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BUPLAST 52.5 MICROGRAMS/H TRANSDERMAL PATCHES

Active substance(s): BUPRENORPHINE

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Package leaflet: Information for the user

Buplast 35 micrograms/h
transdermal patch
Buplast 52.5 micrograms/h
transdermal patch
Buplast 70 micrograms/h
transdermal patch
(buprenorphine)

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 or
pharmacist.
• 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 or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Buplast is and what it is used for
2. What you need to know before you use Buplast
3. How to use Buplast
4. Possible side effects
5. How to store Buplast
6. Contents of the pack and other information

1. What Buplast is and what it is used for
The active substance of Buplast is buprenorphine.
Buplast is an analgesic (a pain-relieving medicine) intended to relieve moderate to severe cancer pain
and severe pain that has not responded to other types of painkillers. Buplast acts through the skin.
Buprenorphine is an opioid (strong pain reliever), which reduces pain by acting on the central nervous
system (specific nerve cells in the spinal cord and in the brain). The effect of the transdermal patch lasts
for up to four days. Buplast is not suitable for the treatment of acute (short-lasting) pain.

2. What you need to know before you use Buplast
Do not use Buplast
• if you are allergic to buprenorphine or any of the other ingredients of this medicine (listed in section 6).
• if you are dependent on strong pain relievers (opioids);
• if you suffer from a disease in which you have or may have great difficulty breathing
• if you are taking monoamine oxidase (MAO) inhibitors (certain medicines used to treat depression) or
you have taken this type of medicine in the last two weeks (see " Other medicines and Buplast");
• if you suffer from myasthenia gravis (a certain type of severe muscle weakness);
• if you suffer from delirium tremens (confusion and trembling caused by abstinence from alcohol
following habitual excessive drinking or occurring during an episode of heavy alcohol consumption);
• if you are pregnant.
Buplast must not be used to treat withdrawal symptoms in drug-dependent persons.
Warnings and precautions
Talk to your doctor or pharmacist before using Buplast
• if you have recently drunk a lot of alcohol;
• if you suffer from seizures or convulsions (fits)
• if your consciousness is disturbed (feeling light-headed or faint) for an unknown reason;
• if you are in a state of shock (cold sweat might be a sign of it);
• if the pressure in your skull is increased (for instance after head injury or in brain disease), and artificial
respiration is not possible;
• if you have difficulty breathing or are taking other medicines that may make you breathe more slowly
or weakly (see "Other medicines and Buplast");
• if your liver does not work properly;
• if you are inclined to abuse medicines or drugs.

Also, please be aware of the following precautions:
• Some people may become dependent on strong pain relievers such as Buplast when they use them
over a long period of time. They may have withdrawal effects when they stop using them (see “If you
stop using Buplast”).
• Fever and external heat may lead to larger quantities of buprenorphine in the blood than normal. Also,
external heat may prevent the transdermal patch from sticking properly. Therefore, do not expose
yourself to external heat (e.g. sauna, infra-red lamps, electric blankets, hot water bottles) and consult
your doctor if you have fever.
Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Children and adolescents
Buplast should not be used in persons below the age of 18 years, because no experience has so far been
gained in this age group.
Other medicines and Buplast
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• Buplast must not be used together with monoamine oxidase (MAO) inhibitors (certain medicines used
to treat depression), or if you have taken this type of medicine for the last 2 weeks.
• Buplast may make some people feel drowsy, sick, or faint or make them breathe more slowly or weakly.
These side effects may be intensified if other medicines that may produce the same effects are taken
at the same time. These other medicines include other strong pain relievers (opioids), certain sleeping
pills, anaesthetics, and medicines used to treat certain psychological diseases such as tranquillizers,
anti-depressants, and neuroleptics.
• If Buplast is used together with some medicines, the effects of the transdermal patch may be increased.
These medicines include e.g. certain anti-infectives/anti-fungals (e.g. containing erythromycin or
ketoconazole) or HIV medicines (e.g. containing ritonavir)
• If Buplast is used together with other medicines, the effects of the transdermal patch may be reduced.
These medicines include certain products, e.g. dexamethasone; medicines to treat epilepsy (e.g.
containing carbamazepine, or phenytoin) or medicines for tuberculosis (e.g. rifampicin).
Buplast with food, drink and alcohol
You should not drink alcohol while using Buplast. Alcohol may intensify certain side effects of the
transdermal patch and you may feel unwell.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this medicine.
There is insufficient experience regarding the use of Buplast in pregnant women. Therefore, you must not
use Buplast during pregnancy.
Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and
passes into breast milk. Therefore, you should not use Buplast if you are breast-feeding.
Driving and using machines
Buplast may make you feel dizzy or drowsy or experience blurred or double vision and 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,
• when your dose is changed,
• when you switch to Buplast from another pain reliever,
• if you also use other medicines that act on the brain,
• if you drink alcohol.
If you are affected, you should not drive or operate machinery whilst using Buplast. This applies also at
the end of treatment with Buplast. Do not drive or operate machinery for at least 24 hours after the patch
has been removed.
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.
Discuss with your doctor or pharmacist if you are unsure about anything.

