 25 micrograms/hr transdermal
patch but will be referred to as Durogesic DTrans throughout the
remainder of this leaflet.
 This medicine is available in other strengths.
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
1. WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR

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 applies 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 applies 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:
- 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.

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.

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.

Durogesic DTrans contains a medicine called fentanyl.
It belongs to a group of strong painkillers called opioids.

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.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC
DTRANS
Do not use Durogesic DTrans if:
 You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6)
 You have pain which lasts only for a short period, such as sudden pain or
pain after having an operation
 You have breathing difficulties, with slow or shallow breathing.
Do not use this medicine if any of the above applies 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 regularly 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.

Your doctor will know which medicines are safe to take with Durogesic
DTrans. You may need to be closely monitored if you are taking some of
the types of medicines listed below or if you stop taking some of the types
of medicines listed below, as this may affect the strength of Durogesic
DTrans you need.
In particular, tell your doctor or pharmacist if you are taking:
 Other medicines for pain, such as other opioid painkillers (such as
buprenorphine, nalbuphine, or pentazocine)
 Medicines for helping you sleep (such as temazepam, zaleplon, or
zolpidem)
 Medicines to help you calm down (tranquillisers, such as alprazolam,
clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for
mental conditions (antipsychotics, such as aripiprazole, haloperidol,
olanzapine, risperidone, or phenothiazines)
 Medicines for relaxing your muscles (such as cyclobenzaprine or
diazepam)
 Some medicines used to treat depression called SSRIs or SNRIs (such
as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine,
paroxetine, sertraline, or venlafaxine). – see below for more information

 Some medicines used to treat depression or Parkinson’s disease called
MAOIs (such as isocarboxazid, phenelzine, selegiline, or
tranylcypromine). You should not take Durogesic DTrans within 14 days
of stopping these medicines. – see below for more information
 Some antihistamines, especially ones that make you sleepy (such as
chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or
hydroxyzine)
 Some antibiotics used to treat infection (such as erythromycin or
clarithromycin
 Medicines used to treat fungal infection (such as itraconazole,
ketoconazole, fluconazole, or voriconazole)
 Medicines used to treat HIV infection (such as ritonavir)
 Medicines used to treat an irregular heart beat (such as amiodarone,
diltiazem, or verapamil)
 Medicines to treat tuberculosis (such as rifampicin)
 Some medicines used to treat epilepsy (such as carbamazepine,
phenobarbital, or phenytoin)
 Some medicines used to treat nausea or motion sickness (such as
phenothiazines)
 Some medicines used to treat heartburn or ulcers (such as cimetidine)
 Some medicines used to treat angina (chest pain) or high blood pressure
(such as nicardipine)
 Some medicines used to treat cancer of the blood (such as idelalisib).
Durogesic DTrans with antidepressants
The risk of side effects increases if you are taking medicines such as
certain antidepressants.
Durogesic DTrans may interact with these medicines and you may
experience changes to mental status such as feeling agitated, seeing,
feeling, hearing, or smelling things that are not there (hallucinations) and
other effects such as changing blood pressure, fast heart beat, high body
temperature, overactive reflexes, lack of coordination, muscle stiffness,
nausea, vomiting and diarrhoea.
Operations
If you think that you are going to receive anaesthesia tell your doctor or
dentist that you are using Durogesic DTrans.
Durogesic DTrans 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 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
Durogesic DTrans can affect your ability to drive and use machines or tools
as it may make you sleepy or dizzy. If this happens, do not drive or use any
tools or machines.
 Do not drive while taking this medicine until you know how it affects you
 It is an offence to drive if this medicine affects your ability to drive
 However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem
and
- You have taken it according to the instructions given by the prescriber
or in the information provided with the medicine and
- It was not affecting your ability to drive safely.

Using and changing the patches
 There is enough medicine in each patch to last 3 days (72 hours)
 You should change your patch every third day, unless your doctor has
told you differently
 Always remove the old patch before applying a new one
 Always change your patch at the same time of day every 3 Days
(72 hours)
 If you are using more than one patch, change all your patches at the
same time
 Make a note of the day, date and time you apply a patch, to remind you
when you need to change your patch
 The following table shows you when to change your patch:
Apply your patch on

