Bupeaze 35 micrograms / h transdermal patches – patient leaflet, side effects, dosage

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) inte

nded to relieve moderate to severe cancer pain and

severe pain that has not responded to other types of pai

nkillers. Bupeaze acts through the skin. When the

transdermal patch is applied to the skin, the active subst

ance buprenorphine passes through the skin into the

blood. 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 ac

ute (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 oth

er ingredients of this medicine (listed in section 6)

• if you are dependent on strong pain relievers (opioid

  s)

• if you suffer from a disease in which you have or ma

  y have great difficulty breathing

• if you are taking monoamine oxidase (MAO) inhibito

  rs (certain medicines used to treat depression) or you

  have taken this type of medicine in the last two wee

• if you suffer from myasthenia gravis (a certain type o

• if you suffer from delirium tremens (confusion and tr

  habitual excessive drinking or occurring during an e

• if you are pregnant.

Bupeaze must not be used to treat withdrawal symptoms Warnings and precautions

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-head
• if you are in a state of shock (cold sweat might be a

• if the pressure in your skull is increased (for instanc

  respiration is not possible

• if you have difficulty breathing or are taking other me

  (see "Other medicines and Bupeaze")

  ks (see "Other medicines and Bupeaze")

  f severe muscle weakness)

  embling caused by abstinence from alcohol following pisode of heavy alcohol consumption)

  in drug-dependent persons.

  ed or faint) for an unknown reason

  sign of it)

  e after head injury or in brain disease), and artificial

  dicines that may make you breathe more slowly or weakly

• if your liver does not work properly
• if you are inclined to abuse medicines or drugs
• if you have depression or other conditions that are tr

• The use of these medicines together with Bupeaze

  life-threatening condition (see “Other medicines and

Also, please be aware of the following precautions:

• Some people may become dependent on strong pai

  long period of time. They may have withdrawal effec Bupeaze”).

• Fever and external heat may lead to larger quantitie

  heat may prevent the transdermal patch from stickin heat (e.g. sauna, infra-red lamps, electric blankets, fever.

Athletes should be aware that this medicine may cause Sleep-related breathing disorders

Bupeaze can cause sleep-related breathing disorders su

eated with antidepressants

can lead to serotonin syndrome, a potentially Bupeaze”).

n relievers such as Bupeaze when they use them over a ts when they stop using them (see “If you stop using

s of buprenorphine in the blood than normal. Also, external g properly. Therefore, do not expose yourself to external hot water bottles) and consult your doctor if you have

a positive reaction to sports doping control tests.

ch as sleep apnoea (breathing pauses during sleep) and

sleep related hypoxemia (low oxygen level in the blood). sleep, night awakening due to shortness of breath, diffic day. If you or another person observe these symptoms, by your doctor.

The risk of experiencing central sleep apnea is depende decreasing your total opioid dosage if you experience ce Children and adolescents

Bupeaze should not be used in persons below the age o in this age group.

Other medicines and Bupeaze

Tell your doctor or pharmacist if you are taking, have rec

• Bupeaze must not be used together with monoamin

  depression), or if you have taken this type of medici

• Bupeaze may make some people feel drowsy, sick,

  These side effects may be intensified if other medici

  The symptoms can include breathing pauses during ulties to maintain sleep or excessive drowsiness during the contact your doctor. A dose reduction may be considered

  nt on the dose of opioids. Your doctor may consider ntral sleep apnea.

  f 18 years, because no experience has so far been gained

  ently taken or might take any other medicines.

  e oxidase (MAO) inhibitors (certain medicines used to treat ne for the last 2 weeks.

  or faint or make them breathe more slowly or weakly. nes that may produce the same effects are taken at the

  same time. These other medicines include other stro anaesthetics, and medicines used to treat certain ps anti-depressants, and neuroleptics.

