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BUTRANS 10 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the user

BuTrans® 5 micrograms/hour Transdermal patch
BuTrans® 10 micrograms/hour Transdermal patch
BuTrans® 20 micrograms/hour Transdermal patch
Buprenorphine
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 any further questions,
ask your doctor 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 any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
In this leaflet:
1. What BuTrans patches are and
what they are used for
2. Before you use BuTrans patches
3. How to use BuTrans patches
4. Possible side effects
5. How to store BuTrans patches
6. Further information

1. What BuTrans patches are
and what they are used for
BuTrans patches contain the
active ingredient buprenorphine
which belongs to a group of
medicines called strong analgesics
or ‘painkillers’. They have been
prescribed for you by your doctor
to relieve moderate, long-lasting
pain that requires the use of a strong
painkiller.
BuTrans patches should not be used
to relieve acute pain.
BuTrans patches act through
the skin. After application,
buprenorphine passes through the
skin into the blood. Each patch lasts
for seven days.

2. Before you use BuTrans
patches
Do not use BuTrans patches:
• if you are allergic (hypersensitive)
to buprenorphine or any of the
other ingredients of BuTrans
patches;
• if you have breathing problems;
• if you are addicted to drugs;
• if you are taking a type of medicine
known as a monoamine oxidase
inhibitor (examples include
tranylcypromide, phenelzine,
isocarboxazid, moclobamide and
linezolid), or you have taken this
type of medicine in the last two
weeks;
• if you suffer from myasthenia
gravis (a condition in which the
muscles become weak);
• if you have previously suffered
from withdrawal symptoms such
as agitation, anxiety, shaking or
sweating upon stopping taking
alcohol.
BuTrans patches must not be used to
treat symptoms associated with drug
withdrawal.

Take special care with BuTrans
• BuTrans patches must not be used
patches
together with a type of medicine
Before treatment with BuTrans patches known as a monoamine oxidase
tell your doctor or pharmacist:
inhibitor (examples include
• if you suffer from seizures, fits or
tranylcypromide, phenelzine,
convulsions;
isocarboxazid, moclobamide and
• if you have a severe headache or
linezolid), or if you have taken this
feel sick due to a head injury or
type of medicine in the last two
increased pressure in your skull (for
weeks.
instance due to brain disease). This • If you take some medicines such
is because the patches may make
as phenobarbital or phenytoin
symptoms worse or hide the extent
(medicines commonly used to
of a head injury;
treat seizures, fits or convulsions),
• if you are feeling light-headed or
carbamazepine (a medicine to
faint;
treat seizures, fits or convulsions
• if you have severe liver problems;
and certain pain conditions), or
• if you have ever been addicted to
rifampicin (a medicine to treat
drugs;
tuberculosis) the effects of BuTrans
• if you have a high temperature, as
patches may be reduced.
this may lead to larger quantities of • BuTrans patches may make some
the active ingredient being absorbed
people feel drowsy, sick or faint or
into the blood than normal.
make them breathe more slowly
or weakly. These side effects may
If you have recently had an operation,
be made worse if other medicines
please speak to your doctor before
that produce the same effects are
using these patches.
taken at the same time. These
include certain medicines to treat
Taking other medicines
depression, anxiety, psychiatric or
Please tell your doctor or pharmacist if
mental disorders, medicines to help
you are taking or have recently taken
you sleep, medicines to treat high
any other medicines, including
blood pressure such as clonidine,
medicines obtained without a
other opioids (which may be found in
prescription. If you use BuTrans
painkillers or certain cough mixtures
patches with some other medicines, the
e.g. morphine, dextropropoxyphene,
effect of BuTrans patches or the other
codeine, dextromethorphan,
medicine may be changed.

