MATRIFEN 12 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance: FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER


Matrifen
Matrifen 12 micrograms/hour transdermal patch
Matrifen 25 micrograms/hour transdermal patch
Matrifen 50 micrograms/hour transdermal patch
Matrifen 75 micrograms/hour transdermal patch
Matrifen 100 micrograms/hour transdermal patch
Fentanyl
IMPORTANT INFORMATION ABOUT
YOUR MEDICINE
• 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 72 hours.
• If your breathing becomes shallow
and weak take the patch off and seek
medical help.
Read all of this leaflet carefully before
you start using this medicine.
– Keep this leaflet. You may need to
read it again.
– If you have further questions, please
ask your doctor or pharmacist.
– This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
– If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Matrifen is and what it is used
for
2. Before you use Matrifen
3. How to use Matrifen
4. Possible side effects
5. How to store Matrifen
6. Further information
1. WHAT MATRIFEN IS AND WHAT IT IS
USED FOR
Matrifen belongs to a group of strong
painkillers called opioids and acts through
blocking the pain signals to the brain.
In Matrifen transdermal patch the
active substance fentanyl is deposited.
Fentanyl is gradually released from the
patch, passes through the skin and into
the body, where it relieves severe and
longlasting pain, which can only be
relieved by opioids. One transdermal
patch relieves pain for 72 hours (3 days).
2. BEFORE YOU USE MATRIFEN
WARNING
Matrifen is a drug that could be lifethreatening to children. This is also the
case with used transdermal patches.
Bear in mind that the design of this
medicinal product could be tempting to
a child.
Matrifen can have life-threatening sideeffects in persons that are not using
prescribed opioid drugs on a regular
basis.
Do not use Matrifen:
• If you are hypersensitive (allergic) to
fentanyl or any of the other
ingredients of the product.
• If you suffer from short-term pain
(e.g. after a surgical procedure)
• If you have severe difficulties in
breathing.
• If your central nervous system (e.g.
your brain or spinal cord) is severely
impaired, for instance by brain injury.
Take special care with Matrifen
Before starting to use Matrifen you
should inform your doctor if you suffer
from any of the below disorders
• asthma, respiratory depression
(reduced ability to breathe) or any
lung disease
• irregular heartbeat
• low blood pressure
• impaired liver function
• impaired kidney function
• If you have had a head injury or brain
disease (e.g. a tumor)
• If you suffer from a disease causing
fatigue and weakness of the muscles
(myasthenia gravis).
Inform your doctor if you develop a
fever during the treatment, as this may
affect the way the medicine passes
through your skin.
Do not expose the patch on your skin to
a direct heat source such as heating
pads, electric blankets, hot-water bottles,
saunas, tanning lamps, solariums or hot
whirlpool spa baths. These may affect
the way the medicine works. You can
shower while wearing a patch and are
allowed to stay outside in the sun, but
you must protect the patch with some
piece of clothing during hot summer
days.
The transdermal patches should not be
divided or cut.
Decreasing relief of pain (tolerance),
physical or psychological dependence
may develop if you use Matrifen for a
longer period. However, this is rarely
seen during treatment of pain due to
cancer.
Elderly patients should be monitored
when using Matrifen.
Matrifen should not be given to children
under 2 years of age or to children who
have not previously been treated with
strong painkillers such as morphine.
Taking other medicines:
Certain other medicines may affect or
be affected by Matrifen. Some of these
medicines are:
• Painkillers (e.g. opioids such as
pentazocin, nalbuphine,
buprenorphine morphine and
codeine), medicines to treat
anxiety and tranquilisers, sleeping
medicines, general anaesthetics,
phentiazines (medicine against
psychosis), sedating antihistamines
(certain medicines against allergy
and travel sickness causing
drowsiness) and muscle relaxants.
• Barbituric acid derivatives (medicine
against epilepsy)
• Ritonavir and nelfinavir (against HIV)
• Itraconazole, ketoconazol, fluconazol
and voriconazol
(against fungal infections)

