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BUTEC 10 MICROGRAM/HOUR TRANSDERMAL PATCH

Active substance(s): 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
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.

BUTEC PAT PIL UK 6511207 V3.indd 2

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, longlasting 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 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
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.
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
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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.

BUTEC PAT PIL UK 6511207 V3.indd 3

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 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
This leaflet was last revised in June 2016
® 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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