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TILOTRANS 25 MICROGRAM/HOUR TRANSDERMAL PATCHES

Active substance(s): FENTANYL

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PATIENT INFORMATION LEAFLET

Tilotrans 25 microgram/hour transdermal patches
Tilotrans 50 microgram/hour transdermal patches
Tilotrans 75 microgram/hour transdermal patches
Tilotrans 100 microgram/hour transdermal patches
(Fentanyl)
Important things you need to know about Tilotrans
·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
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What Tilotrans Patch is and
what it is used for

 Inductors of the enzyme CYP3A4, such as
- rifampicin (antibiotic)
- carbamazepine, phenobarbital or phenytoin
Tilotrans Patch is a strong pain-killing
(medicines used to treat epilepsy)
medicine that belongs to the opioid group.
 Pentazocine, nalbuphine and buprenorphine
(strong painkillers)
Tilotrans Patch relieves prolonged severe pain
 Some medicines used to treat depression
requiring treatment with strong pain-killing
- Selective Serotonin Re-uptake Inhibitor
medicines (e.g. cancer pain).
(SSRI)
Children:
- Serotonin Norepinephrine Re-uptake
Tilotrans Patch can be used in children aged 2 to
Inhibitors (SNRI) or
16 years who have previously used opioid
- Monoamine Oxidase Inhibitors (MAOI)
painkillers.
(such as citalopram, duloxetine,
escitalopram, fluoxetine, fluvoxamine,
What you need to know
paroxetine, sertraline, venlafaxine,
before you use Tilotrans Patch
tranylcypromine).
Your doctor needs to know if you are taking
Do not use Tilotrans Patch:
any of the above medicines, since
 If you are allergic to fentanyl, or any of the
concomitant use may increase the risk of
other ingredients of this medicine (listed in
serotonin syndrome, a potentially lifesection 6)
threatening condition.
 If you have acute pain or pain after an
You should not use Tilotrans Patch during
operation
treatment and within 14 days of stopping
 If the functioning of your nervous system is
MAOI (medicines used to treat
greatly reduced
depression or Parkinson's disease).
 If you suffer from severe breathing problems
 For children in pain under 2 years of age
Tilotrans Patches with alcohol
 For children which have not been treated
You should not consume alcohol during Tilotrans
before with strong painkillers such as
Patch treatmet. Alcohol increases the side effects
morphine
of the medicine.
Warnings and precautions
Pregnancy and breast-feeding
 Tilotrans Patch is a medicinal product that
You should not use Tiloftrans Patch if you are
could be life-threatening to children, even if
pregnant unless your doctor considers the
the patches have been used. Bear in mind
treatment essential. Experience is limited - ask
that a sticky patch could be tempting to a
your doctor for advice. If you become pregnant
child and in some cases may lead to a fatal
during treatment with Tilotrans Patch you should
outcome.
contact your doctor.
 Tilotrans Patch can have life-threatening side
effects in persons who are not using
It is not recommended to use Tilotrans Patch if
prescribed opioid medicines on a regular
you are breast-feeding. Ask your doctor for
basis.
advice. You should not breast-feed for at least 3
days after removing your patch.
Patch sticking to another person
The patch should be used only on the skin of the Driving or using machinery
person for whom it has been prescribed. Cases
You should not drive or use machines without
have been reported where a patch was
first asking your doctor for advice. Tilotrans patch
accidentally stuck to a family member while in
greatly affects reaction capacity, especially at the
close physical contact or sharing the same bed
beginning of treatment and after increasing the
as the patch wearer. A patch sticking to another
dose.
person (particularly a child) may result in an
The medicine can affect your ability to drive as it
overdose. In case the patch sticks to the skin of
may make you sleepy or dizzy.
another person, take the patch off immediately
 Do not drive while taking this medicine until
and seek medical attention (see also section 3
you know how it affects you.
below).
 It is an offence to drive if this medicine
Talk to your doctor before using Tilotrans
affects your ability to drive.
Patch if you have:
 However, you would not be committing an
 asthma, any other lung disease or breathing
offence if:
difficulties
o The medicine has been prescribed to
 disturbances of heart rhythm
treat a medical or dental problem and
 low blood pressure or blood volume
o You have taken it according to the
 reduced liver function
instructions given by the prescriber or in
 reduced kidney function
the information provided with the
 had a brain injury, brain tumour, signs of
medicine and
increased intracranial pressure (e.g.
o It was not affecting your ability to drive
headache, visual disturbances), reduced
safely
consciousness or coma
Talk to your doctor or pharmacist if you are not
 myasthenia gravis (a disease characterised
sure whether it is safe for you to drive while
by muscle weakness)
taking this medicine.
 chronic constipation

2

If you are very ill, very thin or elderly, you may be
more sensitive to the effects of the patches.

3

How to use Tilotrans Patch

The dose is determined by your doctor, who
adjusts it individually for you. Always use
Tilotrans Patch exactly as your doctor has told
Avoid exposing the Tilotrans patch to direct heat you. Check with your doctor or pharmacist if you
source such as heating pads, hot water bottles, are not sure.
electric blankets, heated water beds, heat or
tanning lamps, intensive sun bathing, prolonged Using and changing the patches
 There is enough medicine in each patch to
hot baths, saunas or hot whirlpool spa baths,
last 3 days (72 hours)
while wearing the patch. It is possible that more
 You should change your patch every third
fentanyl is released from the patch at higher
day, unless your doctor has told you
temperature.
otherwise
Tilotrans Patch may cause constipation, talk to
 Always remove the old patch before
your doctor or pharmacist for advice on how to
applying the new one
prevent constipation.
Like many other strong painkillers, repeated use  Always change your patch at the same time
of day every 3 days (72 hours)
of the patches may make you become tolerant to
 Make a note of the day, date and time you
the medicine or become dependent on it.
apply a patch, to remind you when you need
Tell your doctor if you have ever abused or been
to change your patch
dependent on alcohol, prescription medicines or
 The following table shows you which day of
illegal drugs.
the week to change your patch
Children
If you develop fever you should contact your
doctor. The dosage may have to be adjusted.

The use of Tilotrans 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 Tilotrans Patches
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.

Change your patch
at the same time on

Apply your patch
on day
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday









Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Some other medicines can affect or be affected
by Tilotrans Patches. These medicines include:
 Medicines that have a sedative effect, such
as
- 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,
troleandomycin)
- nefazodone (used to treat depression)

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 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
For you and your child, do not apply the patch
on:

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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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