• Concomitant use of Bupeaze and sedative medicine

  risk of drowsiness, difficulties in breathing (respirato Because of this, concomitant use should only be co However if your doctor does prescribe Bupeaze tog concomitant treatment should be limited by your doc Please tell your doctor about all sedative medicines recommendation closely. It could be helpful to inform symptoms stated above. Contact your doctor when

• antidepressants such as moclobemide, tranylcyprom

  paroxetine, sertraline, duloxetine, venlafaxine, amitri interact with Bupeaze and you may experience sym muscles, including the muscles that control moveme

  ng pain relievers (opioids), certain sleeping pills, ychological diseases such as tranquillizers,

  s such as benzodiazepines or related drugs increases the ry depression), coma and may be life-threatening. nsidered when other treatment options are not possible. ether with sedative medicines the dose and duration of tor.

  you are taking, and follow your doctor’s dose friends or relatives to be aware of the signs and experiencing such symptoms.

  ine, citalopram, escitalopram, fluoxetine, fluvoxamine, ptyline, doxepine, or trimipramine. These medicines may ptoms such as involuntary, rhythmic contractions of nt of the eye, agitation, hallucinations, coma, excessive

  sweating, tremor, exaggeration of reflexes, increased

  muscle tension, body temperature above 38°C. Contact

  your doctor when experiencing such symptoms.

  • 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/an

    ti-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. dexamethaso

    ne; medicines to treat epilepsy (e.g. containing

    carbamazepine, or phenytoin) or medicines for tubercu Bupeaze with food, drink and alcohol

You should not drink alcohol while using Bupeaze. Alcohol patch and you may feel unwell. Drinking grapefruit juice ma Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pre or pharmacist for advice before using this medicine.

There is not sufficient experience regarding the use of Bup Bupeaze if you are pregnant.

Buprenorphine, the active substance contained in the trans the breast milk. Therefore, do not use Bupeaze if you are b Driving and using machines

Bupeaze may make you feel dizzy or drowsy or experience such an extent that you may not react adequately or quickl occurrences. This applies particularly

losis (e.g. rifampicin).

may intensify certain side effects of the transdermal y intensify the effects of Bupeaze.

gnant or are planning to have a baby, ask your doctor

eaze in pregnant women. Therefore, do not use

dermal patch, inhibits milk formation and passes into reast-feeding.

blurred or double vision and affect your reactions to y enough in the event of unexpected or sudden

• at the beginning of treatment
• when your dose is changed
• when you switch to Bupeaze from another pain relieve
• 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 machiner treatment with Bupeaze. Do not drive or operate machinery f

Discuss with your doctor or pharmacist if you are unsure abo

The medicine can affect your ability to drive as it may make

• Do not drive while taking this medicine until you know ho
• It is an offence to drive while you have this medicine in y (called the ‘statutory defence’).

• This defence applies when:

  • the medicine has been prescribed to treat a medical

  • you have taken it according to the instructions given

    medicine.

    r

    y whilst using Bupeaze. This applies also at the end of or at least 24 hours after the patch has been removed.

    ut anything.

    you sleepy or dizzy.

    w it affects you.

    our body over a specified limit unless you have a defence

    or dental problem; and

    by the prescriber and in the information provided with the

• Please note that it is still an offence to drive if you are un being affected).

Details regarding a new driving offence concerning driving af https://www.gov.uk/drug-driving-law

Talk to your doctor or pharmacist if you are not sure whether

3. How to use Bupeaze

Always use this medicine exactly as your doctor has told you sure.

Bupeaze is available in three strengths: Bupeaze 35 microgr Transdermal Patches and Bupeaze 70 micrograms/h Transd

The choice of which strength of Bupeaze will suit you best w may change which transdermal patch you use to a smaller o

The recommended dose is:

fit because of the medicine (i.e. your ability to drive is

ter drugs have been taken in the UK may be found here:

it is safe for you to drive while taking this medicine.

. Check with your doctor or pharmacist if you are not

ams/h Transdermal Patches, Bupeaze 52.5 micrograms/h ermal Patches.

ill be made by your doctor. During treatment your doctor r larger one if necessary.

Adults

Unless your doctor has told you differently, attach one Bupea change it after 4 days at the latest. For convenience of use, same days, e.g. always on Monday mornings and Thursday transdermal patch, you should make a note on the calendar take other pain relievers in addition to the transdermal patch, not fully benefit from treatment with Bupeaze.

