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BUTRANS 20MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the patient
BuTrans® 5 micrograms/hour transdermal patches
BuTrans® 10 micrograms/hour transdermal patches
BuTrans® 20 micrograms/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

The name of your medicine is
BuTrans 5 micrograms/hour,
10 micrograms/hour, 20
micrograms/hour transdermal patches
but will be referred to as BuTrans or
patches throughout this leaflet.
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 are and what they
are used for

2. What you need to know before
you use BuTrans
3. How to use BuTrans
4. Possible side effects
5. How to store BuTrans
6. Contents of the pack and other
information

1. What BuTrans are and what
they are used for
BuTrans 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.
BuTrans should not be used to relieve
acute pain.
BuTrans 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:









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.

BuTrans must not be used to treat
symptoms associated with drug
withdrawal.
Warnings and precautions
Talk to your doctor, pharmacist or
nurse before using BuTrans:
 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
Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines.
 BuTrans 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 may be reduced.





BuTrans 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 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 BuTrans 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. Drinking alcohol whilst using
BuTrans may also affect your reaction
time.
Pregnancy breast-feeding and
fertility
You should not use BuTrans 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 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, 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:
 The medicine has been
prescribed to treat a medical
or dental problem; and
 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 BuTrans
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 BuTrans
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 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. 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.






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.

Patients under 18 years of age
BuTrans should not be used in
patients below the age of 18 years.

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.

Patients with kidney
disease/dialysis patients
In patients with kidney disease, no
change in dose is necessary.

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.

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.

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.

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.

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 (see’ Warnings and
precautions' section).
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 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’ 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 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
If you stop using BuTrans 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 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 can have
side effects, although not everybody
gets them.

Serious side effects that may be
associated with BuTrans 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.
In patients treated with BuTrans, 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.
Dry skin.
Spasms, aches and pains.
Difficulty in beginning the flow of
urine.
Fever.
An increase in accidental injuries
(e.g. falls).
Withdrawal symptoms such as
agitation, anxiousness, sweating
or shaking upon stopping using
BuTrans.

If you need to have blood tests remind
your doctor that you are using
BuTrans. This is important because
BuTrans 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 Bu Trans 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. 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 or
search for MHRA Yellow Card in the
Google Play or Apple App Store.
By reporting side effects, you can help
provide more information on the
safety of this medicine.

5. How to store BuTrans
Keep out of the sight and reach of
children.
Do not store above 25°C.
Do not use the patches after the
expiry date which is stated on the
carton and pouch labels after ‘Exp’.
The expiry date refers to the last day
of that month.
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.
If the patches becomes discoloured or
shows any signs of deterioration, seek
the advice of your pharmacist.

Remember if your doctor tells you to
stop taking this medicine, return any
unused medicine to your pharmacist
for safe disposal. Only keep this
medicine if your doctor tells you to.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.

6. Contents of the pack and
other information
What BuTrans contains:
The active ingredient in BuTrans is
buprenorphine.
Each BuTrans 5 micrograms/hour
transdermal patch (active surface
2
area: 6.25 cm ) contains 5mg
buprenorphine and releases 5
micrograms/hour over a period of 7
days.
Each BuTrans 10 micrograms/hour
transdermal patch (active surface
2
area: 12.5 cm ) contains 10mg
buprenorphine and releases 10
micrograms/hour over a period of 7
days.
Each BuTrans 20 micrograms/hour
transdermal patch (active surface
2
area: 25 cm ) contains 20mg
buprenorphine and releases 20
micrograms/hour over a period of 7
days.
The other ingredients are
polyacrylate, levulinic acid, oleyl
oleate, povidone K90 and
polyethylene terephthalate.
What BuTrans look like and
contents of the pack
BuTrans 5 micrograms/hour
transdermal patch: square, beige
coloured patch with rounded corners
®
marked in blue with ‘Norspan 5 mg’
and ‘5 μg/h’ on an aluminium rigid and
removable protective layer.
BuTrans 10 micrograms/hour
transdermal patch: rectangular,
beige coloured patch with rounded
®
corners marked in blue with ‘Norspan
10 mg’ and ‘10 μg/h’ on an aluminium
rigid and removable protective layer.
BuTrans 20 micrograms/hour
transdermal patch: square, beige
coloured patch with rounded corners
®
marked in blue with ‘Norspan 20 mg’

and ‘20 μg/h’ on an aluminium rigid
and removable protective layer.
BuTrans are available in cartons
containing 2 or 4 pouches each
containing a single patch.
Manufactured by: Bard
Pharmaceuticals Limited, Cambridge
Science Park, Milton Road,
Cambridge, CB4 0GW, UK. OR
Mundipharma DC B.V., Hoevelaken,
The Netherlands.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®

BuTrans 5 micrograms/hour
transdermal patches; PL
18799/2649
®
BuTrans 10 micrograms/hour
transdermal patches; PL
18799/2598
®
BuTrans 20 micrograms/hour
transdermal patches; PL
18799/2648

CD

POM

Leaflet date: 13.12.2017
BuTrans is a registered trademark of
Napp Pharmaceuticals.
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
E-mail helplines@arthritiscare.org.uk

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sighted?
Is this leaflet hard
to see or read?
Call 0208 515
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