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BUTEC 10 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE / BUPRENORPHINE / BUPRENORPHINE

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Package leaflet: Information for the patient
Butec® 5 microgram/hour transdermal patches
Butec® 10 microgram/hour transdermal patches
Butec® 20 microgram/hour transdermal patches
Buprenorphine
• These patches contain a strong
pain killer
• 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 immediately
• 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 medical help

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 or 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 Butec patches are and what
they are used for
2. What you need to know before you
use Butec patches
3. How to use Butec patches
4. Possible side effects
5. How to store Butec patches
6. Content of the pack and other
information
1. what Butec patches are and
what they are used for
Butec 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.
Butec patches should not be used to
relieve acute pain.
Butec 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 Butec patches
Do not use Butec 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 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.
Butec patches must not be used to
treat symptoms associated with drug
withdrawal.

Warnings and precautions
Talk to your doctor, pharmacist or
nurse before using Butec 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 Butec patches
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.

• Butec 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 Butec
patches may be reduced.
• Butec 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.
• Butec 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.
Using Butec 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 Butec patches. Drinking
alcohol whilst using Butec patches
may also affect your reaction time.
Pregnancy breast-feeding and
fertility
You should not use Butec patches
if you are pregnant, or are breastfeeding, 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
Butec 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 Butec
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 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 Butec 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.
Three different strengths of Butec
patches are available. Your doctor
will decide which strength of Butec
patch will suit you best.
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 40
micrograms/hour.

Adults and elderly patients
Unless your doctor has told you
differently, attach one Butec 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 Butec 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
Butec 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
Butec patch may be affected and
your doctor will therefore check on
you more closely.

Before applying the Butec 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 Butec 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.
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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 Butec 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 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 Butec
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
Butec patches” below).
If you feel that the effect of the Butec
patch is too weak or too strong, talk
to your doctor or pharmacist.
If you use more Butec 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 Butec
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 Butec patches
If you stop using Butec 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 Butec 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 Butec
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 Butec patches
can have side effects, although not
everybody gets them.
Serious side effects that may be
associated with Butec 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 Butec patches.
In patients treated with Butec
patches, the following other side
effects have been reported:

Very common (probably occurring in
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 (probably occurring in
between 1 and 10 out of every 100
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 (probably occurring in
between 1 and 10 out of every 1,000
people)
• 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 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, chest
pain, fast or irregular heart beat.
• Cough, hiccups, wheezing.
• Wind.
• Weight loss.
• Spasms, aches and pains.
• Difficulty in beginning the flow of
urine, loss of bladder control.
• Inability to fully empty the
bladder.
• Fever.
• An increase in accidental injuries
(e.g. falls).
• Withdrawal symptoms such as
agitation, anxiousness, sweating or
shaking upon stopping using Butec
patches.
If you need to have blood tests remind
your doctor that you are using Butec
patches. This is important because
Butec 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 disease).

• 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 (probably occurring in
fewer than 1 out of every 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.
• Withdrawal symptoms in babies
born to mothers who have been
given Butec 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, 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.
5. How to store Butec patches
Keep this medicine out of the sight and
reach of children.
Do not use Butec patches after the
expiry date which is stated on the
carton and on the pouch. The expiry
date refers to the last day of that
month. After the expiry date, take any
unused patches to a pharmacy.

Do not store Butec patches above
25°C.
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.
6. Contents of the pack and
other information
What Butec patches contain
The active ingredient is
buprenorphine.
Butec 5 microgram/hour transdermal
patch
Each transdermal patch contains
5 mg of buprenorphine in a patch
size of 6.25 cm2 and releases about
5 micrograms of buprenorphine per
hour (over a period of 7 days).
Butec 10 microgram/hour
transdermal patch
Each transdermal patch contains
10 mg of buprenorphine in a patch
size of 12.5 cm2 and releases about
10 micrograms of buprenorphine per
hour (over a period of 7 days).
Butec 20 microgram/hour
transdermal patch
Each transdermal patch contains
20 mg of buprenorphine in a patch

size of 25 cm2 and releases about
20 micrograms of buprenorphine per
hour (over a period of 7 days).
The other ingredients are:
• Polyacrylate (Durotak 387-2051 &
387-2054)
• Levulinic acid
• Oleyl oleate
• Povidone
• Polyethyleneterephthalate
What Butec patches look like and
contents of the pack
Transdermal patch
Three sizes are available.
5 microgram/hour: square, beige
coloured patch with rounded corners
marked Butec 5 μg/h
10 microgram/hour: rectangular,
beige coloured patch with rounded
corners marked Butec 10 μg/h
20 microgram/hour: square, beige
coloured patch with rounded corners
marked Butec 20 μg/h
Butec patches are available in cartons
containing 4 pouches each containing
a single patch.
Marketing Authorisation Holder:
Qdem Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge CB4 0AB,
UK.

Manufacturers:
Bard Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge CB4 0GW,
UK

Mundipharma DC B.V.,
Leusderend 16, 3832 RC Leusden
The Netherlands.
This leaflet was last revised in June
2017

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: Butec patches
Reference number: 40431/0024
® BUTEC, QDEM and the ‘Qdem pharmaceuticals’ logo are registered trade
marks.
© 2015 Qdem Pharmaceuticals Limited
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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