The following table shows you when to change your patch.

ze transdermal patch (as described in detail below) and you can change the transdermal patch twice a week at the evenings. To help you remember when to change your on the outer packaging. If your doctor has advised you to strictly follow the doctor's instructions, otherwise you will

Use in children and adolescents

Bupeaze should not be used in persons below the age of 18 this age group.

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 do Patients with liver disease

In patients with liver disease, the intensity and duration of ac your doctor will check on you more closely.

years, because no experience has so far been gained in

sage adjustment is necessary.

tion of Bupeaze may be affected. If this applies to you,

Package leaflet:

Bupeaze 35 microgr Bupeaze 52.5 microg Bupeaze 70 microgr

Bup

Information for the user

ams/h Transdermal Patches rams/h Transdermal Patches ams/h Transdermal Patches

renorphine

Important things you need to know about

• These patches contain a strong pain killer.
• Ensure that old patches are removed before applyin
• Patches must not be cut.
• Do not expose the patches to a heat source (such a
• Do not soak in a hot bath or take a hot shower whils

• If you develop a fever tell your doctor immediately.

  Bupeaze

  g a new one.

  s a hot water bottle). t wearing a patch.

• Follow the dosage instructions carefully and only ch

• If your breathing becomes shallow and weak take th

  ange your patch patch twice a week at the chosen times. e patch off and seek medical help.

Read all of this leaflet carefully before you start usin

g this medicine because it contains important informatio

n for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor o

• This medicine has been prescribed for you only. Do

  r pharmacist.

  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 pha

  rmacist. This includes any possible side effects not listed in t

  his leaflet. See section 4.

  Method of administration

  Before applying the transdermal patch

  • Choose an area of skin which is flat, clean, free from

    the chest below the collar-bone or on the upper part cannot apply the transdermal patch yourself.

    cuts or scars and hairless on your upper body, preferably on of the back (see adjacent illustrations). Call assistance if you

  • If the chosen area has hairs, cut them off with a pair
  • Avoid skin which is red, irritated or has any other ble

  • The area of skin you choose must be dry and clean.

    soap or other detergents. After a hot bath or shower, lotion, cream or ointment to the chosen area. This mi

Applying the transdermal patch

Step 1: Each transdermal patch is sealed in a sachet. C the sealed edge with scissors. Be careful not to damag Take out the transdermal patch.

of scissors. Do not shave them off!

mishes, for instance large scars.

If necessary, wash it with cold or lukewarm water. Do not use wait until your skin is completely dry and cool. Do not apply ght prevent your transdermal patch from sticking properly.

ut the child-resistant sachet along

e the transdermal patches.

Step 2: The sticky side of the transdermal patch is cove Carefully peel off half the foil. Try not to touch the sticky

Step 3: Stick the transdermal patch onto the area of ski the remaining foil.

Step 4: Press the transdermal patch against your skin w about 30 to 60 seconds. Make sure that the whole trans your skin, especiall

red with a transparent protective foil. part of the transdermal patch.

n you have chosen and remove

ith the palm of your hand for dermal patch is in contact with

y at the edges.

Step 5: Wash your hands after using the transdermal p Wearing the transdermal patch

You may wear the transdermal patch for up to 4 days. P correctly, there is little risk of it coming off. You may sho expose the transdermal patch to extreme heat (e.g. sau bottles).

In the unlikely event that your transdermal patch falls of transdermal patch again. Stick a new one on straight aw Changing the transdermal patch

• Take the old transdermal patch off.

  atch. Do not use any cleansing products.

  rovided that you have applied the transdermal patch wer, bathe or swim while wearing it. However, do not na baths, infra-red lamps, electric blankets, hot water

  f before it needs changing, do not use the same ay (see "Changing the transdermal patch" below).

• Fold it in half with the sticky side inwards.
• Throw it away carefully, out of the sight and reach

• Stick a new transdermal patch on a different skin si

  using the same site again.

How long will you use the patch for

Your doctor will tell you how long you may use Bupeaze because pain may return and you may feel unwell (see If you have the impression that the effect of the Bupeaz doctor or pharmacist.

