DUROGESIC DTRANS 12 TRANSDERMAL PATCH

Active substance: FENTANYL

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CUSTOMER:Waymade

PRE-PRESS NO.:

02-1808

PRODUCT: Durogesic DTrans 12 25 50 75 100mg patch

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

DATE OF PROOF:

06/07/11

DATE:

DATE:

6464/ 2562 2563 2564 2565 2566 G

PROOF HISTORY:
v.1 - waymade - 06/07/11

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2011

Pg 4

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
Common side effects (probably affecting up to 1 in 10 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
Uncommon side effects (probably affecting less 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.
There have been reports of newborn infants experiencing withdrawal effects after their mothers have used
Durogesic DTrans 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 patches, 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.

5. How to store Durogesic DTrans patches
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 your doctor has told you that you no longer need to use Durogesic DTrans patches, you must take any
unused patches to your pharmacy.
If this medicine shows any signs of deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
Where you should keep the patches
Keep all patches (used and unused) out of the reach and sight of children. This medicinal product does not
require any other special storage conditions

6. Further information
What is in Durogesic DTrans patch?
The active ingredient in your Durogesic DTrans patch is fentanyl. Durogesic DTrans patches come in the
following five strengths.
1.

The Durogesic DTrans 12 patch contains 2.1 milligrams (mg) of fentanyl and gives a dose of
12 micrograms (mcg) of fentanyl every hour. The active surface area of each Durogesic DTrans
12 patch is 5.25 cm2.

2.

The Durogesic DTrans 25 patch contains 4.2 milligrams (mg) of fentanyl and gives a dose of
25 micrograms (mcg) of fentanyl every hour. The active surface area of each Durogesic DTrans
25 patch is 10.5 cm2.

3.

The Durogesic DTrans 50 patch contains 8.4 mg of fentanyl and gives a dose of 50 micrograms
(mcg) of fentanyl every hour. The active surface area of each Durogesic DTrans 50 patch is
21.0 cm2.

4.

The Durogesic DTrans 75 patch contains 12.6 mg of fentanyl and gives a dose of 75
micrograms of fentanyl every hour. The active surface area of each Durogesic DTrans 75 patch
is 31.5cm2.

5.

The Durogesic DTrans 100 patch contains 16.8 mg of fentanyl and gives a dose of 100
micrograms (mcg) of fentanyl every hour. The active surface area of each Durogesic DTrans
100 patch is 42.0 cm2.

The inactive ingredients in Durogesic DTrans patches are polyacrylate adhesive, polyethylene
terephthalate /ethyl vinyl acetate film, printing ink and siliconised polyester film.
Each patch is identified using a different colour of printing ink:







Durogesic DTrans 12 patch: Orange
Durogesic DTrans 25 patch: Red
Durogesic DTrans 50 patch: Green
Durogeisc DTrans 75 patch: Blue
Durogesic DTrans 100 patch: Grey

What Durogesic DTrans patches look like and contents of the the pack
Durogesic DTrans is a rectangular shaped, clear patch with a sticky back so that it can be stuck onto the
skin.
Durogesic DTrans patches usually come in cartons containing five patches, but your doctor will have
prescribed the number and strength of patches which is best for you.

POM CD

PL No: 6464/2562 Durogesic DTrans 12 Transdermal Patch
PL No: 6464/2563 Durogesic DTrans 25 Transdermal Patch
PL No: 6464/2564 Durogesic DTrans 50 Transdermal Patch
PL No: 6464/2565 Durogesic DTrans 75 Transdermal Patch
PL No: 6464/2566 Durogesic DTrans 100 Transdermal Patch

These products are manufactured by Janssen Pharmaceutica NV, Turnhoutseweg 30, B 2340 Beerse,
Belgium and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 24.6.2011
Durogesic ® is a registered trademark of Johnson & Johnson
DTrans ® is a registered trademark of Alza Coporation

DUROGESIC® DTrans® 12 Transdermal Patch
DUROGESIC® DTrans® 25 Transdermal Patch
DUROGESIC® DTrans® 50 Transdermal Patch
DUROGESIC® DTrans® 75 Transdermal Patch
DUROGESIC® DTrans® 100 Transdermal Patch

Pg 1

(fentanyl)
Patient Information Leaflet

Your medicine is called by one of the above names, but will be referred to as Durogesic DTrans patches
throughout this leaflet.
Important things you need to know about Durogesic DTrans patches
• 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.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor, nurse or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• If you get side effects and they become serious or if you notice any side effects not listed
in this leaflet, please tell your doctor, nurse or pharmacist
In this leaflet
1. What Durogesic DTrans patches are and what they are used for
2. Before you use Durogesic DTrans patches
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
The name of your medicine is Durogesic DTrans transdermal patch. It is called ‘Durogesic DTrans patch’
or just ‘patch’ in this leaflet.
The patches help 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 patches come in five strengths (see section 6 overleaf).
The medicine passes slowly into your body through your skin.

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)
• 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 patches.
Take special care with Durogesic DTrans patches
• Like some other strong painkillers, Durogesic DTrans patches may make you unusually
drowsy, and breath 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:
• 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 patches, tell your doctor as this may
affect the way the medicine passes through your skin
• 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
• Persistant 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 dependant on it
• Tell your doctor if you have ever abused or been dependant 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:
• 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 (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
• 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.
Pg 2

Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Durogesic DTrans 12 25 50 75 100mg patch

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/ 2562 2563 2564 2565 2566 G

DATE OF PROOF:

06/07/11

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 06/07/11

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED MARCH 2011

Pg 2

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
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.
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.
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.

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

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 which day of the week to change your patch:

Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Change your patch at
the same time on








Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday








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
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:
• 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:

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 patch on the same area of skin
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 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)










If you forget to change your 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 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 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 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 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?
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 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

Where to apply the patch
Adults

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

How quickly will the patches work?

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

If a patch falls off

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

3. How to use Durogesic DTrans patches

Apply your patch on

Pg 3

More about using Durogesic DTrans patches

Grasp both sides of the opened pouch and pull apart
Take the patch out and use straight away
Keep the empty pouch to dispose of the used patch later
Use each patch once only
Do not take the patch out of its pouch 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

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

Don’t expose the 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 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.

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.

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, 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
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

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 pouch and put the pouch in the bin with your household rubbish

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
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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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