BUTRANS 5

Active substance: BUPRENORPHINE

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Package leaflet: Information for the user
BuTrans® 5 micrograms/hour transdermal patches
BuTrans® 10 micrograms/hour transdermal patches
BuTrans® 20 micrograms/hour transdermal patches
Buprenorphine
Read all of this leaflet carefully
before you start using this
medicine.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been prescribed
for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as
yours.
• If any of the side effects become
serious, or if you notice any
side effects not listed in this
leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What BuTrans patches are and
what they are used for
2. Before you use BuTrans patches
3. How to use BuTrans patches
4. Possible side effects
5. How to store BuTrans patches
6. Further information

BUTRANS PIL UK 6507181 V2.indd 2

1. what BuTrans patches are
and what they are used for
BuTrans 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.
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. Before you use BuTrans
patches
Do not use BuTrans patches:
• if you are allergic (hypersensitive)
to buprenorphine or any of the
other ingredients of BuTrans
patches;
• 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 patches must not be used to
treat symptoms associated with drug
withdrawal.

Take special care with BuTrans
patches
Before treatment with BuTrans
patches tell your doctor or pharmacist:
• 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;
• 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.
Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. If you use BuTrans
patches with some other medicines, the

effect of BuTrans patches or the other
medicine may be changed.
• 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
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 not be used
together with benzodiazepines
(medicines used to treat anxiety
or to help you sleep). This
combination may cause serious
breathing problems which may be
fatal.
Using BuTrans patches with 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 and breastfeeding
You should not use BuTrans patches
if you are pregnant, likely to become
pregnant or are breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicines.

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 you should not
drive or operate machinery whilst
using BuTrans patches, or for 24
hours after removing the patch.
3. How to use BuTrans patches
Three different strengths of BuTrans
patches are available. Your doctor will
decide which strength of BuTrans
patch will suit you best. During
treatment, your doctor may change the
patch you use to a smaller or larger
one if necessary. You should not
apply more than two patches at the
same time, regardless of the patch
strength.
Always use the BuTrans patch
exactly as your doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.

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.
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.
• 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.
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27/04/2012 18:53

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

BUTRANS PIL UK 6507181 V2.indd 3

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
pharmacist.

4. Possible side effects
Like all medicines BuTrans patches
can have side effects, although not
everybody gets them.
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 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 patches.
In patients treated with BuTrans
patches, the following other side
effects have been reported:
Very common (probably occurring in
more than 1 in 10 people)
• Headache, dizziness, drowsiness.
• Constipation, dry mouth, feeling or
actually being sick.
• Itching, redness, itching at
application site.

Common (probably occurring in
between 1 and 10 out of every 100
people)
• Loss of appetite.
• Confusion, depression, difficulty in
sleeping, nervousness.
• Tingling or numbness.
• Flushing of the skin.
• Shortness of breath.
• Abdominal pain or discomfort,
diarrhoea, indigestion.
• Sweating, rash, skin eruptions.
• Tiredness, a feeling of unusual
weakness, muscle weakness, pain,
chest pain, swelling of hands,
ankles or feet, redness or rash at the
application site.
Uncommon (probably occurring in
between 1 and 10 out of every 1,000
people)
• Dehydration.
• Mood swings, restlessness,
agitation, anxiety, feeling detached
from oneself, a feeling of extreme
happiness, hallucinations,
nightmares.
• Changes in taste, difficulty in
speaking, reduced sensitivity to
pain or touch, loss of memory,
migraine, fainting, shaking,
problems with concentration or coordination.
• Dry eyes, blurred vision.

• A ringing or buzzing sound in
the ears, a feeling of dizziness or
spinning.
• High or low blood pressure, angina
(severe chest pain associated with
heart disease), fast or irregular heart
beat.
• Worsening of breathing problems
associated with asthma, cough,
hiccups, over breathing, reduced
oxygen in the blood, runny nose,
wheezing.
• Wind.
• Weight loss.
• Dry skin, swelling of the face.
• Muscle cramps, spasms, aches and
pains.
• Difficulty in passing urine.
• A flu like illness, high temperature,
shivering, generally feeling unwell.
• 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)
• Decreased sexual drive, mental
disorder.
• Difficulties with balance.
• Swelling of the eyelids, a reduction in
size of the pupils in the eye.
• Difficulty in breathing.
• Diverticulitis (inflammation of the
intestine), difficulty in swallowing.
• Local allergic reaction with marked
signs of swelling (in such cases
treatment should be stopped).
• Decreased erection, sexual
dysfunction.
Very rare (probably occurring in fewer
than 1 out of every 10,000 people)
• Muscle twitching.
• Ear pain.
• Blisters.
If any of the side effects become
serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. How to store BuTrans patches
Keep out of the reach and sight of
children.
Do not use BuTrans 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 BuTrans 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. Further information
what BuTrans patches contain
The active ingredient is
buprenorphine.
BuTrans 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).
BuTrans 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).

BuTrans 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 BuTrans patches look like
and contents of the pack
Transdermal patch
Three sizes are available.
5 micrograms/hour: square, beige
coloured patch with rounded corners
marked BuTrans 5 μg/h
10 micrograms/hour: rectangular,
beige coloured patch with rounded
corners marked BuTrans 10 μg/h
20 micrograms/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 single patch.

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.,
De Wel 20,
3871 MV Hoevelaken,
The Netherlands.
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
Austria
Norspan®
Belgium
Norspan®
Czech Republic
Norspan®
Denmark
Norspan®
Estonia
Norspan®
Finland
Norspan®
Germany
Norspan®
Hungary
Norspan®
Iceland
Norspan®
Latvia
Norspan®
Lithuania
Norspan®

Luxembourg
Netherlands
Norway
Poland
Portugal

Norspan®
BuTrans ®
Norspan®
Norspan®
Norspan®

Republic of Ireland BuTrans®
Slovak Republic
Norspan®
Sweden
Norspan®
United Kingdom
BuTrans®

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: 16950/0136
This leaflet was last revised in May 2012
BuTrans® transdermal patches are protected by European Patent (UK) Nos.
0430019 and 0964677.
® BuTrans and the NAPP device (logo) are Registered Trade Marks
© 2007-2012 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
6507181

27/04/2012 18:53

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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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