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BUTRANS 20 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the user

BuTrans® 20 micrograms/hour
Transdermal Patch
Buprenorphine
The name of your medicine is BuTrans 20
micrograms/hour Transdermal Patch but will be referred
to as BuTrans throughout this leaflet. This product is
available in different strengths.
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 is and what it is used for
2. Before you use BuTrans
3. How to use BuTrans
4. Possible side effects
5. How to store BuTrans
6. Further information
1. WHAT BUTRANS IS AND WHAT IT IS 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, long-lasting
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. BEFORE YOU USE BUTRANS
Do not use BuTrans:
 if you are allergic (hypersensitive) to buprenorphine or
any of the other ingredients of BuTrans;
 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.
Take special care with BuTrans patches
Before treatment with BuTrans 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 with some other medicines, the effect of
BuTrans or the other medicine may be changed.
 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 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 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 with 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 and breastfeeding
You should not use BuTrans 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 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, 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
Three different strengths of BuTrans 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 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 (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.
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 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 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.

 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

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 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.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

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.

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, 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
heartbeat.
 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.

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.
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 BUTRANS
Keep out of the reach and sight of children.
Do not use BuTrans 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 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 contains:
One transdermal patch (active surface area: 25cm 2)
contains 20 mg of buprenorphine and releases 20
micrograms/hour over a period of 7 days.
The other ingredients are:
 Levulinic Acid
 Oleyl Oleate
 Povidone K90
 Polyacrylate (Durotak 387-2051 & 387-2054)
 Polyethylene terephthalate (foil/backing layer/liner)
What BuTrans looks like and contents of the pack
Beige square patches with rounded corners marked with
Norspan 20µg/h in black ink.

Manufacturer
BuTrans Transdermal Patches are manufactured by
Bard Pharmaceuticals Limited, Cambridge Science
Park, Milton Road, Cambridge CB4 0GW, UK.
Procured from within the EU and repackaged in the UK
by the Parallel Import Product Licence holder: CD
Pharma Ltd, Unit 3 Manor Point, Manor Way,
Borehamwood, Herts WD6 1EE.
BuTrans 20 micrograms/hour Transdermal Patch
PL 20492/0525
CD

POM

BuTrans is a registered trademark.
Date of preparation: 14th April 2016

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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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