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BUTRANS 10MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the user
®

BuTrans 5 micrograms/hour transdermal patches
BuTrans® 10 micrograms/hour transdermal patches
BuTrans® 20 micrograms/hour transdermal patches
(buprenorphine)
The name of your medicine is
BuTrans 5 micrograms/hour,
10 micrograms/hour,
20 micrograms/hour transdermal
patches but will be referred to as
BuTrans patches throughout this
leaflet.
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
patches
Before treatment with BuTrans
patches tell your doctor or pharmacist:
if you suffer from seizures, fits or
convulsions;
if you have a severe headache or
feel sick due to a head injury or
increased pressure in your skull
(for instance due to brain
disease). This is because the
patches may make symptoms
worse or hide the extent of a head
injury;

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

codeine, dextromethorphan,
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.
Using BuTrans patches with
alcohol

You have taken it according to
the instructions given by the
prescriber and in the
information provided with the
medicine.
Please note that it is still an
offence to drive if you are unfit
because of the medicine (i.e. your
ability to drive is being affected).
Details regarding a new driving
offence concerning driving after drugs
have been taken in the UK may be
found here:

Alcohol may make some of the side
effects worse and you may feel unwell
if you drink alcohol whilst wearing
BuTrans patches. Drinking alcohol
whilst using BuTrans patches may
also affect your reaction time.

https://www.gov.uk/drug-driving-law

Pregnancy and breast-feeding

3. How to use BuTrans
patches

You should not use BuTrans patches
if you are pregnant, likely to become
pregnant or are breast-feeding.
Ask your doctor or pharmacist for
advice before taking any medicines.
Driving and using machines
BuTrans patches may affect your
reactions to such an extent that you
may not react adequately or quickly
enough in the event of unexpected or
sudden occurrences. This applies
particularly:
at the beginning of treatment;
if you are taking medicines to treat
anxiety or help you sleep;
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.
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 while you
have this medicine in your body
over a specified limit unless you
have a defence (called the
‘statutory defence’).
This defence applies when:
The medicine has been
prescribed to treat a medical
or dental problem; and

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

Three different strengths of BuTrans
patches are available. Your doctor will
decide which strength of BuTrans
patch will suit you best. During
treatment, your doctor may change
the patch you use to a smaller or
larger one if necessary. You should
not apply more than two patches at
the same time, regardless of the
patch strength.
Always use the BuTrans patch exactly
as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
Adults and elderly patients
Unless your doctor has told you
differently, attach one BuTrans patch
(as described in detail overleaf) and
change it every seventh day,
preferably at the same time of day.
Your doctor may wish to adjust the
dose after 3-7 days until the correct
level of pain control has been found. If
your doctor has advised you to take
other painkillers in addition to the
patch, strictly follow the doctor’s
instructions, otherwise you will not
fully benefit from treatment with the
BuTrans patch. The patch should be
worn for 3 full days before increasing
the dose, this is when the maximum
effect of a given dose is established.

Patients under 18 years of age

Applying the patch

BuTrans patches should not be used
in patients below the age of 18 years.

Step 1: Each patch is
sealed in a pouch. Just
before use, open the
pouch by tearing where
indicated. Take out the
patch. Do not use the
patch if the pouch seal is broken.

Patients with kidney
disease/dialysis patients
In patients with kidney disease, no
change in dose is necessary.
Patients with liver disease
In patients with liver disease, the
effects and period of action of the
BuTrans patch may be affected and
your doctor will therefore check on
you more closely.
Before applying the BuTrans patch
Choose an area of non-irritated,
intact skin on your upper arm,
outer arm, upper chest, upper
back or side of the chest. (See
illustrations below). Ask for
assistance if you cannot apply the
patch yourself.

Step 2: The sticky side of the patch is
covered with a silvery protective foil.
Carefully peel off half the foil. Try not
to touch the sticky part of the patch.
Step 3:Stick the patch
on to the area of skin
you have chosen and
remove the remaining
foil.
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

The BuTrans patch should be
applied to a relatively hairless or
nearly hairless skin site. If no
suitable hair free sites are
available the hairs should be cut
off with a pair of scissors. Do not
shave them off.
Avoid skin which is red, irritated or
has any other blemishes, for
instance large scars.
The area of skin you choose must
be dry and clean. If necessary,
wash it with cold or lukewarm
water. Do not use soap, alcohol,
oil, lotions or other detergents.
After a hot bath or shower, wait
until your skin is completely dry
and cool. Do not apply lotion,
cream or ointment to the chosen
area. This might prevent your
patch from sticking properly.

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’ overleaf).

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.
Duration of treatment
Your doctor will tell you how long you
should be treated with the BuTrans
patch. Do not stop treatment without
consulting a doctor, because your
pain may return and you may feel
unwell (see also ‘If you stop using
BuTrans patches’ overleaf).
If you feel that the effect of the
BuTrans patch is too weak or too
strong, talk to your doctor or
pharmacist.
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.

