BUTRANS 5

Active substance: BUPRENORPHINE

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600x130mm (LSN-CON-08) (L) V1

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1664
BuTrans patch PIL
N/A
UK
6509133
PharmaCode - 3011
N/A
N/A
LTS
600x130mm (LSN-CON-08) (L) V1
N/A

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LSN-CON-08 B
N/A
600x130mm
60x130mm
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Adobe Indesign CS5
Lisa Taylor
2
04-04-14

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V5-2009

6509133

BUTRANS PIL UK 6509133 V2.indd 1

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600x130mm (LSN-CON-08) (L) V1

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
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

BUTRANS PIL UK 6509133 V2.indd 2

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
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.
Pregnancy and breastfeeding
You should not use BuTrans patches
if you are pregnant, likely to become
pregnant or are breastfeeding.
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:
o  he medicine has been prescribed
T
to treat a medical or dental
problem; and
Y
o  ou 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:
https://www.gov.uk/drug-driving-law

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

• 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.
Applying the patch
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.
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
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).

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600x130mm (LSN-CON-08) (L) V1

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” below).
If you feel that the effect of the
BuTrans patch is too weak or
too strong, talk to your doctor or
pharmacist.

BUTRANS PIL UK 6509133 V2.indd 3

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.

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.

BuTrans 10 microgram/hour
transdermal patch
Each transdermal patch contains
10 mg of buprenorphine in a patch
size of 12.5 cm2 and releases about
5. How to store BuTrans patches
10 micrograms of buprenorphine per
Keep out of the reach and sight of children. hour (over a period of 7 days).
BuTrans 20 microgram/hour
Do not use BuTrans patches after the
transdermal patch
expiry date which is stated on the carton
Each transdermal patch contains
and on the pouch. The expiry date refers
20 mg of buprenorphine in a patch
to the last day of that month. After the
expiry date, take any unused patches to a size of 25 cm2 and releases about
20 micrograms of buprenorphine per
pharmacy.
Do not store BuTrans patches above 25°C. hour (over a period of 7 days).
The other ingredients are:
Do not use the patch if the pouch seal is
• Polyacrylate (Durotak 387-2051 &
broken.
387-2054)
Used patches must be folded over on
• Levulinic acid
themselves with the adhesive layer
• Oleyl oleate
inwards, and discarded safely out of sight • Povidone
and reach of children.
• Polyethyleneterephthalate
What BuTrans patches look like
6. Further information
and contents of the pack
Transdermal patch
What BuTrans patches contain
Three sizes are available.
The active ingredient is buprenorphine.
BuTrans 5 microgram/hour transdermal
5 micrograms/hour: square, beige
patch
coloured patch with rounded corners
Each transdermal patch contains 5 mg of marked BuTrans 5 μg/h
buprenorphine in a patch size of 6.25 cm2 10 micrograms/hour: rectangular,
and releases about 5 micrograms of
beige coloured patch with rounded
buprenorphine per hour (over a period of
corners marked BuTrans 10 μg/h
7 days).

20 micrograms/hour: square, beige
coloured patch with rounded corners
marked BuTrans 20 μg/h
BuTrans patches are available in
cartons containing 4 pouches each
containing a single patch.
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge CB4 0GW,
UK.
Manufacturers:
Bard Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge CB4 0GW,
UK
Mundipharma DC B.V.,
De Wel 20,
3871 MV Hoevelaken,
The Netherlands.
This medicinal product is
authorised in the Member States of
the EEA under the following names:
Austria
Norspan®
Belgium
Norspan®
Czech Republic
Norspan®
Denmark
Norspan®
Estonia
Norspan®
Finland
Norspan®
Germany
Norspan®

Hungary
Iceland
Latvia
Lithuania
Luxembourg
Netherlands
Norway

Norspan®
Norspan®
Norspan®
Norspan®
Norspan®
BuTrans ®
Norspan®

Poland
Portugal
Republic of Ireland
Slovak Republic
Sweden
United Kingdom

Norspan®
Norspan®
BuTrans®
Norspan®
Norspan®
BuTrans®

This leaflet is also available in large print, Braille or as
an audio CD. To request a copy, please call the RNIB
Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and
reference number.
These are as follows:
Product name: BuTrans patches
Reference number: 16950/0136
This leaflet was last revised in March 2014
BuTrans® transdermal patches are protected by European Patent (UK) Nos.
0430019 and 0964677.
® BuTrans and the NAPP device (logo) are Registered Trade Marks
© 2007-2014 Napp Pharmaceuticals Ltd
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
6509133

04/04/2014 12:26

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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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