Active substance(s): BUPRENORPHINE
Package leaflet: Information for the patient
BuTrans® 5 microgram/hour transdermal patches
BuTrans® 10 microgram/hour transdermal patches
BuTrans® 20 microgram/hour transdermal patches
• These patches contain a strong pain
• 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)
• Do not soak in a hot bath or take a
hot shower whilst wearing a patch
• If you develop a fever tell your doctor
• Follow the dosage instructions
carefully and only change your patch
on the same day and at the same time
7 days later
• If your breathing becomes shallow
and weak take the patch off and seek
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
• If you have any further questions, ask
your doctor, pharmacist or nurse.
• This medicine has been prescribed for
BUTRANS PAT PIL UK 6512402 V2.indd 2
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. Content of the pack and other
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
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
1. What BuTrans patches are
and what they are used for
• if you have previously suffered
from withdrawal symptoms such as
BuTrans patches contain the active
agitation, anxiety, shaking or sweating
ingredient buprenorphine which belongs
upon stopping taking alcohol.
to a group of medicines called strong
analgesics or ‘painkillers’. They have
BuTrans patches must not be used to
been prescribed for you by your doctor to treat symptoms associated with drug
relieve moderate, long-lasting pain that
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using BuTrans patches:
• if you suffer from seizures, fits or
• 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
Children and adolescents
Do not give this medicine to children below
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 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
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
Using BuTrans patches with food, drink
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
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
• 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
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:
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
Three 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 follow-up
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
During treatment, your doctor may
change the patch you use to a smaller
or larger one if necessary. 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
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
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
• 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
• 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
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
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
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 sight and reach
600x130mm (LSN-CON-08) (L) V1
• 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
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,
BUTRANS PAT PIL UK 6512402 V2.indd 3
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
4. Possible side effects
Like all medicines BuTrans patches can
have side effects, although not everybody
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
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
As with all strong painkillers, there is a risk
that you may become addicted or reliant on
In patients treated with BuTrans patches,
the following other side effects have been
Very common (probably occurring in more
than 1 in 10 people)
• Headache, dizziness, drowsiness.
• Constipation, feeling or actually being
• Itchy skin.
• Rash, redness, itching, inflammation or
swelling of the skin at the application site.
Common (probably occurring in between
1 and 10 out of every 100 people)
• Loss of appetite.
• Confusion, depression, anxiety,
difficulty in sleeping, nervousness,
• 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 (probably occurring in
between 1 and 10 out of every 1,000
• Mood swings, restlessness, agitation,
a feeling of extreme happiness,
hallucinations, nightmares, decreased
sexual drive, aggression.
• Changes in taste, difficulty in speaking,
reduced sensitivity to pain or touch,
tingling or numbness.
• Loss of memory, migraine, fainting,
problems with concentration or
• 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.
Spasms, aches and pains.
Difficulty in beginning the flow of urine.
An increase in accidental injuries (e.g.
• 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)
• Angina (chest pain associated with heart
• 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
• Difficulty in swallowing.
• Local allergic reaction with marked signs of
swelling (in such cases treatment should be
• Swelling and irritation inside the nose.
• Decreased erection, sexual dysfunction.
• A flu like illness.
• Flushing of the skin.
Very rare (probably occurring in fewer than
1 out of every 10,000 people)
• Muscle twitching.
• Ear pain.
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.
• Withdrawal symptoms in babies born to
mothers who have been given Butrans
in pregnancy may include high-pitched
crying, irritability and restlessness,
shaking (tremor), feeding difficulties,
sweating and not putting on weight.
Reporting of side effects
If you get any side effects, talk to your
doctor or 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:
By reporting side effects you can help
provide more information on the safety of this
BuTrans 10 microgram/hour transdermal
Keep this medicine out of the sight and
Each transdermal patch contains 10 mg of
reach of children.
buprenorphine in a patch size of 12.5 cm2
Do not use BuTrans patches after the expiry and releases about 10 micrograms of
date which is stated on the carton and on the buprenorphine per hour (over a period of
pouch. The expiry date refers to the last day
of that month. After the expiry date, take any BuTrans 20 microgram/hour transdermal
unused patches to a pharmacy.
Do not store BuTrans patches above 25°C.
Each transdermal patch contains 20 mg of
buprenorphine in a patch size of 25 cm2
Do not use the patch if the pouch seal is
and releases about 20 micrograms of
buprenorphine per hour (over a period of
Used patches must be folded over on
themselves with the adhesive layer inwards, 7 days).
and discarded safely out of sight and reach The other ingredients are:
• Polyacrylate (Durotak 387-2051
Do not throw away any medicines via
• Levulinic acid
wastewater or household waste. Ask your
• Oleyl oleate
pharmacist how to throw away medicines
you no longer use. These measures will help • Povidone
protect the environment.
What BuTrans patches look like and
6. Contents of the pack and other
contents of the pack
What BuTrans patches contain
Three sizes are available.
The active ingredient is buprenorphine.
5 microgram/hour: square, beige coloured
BuTrans 5 microgram/hour transdermal
patch with rounded corners marked
BuTrans 5 μg/h
Each transdermal patch contains 5 mg of
10 microgram/hour: rectangular, beige
buprenorphine in a patch size of 6.25 cm2 and coloured patch with rounded corners
releases about 5 micrograms of buprenorphine marked BuTrans 10 μg/h
per hour (over a period of 7 days).
5. How to store BuTrans patches
20 microgram/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
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited,
Cambridge Science Park,
Cambridge CB4 0GW,
Bard Pharmaceuticals Limited,
Cambridge Science Park,
Cambridge CB4 0GW,
Mundipharma DC B.V.,
Leusderend 16, 3832 RC Leusden ,
This medicinal product is authorised
in the Member States of the EEA
under the following names:
Republic of Ireland
For UK only:
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
These are as follows:
Product name: BuTrans patches
Reference number: 16950/0136
This leaflet was last revised in June 2017
BuTrans® transdermal patches are protected by European Patent (UK) Nos.
0792145, 1570823, 1731152 and 2305194.
® BUTRANS, NAPP and the NAPP logo are registered trade marks
© 2007-2015 Napp Pharmaceuticals Ltd
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