BUTRANS 5 MICROGRAMS/HOUR TRANSDERMAL PATCH

Active substance: BUPRENORPHINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

BuTrans 5mg 10mg 20mg

ARTWORKER:

DT

DATE OF PROOF:

26/06/14

CODE:

06464/2677 2678 2679G

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 26/06/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO MAY 2012 UK PIL & REPORTING OF SIDE EFFECTS & DRUG DRIVING TEXT

Pg 1

Pg 4

BuTrans® 5 micrograms/hour transdermal patches
BuTrans® 10 micrograms/hour transdermal patches
BuTrans® 20 micrograms/hour transdermal patches

The other ingredients are:
• Polyacrylate
• Levulinic acid
• Oleyl oleate
• Povidone K90
• Polyethylene terephthalate
What BuTrans patches look like and contents of the pack
Transdermal patch
Three sizes are available.
BuTrans 5 microgram/hour transdermal patch: square, beige coloured patch with rounded corners marked in
blue with ‘Norspan 5mg’ and ‘5 µg/h’ on an aluminium rigid and removable protective layer.
BuTrans 10 microgram/hour transdermal patch: rectangular, beige coloured patch with rounded corners
marked in blue with ‘Norspan 10mg’ and ‘10 µg/h’ on an aluminium rigid and removable protective layer.
BuTrans 20 microgram/hour transdermal patch: square, beige coloured patch with rounded corners marked in
blue with ‘Norspan 20mg’ and ‘20 µg/h’ on an aluminium rigid and removable protective layer.
BuTrans patches are available in cartons containing 2 or 4 pouches each containing a single patch.
These products are manufactured by Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road,
Cambridge, CB4 0GW UK and/or Mundipharma DC B.V., Hoevelaken, The Netherlands and procured from
within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
POM
CD

PL No: 06464/2677 BuTrans 5 micrograms/h transdermal patch
PL No: 06464/2678 BuTrans 10 micrograms/h transdermal patch
PL No: 06464/2679 BuTrans 20 micrograms/h transdermal patch

(Buprenorphine)
Patient information leaflet

This product is available in three different strengths 5 micrograms/hour, 10 micrograms/hour and 20
micrograms/hour. Throughout this leaflet these products will be collectively referred to as BuTrans.
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

1. What BuTrans patches are and what they are used for:

Leaflet revision and issue date (Ref.) 26.06.2014

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 is a registered trademark of Mundipharma AG

BuTrans patches should not be used to relieve acute pain.

You can also get support and information about arthritis from Arthritis Care:

BuTrans patches act through the skin. After application, buprenorphine passes through the skin into the blood.
Each patch lasts for seven days.

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

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 breast-feeding
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.

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 if this medicine affects your ability to drive.

However, you would not be committing an offence if:
• 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 or in the information
provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine.
If you are affected you should not drive or operate machinery whilst using BuTrans patches, or for
24 hours after removing the patch.
Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02 1808

PRODUCT:

BuTrans 5mg 10mg 20mg

ARTWORKER:

DT

DATE OF PROOF:

26/06/14

CODE:

06464/2677 2678 2679G

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

PROOF HISTORY:
v.1 - waymade - 26/06/14

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TO MAY 2012 UK PIL & REPORTING OF SIDE EFFECTS & DRUG DRIVING TEXT

Pg 2

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 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 the area of the skin you have chosen and remove the
remaining foil.

Step 4:

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.

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



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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.

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.

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.

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
overleaf.)
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”).
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 previously). 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” overleaf).
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.

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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 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 patches:
Keep out of the sight and reach of children.
Do not use the patch if the pouch seal is broken.
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.
Used patches must be folded over on themselves with the adhesive layer inwards, and discarded safely out of
sight and reach of children.
Do not store BuTrans patches above 25°C.
If this medicine shows any signs of deterioration, you should seek the advice of your pharmacist who will tell
you what to do.

6. Further information:
What BuTrans patches contain
The active ingredient is buprenorphine.
One BuTrans 5 microgram/hour transdermal patch (active surface area:6.25 cm2) contains 5 mg of
buprenorphine
and releases 5 micrograms/hour over a period of 7 days.
One BuTrans 10 microgram/hour transdermal patch (active surface area: 12.5 cm2) contains 10 mg of
buprenorphine and releases 10 micrograms/hour over a period of 7 days.
One BuTrans 20 microgram/hour transdermal patch (active surface area: 25 cm2) contains 20 mg of
buprenorphine and releases 20 micrograms/hour over a period of 7 days.

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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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