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DUROGESIC DTRANS 25MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL / FENTANYL

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Durogesic DTrans with antidepressants

PACKAGE LEAFLET: INFORMATION FOR THE USER

The risk of side effects increases if you are taking medicines such as certain antidepressants.
Durogesic DTrans may interact with these medicines and you may experience changes to
mental status such as feeling agitated, seeing, feeling, hearing, or smelling things that are not
there (hallucinations) and other effects such as changing blood pressure, fast heart beat, high
body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting
and diarrhoea.

Durogesic® DTrans® 25 micrograms/hour Transdermal Patch
(fentanyl)
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.

Operations

If you think that you are going to receive anaesthesia tell your doctor or dentist that you are
using Durogesic DTrans.

Important things you need to know about Durogesic DTrans
transdermal patches








Durogesic DTrans and alcohol

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

Do not drink alcohol while using Durogesic DTrans unless you have talked to your doctor first.
Durogesic DTrans can make you drowsy or breathe more slowly. Drinking alcohol may make
these effects worse.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Durogesic DTrans should not be used during pregnancy unless you have discussed this with
your doctor.

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, pharmacist or nurse
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours
• If you get side effects talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

Durogesic DTrans should not be used during childbirth as the medication can affect the
breathing of the newborn child.
Do not use Durogesic DTrans if you are breastfeeding. You should not breastfeed for 3 days
after removing your Durogesic DTrans patch. This is because the medicine may pass into breast
milk.

What is in this leaflet
1. What Durogesic DTrans is and what it is used for
2. What you need to know before you use Durogesic DTrans
3. How to use Durogesic DTrans
4. Possible side effects
5. How to store Durogesic DTrans
6. Contents of the pack and other information
1.

Driving and using machines

Durogesic DTrans can affect your ability to drive and use machines or tools as it may make you
sleepy or dizzy. If this happens, do not drive or use any tools or machines.
• 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

WHAT DUROGESIC DTRANS IS AND WHAT IT IS USED FOR

The name of your medicine is Durogesic DTrans

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while
taking this medicine.

The patches help relieve pain that is very bad and long-lasting:
• in adults who need continuous pain treatment
• in children above 2 years of age who are already using opioid medication and who need
continuous pain treatment.

3.

Durogesic DTrans contains a medicine called fentanyl.
It belongs to a group of strong painkillers called opioids.

2.

Your doctor will decide which strength of Durogesic DTrans is most suitable for you, taking into
account the severity of your pain, your general condition and type of pain treatment that you
have received so far.

WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS

Do not use Durogesic DTrans if:

Using and changing the patches

You are allergic to fentanyl or any of the other ingredients of this medicine (listed in
section 6)
• You have pain which lasts only for a short period, such as sudden pain or pain after having
an operation
• You have breathing difficulties, with slow or shallow breathing
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.










Warnings and precautions



HOW TO USE DUROGESIC DTRANS

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

Durogesic DTrans can have life-threatening side effects in people who are not already
regularly using prescribed opioid medicines.
Durogesic DTrans is a medicine that could be life-threatening to children, even if the patches
have been used. Bear in mind that a sticky patch (unused or used) could be tempting to a
child and if it sticks to a child’s skin or they put it in their mouth, the result may be fatal.

Patch sticking to another person

The patch should be used only on the skin of the person for whom it has been prescribed. There
have been reports of patches accidentally sticking to a family member while in close physical
contact or sharing the same bed as the person wearing the patch. A patch accidently sticking to
another person (particularly a child) can cause the medicine in the patch to go through the skin
of the other person and cause serious side effects such as breathing difficulties, with slow or
shallow breathing which may be fatal. In case the patch sticks to the skin of another person,
take the patch off right away and get medical attention.

Take special care with Durogesic DTrans

Talk to your doctor or pharmacist before using this medicine if any of the following apply to
you - your doctor may need to check you more closely if:
• You have ever had problems with your lungs or breathing
• You have ever had problems with your heart, liver, kidneys, or low blood pressure
• You have ever had a brain tumour
• You have ever had persistent headaches or a head injury
• You are elderly - you may be more sensitive to the effects of this medicine
• You have a condition called ‘myasthenia gravis’ in which muscles become weak and tire
easily
• You have ever abused or been dependent on alcohol, prescription medicines or illegal drugs
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
using Durogesic DTrans.
Durogesic DTrans may make you unusually drowsy, and make your breathing more slow or
shallow. Very rarely these breathing problems 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 the person wearing the patch
is unusually drowsy, with slow or shallow breathing:
• Take the patch off
• Call a doctor, or go to your nearest hospital straight away
• Keep the person moving and talking as much as possible
• If you get a fever while using Durogesic DTrans, tell your doctor - this may increase the
amount of medicine that passes through your skin
• Durogesic DTrans may cause constipation, talk to your doctor or pharmacist for advice on
how to prevent or relieve constipation
• Repeated, long term use of the patches may make the medicine less effective (you become
‘tolerant’ to it) or you may become dependent on it
See section 4 for a full list of possible side effects.

