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BUPEAZE 35 MICROGRAMS/H TRANSDERMAL PATCHES

Active substance(s): BUPRENORPHINE

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Process Black

Colours

Dimensions: 280 x 410 mm

Guides

25/05/2017
Date Created:

Die Cut

UK
Country:

Technical Information

N/A
Pack Size:

2.3

Leaflet
Component:

Version:

Transdermal Patch
Form:

Date Modified: 26/07/2017

5, 10, 20 mcg/h
Strength

Product Name: (Bupeaze) Buprenorphine

Dr Reddy’s
Brand:

Package leaflet: Information for the user
Bupeaze 35 micrograms/h Transdermal Patches
Bupeaze 52.5 micrograms/h Transdermal Patches
Bupeaze 70 micrograms/h Transdermal Patches
Buprenorphine
Important things you need to know about Bupeaze









These patches contain a strong pain killer.
Ensure that old patches are removed before applying a new one.
Patches must not be cut.
Do not expose the patches to a heat source (such as a hot water bottle).
Do not soak in a hot bath or take a hot shower whilst wearing a patch.
If you develop a fever tell your doctor immediately.
Follow the dosage instructions carefully and only change your patch patch twice a week at the chosen times.
If your breathing becomes shallow and weak take the patch off and seek medical help.

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 Bupeaze is and what it is used for
2. What you need to know before you use Bupeaze
3. How to use Bupeaze
4. Possible side effects
5. How to store Bupeaze
6. Contents of the pack and other information

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.

1. What Bupeaze is and what it is used for
The active substance of Bupeaze is buprenorphine.
Bupeaze 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. Bupeaze 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. Bupeaze is not suitable for the
treatment of acute (short-lasting) pain.

2. What you need to know before you use Bupeaze
Do not use Bupeaze
• 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 Bupeaze")
• 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.
Bupeaze must not be used to treat withdrawal symptoms in drug-dependent persons.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.
Bupeaze is available in three strengths: Bupeaze 35 micrograms/h Transdermal Patches, Bupeaze 52.5 micrograms/h
Transdermal Patches and Bupeaze 70 micrograms/h Transdermal Patches.
The choice of which strength of Bupeaze 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 Bupeaze 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 Bupeaze.

Elderly patients

No dosage adjustment is needed for elderly patients.

Warnings and precautions

Patients with kidney disease / dialysis patients

Talk to your doctor or pharmacist before using Bupeaze
• 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 Bupeaze")
• if your liver does not work properly
• if you are inclined to abuse medicines or drugs

480 mm

3. How to use Bupeaze

Also, please be aware of the following precautions:
• Some people may become dependent on strong pain relievers such as Bupeaze 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 Bupeaze”).
• 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.

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 Bupeaze may be affected. If this applies to you,
your doctor will check on you more closely.

Use in children and adolescents

Bupeaze 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.

Children and adolescents

Bupeaze 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 Bupeaze
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.






Bupeaze 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.
Bupeaze 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 Bupeaze 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 Bupeaze 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).



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.

Bupeaze with food, drink and alcohol

You should not drink alcohol while using Bupeaze. 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 Bupeaze in pregnant women. Therefore, you must not use
Bupeaze during pregnancy.
Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and passes into
breast milk. Therefore, you should not use Bupeaze if you are breast-feeding.

Driving and using machines

60 mm

Bupeaze 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 Bupeaze 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 Bupeaze. This applies also at the end of
treatment with Bupeaze. Do not drive or operate machinery for at least 24 hours after the patch has been removed.

70 mm

70 mm

70 mm
280 mm

70 mm

280 mm

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.

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.
The following table shows you when to change your patch:
Apply/change your
Apply/change your
patch in morning of patch in evening of
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Duration of treatment

Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

If you use more Bupeaze 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 pin-point pupils and
breathing may become slow and weak. You may also get cardiovascular collapse.

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 Bupeaze 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 Bupeaze 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 Yellow Card Scheme, website
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 Bupeaze






6. Contents of the pack and other information
What Bupeaze contains

-

The active substance is buprenorphine.
Each 35 micrograms/h transdermal patch of 25 cm2 contains 20 mg of buprenorphine and releases
35 micrograms of buprenorphine per hour.
Each 52.5 micrograms/h transdermal patch of 37.5 cm2 contains 30 mg of buprenorphine and releases
52.5 micrograms of buprenorphine per hour.
Each 70 micrograms/h 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

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.

If you forget to use Bupeaze

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 Bupeaze

If you interrupt or finish using Bupeaze 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 Bupeaze 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

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

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.

What Bupeaze looks like and contents of the pack

Each transdermal patch is rectangular beige coloured with rounded corners and is imprinted (35 micrograms/h
patch) “Buprenorphin” and “35 μg/h”, (52.5 micrograms/h patch) “Buprenorphin” and “52.5 μg/h” and (70
micrograms/h patch) “Buprenorphin” and “70 μg/h”.
Each transdermal patch is sealed in one child-resistant sachet. The patches are available in packs containing 3, 4,
5, 6, 8, 10, 12, 16, 18, 20 or 24 transdermal patches.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg, 86156, Germany
This leaflet was last revised in 07/2017

480 mm

Your doctor will tell you how long you may use Bupeaze. Do not stop using Bupeaze on your own account,
because pain may return and you may feel unwell (see also "If you stop using Bupeaze" below).
If you have the impression that the effect of the Bupeaze transdermal patch is too weak or too strong, tell your
doctor or pharmacist.

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

+ Expand Transcript

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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