3. How to use Buplast
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.

Buplast is available in three strengths: Buplast 35 microgram/h transdermal patch, Buplast
52.5 microgram/h transdermal patch and Buplast 70 microgram/h transdermal patch.
The choice of which strength of Buplast will suit you best will be made by your doctor. During treatment
your doctor may change which transdermal patch you use to a smaller or larger one if necessary.
The recommended dose is:
Adults
Unless your doctor has told you differently, attach one Buplast transdermal patch (as described in detail
below) and change it after 4 days at the latest. For convenience of use, you can change the transdermal
patch twice a week at the same days, e.g. always on Monday mornings and Thursday evenings. To help
you remember when to change your transdermal patch, you should make a note on the calendar on the
outer packaging. If your doctor has advised you to take other pain relievers in addition to the transdermal
patch, strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment
with Buplast.
Elderly patients
No dosage adjustment is needed for elderly patients.
Patients with kidney disease / dialysis patients
In patients with kidney disease and in dialysis patients, no dosage adjustment is necessary.
Patients with liver disease
In patients with liver disease, the intensity and duration of action of Buplast may be affected. If this
applies to you, your doctor will check on you more closely.
Use in children and adolescents
Buplast should not be used in persons below the age of 18 years, because no experience has so far been
gained in this age group.
Route of administration
The patch is for transdermal use.
When the transdermal patch is applied to the skin, the active substance buprenorphine passes through
the skin into the blood.
Method of administration
Before applying the transdermal patch
• Choose an area of skin which is flat,
clean, free from cuts or scars and hairless
on your upper body, preferably on the
chest below the collar-bone or on the
upper part of the back (see adjacent
illustrations). Call assistance if you
cannot apply the transdermal patch
yourself.

• If the chosen area has hairs, cut them 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 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
transdermal patch from sticking properly.

Applying the transdermal patch
• Step 1: Each transdermal patch is sealed in a sachet. Just before
use, cut the sachet along the sealed edge with scissors. Take out
the transdermal patch.

• Step 2: The sticky side of the transdermal patch is covered with a
transparent protective foil. Carefully peel off one part of the foil.
Try not to touch the sticky part of the transdermal patch.

If you forget to use Buplast
If you forget an application, stick a new transdermal patch on as soon as you remember. You will then
need to change your routine, e.g. if you usually apply your transdermal patches on Mondays and
Thursdays, but you forget and don’t stick on a new transdermal patch until Wednesday, you will need to
change your transdermal patches on Wednesdays and Saturdays from then on. Make a note of the new
pair of days on the calendar on the outer packaging. If you are very late changing your transdermal patch,
pain may return. In this case please contact your doctor.
Never apply twice the number of transdermal patches to make up for the forgotten application!
If you stop using Buplast
If you interrupt or finish using Buplast too soon, pain may return. If you wish to stop use on account of
unpleasant side effects, please consult your doctor. He/she will tell you what can be done and whether
you can be treated with other medicines.
Some people may experience withdrawal-effects when they have used strong pain relievers for a long
time and stop using them. The risk of having effects after you stop using Buplast is very low. However, if
you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestion
problems, tell your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
• Step 3: Stick the transdermal patch onto the area of skin you
have chosen and remove the remaining foil.

• Step 4: Press the transdermal patch against your skin with
the palm of your hand for about 30 to 60 seconds. Make sure
that the whole transdermal patch is in contact with your skin,
especially at the edges.