Apply your patch on

Change your patch on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

Friday

Monday

Saturday

Tuesday

Sunday

Wednesday

Where to apply the patch
Adults


Apply the patch on a flat part of your upper body or arm (not over a joint).

Children






Side effects and Durogesic DTrans


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 when to change your patch:

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.
Watch your child very closely for 48 hours after:
• The first patch has been put on
• A higher dose patch has been put on
It may take some time for the patch to have its maximum effect. Therefore, your child
might need to use other painkillers as well until the patches become effective. Your doctor
will talk to you about this.

Adults and Children:

Do not apply the patch on
• The same place twice in a row.
• Areas that you move a lot (joints), skin that is irritated or with cuts.
• 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.

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 sachet
• Each patch is sealed in its own sachet
• Tear or cut open the sachet at the notch, shown by the arrow
• Gently tear or cut off the edge of the sachet completely (if you use scissors, cut close to the
sealed edge of the sachet to avoid damaging the patch)

When you are wearing the patch do not expose it to direct heat such as heating pads,
electric blankets, hot-water bottles, heated water beds or heat or tanning lamps. Do not
sunbathe, have long hot baths or saunas or use hot whirlpool spa baths. If you do, you may
increase the amount of medicine you get from the patch.

Other medicines and Durogesic DTrans

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 if you buy any medicines
from your pharmacy.
Your doctor will know which medicines are safe to take with Durogesic DTrans. You may need to
be closely monitored if you are taking some of the types of medicines listed below or if you stop
taking some of the types of medicines listed below, as this may affect the strength of Durogesic
DTrans you need.
In particular, tell your doctor or pharmacist if you are taking:
• Other medicines for pain, such as other opioid painkillers (such as buprenorphine,
nalbuphine, or pentazocine).
• Medicines for helping you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquillisers, such as alprazolam, clonazepam, diazepam,
hydroxyzine, or lorazepam) and medicines for mental conditions (antipsychotics, such as
aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines for relaxing your muscles (such as cyclobenzaprine or diazepam).
• Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram,
duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). –
see below for more information.
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as
isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not take Durogesic
DTrans within 14 days of stopping these medicines. – see below for more information.
• Some antihistamines, especially ones that make you sleepy (such as chlorpheniramine,
clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infection (such as erythromycin or clarithromycin.
• Medicines used to treat fungal infection (such as itraconazole, ketoconazole, fluconazole, or
voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat an irregular heart beat (such as amiodarone, diltiazem, or
verapamil).
• Medicines to treat tuberculosis (such as rifampicin).
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or
phenytoin).
• Some medicines used to treat nausea or motion sickness (such as phenothiazines).
• Some medicines used to treat heartburn or ulcers (such as cimetidine).
• Some medicines used to treat angina (chest pain) or high blood pressure (such as
nicardipine).
• Some medicines used to treat cancer of the blood (such as idelalisib).










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

Step 3: Peel and press
• Make sure that the patch will be covered by loose clothing and not stuck under a tight or
elasticated band
• Carefully peel one half of the shiny plastic backing away from the centre of the patch. Try
not to touch the sticky side of the patch
• Press this sticky part of the patch onto the skin
• Remove the other part of the backing and press the whole patch onto the skin with the palm
of your hand
• Hold for at least 30 seconds. Make sure it sticks well, especially the edges
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 sachet and dispose of the sachet as instructed by your pharmacist
• Keep used patches out of sight and reach of children
• even used patches contain some medicine which may harm children and may even be
fatal
Step 5: Wash
• Always wash your hands after you have handled the patch using clean water only

Page 1 of 2

5.

More about using Durogesic DTrans

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
• While you are wearing the patch do not expose it to direct heat such as heating pads,
electric blankets, hot-water bottles, heated water beds, heat or tanning lamps. Do no
sunbathe, have long hot baths or saunas. If you do, you may increase the amount of
medicine you get from the patch

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.

How long to keep Durogesic DTrans for

Do not use Durogesic DTrans after the expiry date which is stated on the carton and sachet. 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.

How quickly will the patches work?




It may take some time for your first patch to have its maximum effect.
Your doctor may give you other painkillers as well 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

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

If your pain gets worse




If your Durogesic DTrans patch appears to be discoloured or show any other signs of
deterioration, please return to your pharmacist who will advise you further.

