DUROGESIC DTRANS 12 MICROGRAMS PER HOUR TRANSDERMAL PATCH

Active substance: FENTANYL

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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):


Feeling or being sick



Constipation, diarrhoea



Itching



Headache





If your doctor has told you that you no longer need to use the
patches, take any unused patches to your pharmacy.



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.

Allergic reaction

6. Further information

Loss of appetite, stomach pain

What Durogesic DTrans Patches contains



Not being able to sleep, drowsiness, tiredness, feeling weak





Feeling worried or depressed, hallucinations (seeing, feeling or
hearing things that are not there), dizziness,
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):



Durogesic DTrans patches contain 2.1mg of fentanyl and gives
a dose of 12 micrograms of fentanyl every hour. The active
surface area of Durogesic Durogesic Dtrans Patches is
5.25cm2.
Durogesic DTrans patches also contain the following inactive
ingredients: polyacrylate adhesive, polyethylene terephthalate/
ethyl vinyl acetate copolymer, orange printing ink and
siliconised polyester film.

Important things you need to know about Durogesic DTrans
transdermal patches




Do not expose the patches to a heat source (such as a hot
water bottle)



If your breathing becomes shallow and weak take the patch off
and seek medical help



Keep this leaflet. You may need to read it again



Brain tumours



If you have any further questions, ask your doctor, nurse or
pharmacist



Persistent headaches or a head injury

Durogesic DTrans Patches are available in packs of 5 patches.
Product Licence holder



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

Tiny pupils



Feeling giddy

Manufacturer



Bluish colouration of the skin, eczema and/or other skin
disorders including dermatitis where the patch is placed

This product is manufactured by Janssen Pharmaceutica NV,
Turnhoutseweg 30, B-2340 Beerse, Belgium.
POM

1. What Durogesic DTrans patches are and what they are used for

PL No: 19488/1316

Leaflet revision date: 28 November 2013

3. How to use Durogesic DTrans patches

Durogesic is a registered trade mark of Janssen-Cilag, UK.

4. Possible side effects
5. How to store Durogesic DTrans patches

S1316 LEAFLET Durogesic 20131128.doc

6. Further information

1. What Durogesic DTrans Patches are and what they are used
for

If you get any of these side effects, tell your doctor, nurse or
pharmacist.

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)

By reporting side effects, you can help provide more information on
the safety of this medicine.



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

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 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

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:

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.



Other medicines for pain, such as other opioid painkillers
(buprenorphine, nalbuphine or pentazocine)



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.

5. How to store Durogesic DTrans Patches



2. Before you use Durogesic DTrans patches

The name of your medicine is Durogesic DTrans transdermal patch.
It is called ‘Durogesic DTrans patch’ or just ‘patch’ in this leaflet.

Reporting of side effects

Your doctor might need to check you more closely.

In this leaflet

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

Check with your doctor or pharmacist before using this
medicine if you have ever had:

Durogesic DTrans patches are rectangular shaped, clear patches
with a sticky back with 'Durogesic 12μg fentanyl/h' in orange
marked on the front. The patches are individually packed in a
pouch.



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.



Problems with your heart or blood pressure and blood
volume, liver or kidneys

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

There have been reports of newborn infants experiencing
withdrawal effects after their mothers have used Durogesic DTrans
for a long time during pregnancy.

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

Problems with your lungs or breathing

Sensation of pins and needles

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.







If you get any of these side effects, tell your doctor, nurse or
pharmacist.

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

Follow the dosage instructions carefully and only change your
patch every 3 days (72 hours)



Keep moving and talking as much as possible



If you develop a fever tell your doctor immediately



Call a doctor, or go to your nearest hospital, straight away



Patches must not be cut



Take the patch off





Confusion

Drug withdrawal effects (such as sickness, feeling sick,
diarrhoea, anxiety or shivering), flu-like symptoms.



These patches contain a strong pain killer
Ensure that old patches are removed before applying a new
one

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 lifethreatening 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:

The rest of this leaflet includes more detail and other important
information on the safe and effective use of this medicine.

What Durogesic DTrans Patches looks like and contents of the
pack







DUROGESIC DTRANS 12 micrograms per hour
TRANSDERMAL PATCH
(fentanyl)







Take special care with Durogesic DTrans patches

Where you should keep the patches



Shaking, decreased feeling or sensitivity, especially in the skin

PACKAGE LEAFLET: INFORMATION FOR THE USER

If the patch becomes discoloured or shows any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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



S1316 LEAFLET Durogesic 20131128.doc

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



 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

Medicines used to treat an irregular heart beat, such as
amiodarone, diltiazem or verapamil

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 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.

 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:

More about using Durogesic DTrans patches

4. Possible side effects

How quickly will the patches work?

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.



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



The same place twice in a row.

If you forget to change your patch



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

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



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

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.



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.

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

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


If you use too many patches or the wrong strength patch

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.

Pregnancy and breast-feeding

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.

Step 1: Preparing the skin

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)

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



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





Take the patch out and use straight away

Always change your patch at the same time of day every 3
days (72 hours)



Keep the empty pouch to dispose of the used patch later



If you are using more than one patch, change all your patches
at the same time



Use each patch once only



Do not take the patch out of its pouch until you are ready to use
it




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

Change your patch at
the same time on

Monday

Thursday

Tuesday

Saturday

Thursday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the patch

Dizziness, drowsiness or not being able to sleep



Headache





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

Adults

Step 4: Disposing of the patch

 Apply the patch on a flat part of your upper body or arm
Children



As soon as you take a patch off, fold it firmly in half so that the
sticky side sticks to itself

 Always apply the patch to the upper back to make it difficult
for your child to reach it or take it off



Your child’s upper back

Leave another 3 days (72 hours) before changing the new
patch as usual

 Every so often check that the patch remains stuck to the skin



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

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

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)

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?



Sensation of pins and needles, shaking, feeling giddy



Muscle spasms



Stomach ache, indigestion, difficulty passing urine

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



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



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, especially in bed



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



Put it back in its original pouch and put the pouch in the bin with
your household rubbish

 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

Your upper body or arm




Inspect the patch for any damage

Sunday

Friday



Friday

Wednesday

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




Grasp both sides of the opened pouch and pull apart

Convulsions, fits or seizures. This affects less than 1 in 100
people.



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:











There is enough medicine in each patch to last 3 days (72
hours)

These may be signs of a severe allergic reaction. This only
happens in a small number of people

The following side effects have also been reported

Each patch is sealed in its own pouch



Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin.

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

 Do not stick a patch on straight after a hot bath or shower
Step 2: Open the pouch


Feeling unusually drowsy, breathing more slowly or weakly than
expected.

Don’t put a tight or elasticated band over the patch

Don’t expose the patch to direct heat such as heating pads, hotwater 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.

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



Body temperature changes



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

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


Tiny pupils



Incomplete obstruction of the small or large intestine

Expand view ⇕

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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