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DUROGESIC DTRANS 25MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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Durogesic® DTrans® 25 micrograms/hour Transdermal Patch
(fentanyl)
PATIENT INFORMATION LEAFLET
Durogesic DTrans Patch is available in the following strengths: 12 micrograms/hour,
25 micrograms/hour, 50 micrograms/hour, 75 micrograms/hour and 100 micrograms/hour.
This leaflet only applies to the 25 micrograms/hour Durogesic DTrans Patch.
Important things you need to know about Durogesic DTrans Patch

The Durogesic DTrans Patch contains a strong pain killer

Ensure that the old Durogesic DTrans Patch is removed before applying a new one

Durogesic DTrans Patch must not be cut

Do not expose the Durogesic DTrans Patch 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 Durogesic DTrans Patch every
3 days (72 hours)

If your breathing becomes shallow and weak take the Durogesic DTrans 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
1.
2.
3.
4.
5.
6.
1.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Durogesic DTrans Patch.

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 Patch.

Using Durogesic DTrans Patch and drinking alcohol
Do not drink alcohol unless you have talked to your doctor first.

Durogesic DTrans Patch 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 Patch if you are pregnant, think you may be
pregnant or might become pregnant. Durogesic DTrans Patch 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 Patch. 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.

this leaflet
What Durogesic DTrans Patch is and what it is used for
Before you use Durogesic DTrans Patch
How to use Durogesic DTrans Patch
Possible side effects
How to store Durogesic DTrans Patch
Further information

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines

Durogesic DTrans Patch 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 using this
medicine.

WHAT DUROGESIC DTRANS PATCH IS AND WHAT IT IS USED FOR

The name of your medicine is Durogesic DTrans 25 micrograms/hour Transdermal Patch. It is called
Durogesic DTrans Patch in this leaflet.
The Durogesic DTrans Patch helps to 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 medicine passes slowly into your body through your skin.

2.

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 Patch. 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 Patch
you need.

BEFORE YOU USE DUROGESIC DTRANS PATCH

Durogesic DTrans Patch can be used in children aged 2 to 16 years who have previously used opioid
painkillers. If the Durogesic DTrans Patch has been prescribed for your child, the ‘you’ stated
everywhere below should be read as ‘your child’.

3.

Do not use Durogesic DTrans Patch if:

Using and changing the Durogesic DTrans Patch





You are allergic to fentanyl, Durogesic DTrans Patch or anything in Durogesic DTrans Patch (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 Patch.






Warning and precaution



Durogesic DTrans Patch 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 Patch can have life-threatening side effects in persons who are not using
prescribed opioid medicines on a regular basis.



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 Patch

Like some other strong painkillers, Durogesic DTrans Patch 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
Patch) 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 Patch, tell your doctor as this may affect
the way the medicine passes through your skin

Don’t expose the Durogesic DTrans 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 Durogesic
DTrans Patch

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 Patch

Like many other strong painkillers, repeated use of the Durogesic DTrans Patch 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 Patch 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 Patch.



Change your patch at the same time on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the Durogesic DTrans Patch
Adults


Apply the Durogesic DTrans Patch on a flat part of your upper body or arm

Children






Always apply the Durogesic DTrans 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 Durogesic DTrans Patch remains stuck to the skin
It is important that your child does not remove the Durogesic DTrans Patch and put it in their
mouth as this could be life-threatening or even fatal
It may take some time before the Durogesic DTrans Patch becomes fully effective. Therefore, your
child might need additional painkillers until the Durogesic DTrans Patch becomes effective. Your
doctor will advise you on this if it is needed
Children should be monitored very closely for 48 hours after:

The first Durogesic DTrans Patch has been put on

A higher dose Durogesic DTrans Patch has been put on

For




you or your child, do not apply the Durogesic DTrans 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 Durogesic DTrans Patch on the
same area of skin.

Putting a Durogesic DTrans Patch on
Step 1: Preparing the skin




Other makes of Durogesic DTrans Patch

There are other makes of fentanyl transdermal patch available, but they are not all the same. If your
Durogesic DTrans Patch looks different from one you have used before you should check with your
doctor or pharmacist before using it.



Make sure your skin is completely dry, clean and cool before you put the Durogesic DTrans 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
Durogesic DTrans Patch
Do not stick a Durogesic DTrans Patch on straight after a hot bath or shower

Step 2: Open the pouch

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 Patch 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
Patch 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

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

Patch sticking to another person

Taking other medicines

HOW TO USE DUROGESIC DTRANS PATCH

Always use this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.





