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MATRIFEN 100MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): FENTANYL / FENTANYL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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)
Your medicine is called one of the above names but throughout this
leaflet will be referred to as Matrifen.
Important things you need to know about Matrifen transdermal
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.
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 further questions, please ask your doctor, pharmacist or
nurse.
− This medicine has been prescribed for you 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 any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Matrifen is and what it is used for
2. What you need to know before you use Matrifen
3. How to use Matrifen
4. Possible side effects
5. How to store Matrifen
6. Contents of the pack and further information
1. What Matrifen is and what it is used for
Matrifen transdermal patch contains the active substance fentanyl.
Fentanyl belongs to a group of strong painkillers called opioids and acts
through blocking the pain signals to the brain. Fentanyl is gradually
released from the patch, passes through the skin and into the body.
Matrifen is used for:
Adults:
Long term pain that can only be adequately controlled by strong
analgesics.
Children:
Long term management of severe chronic pain in children receiving
opioid therapy from 2 years of age.
One transdermal patch relieves pain for 72 hours (3 days).
2. What you need to know before you use Matrifen
Matrifen 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 Matrifen:
• If you are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6).
• 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.
Warnings and precautions
WARNING
Matrifen is a medicinal product that could be life-threatening 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 which in cases may lead to a fatal outcome. Matrifen can
have life-threatening side effects in persons that are not using
prescribed opioid drugs on a regular basis.

Patch sticking to another person
The patch should be used only on the skin of the person for whom it was
ordered by the doctor. Cases have been reported where a patch was
accidentally stuck to a family member while in close physical contact or
sharing the same bed as the patch wearer. A patch sticking to another
person (particularly a child) may result in an overdose. In case the patch
sticks to the skin of another person, take the patch off immediately and
seek medical attention.
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)
• Matrifen may cause constipation, talk to your doctor or pharmacist
for advice on how to prevent constipation.
Inform your doctor if you develop a fever during the treatment, as the
increased body temperature may cause too much medicine to pass
through the skin.
For the same reason you should avoid exposing the patch on the skin to
direct heat such as heating pads, electric blankets, hot-water bottles,
heated water beds, sauna, tanning lamps, solarium, hot baths or hot
water whirlpool spa baths. You can shower while wearing a patch and it
is 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.
Children
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.
Other medicines and Matrifen
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
Certain other medicines may affect or be affected by Matrifen. Some of
these medicines are:
• Painkillers (e.g. opioids such as morphine and codeine), as well as
pentazocin, nalbuphine and buprenorphine)
• Medicines to treat anxiety and tranquilisers, sleeping medicines and
general anaesthetics, phenothiazines (medicine against psychosis)
• Sedating antihistamines (certain medicines against allergy and
travel sickness causing drowsiness)
• Medicines used as muscle relaxants
• Some medicines used to treat epilepsy (such as carbamazapine,
phenobarbital or phenytoin)
• Rifampicin (for treatment of tuberculosis)
• Ritonavir and nelfinavir (against HIV)
• Itraconazole, ketoconazole, fluconazole and voriconazole (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
• Some medicines used to treat depression (such as citalopram,
duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine,
sertraline, venlafaxine)
• Macrolide Antibiotics (e.g. erythromycin, troleandomycin and
clarithromycin)
• Nefazodone (against depression)
• Medicines to treat an irregular heartbeat, such as amiodarone,
diltiazem or verapamil.
Matrifen with alcohol
You should not drink alcohol whilst using Matrifen patches, as this may
increase the risk of serious side effects and cause breathing difficulties,
a fall of blood pressure, extreme drowsiness and coma.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine. 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. Breastfeeding should therefore be discontinued for at least 72 hours after
removal of the patch. Do not use Matrifen if you are pregnant or breastfeeding 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.
The medicine can affect your ability to drive as it may make you sleepy
or dizzy.
• Do not drive while taking this medicine until you know how it affects
you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental
problem and
• You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely

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).
• Grasp both sides of the opened pouch and pull apart.

Talk to your doctor or pharmacist if you are not sure whether it is safe
for you to drive while taking this medicine.
3. How to use Matrifen
Always use this medicine exactly as your doctor has told you. 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.
The recommended dose is one patch every three days. According to
your reaction the strength of the patch or the number of patches may
need to be adjusted. The effect is reached within 24 hours after the first
patch has been applied. Do not discontinue treatment without consulting
your doctor.
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. 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:
Apply your patch on
Change your patch at the same time on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

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

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



Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• Apply the patch on a flat part of your upper body or 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 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









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.
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 discard according to local
requirements or hand in to your pharmacist
• Even used patches contain some medicine which may harm
children and may be fatal, so keep your used patches out of the
sight and reach of children.
Step 5: Wash
• Wash your hands afterwards with clean water.
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 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 your 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 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 (See also section 2 above)
• 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 stick to your
partner or child, especially while sharing a bed or in close contact.
• If a patch accidentally sticks to another person, take it off straight
away and seek immediate medical attention.

Other side effects
Very common: may affect more than 1 in 10 people
• drowsiness
• dizziness
• headache
• feeling sick, being sick (vomiting)
• constipation.

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.

How long will you use the patches for?
• Matrifen patches are for long-term pain. Your doctor will be able to
tell you how long you can expect to use the patches.

