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Active substance(s): FENTANYL

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Tilofyl 25 microgram/hour transdermal patches
Tilofyl 50 microgram/hour transdermal patches
Tilofyl 75 microgram/hour transdermal patches
Tilofyl 100 microgram/hour transdermal patches
Important things you need to know about Tilofyl
These patches contain a strong painkiller
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
• 
• 
• 
  





What Tilofyl Patch is and
what it is used for

 Pentazocine, nalbuphine and buprenorphine
(strong painkillers)
 Some medicines used to treat depression
Tilofyl Patch is a strong pain-killing medicine
- Selective Serotonin Re-uptake Inhibitor
that belongs to the opioid group.
- Serotonin Norepinephrine Re-uptake
Tilofyl Patch relieves prolonged severe pain
Inhibitors (SNRI) or
requiring treatment with strong pain-killing
- Monoamine Oxidase Inhibitors (MAOI)
medicines (e.g. cancer pain).
(such as citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine,
Tilofyl Patch can be used in children aged 2 to 16
paroxetine, sertraline, venlafaxine,
years who have previously used opioid
Your doctor needs to know if you are taking
any of the above medicines, since
What you need to know
concomitant use may increase the risk of
before you use Tilofyl Patch
serotonin syndrome, a potentially lifeDo not use Tilofyl Patch:
threatening condition.
 if you are allergic to fentanyl, or any of the
You should not use Tilofyl Patch during
other ingredients of this medicine (listed in
treatment and within 14 days of stopping
section 6)
MAOI (medicines used to treat
 if you have acute pain or pain after an
depression or Parkinson's disease).
Tilofyl Patch with alcohol
 if the functioning of your nervous system is
You should not consume alcohol during Tilofyl
greatly reduced
 if you suffer from severe breathing problems Patch treatmet. Alcohol increases the side effects
of the medicine.
 for children in pain under 2 years of age
 for children which have not been treated
Pregnancy and breast-feeding
before with strong painkillers such as
You should not use Tilofyl Patch if you are
pregnant unless your doctor considers the
treatment essential. Experience is limited - ask
Warnings and precautions
 Tilofyl Patch is a medicinal product that could your doctor for advice. If you become pregnant
during treatment with Tilofyl Patch you should
be life-threatening to children, even if the
patches have been used. Bear in mind that a contact your doctor.
sticky patch could be tempting to a child and
It is not recommended to use Tilofyl Patch if you
in some cases may lead to a fatal outcome.
are breast-feeding. Ask your doctor for advice.
You should not breast-feed for at least 3 days
 Tilofyl Patch can have life-threatening side
after removing your patch.
effects in persons who are not using
prescribed opioid medicines on a regular
Driving or using machines
You should not drive or use machines without
first asking your doctor for advice. Tilofyl patch
Patch sticking to another person
The patch should be used only on the skin of the greatly affects reaction capacity, especially at the
beginning of treatment and after increasing the
person for whom it has been prescribed. Cases
have been reported where a patch was
accidentally stuck to a family member while in
The medicine can affect your ability to drive as it
close physical contact or sharing the same bed
may make you sleepy or dizzy.
as the patch wearer. A patch sticking to another
 Do not drive while taking this medicine until
person (particularly a child) may result in an
you know how it affects you.
overdose. In case the patch sticks to the skin of
 It is an offence to drive if this medicine
another person, take the patch off immediately
affects your ability to drive.
and seek medical attention (see also section 3
 However, you would not be committing an
offence if:
o The medicine has been prescribed to
Talk to your doctor before using Tilofyl Patch
treat a medical or dental problem and
if you have:
o You have taken it according to the
 asthma, any other lung disease or breathing
instructions given by the prescriber or in
the information provided with the
 disturbances of heart rhythm
medicine and
 low blood pressure or blood volume
o It was not affecting your ability to drive
 reduced liver function
 reduced kidney function
 had a brain injury, brain tumour, signs of
Talk to your doctor or pharmacist if you are not
increased intracranial pressure (e.g.
sure whether it is safe for you to drive while
headache, visual disturbances), reduced
taking this medicine.
consciousness or coma
 myasthenia gravis (a disease characterised
How to use Tilofyl Patch
by muscle weakness)
 chronic constipation
The dose is determined by your doctor, who