• MAO-inhibitors (e.g. moclobemide
against depression or selegiline
against Parkinson’s disease). You
should not take Matrifen within
14 days of stopping these medicines.
• Macrolide Antibiotics (e.g.
azithromyzin, erythromycin,
troleandomycin and clarithromycin
• Nefazodone (against depression)
• Medicines to treat an irregular
heartbeat, such as amiodarone,
diltiazem or verapamil.
Please inform your doctor or pharmacist
if you are taking or have recently taken
any other medicines, including
medicines obtained without a prescription.
Using Matrifen with food and drink
Alcohol may increase the risk of
breathing problems.
Pregnancy and breast-feeding
Safe use during pregnancy has not been
established. Fentanyl should not be used
during childbirth since fentanyl may
cause difficulties in breathing in the
newborn child. Fentanyl is excreted into
breast milk and may cause sedation and
respiratory depression (reduced ability
to breathe) in the breast-fed child.
Breast-feeding should therefore be
discontinued for at least 72 hours after
removal of the patch. Do not use
Matrifen if you are pregnant or
breast-feeding unless your doctor has
weighed the risks of not using to be
greater than using Matrifen. Long-term
treatment during pregnancy may cause
withdrawal symptoms in the newborn
child. If you get pregnant during
treatment with Matrifen, consult your
doctor.
Driving and using machines:
Fentanyl transdermal patch can make
you drowsy; if this happens do not
drive, use tools or machinery.
3. HOW TO USE MATRIFEN
Always use Matrifen exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
The dose is determined by your doctor,
who will adjust it for you individually.
Always follow your doctor’s instructions.
Do not discontinue treatment without
consulting your doctor.
Using and changing the patch
• 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 otherwise
• Always remove the old patch before
applying the new one
• Always change your patch at the same
time of day every 3 days (72 hours)
• Make a note of the day, date and time
you apply a patch, to remind you
when you need to change your patch.
On the outer package you can write
the date and time you applied the
patch to help you remember
• The following table shows you which
day of the week to change your patch:
If you apply
the patch on:

Change your
patch on:

Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply Matrifen transdermal
patch
Adults - Find a flat part of your upper
body (trunk) or upper arm.
Children –
• 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 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 need to be monitored very
closely for 48 hours after:
– The first patch has been put on
– A higher dose patch has been put on.
Do not apply the patch on:
• The same place twice in a row.
• Sensitive areas that you move a lot,
cuts, spots or other skin blemishes.
• Body parts that have been irradiated
in connection with radiation therapy.
• 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 7 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
clean, dry and cool before applying
the patch
• If you need to clean the skin, just use
cold water
• Do not use soap or any other
cleansers, creams, moisturisers, oils,
powders or talc before applying the
patch
• Do not stick the 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 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)
• Grasp both sides of the opened pouch
and pull apart
• Take the patch out and use it 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
• Always remove the old patch before
applying a new one.
Step 4: Disposing of the Patch
• As soon as you take the patch off,
fold the used patch firmly in half so
that the sticky side sticks to itself
• Put the used patch in the original
pouch and discard according to local
requirements or hand in to your
pharmacist
• 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.
More about using Matrifen patches:
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 your 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 you use more Matrifen than you
should
If you or someone you know has stuck
on too many patches or the wrong
strength patch, take the patches off and
contact the doctor or the nearest hospital
straight away. While waiting for the
doctor, keep the person awake by talking
to or shaking her/him now and then.
Signs of an 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 you forget to use or 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 contact your doctor
because you might need extra
painkillers, but do not apply an extra
patch.
If the patch falls off
• If the 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 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 patch keeps falling off, talk to
your doctor, nurse or pharmacist.
If a patch sticks to another person
• Only use the patch on the skin of
the person who it is prescribed for
• Make sure the patch does not get
rubbed off and stick to your partner,
especially in bed
• If a patch accidentally sticks to
another person, take it off straight
away and talk to your doctor.
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
strength patch when you restart.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Matrifen can have
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 before.
• 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.
If you notice any of the above, follow
the guidance above and keep moving as
much as possible.
Other side effects
Very common (affects more than 1 user
in 10):
Drowsiness, dizziness, headache,
feeling sick, being sick (vomiting),
constipation.
Common (affects 1 to 10 users in 100):
Hypersensitivity, anorexia, difficulties in
sleeping, confusion, depression,
anxiety, hallucinations, shivering,
feelings of stinging in the skin
(paraesthesia), feeling giddy, irregular
heartbeat, high blood pressure,
breathlessness, diarrhoea, dry mouth,
stomach troubles, sweating, itching,