Change your patch on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the patch
Adults
 Apply the patch on a flat part of your upper body or arm (not over a joint).
Children
 Always apply the patch to the upper back to make it difficult for your child
to reach it or take it off
 Every so often check that the patch remains stuck to the skin
 It is important that your child does not remove the patch and put it in their
mouth as this could be life threatening or even fatal
 Watch your child very closely for 48 hours after:
- The first patch has been put on
- A higher dose patch has been put on
 It may take some time for the patch to have its maximum effect.
Therefore, your child might need to use other painkillers as well until the
patches become effective. Your doctor will talk to you about this.
Adults and Children
Do not apply the patch on:
 The same place twice in a row
 Areas that you move a lot (joints), skin that is irritated or with cuts
 Skin that is very hairy. If there is hair, do not shave it (shaving irritates the
skin). Instead, clip the hair as close to the skin as possible.
Putting a patch on
Step 1: Preparing the skin
 Make sure your skin is completely dry, clean and cool before you put the
patch on
 If you need to clean the skin, just use cold water
 Do not use soap or any other cleansers, creams, moisturisers, oils or talc
before applying the patch
 Do not stick a patch on straight after a hot bath or shower.
Step 2: Open the sachet
 Each patch is sealed in its own sachet
 Tear or cut open the sachet at the notch, shown by the arrow
 Gently tear or cut off the edge of the sachet completely (if you use
scissors, cut close to the sealed edge of the sachet to avoid damaging
the patch)

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.










Grasp both sides of the opened sachet and pull apart
Take the patch out and use straight away
Keep the empty sachet to dispose of the used patch later
Use each patch once only
Do not take the patch out of its sachet until you are ready to use it
Inspect the patch for any damage
Do not use the patch if it has been divided, cut or looks damaged
Never divide or cut the patch.

Step 3: Peel and press
 Make sure that the patch will be covered by loose clothing and not stuck
under a tight or elasticated band
 Carefully peel one half of the shiny plastic backing away from the centre
of the patch. Try not to touch the sticky side of the patch
 Press this sticky part of the patch onto the skin
 Remove the other part of the backing and press the whole patch onto the
skin with the palm of your hand
 Hold for at least 30 seconds. Make sure it sticks well, especially the
edges.
Step 4: Disposing of the patch
 As soon as you take a patch off, fold it firmly in half so that the sticky side
sticks to itself
 Put it back in its original sachet and dispose of the sachet as instructed
by your pharmacist
 Keep used patches out of sight and reach of children - even used
patches contain some medicine which may harm children and may even
be fatal.
Step 5: Wash
 Always wash your hands after you have handled the patch using clean
water only.
More about using Durogesic DTrans
Everyday activities while using the patches
 The patches are waterproof
 You can shower or bathe while wearing a patch, but do not scrub the
patch itself
 If your doctor agrees, you can exercise or play sport while wearing the
patch
 You can also swim while wearing the patch, but:
- Don’t use hot whirlpool spa baths
- Don’t put a tight or elasticated band over the patch
 While you are wearing the patch do not expose it to direct heat such as
heating pads, electric blankets, hot-water bottles, heated water beds,
heat or tanning lamps. Do not sunbathe, have long hot baths or saunas. If
you do, you may increase the amount of medicine you get from the patch.
How quickly will the patches work?
 It may take some time for your first patch to have its maximum effect
 Your doctor may give you other painkillers as well for the first day or so
 After this, the patch should help to relieve pain continuously so that you
can stop taking other painkillers. However, your doctor may still prescribe
extra painkillers from time to time.
How long will you use the patches for?
 Durogesic DTrans patches are for long-term pain.
Your doctor will be able to tell you how long you can expect to use the
patches.
If your pain gets worse
 If your pain gets worse while you are using these patches, your doctor
may try a higher strength patch, or give you additional painkillers (or both)
 If increasing the strength of the patch does not help, your doctor may
decide to stop the use of the patches.
If you use too many patches or the wrong strength patch
If you have stuck on too many patches or the wrong strength patch, take the
patches off and contact a doctor straight away.
Signs of overdose include trouble breathing or shallow breathing, tiredness,
extreme sleepiness, being unable to think clearly, walk or talk normally and
feeling faint, dizzy or confused.
If you forget to change your patch
 If you forget, change your patch as soon as you remember and make
note of the day and time. Change the patch again after 3 days
(72 hours) as usual
 If you are very late changing your patch, you should talk to your doctor
because you might need some extra painkillers, but do not apply an extra
patch.
If a patch falls off
 If a patch falls off before it needs changing, stick a new one on straight
away and make note of the day and time. Use a new area of skin on:
- Your upper body or arm
- Your child’s upper back
 Let your doctor know this has happened and leave the patch on for
another 3 days (72 hours) or as directed by your doctor, before changing
the new patch as usual
 If your patches keep falling off, talk to your doctor, pharmacist or nurse.

