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BUTRANS 15 MICROGRAM/HOUR

Active substance(s): BUPRENORPHINE / BUPRENORPHINE / BUPRENORPHINE

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

Package leaflet: Information for the patient

BuTrans® 15 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, pharmacist or nurse.

BUTRANS PAT 15MG PIL UK P1618-A V1.indd 2

• 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

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
1. what BuTrans patches are
weeks;
and what they are used for
• if you suffer from myasthenia
gravis (a condition in which the
BuTrans patches contain the active
muscles become weak);
ingredient buprenorphine which
• if you have previously suffered
belongs to a group of medicines called
from withdrawal symptoms such
strong analgesics or ‘painkillers’.
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.
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 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 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 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 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.
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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 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.

BUTRANS PAT 15MG PIL UK P1618-A V1.indd 3

• 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.
• 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

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
4. Possible side effects
1 and 10 out of every 100 people)
Like all medicines, BuTrans patches
• Loss of appetite.
can cause side effects, although not
• Confusion, depression, anxiety,
everybody gets them.
difficulty in sleeping, nervousness,
shaking (tremors).
Serious side effects that may be
• Shortness of breath.
associated with BuTrans patches are
• Abdominal pain or discomfort,
similar to those seen with other strong
painkillers and include difficulty in
diarrhoea, indigestion, dry mouth.
breathing and low blood pressure.
• Sweating, rash, skin eruptions.
• Tiredness, a feeling of unusual
This medicine can cause allergic
weakness, muscle weakness, swelling
reactions, although serious allergic
of hands, ankles or feet.
reactions are rare. Remove the patch
and tell your doctor immediately
Uncommon (probably occurring in between
if you get any sudden wheeziness,
1 and 10 out of every 1,000 people)
difficulties in breathing, swelling of
• Mood swings, restlessness, agitation,
the eyelids, face or lips, rash or itching
a feeling of extreme happiness,
especially those covering your whole
hallucinations, nightmares, decreased
body.
sexual drive, aggression.
As with all strong painkillers, there is • Changes in taste, difficulty in speaking,
reduced sensitivity to pain or touch,
a risk that you may become addicted
tingling or numbness,
or reliant on BuTrans patches.
• Loss of memory, migraine, fainting,
In patients treated with BuTrans
problems with concentration or
patches, the following other side
co-ordination.
effects have been reported:
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.

• 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 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
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
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, 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.

6. Contents of the pack and other
information
What BuTrans patches contain

The active ingredient is buprenorphine.
BuTrans 15 microgram/hour
transdermal patch
Each transdermal patch contains 15 mg of
buprenorphine in a patch size of 18.75 cm2
and releases about 15 micrograms of
5. How to store BuTrans patches
buprenorphine per hour (over a period of
7 days).
Keep this medicine out of the sight and The other ingredients are:
reach of children.
• Polyacrylate (Durotak 387-2051
Do not use BuTrans patches after the
& 387-2054)
expiry date which is stated on the carton • Levulinic acid
and on the pouch. The expiry date refers • Oleyl oleate
to the last day of that month. After the
• Povidone
expiry date, take any unused patches to • Polyethyleneterephthalate
a pharmacy.
What BuTrans patches look like and
Do not store BuTrans patches above 25°C. contents of the pack
Do not use the patch if the pouch seal is Transdermal patch.
broken.
15 microgram/hour: rectangular, beige
Used patches must be folded over on
coloured patch with rounded corners
themselves with the adhesive layer
marked BuTrans 15 μg/h
inwards, and discarded safely out of
BuTrans patches are available in
sight and reach of children.
cartons containing 4 pouches each
Do not throw away any medicines via
containing a single patch.
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the environment.

Marketing Authorisation Holder
Napp Pharmaceuticals Limited,
Cambridge Science Park,
Milton Road,
Cambridge,
CB4 0GW,
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: BuTrans patches
Reference number: 16950/0349
This leaflet was last revised in June 2017

BuTrans® transdermal patches are protected by European Patent (UK) Nos.
0430019 and 0964677.
® BUTRANS and the NAPP device (logo) are Registered Trade Marks
© 2014 Napp Pharmaceuticals Ltd
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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