Skip to Content

UK Edition. Click here for US version.

DUROGESIC DTRANS 100MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL

View full screen / Print PDF » Download PDF ⇩
Transcript
final mock-up

Assessed against UK PIL dated Jan-13

Operations or tests

Durogesic® DTrans® 100 micrograms/hour Transdermal Patch
(fentanyl)

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

PATIENT INFORMATION LEAFLET

Do not drink alcohol unless you have talked to your doctor first.

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 100 micrograms/hour Durogesic DTrans Patch.

Durogesic DTrans Patch can make you drowsy or breathe more slowly. Drinking alcohol may make
these effects worse.

Important things you need to know about Durogesic DTrans Patch

The Durogesic DTrans Patch contains a strong pain killer

Ensure that 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

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

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

Driving and using machines

In
1.
2.
3.
4.
5.
6.




1.

Durogesic DTrans Patch can make you drowsy. If this happens, do not drive or use any tools or
machines.

3.

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.

Using and changing the Durogesic DTrans Patch

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







WHAT DUROGESIC DTRANS PATCH IS AND WHAT IT IS USED FOR

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

The name of your medicine is Durogesic DTrans 100 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.

By Nafisa Potrick at

BEFORE YOU USE DUROGESIC DTRANS PATCH

Change your patch at the same time on

Monday

Thursday

Tuesday

Friday

Wednesday

Saturday

Thursday

Sunday

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’.

Friday

Monday

Saturday

Tuesday

Do not use Durogesic DTrans Patch if:

Sunday

Wednesday



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

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.

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





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




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

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.

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 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

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.

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




If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using
Durogesic DTrans Patch.
Page 1 of 2

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, so keep your
used Durogesic DTrans Patch out of the reach and sight of children

Step 5: Wash

The following side effects have been reported during clinical trials in children
(up to 18 years of age):

More about using Durogesic DTrans Patch

Very common side effects (probably affecting more than 1 in 10 people):



Wash your hands afterwards with clean water

How quickly will the Durogesic DTrans Patch work?




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 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.







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




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.
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 less than 1 in 100 people.

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




Feeling sick (nausea) or being sick (vomiting), constipation
Dizziness, drowsiness or not being able to sleep
Headache

Common (affects less than 1 in 10 people):

















Allergic reaction
Awareness of unusual heart beats (also called palpitations), fast heart rate
High blood pressure
Loss of appetite or dry mouth
Feeling nervous, worried or depressed
Confusion, hallucinations (seeing, feeling or hearing things that are not there)
Sensation of pins and needles, shaking, feeling giddy
Muscle spasms
Stomach ache, indigestion, difficulty passing urine
Diarrhoea
Feeling cold, excessive sweating
General feelings of discomfort, tiredness, weakness
Swelling of hands, ankles or feet
Itchy skin, rashes or redness of the skin

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

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 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.
If your medicine appears to be discoloured or show any other signs of deterioration, take them back to
your pharmacist who will advise you what to do.

Where you should keep the patches

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.
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 16.8 milligrams of fentanyl (absorption rate approx 100
micrograms/hour: active surface area 42.0cm2).
The other ingredients are polyacrylate Duro-Tak 87-4287,
polyethylene terephthalate/ethylene vinyl acetate laminate, grey printing ink and
siliconised polyester film.

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

Durogesic DTrans Patch is a rectangular shaped, clear patch with Durogesic® 100µg fentanyl/h printed
in grey on one side with a sticky back so that it can be stuck onto the skin.
Durogesic DTrans Patch is available in cartons containing five patches.
Your doctor will have prescribed the number and strength of patches which is best for you.
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: 21828/0352
®

POM

CD

®

Durogesic and DTrans are registered trademarks of Janssen-Cilag.
For information in large print, tape, CD or Braille, please call 01302 552940 and ask for the
Regulatory Department.
The leaflet revision date is: 03.12.13

Flu-like symptoms
Slow heart rate
Low blood pressure
Decreased feeling of sensitivity, especially in the skin
Bluish colouration of the skin
Feeling agitated, disorientated, excited or unusually carefree
Loss of memory
Eczema and/or other skin disorders including dermatitis where the patch is placed
Disorders of sexual function
Complete obstruction of the intestine
Muscle twitching
Fever, body temperature changes
Drug withdrawal effects (such as sickness, feeling sick, diarrhoea, anxiety or shivering)

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

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.

Uncommon (affects less than 1 in 100 people):














Allergic reaction
Loss of appetite, stomach pain
Not being able to sleep, drowsiness, tiredness, feeling weak
Feeling worried or depressed, hallucinations (seeing, feeling or hearing things that are not there),
dizziness
Shaking, decreased feeling or sensitivity, especially in the skin
Dry mouth
Rash, excessive sweating, redness of the skin
Muscle spasms
Difficulty passing urine
Swelling of hands, ankles or feet
Skin reactions where the patch is placed

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

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 talk
to a doctor

How long will you use the Durogesic DTrans Patch for?






Uncommon side effects (probably affecting less than 1 in 100 people):

If a Durogesic DTrans Patch falls off




Headache
Feeling or being sick
Constipation, diarrhoea
Itching

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









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








Tiny pupils
Incomplete obstruction of the small or large intestine

Page 2 of 2

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.

Hide