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DUROGESIC DTRANS 100 MICROGRAMS PER HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL

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

S888-891 LEAFLET Durogesic 20160413

PACKAGE LEAFLET: INFORMATION FOR THE USER

Transdermal Patch
Durogesic®

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

Durogesic®



Once the pouch is opened the patch must be used straight
away.



Do not use Durogesic 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If they are out of date then take them to your pharmacy.



If your doctor has told you that you no longer need to use
Durogesic Patches then you must take any unused patches to
your pharmacy.

Where should I keep Durogesic Patches?


Like all medicines, you should always keep used and unused
Durogesic Patches safely out of the sight and reach of children.



Keep Durogesic Patches dry. Do not store above 25°C.

Durogesic® DTrans® 100 micrograms per hour
(fentanyl)

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.



Each Durogesic 25 micrograms per hour Transdermal Patch
contains 4.2 mg of fentanyl (absorption rate approximately
25 mcg/ hr : Active surface area 10.5 cm2).



Each Durogesic 50 micrograms per hour Transdermal Patch
contains 8.4 mg of fentanyl (absorption rate approximately
50 mcg/ hr : Active surface area 21.0 cm2).



Each Durogesic 75 micrograms per hour Transdermal Patch
contains 12.6 mg of fentanyl (absorption rate approximately
75 mcg/ hr : Active surface area 31.5 cm2).





Each Durogesic 100 micrograms per hour Transdermal Patch
contains 16.8 mg of fentanyl (absorption rate approximately
100 mcg/ hr : Active surface area 42.0 cm2).
Durogesic Patches also contains the following inactive
ingredients: polyacrylate adhesive, polyethylene terephthalate/
ethylene vinyl acetate film, red/green/blue/grey printing ink and
siliconised polyester film.

What Durogesic DTrans Patches looks like and contents of the
pack
Each Durogesic 25 micrograms per hour Transdermal Patch is
rectangular shaped, clear patch with a sticky back with 'Durogesic
25ug fentanyl/h' in red marked on the back.
Each Durogesic 50 micrograms per hour Transdermal Patch is
rectangular shaped, clear patch with a sticky back with 'Durogesic
50ug fentanyl/h' in green marked on the back.
Each Durogesic 75 micrograms per hour Transdermal Patch is
rectangular shaped, clear patch with a sticky back with 'Durogesic
75ug fentanyl/h' in blue marked on the back.
Each Durogesic 100 micrograms per hour Transdermal Patch is
rectangular shaped, clear patch with a sticky back with 'Durogesic
100ug fentanyl/h' in grey marked on the back.
Durogesic DTrans Patches are available in packs of 5 patches for
all strengths.

This product is manufactured by Janssen-Pharmaceutica N.V.,
Turnhoutseweg 30, 2340 Beerse, Belgium.
POM
PL. 19488/0888
PL. 19488/0889
PL. 19488/0890
PL. 19488/0891

Durogesic DTrans 25 micrograms
per hour Transdermal Patch
Durogesic DTrans 50 micrograms
per hour Transdermal Patch
Durogesic DTrans75 micrograms per
hour Transdermal Patch
Durogesic DTrans 100 micrograms
per hour Transdermal Patch

Leaflet revision date: 13 April 2016
Durogesic® is a registered trade mark of Janssen-Cilag Ltd.
D-Trans is a registered trade mark of Alza Corp, USA.
For information in large print, tape, CD or Braille, telephone
02087997607.
S888-891 LEAFLET Durogesic 20160413

Keep moving and talking as much as possible



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

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

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 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

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



In this leaflet

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

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:

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



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

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



Medicines for helping you sleep

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.



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

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:




Some antihistamines (especially ones that make you sleepy)

You are allergic to fentanyl, Durogesic or anything in Durogesic
DTrans patches (listed in section 6 overleaf)





Some antibiotics used to treat infection, such as erythromycin,
clarithromycin or troleandomycin

You have pain which lasts only for a short period





Your child who is in pain is under 2 years old

Medicines used to treat fungal infection, such as itraconazole,
ketoconazole, fluconazole or voriconazole



Your child has not been treated with strong painkillers such as
morphine



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

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.