patch. The patch should be worn for
• The BuTrans patch should be applied
3 full days before increasing the dose,
to a relatively hairless or nearly
this is when the maximum effect of a
hairless skin site. If no suitable hair
given dose is established.
free sites are available the hairs
should be cut off with a pair of
3. How to use BuTrans patches
Patients under 18 years of age
scissors. Do not shave them off.
The medicine can affect your ability
BuTrans patches should not be used • Avoid skin which is red, irritated or
to drive as it may make you sleepy or Three different strengths of BuTrans
in patients below the age of 18 years.
has any other blemishes, for
patches are available. Your doctor will
dizzy.
instance large scars.
Patients
with
kidney
disease/
decide
which
strength
of
BuTrans
• Do not drive while taking this
• The area of skin you choose must be
dialysis
patients
patch
will
suit
you
best.
During
Using BuTrans patches with alcohol medicine until you know how it
dry and clean. If necessary, wash it
treatment, your doctor may change the In patients with kidney disease, no
Alcohol may make some of the side
affects you.
with cold or lukewarm water. Do not
patch
you
use
to
a
smaller
or
larger
change
in
dose
is
necessary.
effects worse and you may feel unwell • It is an offence to drive while you
use soap, alcohol, oil, lotions or other
one
if
necessary.
You
should
not
if you drink alcohol whilst wearing
have this medicine in your body
detergents. After a hot bath or
Patients
with
liver
disease
apply more than two patches at the
BuTrans patches. Drinking alcohol
over a specified limit unless you
shower, wait until your skin is
In
patients
with
liver
disease,
the
whilst using BuTrans patches may
have a defence (called the ‘statutory same time, regardless of the patch
completely dry and cool. Do not
effects and period of action of the
strength.
also affect your reaction time.
defence’).
apply lotion, cream or ointment to the
BuTrans
patch
may
be
affected
and
Always use the BuTrans patch
• This defence applies when:
chosen area. This might prevent your
your
doctor
will
therefore
check
on
Pregnancy and breastfeeding
o The medicine has been prescribed exactly as your doctor has told you.
patch from sticking properly.
you more closely.
You should not use BuTrans patches
You
should
check
with
your
doctor
or
to treat a medical or dental
if you are pregnant, likely to become
pharmacist
if
you
are
not
sure.
problem; and
Before applying the BuTrans patch Applying the patch
pregnant or are breastfeeding.
o You have taken it according to
Step 1: Each patch is sealed
• Choose an area of non-irritated,
Adults and elderly patients
the instructions given by the
in a pouch. Just before use,
intact
skin
on
your
upper
arm,
outer
Ask your doctor or pharmacist for
Unless your doctor has told you
prescriber and in the information
open the pouch by tearing
advice before taking any medicines.
differently, attach one BuTrans patch arm, upper chest, upper back or
provided with the medicine.
where indicated. Take out
side of the chest. (See illustrations
(as described in detail below) and
• Please note that it is still an offence
the patch. Do not use the
Driving and using machines
below).
Ask
for
assistance
if
you
change it every seventh day,
to drive if you are unfit because of
patch if the pouch seal is broken.
BuTrans patches may affect your
cannot apply the patch yourself.
preferably at the same time of day.
the medicine (i.e. your ability to
Step 2: The sticky side of the patch is
reactions to such an extent that you
Your doctor may wish to adjust the
drive is being affected).
covered with a silvery protective foil.
may not react adequately or quickly
dose after 3-7 days until the correct
Carefully peel off half the foil. Try not
enough in the event of unexpected
level of pain control has been found.
Details regarding a new driving
to touch the sticky part of the patch.
or sudden occurrences. This applies
If
your
doctor
has
advised
you
to
take
offence concerning driving after drugs
Step 3: Stick the patch on to
particularly:
other
painkillers
in
addition
to
the
have been taken in the UK may be
the area of skin you have
• at the beginning of treatment;
patch, strictly follow the doctor’s
found here:
chosen and remove the
• if you are taking medicines to treat
instructions, otherwise you will not
remaining foil.
anxiety or help you sleep;
https://www.gov.uk/drug-driving-law
fully benefit from treatment with the
BuTrans
noscapine), antihistamines which
make you drowsy, or anaesthetics
such as halothane.
• BuTrans patches must not be used
together with benzodiazepines
(medicines used to treat anxiety or
to help you sleep). This combination
may cause serious breathing
problems which may be fatal.

• if your dose is increased.
If you are affected you should not
drive or operate machinery whilst
using BuTrans patches, or for 24 hours
after removing the patch.

Talk to your doctor or pharmacist if
you are not sure whether it is safe
for you to drive while taking this
medicine.

Step 4: Press the patch against your
skin with the palm of your hand and
count slowly to 30. Make sure that
the whole patch is in contact with
your skin, especially at the edges.
Wearing the patch
You should wear the patch for seven
days. Provided that you have
applied the patch correctly, there is
little risk of it coming off. If the edges
of the patch begin to peel off, they
may be taped down with a suitable
skin tape. You may shower, bathe or
swim whilst wearing it.
Do not expose the patch to extreme
heat (e.g. heating pads, electric
blanket, heat lamps, sauna, hot tubs,
heated water beds, hot water bottle,
etc) as this may lead to larger
quantities of the active ingredient
being absorbed into the blood than
normal. External heat may also
prevent the patch from sticking
properly. If you have a high
temperature this may alter the
effects of BuTrans patches (see
“Take special care” section above).
In the unlikely event that your patch
falls off before it needs changing, do
not use the same patch again. Stick
a new one on straight away (see
“Changing the patch” below).

