DUROGESIC DTRANS 12MICROGRAMS/HR TRANSDERMAL PATCH

Active substance: 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
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
• Durogesic DTrans transdermal patches are available in other strengths
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

• 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.

1. What Durogesic DTrans patches are and what they are used for
The name of your medicine is either Durogesic DTrans 12 micrograms/hr
transdermal patch, or Durogesic DTrans 25 micrograms/hr transdermal
patch. It is called ‘Durogesic DTrans patch’ or just ‘patch’ in this leaflet.
The patches help relieve pain that is very bad and long-lasting.
Durogesic DTrans patch contains a medicine called fentanyl. It belongs
to a group of strong painkillers called opioids. The patches come in five
strengths. The medicine passes slowly into your body through your skin.
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 lifethreatening to children, even if the patches have been used. Bear in
mind that a sticky patch could be tempting to a child and in some
cases may lead to a fatal outcome.
• 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

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

• 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)

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

Rare side effects (probably affecting fewer than 1 in 1,000 people):
• Tiny pupils
• Incomplete obstruction of the small or large intestine

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.

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.
If your patches become discoloured or show any sign of deterioration,
return them to your pharmacist.
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.
Durogesic DTrans patches come in the following strengths.

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 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 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

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.

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

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 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

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
Manufacturer
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse,
Belgium
Janssen-Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse,
Belgium
PL:33532/0158 Durogesic DTrans 12 micrograms/hr transdermal patch
PL:33532/0159 Durogesic DTrans 25 micrograms/hr transdermal patch
Leaflet date: 20th August 2014
Leaflet code: xxxxxxxxx

C.D.

Durogesic and DTrans are registered trademarks of xxxxxxxxxxx
xxxxxxxxxxxxxxx xxxxxxxxxxxxx

POM

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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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