DUROGESIC DTRANS 12 MICROGRAMS/HR TRANSDERMAL PATCH

Active substance: FENTANYL

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Assessed against UK PIL dated January 2013
504211/PL1b
PACKAGE LEAFLET: INFORMATION FOR THE USER

®

By Nafisa Potrick at

®

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
Durogesic® DTrans® 100 micrograms/hr 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 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 patch’ or just
‘patch’ in this leaflet.

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.

The patches help relieve pain that is very bad and long-lasting.

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 apply to you or your child. If you are not sure, talk to
your doctor or pharmacist before using Durogesic DTrans patches.

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.

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:








Change your patch at
the same time on

Apply your patch on
Monday



Thursday

Tuesday



Friday

Wednesday



Saturday

Thursday



Sunday

Friday





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)

Tuesday

Sunday

You should allow several days to pass before you put a new patch on the same area
of skin.

Monday

Saturday

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

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

• 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

Turn over

3. How to use Durogesic DTrans patches (continued)
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, so keep your used
patches out of the reach and sight of children
Step 5: Wash
• Wash your hands afterwards with clean water

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

• 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 sticks 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 talk to a doctor

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

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 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 less 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 less 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

Rare side effects (probably affecting less 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 less 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.

Uncommon (affects less than 1 in 100 people):
• Flu-like symptoms
• Slow heart rate
• Low blood pressure
• Decreased feeling of sensitivity, especially in the skin
• 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)

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.
If you notice any other side effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.

Where you should keep the patches

5. How to store Durogesic DTrans patches

Keep out of the sight and reach of children. This medicinal product does not require any other
special storage conditions.

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.

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:

Durogesic DTrans
12 micrograms/hr
transdermal patch

2.1 milligrams
(mg) of fentanyl

12 micrograms (mcg)
of fentanyl per hour

5.25 square
centimetres (cm2)

Durogesic DTrans
25 micrograms/hr
transdermal patch

4.2 mg fentanyl

25 mcg per hour

10.5 cm2

If you notice any sign of discolouration or deterioration of your medicine, tell your pharmacist
immediately.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.

Each patch is a rectangular shaped, clear patch with a sticky back and 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 patches look like and contents of the pack
2

Durogesic DTrans
50 micrograms/hr
transdermal patch

8.4 mg fentanyl

50 mcg per hour

21 cm

Durogesic DTrans
75 micrograms/hr
transdermal patch

12.6 mg fentanyl

75 mcg per hour

31.5 cm2

Durogesic DTrans
100 micrograms/hr
transdermal patch

16.8 mg fentanyl

100 mcg per hour

42 cm2

The other ingredients in the patch are:
• Polyethylene terephthalate/ethyl vinyl acetate laminate
• Polyacrylate adhesive
• Siliconised polyester film which is removed before use

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 0HJ.
Manufactured by Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse, B-2340, Belgium.
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
POM CD
Durogesic DTrans 100 micrograms/hr Transdermal Patches
PL No: 18067/0425
This leaflet was last revised on 2nd December 2013.
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
504211/PL1b

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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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