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)




Manufacturer

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





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



Keep this leaflet. You may need to read it again

2. Before you use Durogesic DTrans patches

What Durogesic DTrans Patches contain

Take the patch off



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

6. Further information



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

Important things you need to know about Durogesic DTrans
transdermal 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:



Transdermal Patch

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.

DTrans® 75 micrograms per hour
Transdermal Patch

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.

How long should I keep my Durogesic Patches?

DTrans® 50 micrograms per hour
Transdermal Patch

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

5. How to store Durogesic DTrans patches



Durogesic® DTrans® 25 micrograms per hour

Like many other strong painkillers, repeated use of the patches may
make you become tolerant to the medicine or become dependent
on it.

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

Take special care with Durogesic DTrans patches

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.

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

Putting a patch on

If a patch sticks to another person (See also section 2 above)



Feeling nervous, worried or depressed

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.

Step 1: Preparing the skin



Only use the patch on the skin of the person who it was
prescribed for



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



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



Sensation of pins and needles, shaking, feeling giddy



Muscle spasms

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.



Stomach ache, indigestion, difficulty passing urine



Diarrhoea



Feeling cold, excessive sweating

How long will you use the patches for?



General feelings of discomfort, tiredness, weakness

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.



Swelling of hands, ankles or feet



Itchy skin, rashes or redness of the skin

If your pain gets worse

Uncommon (affects fewer than 1 in 100 people):

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.



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)

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.



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:

Feeling agitated, disorientated, excited or unusually carefree

Take the patch out and use straight away





Loss of memory



Keep the empty pouch to dispose of the used patch later

If you have been using them for some time your body may have
got used to them. Stopping suddenly may make you feel unwell





Use each patch once only

Eczema and/or other skin disorders including dermatitis where
the patch is placed



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



Disorders of sexual function



Complete obstruction of the intestine



Inspect the patch for any damage

Everyday activities while using the patches



Muscle twitching



Do not use the patch if it has been divided, cut or looks
damaged





Fever, body temperature changes



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

Never divide or cut the patch



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

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday





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, 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.

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


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

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

If you forget to change your patch



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:

If you use too many patches or the wrong strength 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 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


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



It may take up to a day before your first patch is working
completely



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

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

Wash your hands afterwards with clean water



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



Step 5: Wash

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

Sensitive areas that you move a lot, skin with cuts, spots or
other skin blemishes

If your doctor agrees, you can exercise or play sport while
wearing the patch

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


Tiny pupils



Incomplete obstruction of the small or large intestine

The following side effects have been reported during clinical
trials in children (up to 18 years of age):
Very common side effects (probably affecting more than 1 in
10 people):


Headache



Feeling or being sick



Constipation, diarrhoea



Itching



Saturday

The same place twice in a row.



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

Wednesday



You can shower or bathe while wearing a patch, but do not
scrub the patch itself

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.

Friday





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

Tuesday

 A higher dose patch has been put on
For you or your child, do not apply the patch on:

The patches are waterproof



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

The first patch has been put on

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

4. Possible side effects







Step 4: Disposing of the patch

Thursday



Blurred vision

If you want to stop using the patches


Monday



Decreased feeling of sensitivity, especially in the skin



Bluish colouration of the skin

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



Low blood pressure







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

Slow heart rate



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



Change your patch at
the same time on

Adults

Flu-like symptoms



Talk to your doctor before you stop using these patches

Apply your patch on

Where to apply the patch





Step 3: Peel and press

You should change your patch every third day, unless your
doctor has told you differently

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)

Grasp both sides of the opened pouch and pull apart

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



If a patch accidentally sticks to another person, take it off
straight away and seek immediate medical attention





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





3. How to use Durogesic DTrans patches





Sudden swelling of the face or throat, severe irritation,
reddening or blistering of your skin.
These may be signs of a severe allergic reaction. This only
happens in a small number of people



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



Reduced consciousness or loss of consciousness. These affect
fewer than 1 in 100 people

The following side effects have also been reported
Very common (affects more than 1 in 10 people):


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



Dizziness, drowsiness or not being able to sleep



Headache

Common (affects fewer than 1 in 10 people):


Allergic reaction



Awareness of unusual heart beats (also called palpitations), fast
heart rate



High blood pressure



Loss of appetite or dry mouth



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.

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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