Bupeaze 52.5 Micrograms/H Transdermal Patches

UIUI 083


Package leaflet: Infdrmation for the user

Bupeaze 35 micrograms/h Transdermal Patches Bupeaze 52.5 micrograms/h Transdermal Patches Bupeaze 70 micrograms/h T ransdermal Patches

!    Buprenbrphine

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 hot 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 phahnacist. This includes any possible side effects not listed in this leaflet. See section 4.


_Whal isjnthisJeaflet

1.    What Bupeaze is and what it is used for

2.    What you need to know before you use

3.    How to use Bupeaze

4.    Possible side effects

5.    How to store Bupeaze

6.    Contents of the pack and other information


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

410 mm

Do not use Bupeaze

•    if you are allergic to buprenorphine or any of the othejr ingredients of this medicine (listed in section 6)

•    if you are dependent on strong pain relievers (opioidsj)

•    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.

Warnings and precautions

Talk to your doctor or pharmacist before using Bupeaze |

•    ” If you" have recently drunkalot 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.    [

Also, please be aware of the following precautions:    [

• Some people may become dependent on strong plain 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”).    [

_ Feverand_e_xt_em_al_h_eat_mayjead toJarger_quan_titie_£_of buprenorphinejnthe bloodthan normaj._Also,_

. Driving_and_using_mactiinei___________

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    i

•    when your dose is changed    !

•    when you switch to Bupeaze from another pain relidver

•    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 macjhinery 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.    >


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 kn()w how it affects you.

•    It is an offence to drive if this medicine affects yourjability to drive.

•    However, you would not be committing an offence |f:

“    “ the medicine fias"beeri~prescribed fo“treafa~m^dicaroFdenial problem arid" “

-    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. I


Discuss with your doctor or pharmacist if you are unsure! about anything.

3. How to use Bupeaze

Always use this medicine exactly as your doctor has toljf 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 W) 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 u$e to a smaller or larger one if necessary.


The recommended dose is:    1

Adults    1


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, yjou should make a note on the calendar on the outer packaging. If your doctor has advised you to take oth^r pain relievers in addition to the transdermal patch, strictly follow the doctor's instructions, otherwise you willj not fully benefit from treatment with Bupeaze.


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, rjo 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.



external heat may prevent the transdermal patch [from sticking properly. Therefore, do not expose yourself to external heat (e.g. sauna, infra-red lamqs, 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

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 tyfcje of medicine for the last 2 weeks.

•    Bupeaze may make some people feel drowsy, si<)k, or faint or make them breathe more slowly or weakly. These side effects may be intensified if othef medicines that may produce the same effects are

— Taken at-the same-time. These-other medicines-include other-strong pain fetievers-Jepioids), -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 anjti-infectives/anti-fungals (e.g. containing erythromycin or ketoconazole) or HIV medicines (e.g. containing ritpnavir).

•    If Bupeaze is used together with other medicines, thq 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).

Bupeaze with food, drink and alcohol

You should not drink alcohol while using Bupeaze. transdermal patch and you may feel unwell.

Alcohol may intensify certain side effects of the

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.    I


Route of administration    I

The patch is for transdermal use.    !

When the transdermal patch is applied to the skin, thejactive 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 f(om 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.

Front    i






Pregnancy, breast-feeding and fertility

Tfyou-are pregnant er-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 useBujjeazeif you_arebreast-fe_edi_ng._ _

If the chosen area has hairs, cut them off with a pai( 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-ir-shower, wait until you i^skinls-comp letely-dry-and— cool. Do not apply lotion, cream or ointment tb the chosen area. This might prevent your transdermal patch from sticking properly.    \


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