If you are very ill, very thin or elderly, you may be adjusts it individually for you. Always use Tilofyl
Patch exactly as your doctor has told you. Check
more sensitive to the effects of the patches.
with your doctor or pharmacist if you are not
If you develop fever you should contact your
doctor. The dosage may have to be adjusted.
Using and changing the patches
 There is enough medicine in each patch to
Avoid exposing the Tilofyl patch to direct heat
last 3 days (72 hours)
source such as heating pads, hot water bottles,
 You should change your patch every third
electric blankets, heated water beds, heat or
day, unless your doctor has told you
tanning lamps, intensive sun bathing, prolonged
hot baths, saunas or hot whirlpool spa baths,
 Always remove the old patch before
while wearing the patch. It is possible that more
applying the new one
fentanyl is released from the patch at higher
 Always change your patch at the same time
of day every 3 days (72 hours)
Tilofyl Patch may cause constipation, talk to your
 Make a note of the day, date and time you
doctor or pharmacist for advice on how to
apply a patch, to remind you when you need
prevent constipation.
to change your patch
Like many other strong painkillers, repeated use
of the patches may make you become tolerant to  The following table shows you which day of
the week to change your patch
the medicine or become dependent on it.
Tell your doctor if you have ever abused or been
Change your patch
Apply your patch
dependent on alcohol, prescription medicines or
at the same time on
on day
illegal drugs.
The use of Tilofyl Patch is not recommended in
children under 2 years of age. Do not use in
children which have not been treated before with
strong painkillers such as morphine.
Other medicines and Tilofyl Patches
Where to apply the patch
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
 Apply the patch on a flat part of your upper
Some other medicines can affect or be affected
by Tilofyl Patch. These medicines include:
 Medicines that have a sedative effect, such
- opioids (e.g. morphine and codeine)
- sedatives
- sleeping pills
- anaesthetic agents
- phenothiazides (antipsychotic agents)
- medicines to relieve anxiety
- muscle relaxants
- sedative antihistamines
- alcohol
 Inhibitors of the enzyme CYP3A4 (enzyme in
the liver, which mainly metabolises fentanyl
in the body), e.g.
- ritonavir and nelfinavir (antiviral agents)
- ketoconazole, itraconazole, fluconazole and
voriconazole (anti-fungal agents),
- verapamil, diltiazem and amiodarone (e.g.
used for treating irregular heart beat)
- some macrolide antibiotics (e.g.
clarithromycin, erythromycin,
- nefazodone (used to treat depression)
 Inductors of the enzyme CYP3A4, such as
- rifampicin (antibiotic)
- carbamazepine, phenobarbital or phenytoin
(medicines used to treat epilepsy)

body or arm.
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
For you and your child, do not apply the patch
 The same place twice in a row
 Sensitive areas that you move a lot, 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 on a new patch on the same area of
Putting a patch on
Step 1: Preparing the skin
Make sure your skin is completely clean, dry
and cool before you put the patch on
If you need to clean the skin, just use cold
 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 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
 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 the patch off, fold it
firmly in half so that the sticky side sticks to
 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
Step 5: Wash
Wash your hands afterwards with clean water.

 Headache
Common, affects 1 to 10 per 100 users
 Feeling your heartbeat, fast heart rate
 Muscle spasms
 Shaking, sensation of pins and needles
 Feeling breathless
 Diarrhoea
 Dry mouth, loss of appetite
 Stomach ache, indigestion
 Difficulty passing urine
 Excessive sweating, feeling cold
 Itchy skin, rashes or redness of the skin
 High blood pressure
 General feeling of discomfort, tiredness,
 Swelling of hands, ankles or feet
 Allergic reaction
 Feeling nervous, worried or depressed
 Not able to sleep
 Confusion, seeing, feeling or hearing things
that are not there (hallucinations)
 A feeling of dizziness or "spinning"
Uncommon, affects 1 to 10 per 1,000 users
 Slow heart rate
 Bluish colouration of the skin
 Decreased feeling of sensitivity, especially
in the skin
 Fits
 Blurred vision
 Muscle twitching
 Loss of memory
 Severe breathing difficulties
 Complete blockage of the gut
 Disorders of sexual function
 Eczema and/or other skin disorders including
dermatitis where the patch is placed
 Low blood pressure
 Flu-like symptoms
 Fever, body temperature changes
 Drug withdrawal effects (such as sickness,
feeling sick, diarrhoea, anxiety or shivering)
 Feeling agitated, disorientated, excited or
unusually carefree
Rare, occurs in 1 to 10 per 10,000 users
 Tiny pupils
 Incomplete blockage of the gut
 Transient cessation of breathing, reduced
 Irregular heart beat
Frequency not known, according to the
available data
 Abnormal slow breathing
 Severe and sometimes fatal allergic reaction
affecting the whole body
Like many other strong painkillers, repeated use
of the patches may make you become tolerant to
the medicine or become dependent on it.