If you want to stop using the patches
 Talk to your doctor before you stop using these patches
 If you have been using them for some time your body may have got used
to them. Stopping suddenly may make you feel unwell
 If you stop using the patches, don’t start again without asking your doctor
first. You might need a different patch strength when you restart.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you or your partner, or carer, notice any of the following about the
person wearing the patch, take the patch off and call a doctor, or go to
your nearest hospital, straight away. You may need urgent medical
treatment.
 Feeling unusually drowsy, breathing that is more slow or shallow than
expected.
Follow the advice above and keep the person who was wearing the patch
moving and talking as much as possible. Very rarely these breathing
difficulties can be life-threatening or even fatal, especially in people who
have not used strong opioid painkillers (like Durogesic DTrans or
morphine) before. (Uncommon, this may affect up to 1 in 100 people)
 Sudden swelling of the face or throat, severe irritation, reddening or
blistering of your skin.
These may be signs of a severe allergic reaction. (frequency cannot be
estimated from the available data.)
 Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)
 Reduced consciousness or loss of consciousness. (Uncommon, these
may affect up to 1 in 100 people.)
The following side effects have also been reported
Very common (may affect more than 1 in 10 people)
 Nausea, vomiting, constipation
 Feeling sleepy (somnolence)
 Feeling dizzy
 Headache.
Common (may affect up to 1 in 10 people)
 Allergic reaction
 Loss of appetite
 Difficulty sleeping
 Depression
 Feeling anxious or confused
 Seeing, feeling, hearing, or smelling things that are not there
(hallucinations)
 Muscle tremors or spasms
 Unusual feeling in the skin, such as tingling or crawling feelings
(paraesthesia)
 Spinning sensation (vertigo)
 Heart beat feels fast or uneven (palpitations, tachycardia)
 High blood pressure
 Being short of breath (dyspnoea)
 Diarrhoea
 Dry mouth
 Stomach pain or indigestion
 Excessive sweating
 Itching, skin rash or redness of the skin
 Being unable to pass urine or empty bladder completely
 Feeling very tired, weak or generally unwell
 Feeling cold
 Swollen hands, ankles or feet (peripheral oedema).
Uncommon (may affect up to 1 in 100 people)
 Feeling agitated or disoriented
 Feeling extremely happy (euphoria)
 Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
 Loss of memory
 Blurred vision
 Slow heart beat (bradycardia) or low blood pressure
 Blue colour to the skin caused by low oxygen in the blood (cyanosis)
 Loss of contractions of the gut (ileus)
 Itchy skin rash (eczema), allergic reaction or other skin disorders where
the patch is placed
 Flu-like illness
 Feeling of body temperature change
 Fever
 Muscle twitching
 Difficulty getting and keeping an erection (impotence) or problems having
sex.

Rare side effects (may affect up to 1 in 1000 people)
 Constricted pupils (miosis)
 Stopping breathing from time to time (apnoea).

Manufactured by
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse,
Belgium.

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.

Janssen-Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

Repeated use of the patches may make the medicine become less effective
(you become ‘tolerant’ to it) or become dependent on it.
If you switch from a different painkiller to Durogesic DTrans or if you
suddenly stop using Durogesic DTrans, you may notice withdrawal effects
such as sickness, feeling sick, diarrhoea, anxiety or shivering. Tell your
doctor if you notice any of these effects.
There have been reports also of newborn infants experiencing withdrawal
effects after their mothers have used Durogesic DTrans for a long time
during pregnancy.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE DUROGESIC DTRANS
Where you should keep the patches
Keep all patches (used and unused) out of the sight and reach of children.
If your patches become discoloured or show any sign of deterioration,
return them to your pharmacist.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active substance in Durogesic DTrans patches is fentanyl.
Durogesic DTrans patches come in the following strengths.
The Durogesic DTrans 12 micrograms/hr transdermal patch contains
2.1 mg of fentanyl (absorption rate approximately 12 micrograms/hour).
Active surface area 5.25cm2.
The Durogesic DTrans 25 micrograms/hr transdermal patch contains
4.2 mg of fentanyl (absorption rate approximately 25 micrograms/hour).
Active surface area 10.5cm2.
The other ingredients are polyacrylate adhesive, polyethylene
terephthalate /ethyl vinyl acetate film, orange or red printing ink and
siliconised polyester film.
Each patch is identified using a different colour of printing ink:
Durogesic DTrans 12 micrograms/hr transdermal patch: Orange
Durogesic DTrans 25 micrograms/hr transdermal patch: Red
What Durogesic DTrans patches look like and contents of the pack
Durogesic DTrans 12 micrograms/hr transdermal patch is a rectangular
shaped, clear patch with a sticky back marked in orange ink ‘Durogesic
12 μg fentanyl/h’ on one side and plain on the other side.
Durogesic DTrans 25 micrograms/hr transdermal patch is a rectangular
shaped, clear patch with a sticky back marked in red ink ‘Durogesic 25 μg
fentanyl/h’ on one side and plain on the other side.
The patches come in cartons containing five patches, but your doctor will
have prescribed the number and strength of patches which is best for you.

Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
PL 33532/0158 Durogesic® DTrans® 12 micrograms/hr transdermal patch
PL 33532/0159 Durogesic® DTrans® 25 micrograms/hr transdermal patch
Leaflet dated 30th May 2017
Leaflet coded xxxxxxxxx

CD

POM

Durogesic® is a registered trademark of Janssen-Cilag Ltd.
DTrans® is a registered trademark of Alza Corporation.

To request a copy of this leaflet in
Braille, large print or audio please call
01922 745645 and ask for the
Regulatory Department.

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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