If you forget to apply the BuTrans
patch
Stick a new patch on as soon as you
remember. Also make a note of the
date, as your usual day of changing
may now be different. If you are very
late changing your patch, your pain
may return. In this case, please
contact your doctor.
Do not apply additional patches to
make up for the forgotten application.
If you stop using BuTrans patches
If you stop using BuTrans patches too
soon or you interrupt your treatment
your pain may return. If you wish to
stop treatment please consult your
doctor. They will tell you what can be
done and whether you can be treated
with other medicines.
Some people may have side effects
when they have used strong
painkillers for a long time and stop
using them.
The risk of having effects after
stopping BuTrans patches is very low.
However, if you feel agitated, anxious,
nervous or shaky, if you are
overactive, have difficulty sleeping or
digestive problems, tell your doctor.
The pain relieving effect of BuTrans
patch is maintained for some time
after removal of the patch. You should
not start another opioid analgesic
(strong painkiller) within 24 hours after
removal of the patch.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines BuTrans patches
can have side effects, although not
everybody gets them.
Serious side effects that may be
associated with BuTrans patches are
similar to those seen with other strong
painkillers and include difficulty in
breathing and low blood pressure.

This medicine can cause allergic
reactions, although serious allergic
reactions are rare. Remove the patch
and tell your doctor immediately if you
get any sudden wheeziness,
difficulties in breathing, swelling of the
eyelids, face or lips, rash or itching
especially those covering your whole
body.
As with all strong painkillers, there is a
risk that you may become addicted or
reliant on BuTrans patches.
In patients treated with BuTrans
patches, the following other side
effects have been reported:
Very common (probably occurring in
more than 1 in 10 people)
Headache, dizziness, drowsiness.
Constipation, dry mouth, feeling or
actually being sick.
Itching, redness, itching at
application site.
Common (probably occurring in
between 1 and 10 out of every 100
people)
Loss of appetite.
Confusion, depression, difficulty in
sleeping, nervousness.
Tingling or numbness.
Flushing of the skin.
Shortness of breath.
Abdominal pain or discomfort,
diarrhoea, indigestion.
Sweating, rash, skin eruptions.
Tiredness, a feeling of unusual
weakness, muscle weakness,
pain, chest pain, swelling of
hands, ankles or feet, redness or
rash at the application site.
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
than 1 out of every 10,000 people)
Muscle twitching.
Ear pain.
Blisters.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also
report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

The other ingredients are:
polyacrylate, levulinic acid, oleyl
oleate, povidone K90 and
polyethylene terephthalate.

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

BuTrans 5 microgram/hour
transdermal patch: square, beige
coloured patch with rounded corners
marked in blue with ‘Norspan 5mg’
and ‘5 μg/h’ on an aluminium rigid and
removable protective layer.

5. How to store BuTrans
patches
Keep out of the sight and reach of
children.
Do not store above 25°C.
Do not use the medicine after the
expiry date which is stated on the
carton and pouch label after ‘Exp’.
The expiry date refers to the last day
of that month.
Do not use the patch if the pouch seal
is broken.
Used patches must be folded over on
themselves with the adhesive layer
inwards, and discarded safely out of
sight and reach of children.
If this medicine becomes discoloured
or shows any signs of deterioration,
seek the advice of your pharmacist.

6. Further information

What BuTrans patches look like
and contents of the pack
Transdermal patch
Three sizes are available.

BuTrans 10 microgram/hour
transdermal patch: rectangular, beige
coloured patch with rounded corners
marked in blue with ‘Norspan 10mg’
and ‘10 μg/h’ on an aluminium rigid
and removable protective layer.
BuTrans 20 microgram/hour
transdermal patch: square, beige
coloured patch with rounded corners
marked in blue with ‘Norspan 20mg’
and ‘20 μg/h’ on an aluminium rigid
and removable protective layer.
BuTrans patches are available in
cartons containing 2 or 4 pouches
each containing a single patch.
Manufactured by:
Bard Pharmaceuticals Limited,
Cambridge Science Park, Milton
Road, Cambridge, CB4 0GW UK.
OR

What BuTrans patches contains:
The active ingredient in BuTrans
patches is buprenorphine.
One BuTrans 5 microgram/hour
transdermal patch (active surface
area: 6.25 cm2) contains 5mg
buprenorphine and releases
5 micrograms/hour over a period of
7 days.
One BuTrans 10 microgram/hour
transdermal patch (active surface
area: 12.5 cm2) contains 10mg
buprenorphine and releases
10 micrograms/hour over a period of
7 days.
One BuTrans 20 microgram/hour
transdermal patch (active surface
area: 25 cm2) contains 20mg
buprenorphine and releases 20
micrograms/hour over a period of
7 days.

Mundipharma DC B.V., Hoevelaken,
The Netherlands.
Procured from within the EU &
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
BuTrans® 5 micrograms/hour
transdermal patches
PL 18799/2649
BuTrans® 10 micrograms/hour
transdermal patches
PL 18799/2598
BuTrans® 20 micrograms/hour
transdermal patches
PL 18799/2648
POM

CD

Leaflet date: 25.07.2016

BuTrans is a registered trademark of
Mundipharma AG
You can also get support and
information about arthritis from
Arthritis Care:
Phone free: 0808 800 4050 12pm to
4pm Monday to Friday
(or 020 7380 6555 10am to 4pm
standard call charges apply).
OR
write to: Helplines, Arthritis Care, 18
Stephenson Way, London, NW1 2HD.
OR
email helplines@arthritiscare.org.uk

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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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