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DUROGESIC DTRANS 12 MCG/HR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Durogesic® DTrans® transdermal patch
Fentanyl
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
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
• 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
(see section 6 overleaf). The medicine passes slowly into your body through
your skin.

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
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.
Warning and precaution




Durogesic DTrans is a medicinal product that could be life-threatening 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.
Durogesic DTrans can have life-threatening side effects in persons who
are not using prescribed opioid medicines on a regular basis.

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.

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






Medicines used to treat an irregular heart beat, such as amiodarone,
diltiazem or verapamil
Rifampicin (for treatment of TB)
Some medicines used to treat epilepsy (such as carbamazepine,
phenobarbital or phenytoin)

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
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.
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.
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
Driving and using machines
Durogesic DTrans patches can make you drowsy. If this happens, do not drive
or use any tools or machines.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.

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.

3. How to use Durogesic DTrans patches
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
• 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 which day of the week to change your
patch:
Apply your patch on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Change your patch at
the same time on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper body or arm
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
• 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
You should allow several days to pass before you put a new patch on the
same area of skin.
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 pouch
• Each patch is sealed in its own pouch
• Tear or cut open the pouch at the notch, shown by the arrow
• 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)










Grasp both sides of the opened pouch and pull apart
Take the patch out and use straight away
Keep the empty pouch to dispose of the used patch later
Use each patch once only
Do not take the patch out of its pouch 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 pouch and put the pouch in the bin with your
household rubbish



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

Step 5: Wash
• Wash your hands afterwards with clean water
More about using Durogesic DTrans patches
How quickly will the patches work?
• It may take up to a day before your first patch is working completely
• 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
If you forget to change your patch
• 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
• 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
If a patch sticks to another person (See also section 2 above)
• Only use the patch on the skin of the person who it was prescribed for
• 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.
• If a patch accidentally sticks to another person, take it off straight away
and seek immediate medical attention
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 extra painkillers (or both)



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

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
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
• Don’t expose the patch to direct heat such as heating pads, hot-water
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.

4. Possible side effects
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.
• 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


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



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 also been reported

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


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



Dizziness, drowsiness or not being able to sleep



Headache

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



Feeling nervous, worried or depressed



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



Sensation of pins and needles, shaking, feeling giddy



Muscle spasms



Stomach ache, indigestion, difficulty passing urine



Diarrhoea



Feeling cold, excessive sweating



General feelings of discomfort, tiredness, weakness



Swelling of hands, ankles or feet



Itchy skin, rashes or redness of the skin

Uncommon (affects fewer than 1 in 100 people):


Flu-like symptoms



Slow heart rate



Low blood pressure



Decreased feeling of sensitivity, especially in the skin



Blurred vision



Bluish colouration of the skin



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



Muscle twitching



Fever, body temperature changes



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

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


Tiny pupils



Incomplete obstruction of the small or large intestine

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):


Confusion



Sensation of pins and needles



Tiny pupils



Feeling giddy



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.

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.
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.

5. How to store Durogesic DTrans patches
How long to keep Durogesic DTrans patches for
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.
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. Further information
The active substance in Durogesic DTrans patches is fentanyl.
The patches come in 5 different strengths (see table below).
Name of patch

Each patch
contains:

Each patch gives
a dose of:

Active surface
area of each
patch is:
5.25 square
centimetres (cm2)

Durogesic DTrans 12
mcg/hr transdermal
patch
Durogesic DTrans 25
mcg/hr transdermal
patch
Durogesic DTrans 50
mcg/hr transdermal
patch
Durogesic DTrans 75
mcg/hr transdermal
patch
Durogesic DTrans 100
mcg/hr transdermal
patch

2.1 milligrams
(mg) of fentanyl
4.2 mg fentanyl

12 micrograms
(mcg) of fentanyl
per hour
25 mcg per hour

8.4 mg fentanyl

50 mcg per hour

21 cm2

12.6 mg fentanyl

75 mcg per hour

31.5 cm2

16.8 mg fentanyl

100 mcg per hour

42 cm2

10.5 cm2

The other ingredients in the patch are:
• Polyester/ethyl vinyl acetate
• Polyacrylate adhesive
• Siliconised polyester film which is removed before use
Each patch is identified using a different colour of printing ink:
• Durogesic DTrans 12 mcg/hr transdermal patch:
Orange
• Durogesic DTrans 25 mcg/hr transdermal patch:
Red
• Durogesic DTrans 50 mcg/hr transdermal patch:
Green
• Durogesic DTrans 75 mcg/hr transdermal patch:
Blue
• Durogesic DTrans 100 mcg/hr transdermal patch:
Grey
What Durogesic DTrans patches look like and contents of the pack
Durogesic is a clear, rectangular patch with rounded corners, marked with the
product name, strength and a border in coloured ink. The patch has a sticky
back so that it can be stuck onto the skin.
The patches come in individually wrapped heat-sealed (acrylonitrile film)
pouches, and usually come in cartons containing five patches, but your doctor
will have prescribed the number and strength of patches which is best for you.
The product licence is held by:
JANSSEN-CILAG LTD, 50-100 Holmers Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
Durogesic DTrans patches are made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

For information in large print, tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in November 2015.

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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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