Changing the patch
• Take the old patch off.
• Fold it in half with the sticky side
inwards.
• Open and take out a new patch.
Use the empty pouch to dispose of
the old patch. Now discard the
pouch safely.
• Even used patches contain some
active ingredient that may harm
children or animals, so make sure
your used patches are always kept
out of the reach and sight of them.
• Stick a new patch on a different
appropriate skin site (as described
above). You should not apply a new
patch to the same site for 3-4 weeks.
• Remember to change your patch at
the same time of day. It is important
that you make a note of the time of
day.

If you use more BuTrans patches
than you should
As soon as you discover that you have
used more patches than you should,
remove all patches and call your
doctor or hospital straight away.
People who have taken an overdose
may feel very sleepy and sick. They
may also have breathing difficulties or
lose consciousness and may need
emergency treatment in hospital.
When seeking medical attention make
sure that you take this leaflet and any
remaining patches with you to show to
the doctor.

Some people may have side effects
those covering your whole body.
when they have used strong painkillers As with all strong painkillers, there is a
for a long time and stop using them.
risk that you may become addicted or
The risk of having effects after
reliant on BuTrans patches.
stopping BuTrans patches is very low.
However, if you feel agitated, anxious, In patients treated with BuTrans
nervous or shaky, if you are overactive, patches, the following other side
effects have been reported:
have difficulty sleeping or digestive
problems, tell your doctor.
Very common (probably occurring in
The pain relieving effect of BuTrans
more than 1 in 10 people)
patch is maintained for some time
• Headache, dizziness, drowsiness.
after removal of the patch. You
• Constipation, dry mouth, feeling or
should not start another opioid
actually being sick.
analgesic (strong painkiller) within
• Itching, redness, itching at
24 hours after removal of the patch.
application site.
If you forget to apply the BuTrans
If you have any further questions on
Common (probably occurring in
patch
the use of this product, ask your
between 1 and 10 out of every 100
Stick a new patch on as soon as you doctor or pharmacist.
people)
remember. Also make a note of the
• Loss of appetite.
4. Possible side effects
date, as your usual day of changing
• Confusion, depression, difficulty in
may now be different. If you are very
Like all medicines BuTrans patches
sleeping, nervousness.
Duration of treatment
late changing your patch, your pain
can have side effects, although not
• Tingling or numbness.
Your doctor will tell you how long you may return. In this case, please
everybody gets them.
• Flushing of the skin.
should be treated with the BuTrans
contact your doctor.
Serious side effects that may be
• Shortness of breath.
patch. Do not stop treatment without
Do not apply additional patches to
associated with BuTrans patches are • Abdominal pain or discomfort,
consulting a doctor, because your pain make up for the forgotten application.
similar to those seen with other strong
diarrhoea, indigestion.
may return and you may feel unwell
• Sweating, rash, skin eruptions.
If you stop using BuTrans patches painkillers and include difficulty in
(see also “If you stop using BuTrans
• Tiredness, a feeling of unusual
If you stop using BuTrans patches too breathing and low blood pressure.
patches” below).
This medicine can cause allergic
weakness, muscle weakness, pain,
soon or you interrupt your treatment
If you feel that the effect of the
reactions, although serious allergic
chest pain, swelling of hands,
your pain may return. If you wish to
BuTrans patch is too weak or
reactions are rare. Remove the patch
ankles or feet, redness or rash at the
stop
treatment
please
consult
your
too strong, talk to your doctor or
and tell your doctor immediately if you
application site.
doctor.
They
will
tell
you
what
can
be
pharmacist.
done and whether you can be treated get any sudden wheeziness, difficulties
in breathing, swelling of the eyelids,
with other medicines.
face or lips, rash or itching especially

Uncommon (probably occurring in
between 1 and 10 out of every 1,000
people)
• Dehydration.
• Mood swings, restlessness,
agitation, anxiety, feeling detached
from oneself, a feeling of extreme
happiness, hallucinations,
nightmares.
• Changes in taste, difficulty in
speaking, reduced sensitivity to pain
or touch, loss of memory, migraine,
fainting, shaking, problems with
concentration or co-ordination.
• Dry eyes, blurred vision.
• A ringing or buzzing sound in
the ears, a feeling of dizziness or
spinning.
• High or low blood pressure, angina
(severe chest pain associated with
heart disease), fast or irregular heart
beat.
• Worsening of breathing problems
associated with asthma, cough,
hiccups, over breathing, reduced
oxygen in the blood, runny nose,
wheezing.
• Wind.
• Weight loss.
• Dry skin, swelling of the face.
• Muscle cramps, spasms, aches and
pains.
• Difficulty in passing urine.