Common: may affect up to 1 in 10 people
• hypersensitivity
• loss of appetite, difficulties in sleeping
• confusion, depression, anxiety, hallucinations
• shivering
• feelings of stinging in the skin (paraesthesia)
• feeling giddy
• irregular heartbeat, fast heart rate
• high blood pressure
• diarrhoea, dry mouth, stomach troubles
• sweating
• itching, rash, blushing
• muscle spasms
• difficulties in passing urine

tiredness
• swelling of hands, ankles or feet
• weakness
• feeling of discomfort, feeling cold.

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.

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 forget to use or change your patch
• You should change your patch at the same time every three days, if
not otherwise instructed by your doctor. If you forget to change your
patch, change it as soon as you remember.
• If you are very late changing your patch, you should contact your
doctor because you might need some 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:
− 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 you stop using Matrifen
• 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.
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.
• You can also swim while wearing the patch, but:
• Don’t use hot whirlpool spa baths.
• Don’t put a tight or elasticated band over the patch.
• Don’t expose the patch to direct heat such as heating pads, hotwater bottles, electric blankets, heated water beds, heat or tanning
lamps, intensive sun bathing, prolonged hot baths or saunas. These
may affect the way the medicine is absorbed through the skin.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If any of the following serious side effects occur, you should
remove the patch and immediately contact your doctor or visit a
hospital. 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 Matrifen or morphine) before. If you, or your partner
or carer, notice that you or your child are breathing much more
slowly or weakly, 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 fewer than 1 in 100
people.
• Reduced consciousness or loss of consciousness. These affect
fewer than 1 in 100 people.

Uncommon: may affect up to 1 in 100 people
• loss of memory
• feeling agitated, disorientated, excited or unusually carefree
• decreased feeling of sensitivity especially in the skin
• slow heart rate
• bluish coloration of the skin
• low blood pressure
• obstruction of the bowel
• eczema and/or other skin disorders including skin reactions where
the patch is placed
• muscle twitching
• disorders of sexual function
• fever, flu-like symptoms, body temperature changes, drug
withdrawal effects (being sick, feeling sick, diarrhoea, anxiety or
shivering).
Rare: may affect up to 1 in 1,000 people
• tiny pupils
• partial obstruction of the small or large bowel.
Additional side effects in children and adolescents:
Very common: may affect more than 1 in 10
people
• headache
• feeling or being sick
• constipation, diarrhoea
• itching
Common: may affect 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: may affect up to 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.

Reporting of side effects
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring of the
benefit/risk balance of the medicinal product. Healthcare professionals
are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
5. How to store Matrifen
Keep unused and used patches out of the sight and reach of children.
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.
Handling the patch
Accidental exposure to used and unused patches particularly in children
may lead to a fatal outcome. Used patches should be folded so that the
adhesive side of the patch adheres to itself and then they should be
safely discarded. Unused patches should be returned to the hospital or
pharmacy. 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 Matrifen transdermal patches contain:
The active substance in Matrifen patches is Fentanyl.
The patches come in 5 different strengths (see below).
Each Matrifen 12 micrograms/hr transdermal patch contains 1.38
milligrams of fentanyl (absorption rate approx 12 micrograms/hour for 72
hours). The active surface area of each Matrifen12 micrograms/hr
transdermal patch is 4.2 cm2.
Each Matrifen 25 micrograms/hr transdermal patch contains 2.75
milligrams of fentanyl (absorption rate approx 25 micrograms/hour for 72
hours). The active surface area of each Matrifen 25 micrograms/hr
transdermal patch is 8.4 cm2.
Each Matrifen 50 micrograms/hr transdermal patch contains 5.5
milligrams of fentanyl (absorption rate approx 50 micrograms/hour for 72
hours). The active surface area of each Matrifen 50 micrograms/hr
transdermal patch is 16.8 cm2.
Each Matrifen 75 micrograms/hr transdermal patch contains 8.25
milligrams of fentanyl (absorption rate approx 75 micrograms/hour for 72
hours). The active surface area of each Matrifen 75 micrograms/hr
transdermal patch is 25.2 cm2.
The Matrifen 100 micrograms/hr transdermal patch contains 11
milligrams of fentanyl (absorption rate approx 100 micrograms/hour for
72 hours). The active surface area of each Matrifen 100 micrograms/hr
transdermal patch is 33.6 cm2.
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 The transdermal patches are imprinted
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
Each pack contains 5 transdermal patches.

Manufacturer:
Takeda Pharma A/S,
Dybendal Alle 10, DK-2630 Taastrup,
Denmark.
and
Takeda GmbH,
Robert-Bosch-Strasse 8, D-78224 Singen,
Germany.
Procured within the EU
Product licence Holder:
Ecosse Pharmaceuticals Limited,
3 Young Place,
East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place,
East Kibride G75 0TD.
Matrifen 12 micrograms/hour Transdermal Patch PL 19065/0536
Matrifen 25 micrograms/hour Transdermal Patch PL 19065/0537
Matrifen 50 micrograms/hour Transdermal Patch PL 19065/0538
Matrifen 75 micrograms/hour Transdermal Patch PL 19065/0539
Matrifen 100 micrograms/hour Transdermal Patch PL19065/0540
This leaflet was last approved 07/10/2016
POM
E0536/1
Matrifen® is a trademark of Takeda Pharma A/S

CD

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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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