Each Durogesic DTrans 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 Durogesic DTrans Patch)










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

Page 1 of 2

Step 3: Peel and press






Make sure that the Durogesic DTrans 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 Durogesic DTrans
Patch. Try not to touch the sticky side of the Durogesic DTrans Patch
Press this sticky part of the Durogesic DTrans Patch onto the skin
Remove the other part of the backing and press the whole Durogesic DTrans 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 Durogesic DTrans Patch




As soon as you take a Durogesic DTrans 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 Durogesic DTrans Patch contains some medicine which may harm children and may be
fatal, so keep your used Durogesic DTrans Patch out of the sight and reach of children

Step 5: Wash


Wash your hands afterwards with clean water





It may take up to a day before your first Durogesic DTrans Patch is working completely
Your doctor may give you extra painkillers for the first day or so
After this, the Durogesic DTrans 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 Durogesic DTrans Patch



If you forget, change your Durogesic DTrans Patch as soon as you remember and make a note of
the day and time. Change the Durogesic DTrans Patch again after 3 days (72 hours) as usual
If you are very late changing your Durogesic DTrans Patch, you should talk to your doctor because
you might need some extra painkillers, but do not apply an extra Durogesic DTrans patch

If you use too many Durogesic DTrans Patch or the wrong strength Durogesic
DTrans Patch

If you have stuck on too many Durogesic DTrans Patch or the wrong strength Durogesic DTrans patch,
take the Durogesic DTrans Patch 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.

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






If a Durogesic DTrans 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 Durogesic DTrans Patch as usual
If your Durogesic DTrans Patch keeps falling off, talk to your doctor, nurse or pharmacist

If a Durogesic DTrans Patch sticks to another person (See also section 2 above)




Only use the Durogesic DTrans Patch on the skin of the person who it was prescribed for
Make sure the Durogesic DTrans Patch does not get rubbed off and sticks to your partner or child,
especially while sharing a bed or in close contact
If a Durogesic DTrans Patch accidentally sticks to another person, take it off straight away and
seek immediate medical attention

How long will you use the Durogesic DTrans Patch for?

Durogesic DTrans Patch is for long-term pain. Your doctor will be able to tell you how long you can
expect to use the Durogesic DTrans Patch.

If your pain gets worse



If your pain gets worse while you are using the Durogesic DTrans Patch, your doctor may try a
higher strength Durogesic DTrans Patch, or give you extra painkillers (or both)
If increasing the strength of the Durogesic DTrans Patch does not help, your doctor may stop the
Durogesic DTrans Patch

If you want to stop using the Durogesic DTrans Patch




Talk to your doctor before you stop using the Durogesic DTrans Patch
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 Durogesic DTrans Patch, don’t start again without asking your doctor first.
You might need a different Durogesic DTrans Patch strength when you restart

Everyday activities while using the Durogesic DTrans Patch






The Durogesic DTrans Patch is waterproof
You can shower or bathe while wearing a Durogesic DTrans Patch, but do not scrub the Durogesic
DTrans Patch itself
If your doctor agrees, you can exercise or play sport while wearing the Durogesic DTrans Patch
You can also swim while wearing the Durogesic DTrans Patch, but:

Don’t use hot whirlpool spa baths

Don’t put a tight or elasticated band over the Durogesic DTrans Patch
Don’t expose the Durogesic DTrans 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 Patch can cause side effects, although not everybody gets them.

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

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):







If a Durogesic DTrans Patch falls off


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)

Common side effects (probably affecting up to 1 in 10 people):

More about using Durogesic DTrans Patch
How quickly will the Durogesic DTrans Patch work?








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 Patch 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 Patch, 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 PATCH

How long to keep Durogesic DTrans Patch for

Do not use Durogesic DTrans Patch 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 Durogesic DTrans Patch is out of date, take
them to your pharmacy.
If your doctor has told you that you no longer need to use the Durogesic DTrans Patch, take any
unused Durogesic DTrans Patch to your pharmacy.
If your Durogesic DTrans Patch appears to be discoloured or show any other signs of deterioration,
please return to your pharmacist who will advise you further.

Where you should keep the Durogesic DTrans Patch

Keep all Durogesic DTrans Patch (used and unused) out of the sight and reach of children. This
medicinal product does not require any other special storage conditions.
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.

6.

FURTHER INFORMATION

The active substance in Durogesic DTrans Patch is fentanyl. Each transdermal patch contains
4.2 milligrams of fentanyl (absorption rate approx 25 micrograms/hour: active surface area 10.5cm2).
The other ingredients are polyacrylate adhesive, polyethylene terephthalate/ethyl vinyl acetate film,
red printing ink and siliconised polyester film.

Take the Durogesic DTrans 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 Patch 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.

What a Durogesic DTrans Patch looks like and contents of the pack

The following side effects have also been reported

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

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

PL No: 21828/0343





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

Durogesic DTrans Patch is a rectangular shaped, clear, patch with Durogesic® 25µg fentanyl/h printed
in red on one side with a sticky back so that it can be stuck onto the skin.
The Durogesic DTrans Patch usually comes in cartons containing five Durogesic DTrans Patch, but your
doctor will have prescribed the number and strength of Durogesic DTrans Patch which is best for you.

Manufacturer

Durogesic DTrans Patch is manufactured by: Janssen-Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.

CD

Durogesic® and DTrans® are registered trademarks of Janssen-Cilag.
For information in large print, tape, CD or Braille, telephone 01302 365000 and ask for the
Regulatory Department.
The leaflet revision date is: 31.07.14

Uncommon (affects fewer than 1 in 100 people):









POM

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
Page 2 of 2

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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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