How to dispose of used patches or patches you no longer use

A used or unused patch accidentally sticking to another person, especially a child, may be fatal.
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 sachet and stored
out of sight and reach of other people, especially children, until safely disposed. Ask your
pharmacist how to throw away medicines you no longer use.

How long will you use the patches for?


HOW TO STORE DUROGESIC DTRANS

Where you should keep the patches

If your pain gets worse while you are using these patches, your doctor may try a higher
strength patch, or give you additional painkillers (or both)
If increasing the strength of the patch does not help, your doctor may decide to stop the use
of the patches

Do not throw away any medicines via wastewater or household waste. These measures will help
protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Durogesic DTrans contains

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 straight away.

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).

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.

The other ingredients are polyacrylate adhesive, polyethylene terephthalate/ethyl vinyl
acetate film, red printing ink and siliconised polyester film.

If you forget to change your patch

What Durogesic DTrans looks like and contents of the pack




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.

If you forget, change your patch as soon as you remember and make 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.

The Durogesic DTrans patch usually comes in cartons containing five Durogesic DTrans patches,
but your doctor will have prescribed the number and strength of Durogesic DTrans patch which
is best for you.

If a patch falls off





If a patch falls off before it needs changing, stick a new one on straight away and make note
of the day and time. Use a new area of skin on:
• Your upper body or arm
• Your child’s upper back
Let your doctor know this has happened and leave the patch on for another 3 days
(72 hours) or as directed by your doctor, before changing the new patch as usual
If your patches keep falling off, talk to your doctor, pharmacist or nurse

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

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your partner, or carer, notice any of the following about the person wearing
the patch, take the patch off and call a doctor, or go to your nearest hospital, straight
away. You may need urgent medical treatment.
• Feeling unusually drowsy, breathing that is more slow or shallow than expected.
Follow the advice above and keep the person who was wearing the patch moving and talking
as much as possible. 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. (Uncommon, this may affect up to 1 in 100 people)


Sudden swelling of the face or throat, severe irritation, reddening or blistering of your skin.
These may be signs of a severe allergic reaction. (frequency cannot be estimated from the
available data.)



Fits (seizures). (Uncommon, this may affect up to 1 in 100 people.)



Reduced consciousness or loss of consciousness. (Uncommon, these may affect up to
1 in 100 people.)

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.
Product Licence holder:
Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0343

Blind or partially sighted?
Is this leaflet hard to see or read?
Call +44 (0) 1302 365000 (Regulatory)
Please be ready to give the following
information:
Product name:
Durogesic DTrans 25 micrograms/hour
Transdermal Patch
Reference No: 21828/0343

Nausea, vomiting, constipation
Feeling sleepy (somnolence)
Feeling dizzy
Headache

Common (may affect up to 1 in 10 people)























Allergic reaction
Loss of appetite
Difficulty sleeping
Depression
Feeling anxious or confused
Seeing, feeling, hearing, or smelling things that are not there (hallucinations)
Muscle tremors or spasms
Unusual feeling in the skin, such as tingling or crawling feelings (paraesthesia)
Spinning sensation (vertigo)
Heart beat feels fast or uneven (palpitations, tachycardia)
High blood pressure
Being short of breath (dyspnoea)
Diarrhoea
Dry mouth
Stomach pain or indigestion
Excessive sweating
Itching, skin rash or redness of the skin
Being unable to pass urine or empty bladder completely
Feeling very tired, weak or generally unwell
Feeling cold
Swollen hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)
















Feeling agitated or disoriented
Feeling extremely happy (euphoria)
Decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
Loss of memory
Blurred vision
Slow heart beat (bradycardia) or low blood pressure
Blue colour to the skin caused by low oxygen in the blood (cyanosis)
Loss of contractions of the gut (ileus)
Itchy skin rash (eczema), allergic reaction or other skin disorders where the patch is placed
Flu-like illness
Feeling of body temperature change
Fever
Muscle twitching
Difficulty getting and keeping an erection (impotence) or problems having sex

Rare side effects (may affect up to 1 in 1000 people)



CD

Durogesic® and DTrans® are registered trademarks of Janssen-Cilag.

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






POM

The leaflet revision date is: 09.05.17

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Manufacturer

Constricted pupils (miosis)
Stopping breathing from time to time (apnoea)

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.
Repeated use of the patches may make the medicine become less effective (you become
‘tolerant’ to it) or become dependent on it.
If you switch from a different painkiller to Durogesic DTrans or if you suddenly stop using
Durogesic DTrans, you may notice withdrawal effects such as sickness, feeling sick, diarrhoea,
anxiety or shivering. Tell your doctor if you notice any of these effects.
There have been reports also of newborn infants experiencing withdrawal effects after their
mothers have used Durogesic DTrans for a long time during pregnancy.

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.

Page 2 of 2

Expand Transcript

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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