Children and adolescents
The side effect profile in children and
adolescents was similar to that observed in
How quickly will the patches work?
adults. Very common side effects reported were
 It may take up to a day before your first
fever, headache, vomiting, feeling sick,
patch is working completely
 Your doctor may give you extra painkillers for constipation, diarrhea and pruritus.
your first day or so
Reporting of side effects
After this, the patch should help to relieve
If you get any side effects, talk to your doctor or
pain continuously so that you can stop taking pharmacist. This includes any possible side
other painkillers. However, your doctor may
effects not listed in this leaflet. You can also
still prescribe extra painkillers from time to
report side effects directly via the internet at
time By reporting side
More about using Tilofyl patches

If you forget to change the 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 extra painkillers, but do not apply an
extra patch

effects you can help provide more information on
the safety of this medicine.

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

Do not use this medicine after the expiry date
which is stated on the pack. The expiry date
refers to the last day of that month.

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.


How to store Tilofyl Patch

Keep all patches (used and unused) out of the
sight and reach of children.
Store in the original package. Do not refrigerate
or freeze!

Handling the patch
Used patches should be folded firmly in half so
that the sticky side of the patch sticks to itself and
then they should be safely discarded after putting
them back into the original pouch. Accidental
exposure to used and unused patches
particularly in children may be fatal. Unused
patches should be returned to the pharmacy.

If the patch falls off
 If the patch falls off before it needs changing,
Contents of the pack and
stick a new one on straight away and make a
other information
note of the day and time. Use a new area on:
-On your upper body or arm
What Tilofyl Patches contains:
- Your child's upper back
 The active substance is fentanyl.
 Leave another 3 days (72 hours) before
Each transdermal patch (active surface area
changing the new patch as usual
10, 20, 30 and 40 cm²) contains: 2.5 mg, 5
 If your patch keeps falling off, talk to your
mg, 7.5 mg or 10 mg fentanyl (which
doctor, nurse or pharmacist
corresponds to a release rate of 25, 50, 75 or
If the patch sticks to another person (see also
100 micrograms/hour of fentanyl)
section 2 above)
 The other ingredients are:
 Only use the patch on the skin of the person
Outer membrane: polyethylene-terephthalate
who it is prescribed for
/ ethylenvinylacetate-copolymer.
 Make sure the patch does not get rubbed off
Medicinal product container: ethanol 96%,
and sticks to your partner, especially in bed
hydroxyethylcellulose, purified water.
 If a patch accidently sticks to another
Control membrane: ethylenvinylacetateperson, take it off straight away and seek
immediate medical attention.
Adhesive membrane: silicon medical
If your pain gets worse
Protective membrane: (removed before the
If your pain gets worse while you are using
patch is stuck onto the skin) polyethylenethese patches, your doctor may try a higher
terephthalate, release coated
strength patch, or give you extra painkillers
(or both)
What Tilofyl Patches looks like and contents
 If increasing the strength of the patch does
of the pack:
not help, your doctor may stop the patches
Tilofyl Patch is a transparent oblong transdermal


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 fell 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

patch packed in a sachet which consists of a
protective membrane (removed before the patch
is stuck onto the skin), and four functional layers:
an outer membrane, a medicinal product
container, a control membrane and an adhesive
membrane. With the adhesive membrane Tilofyl
Patch can be stuck onto the skin.

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

Not all pack sizes may be marketed.


Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
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. If you notice any of the above, follow
the guidance above and keep moving as
much as possible.
 Cramp-like pain, vomiting, feeling of bloating
(intestinal paralysis)
 Breathlessness, rash, wheezing (acute
allergic reaction)
 Reduced consciousness or loss of

Tilofyl Patch is available in packs with 3, 5, 7, 10,
14 and 20 transdermal patches.

Marketing Authorisation Holder:
Tillomed Laboratories Ltd
3 Howard Road,
Eaton Socon, St Neots, Cambridgeshire
PE19 8ET, UK
Hexal AG,
Industriestrasse 25,
D-83607 Holzkirchen, Germany
Product Licence Numbers:
Tilofyl 25 microgram/hour Patches:
PL 11311/0311
Tilofyl 50 microgram/hour Patches:
PL 11311/0312
Tilofyl 75 microgram/hour Patches:
PL 11311/0313
Tilofyl 100 microgram/hour Patches:
PL 11311/0314
This leaflet was last revised in May 2015.

Side effects
Very common, affects more than 1 per 10 users
 Feeling sick or being sick, constipation
 Dizziness, sleepiness


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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.