• A flu like illness, high temperature,
shivering, generally feeling unwell.
• An increase in accidental injuries
(e.g. falls).
• Withdrawal symptoms such as
agitation, anxiousness, sweating or
shaking upon stopping using
BuTrans patches.
If you need to have blood tests
remind your doctor that you are using
BuTrans patches. This is important
because BuTrans patches may
change the way your liver works and
this could affect the results of some
blood tests.
Rare (probably occurring in between
1 and 10 out of every 10,000 people)
• Decreased sexual drive, mental
disorder.
• Difficulties with balance.
• Swelling of the eyelids, a reduction
in size of the pupils in the eye.
• Difficulty in breathing.
• Diverticulitis (inflammation of the
intestine), difficulty in swallowing.
• Local allergic reaction with marked
signs of swelling (in such cases
treatment should be stopped).
• Decreased erection, sexual
dysfunction.

Very rare (probably occurring in fewer 6. Further information
than 1 out of every 10,000 people)
What BuTrans patches contain
• Muscle twitching.
The active ingredient is buprenorphine.
• Ear pain.
• Blisters.
BuTrans 5 microgram/hour
Reporting of side effects
Transdermal patch
If you get any side effects, talk to your One transdermal patch (active surface
doctor, pharmacist or nurse. This
area 6.25 cm2) contains 5mg of
includes any possible side effects not buprenorphine and releases 5
listed in this leaflet. You can also
micrograms/hour (over a period of 7
report side effects directly via the
days).
Yellow Card Scheme at:
BuTrans 10 microgram/hour
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help Transdermal patch
patch (active surface
provide more information on the safety One transdermal
area 12.5 cm2) contains 10mg of
of this medicine.
buprenorphine and releases 10
5. How to store BuTrans patches micrograms/hour (over a period of 7
days).
Keep out of the reach and sight of
BuTrans 20 microgram/hour
children.
Do not use BuTrans patches after the Transdermal patch
One transdermal patch (active surface
expiry date which is stated on the
area 25.5 cm2) contains 20mg of
carton and on the pouch. The expiry
buprenorphine and releases 20
date refers to the last day of that
month. After the expiry date, take any micrograms/hour (over a period of 7
days).
unused patches to a pharmacy.
Do not store above 25°C.
Do not use the patch if the pouch seal The other ingredients are:
• Polyacrylate (Durotak 387-2051 &
is broken.
387-2054)
Used patches must be folded over on
• Levulinic acid
themselves with the adhesive layer
inwards, and discarded safely out of • • Oleyl oleate
• Povidone
sight and reach of children.
• Polyethylene terephthalate

What BuTrans patches look like
and contents of the pack
Transdermal patch
Three sizes are available.
5 micrograms/hour: square, beige
coloured patch with rounded corners
marked Norspan 5mg and 5 μg on an
aluminium rigid with a removable
protective layer.
10 micrograms/hour: rectangular,
beige coloured patch with rounded
corners marked Norspan 10mg and
10μg on an aluminium rigid with a
removable protective layer.
20 micrograms/hour: square, beige
coloured patch with rounded corners
marked Norspan 20mg and 20μg on
an aluminium rigid with a removable
protective layer.
BuTrans patches are available in
cartons containing 4 pouches each
containing a single patch.
Procured from within the EU by PL
holder PilsCo Ltd, 10-16 Colvilles
Place, East Kilbride, G75 0SN.
Repackaged by Cross Healthcare Ltd,
Unit 2A, Bandeath Industrial Estate,
Stirling, FK7 7NP.

Manufacturer
Mundipharma DC B.V.
Hoevelaken
Netherlands
or
Bard Pharmaceuticals Ltd.
Cambridge
United Kingdom
PL 39467/0222
BuTrans 5 microgram/hour
transdermal patch
PL 39467/0223
BuTrans 10 microgram/hour
transdermal patch
PL 39467/0224
BuTrans 20 microgram/hour
transdermal patch
This leaflet was last revised
08/01/2015
BuTrans® is a registered trademark
of Mundipharma AS

POM

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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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