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BUTRANS 15 MICROGRAM/HOUR

Active substance(s): BUPRENORPHINE

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

Package leaflet: Information for the patient

BuTrans® 15 microgram/hour transdermal patches
Buprenorphine
Read all of this leaflet carefully
before you start using this
medicine because it contains
important information for you.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor, pharmacist or nurse.
• This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
• If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What BuTrans patches are and
what they are used for
2. What you need to know before you
use BuTrans patches
3. How to use BuTrans patches
4. Possible side effects
5. How to store BuTrans patches
6. Contents of the pack and other
information

BUTRANS PAT 15MG PIL UK P1251-A V3.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. What you need to know before
you use BuTrans patches
Do not use BuTrans patches:
• if you are allergic to buprenorphine
or any of the other ingredients of
this medicine (listed in section 6);
• 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
tranylcypromine, phenelzine,
isocarboxazid, moclobemide 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.
Warnings and precautions
Talk to your doctor, pharmacist or
nurse before using BuTrans patches:
• 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 or alcohol;
• 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.
Children and adolescents
Do not give this medicine to children
below 18 years.
Other medicines and BuTrans
patches
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
• BuTrans patches must not be used
together with a type of medicine
known as a monoamine oxidase
inhibitor (examples include
tranylcypromine, phenelzine,
isocarboxazid, moclobemide 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 pain,
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 be used
with caution if you are also taking
benzodiazepines (medicines used to
treat anxiety or to help you sleep).
This combination may cause serious
breathing problems which could
be fatal in case of overdose. Tell
your doctor if you are taking this
combination.
Using BuTrans patches with food,
drink and 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, breast-feeding and fertility
You should not use BuTrans patches if
you are pregnant or are breast-feeding,
think you may be pregnant or are
planning to have a baby.
Ask your doctor or pharmacist for
advice before taking this medicine.
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 (e.g. feel dizzy,
drowsy or have blurred vision), 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 The medicine has been
prescribed to treat a medical
or dental problem; and
o 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 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
Always use this medicine exactly as
your doctor or pharmacist has told you.
Check with your doctor or pharmacist
if you are not sure.
Different strengths of BuTrans patches
are available. Your doctor will decide
which strength of BuTrans patch will
suit you best.
When people first start using BuTrans,
they often experience some nausea and
vomiting (see section 4). This usually
passes after the first week of treatment.
It’s a good idea to book a followup appointment with your doctor a
week or two after you first start using
BuTrans patches to ensure that you are
taking the correct dose and to manage
any side effects.

During treatment, your doctor may
change the patch you use to a smaller
or larger one if necessary, or tell
you to use a combination of up to
two patches. Do not cut or divide
the patch or use a higher dose than
recommended. You should not
apply more than two patches at the
same time up to a maximum total
dose of 40 micrograms/hour.
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
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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.

BUTRANS PAT 15MG PIL UK P1251-A V3.indd 3

• 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.
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 cause 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 (may affect more than 1
in 10 people)
• Headache, dizziness, drowsiness.
• Constipation, feeling or actually
being sick.

• Itchy skin.
• Rash, redness, itching, inflammation
or swelling of the skin at the
application site.
Common (may affect up to 1 in 10
people)
• Loss of appetite.
• Confusion, depression, anxiety,
difficulty in sleeping, nervousness,
shaking (tremors).
• Shortness of breath.
• Abdominal pain or discomfort,
diarrhoea, indigestion, dry mouth.
• Sweating, rash, skin eruptions.
• Tiredness, a feeling of unusual
weakness, muscle weakness,
swelling of hands, ankles or feet.
Uncommon (may affect up to 1 in 100
people)
• Mood swings, restlessness, agitation,
a feeling of extreme happiness,
hallucinations, nightmares.
• Changes in taste, difficulty in
speaking, reduced sensitivity to pain
or touch, tingling or numbness,
• Loss of memory, migraine, fainting,
problems with concentration or coordination.
• Dry eyes, blurred vision.
• A ringing or buzzing sound in the
ears, a feeling of dizziness or spinning.
• High or low blood pressure, chest
pain, fast or irregular heart beat.








