Skip to Content

BUTRANS 5 MICROGRAMS/HOUR TRANSDERMAL PATCHES

Active substance: BUPRENORPHINE

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET

2639
13.02.15[2]

BuTrans® 5 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.
This medicine is available using the above name but will be referred to as
BuTrans patches throughout this leaflet. Also available in other strengths.
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
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 are affected 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:
 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 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.

 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.

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 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.

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.

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.

 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).

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 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, 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.
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 effect 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 BuTrans patches
Keep out of the sight and reach 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.
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.
If the patches become discoloured or show any other signs of
deterioration, consult your pharmacist who will tell you what to do.
6. Further information
What BuTrans patches contain
The active ingredient is buprenorphine.
One transdermal patch (active surface area: 6.25 cm2) contains 5 mg of
buprenorphine and releases 5 micrograms/hour over a period of 7 days.
The other ingredients are:
 Polyacrylate (Durotak 387-2051 & 387-2054)
 Levulinic acid
 Oleyl oleate
 Povidone
 Polyethylene terephthalate
What BuTrans patches look like and contents of the pack
BuTrans 5 microgram/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 patches are available in cartons containing 4 pouches each
containing a single patch.
Manufacturer and Product Licence Holder
Manufactured by
Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.
Mundipharma DC B.V., De Wel 20, 3871 MV Hoevelaken, The
Netherlands.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

CD

PL 20636/2639

Leaflet revision and issue date (Ref.) 13.02.15[2]
BuTrans is a trademark of Mundipharma AG.
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
Norspan®
Netherlands
BuTrans®
Norway
Norspan®
Poland
Norspan®
Portugal
Norspan®
Republic of Ireland BuTrans®
Slovak Republic
Norspan®
Sweden
Norspan®
United Kingdom
BuTrans®

Expand view ⇕

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.

Hide