• Step 5: Wash your hands after using the transdermal patch.
Do not use any cleansing products.
Wearing the transdermal patch
You may wear the transdermal patch for up to 4 days. Provided that you have applied the transdermal
patch correctly, there is little risk of it coming off. You may shower, bathe or swim while wearing it.
However, do not expose the transdermal patch to extreme heat (e.g. sauna baths, infra-red lamps, electric
blankets, hot water bottles).
In the unlikely event that your transdermal patch falls off before it needs changing, do not use the same
transdermal patch again. Stick a new one on straight away (see "Changing the transdermal patch" below).
Changing the transdermal patch
• Take the old transdermal patch off.
• Fold it in half with the sticky side inwards.
• Throw it away carefully.
• Stick a new transdermal patch on a different skin site (as described above). Wait at least one week
before using the same site again.
Duration of treatment
Your doctor will tell you how long you may use Buplast. Do not stop using Buplast on your own account,
because pain may return and you may feel unwell (see also "If you stop using Buplast" below).
If you have the impression that the effect of the Buplast transdermal patch is too weak or too strong, tell
your doctor or pharmacist.
If you use more Buplast than you should
If this happens there may be signs of an overdose of the substance buprenorphine. An overdose may
intensify the side effects of buprenorphine such as drowsiness, nausea, and vomiting. You may get pinpoint pupils and breathing may become slow and weak. You may also get cardiovascular collapse.
As soon as you discover that you have used more transdermal patches than you should, remove the
excess transdermal patches and talk to a doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty
in swallowing or breathing, hives, fainting, yellowing of the skin and eyes (also called jaundice), remove
the transdermal patch and call your doctor immediately or seek help at the casualty department of the
nearest hospital. These can be symptoms of a very rare serious allergic reaction.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people):
• nausea (feeling sick)
• redness, itching
Common (may affect up to 1 in 10 people):
• dizziness, headache
• shortness of breath
• vomiting, constipation
• skin changes (exanthema, generally on repeated use), sweating
• oedema (e.g. swelling of the legs), tiredness
Uncommon (may affect up to 1 in 100 people):
• confusion, sleep disorder, restlessness
• various degrees of sedation (calmness), ranging from tiredness to muzziness
• circulation disorders (such as low blood pressure or, rarely, even circulatory collapse)
• dry mouth
• rash
• difficulty in passing water, urinary retention (less urine than normal)
• weariness
Rare (may affect up to 1 in 1,000 people):
• loss of appetite
• illusions such as hallucinations, anxiety and nightmares, reduced sex drive
• difficulties concentrating, speech disorder, muzziness, disturbed balance, abnormal skin sensations
(numbness, prickling or burning sensations)
• visual disturbance, blurred vision, swollen eyelids
• hot flushes
• difficulty breathing (respiratory depression)
• heartburn
• hives
• erection difficulties
• withdrawal symptoms (see below), administration site reactions
Very rare (may affect up to 1 in 10,000 people):
• serious allergic reactions (see below)
• dependence, mood swings
• muscle twitching, taste disorders
• pin-point pupils
• ear pain
• abnormally rapid breathing, hiccups
• retching
• pustules, small blisters
• chest pain
If you notice any of the side effects listed above, tell your doctor as soon as possible.

In some cases delayed allergic reactions occurred with marked
signs of inflammation. In such a case you should stop using Buplast
after you have talked to your doctor.
Some people may have withdrawal symptoms when they have
used strong pain relievers for a long time and stop using them. The
risk of having withdrawal effects when you stop using Buplast is
low. However, if you feel agitated, anxious, nervous or shaky, if you
are overactive, have difficulty sleeping or digestion problems, tell
your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects, you can help provide
more information on the safety of this medicine.

5. How to store Buplast
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP. The
expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• After removing a patch, fold it in half with the sticky sides inwards and press them together. Return the
used patch to its sachet and carefully dispose the transdermal patch.
• Do not throw away any medicines via wastewater . Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Buplast contains
• The active substance is buprenorphine.
35 micrograms /h:
Each transdermal patch of 25 cm2 contains 20 mg of buprenorphine and releases 35 micrograms of
buprenorphine per hour.
52.5 micrograms /h:
Each transdermal patch of 37.5 cm2 contains 30 mg of buprenorphine and releases 52.5 micrograms
of buprenorphine per hour.
70 micrograms /h:
Each transdermal patch of 50 cm2 contains 40 mg of buprenorphine and releases 70 micrograms of
buprenorphine per hour.
• The other ingredients are:
Adhesive matrix (containing buprenorphine): povidone K90, levulinic acid, oleyl oleate, Poly[acrylic
acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5)
Adhesive matrix (without buprenorphine): Poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-co(2-hydroxyethyl)acrylate-co-vinylacetate] (68:0,15:5:27),
Separating foil between adhesive matrices with and without buprenorphine: Polyethylene
terephthalate film,
Backing foil: polyester,
Release liner: Polyethylene terephthalate film, siliconised
Blue printing ink
What Buplast looks like and contents of the pack
Each transdermal patch is rectangular beige coloured with rounded corners and is imprinted
35 μg/h:
“Buprenorphin” and “35 μg/h”
52.5 μg/h:
“Buprenorphin” and “52.5 μg/h”
70 μg/h:
“Buprenorphin” and “70 μg/h”
Each transdermal patch is sealed in one child-resistant sachet. The patches are available in packs
containing 4, 5, 8, 10, 16 or 20 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Tesa Labtec GmbH, Heykenaukamp 10, 21147 Hamburg, Germany
Mylan Hungary Kft., Mylan utca 1, Komárom, HU-2900, Hungary
This leaflet was last revised in 12/2015

16181-90030-00 / 687391

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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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