Cough, hiccups, wheezing.
Wind.
Weight loss.
Dry skin.
Spasms, aches and pains.
Difficulty in beginning the flow of
urine.
• Inability to fully empty the bladder.
• 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 (may affect up to 1 in 1,000 people)
• Angina (chest pain associated with heart
disease).
• Decreased sexual drive, mental disorder.
• Difficulties with balance.
• Swelling of the eyelids or face, a
reduction in size of the pupils in the eye.
• Difficulty in breathing, worsening of
asthma, over breathing.
• A feeling of faintness, especially on
standing up.
• Difficulty in swallowing.

• Local allergic reaction with marked
signs of swelling (in such cases
treatment should be stopped).
• Swelling and irritation inside the nose.
• Decreased erection, sexual dysfunction.
• A flu like illness.
• Flushing of the skin.
• Dehydration.
Very rare (may affect up to 1 in 10,000
people)
• Muscle twitching.
• Ear pain.
• Blisters.
Not known (frequency cannot be
estimated from the available data)
• Seizures, fits or convulsions.
• Inflammation of the bowel wall.
Symptoms may include fever, vomiting
and stomach pain or discomfort.
• Colicky abdominal pain or discomfort.
• Feeling detached from oneself.
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. By
reporting side effects you can help
provide more information on the safety of
this medicine.

Each transdermal patch contains
Manufacturers
Mundipharma DC B.V.,
15 mg of buprenorphine in a patch
De Wel 20,
Bard Pharmaceuticals Limited,
2
size of 18.75 cm and releases about Cambridge Science Park,
3871 MV Hoevelaken,
Keep this medicine out of the sight
15 micrograms of buprenorphine per Milton Road,
The Netherlands.
and reach of children.
hour (over a period of 7 days).
Cambridge CB4 0GW,
Do not use BuTrans patches after the
The other ingredients are:
UK
expiry date which is stated on the
• Polyacrylate (Durotak 387-2051 &
carton and on the pouch. The expiry
387-2054)
date refers to the last day of that
This leaflet is also available in large print, Braille or as
month. After the expiry date, take any • Levulinic acid
an audio CD. To request a copy, please call the RNIB
• Oleyl oleate
unused patches to a pharmacy.
• Povidone
Do not store BuTrans patches above
Medicine Information line (free of charge) on:
• Polyethylene terephthalate
25°C.
0800 198 5000
What BuTrans patches look like and
Do not use the patch if the pouch seal contents of the pack
You
will
need
to
give
details of the product name and
is broken.
Transdermal patch.
reference
number.
Used patches must be folded over on
Rectangular, beige coloured patch
themselves with the adhesive layer
These
are
as
follows:
with rounded corners marked BuTrans
inwards, and discarded safely out of
Product name: BuTrans patches
15 μg/h
sight and reach of children.
BuTrans patches are available in
Reference number: 16950/0349
Do not throw away any medicines
cartons containing 4 pouches each
via wastewater or household waste.
This leaflet was last revised in May 2015.
containing a single patch.
Ask your pharmacist how to throw
Marketing Authorisation Holder
BuTrans® transdermal patches are protected by European Patent (UK) Nos.
away medicines you no longer use.
0430019 and 0964677.
These measures will help protect the
Napp Pharmaceuticals Limited
environment.
Cambridge Science Park
® BuTrans, NAPP and the ‘NAPP’ logo are registered trade marks
Milton Road
© 2014 Napp Pharmaceuticals Ltd
6. Contents of the pack and
Cambridge
You can also get support and information about arthritis from Arthritis Care:
CB4 0GW
other information
Phone free: 0808 800 4050 12pm to 4pm Monday to Friday (or 020 7380 6555
UK
10am to 4pm standard call charges apply).
What BuTrans patches contain
Or write to: Helplines, Arthritis Care, 18 Stephenson Way,
The active ingredient is
London, NW1 2HD.
buprenorphine.
Or email helplines@arthritiscare.org.uk
5. How to store BuTrans patches

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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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