rash, blushing, muscle spasm,
difficulties in passing urine, tiredness,
swelling of hands, ankles or feet,
weakness, feeling of discomfort,
feeling cold.
Uncommon (affects 1 to 10 users in
1,000):
Disorientation, unnatural feeling of
happiness, loss of memory,
restlessness, decreased feeling of
sensitivity in the skin, convulsions (fits),
slow heart rate, bluish colouration of the
skin, low blood pressure, difficulty in
breathing, obstruction of the bowel,
eczema and/or other skin disorders
including skin reactions where the patch
is placed, muscle twitching, disorders of
sexual function, flu-like symptoms, body
temperature changes, drug withdrawal
effects (being sick, feeling sick,
diarrhoea, anxiety or shivering).
Rare (affects 1 to 10 users in 10,000):
Tiny pupils, difficulty in breathing,
partial obstruction of the small or large
bowel, eczema and dermatitis
(inflammation of the skin) where the
patch is placed.
Other adverse reactions
Decreasing relief of pain (tolerance),
physical and psychological dependence
can develop during long-term use of
fentanyl.
Opioid withdrawal symptoms (such as:
feeling sick, being sick, diarrhoea,
anxiety and shivering) are possible in
some patients after conversion from
their previous opioid analgesics to
Matrifen transdermal patch.
The side effects observed in children and
adolescents treated with fentanyl are
similar to those observed in adults. Side
effects reported as very common in
clinical trials in children were fever,
being or feeling sick.
Please inform your doctor if any of the
side effects gets serious, or if you
experience disturbing side effects or
notice any side effects not mentioned in
this leaflet.
5. HOW TO STORE MATRIFEN
Keep out of the reach and sight of
children, even after use. High quantities
of the drug remain in the transdermal
patches even after use.
Do not use Matrifen after the expiry date
stated on the package. The expiry date
refers to the last day of that month.
This medicinal product does not
require any special storage conditions.
For environmental and safety reasons,
used as well as unused and out of date
patches must be discarded according to
local requirements or returned to the
pharmacy for disposal. Used patches
should be folded in half with the sticky
sides together and kept in the outer
package until discarded or delivered to
the pharmacy.
6. FURTHER INFORMATION
What Matrifen, transdermal patch
contains
The active substance is: Fentanyl.
1 transdermal patch contains 1.38 mg,
2.75 mg, 5.5 mg, 8.25 mg or 11 mg in a
patch of 4.2, 8.4, 16.8, 25.2 or 33.6 cm2
and releases 12, 25, 50, 75 or 100
micrograms/hour respectively.
Other ingredients are: Dipropylene
glycol, hydroxypropyl cellulose,
dimeticone, silicone adhesives (amine
resistant), ethylene vinyl acetate (EVA,
release membrane), polyethylene
terephthalate (PET, backing film),
fluoropolymercoated polyester
(protective film) and printing ink.
What Matrifen looks like and contents of
the pack
Matrifen is a transparent and rectangular
transdermal patch, each patch is packed
in a heat-sealed pouch made of paper,
aluminium and polyacrylonitrile (PAN).
The transdermal patches are equipped
with a coloured imprint with trade
name, active substance and strength:
12 micrograms/hour patch: brown imprint
25 micrograms/hour patch: red imprint
50 micrograms/hour patch: green imprint
75 micrograms/hour patch: light blue
imprint
100 micrograms/hour patch: grey imprint
The patches are supplied in carton
containing 1, 2, 3, 4, 5, 8, 10, 16, and
20 patches. Not all pack sizes may be
marketed
Marketing Authorisation Holder
Nycomed UK Ltd.,
Three Globeside Business Park,
Fieldhouse Lane, Marlow, Bucks,
SL7 1HZ, UK
Manufacturer:
Nycomed Danmark ApS,
PO Box 88, Langebjerg 1,
DK-4000 Roskilde, Denmark
Nycomed GmbH,
Robert-Bosch-Strasse 8,
78224 Singen, Germany
This leaflet was last approved in
03/2011.

GBR-7

650XXXX

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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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