If you use more Bupeaze than you should

If this happens there may be signs of an overdose of th side effects of buprenorphine such as drowsiness, naus breathing may become slow and weak. You may also g

As soon as you discover that you have used more trans transdermal patches and talk to a doctor or pharmacist.

of children.

te (as described above). Wait at least one week before

. Do not stop using Bupeaze on your own account, also "If you stop using Bupeaze" below).

e transdermal patch is too weak or too strong, tell your

e substance buprenorphine. An overdose may intensify the ea, and vomiting. You may get pin-point pupils and et cardiovascular collapse.

dermal patches than you should, remove the excess

If you forget to use Bupeaze

If you forget an application, stick a new transdermal pat change your routine, e.g. if you usually apply your trans and don’t stick on a new transdermal patch until Wedne Wednesdays and Saturdays from then on. Make a note packaging. If you are very late changing your transderm doctor.

Never apply twice the number of transdermal patches to If you stop using Bupeaze

If you interrupt or finish using Bupeaze too soon, pain m side effects, please consult your doctor. He/she will tell other medicines.

Some people may experience withdrawal-effects when t stop using them. The risk of having effects after you sto anxious, nervous or shaky, if you are overactive, have d

If you have any further questions on the use of this med

ch on as soon as you remember. You will then need to dermal patches on Mondays and Thursdays, but you forget sday, you will need to change your transdermal patches on of the new pair of days on the calendar on the outer al patch, pain may return. In this case please contact your

make up for the forgotten application!

ay return. If you wish to stop use on account of unpleasant you what can be done and whether you can be treated with

hey have used strong pain relievers for a long time and p using Bupeaze is very low. However, if you feel agitated, ifficulty sleeping or digestion problems, tell your doctor.

icine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,

• If you experience swelling of the hands, feet, ankles

  swallowing or breathing, hives, fainting, yellowing o transdermal patch and call your doctor immediately hospital. These can be symptoms of a very rare ser

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• nausea (feeling sick)

• redness, itching

  although not everybody gets them.

  , face, lips, mouth, or throat which may cause difficulty in f the skin and eyes (also called jaundice), remove the or seek help at the casualty department of the nearest ious allergic reaction.

  Common (may affect up to 1 in 10 people):

  • dizziness, headache
  • shortness of breath
  • vomiting, constipation
  • skin changes (exanthema, generally on repeated use
  • 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
• circulation disorders (such as low blood pressure or, r
• dry mouth
• rash
• difficulty in passing water, urinary retention (less urine

• weariness

  ), sweating

  tiredness to muzziness

  arely, even circulatory collapse)

  than normal)

Rare (may affect up to 1 in 1,000 people):

• loss of appetite
• illusions such as hallucinations, anxiety and nightmar

• difficulties concentrating, speech disorder, muzziness

  (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

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

  es, reduced sex drive

  , disturbed balance, abnormal skin sensations

  reactions

• ear pain
• abnormally rapid breathing, hiccups
• retching
• pustules, small blisters
• chest pain

Not known (Frequency cannot be estimated from the ava

• dermatitis contact (skin rash with inflammation which If you notice any of the side effects listed above, tell your d

In some cases delayed allergic reactions occurred with ma stop using Bupeaze after you have talked to your doctor. Some people may have withdrawal symptoms when they using them. The risk of having withdrawal effects when yo agitated, anxious, nervous or shaky, if you are overactive, doctor.

Reporting of side effects

ilable data)

may include burning sensation), skin discolouration octor as soon as possible.

rked signs of inflammation. In such a case you should

have used strong pain relievers for a long time and stop u stop using Bupeaze is low. However, if you feel have difficulty sleeping or digestion problems, tell your

If you get any side effects, talk to your doctor or pharmacis this leaflet. You can also report side effects directly via the www.mhra.gov.uk/yellowcard or search for MHRA Yellow C side effects, you can help provide more information on the

5. How to store Bupeaze

• Keep this medicine out of the sight and reach of c

• Do not use this medicine after the expiry date which is

  date refers to the last day of that month.

• This medicine does not require any special storage co
• After removing a patch, fold it in half with the sticky sid patch to its sachet and carefully dispose the transderm
• Do not throw away medicines via wastewater. Ask you longer use. These measures will help protect the envi

6. Contents of the pack and other informati

t. This includes any possible side effects not listed in Yellow Card Scheme website

ard in the Google Play or Apple App Store. By reporting safety of this medicine.

hildren.

stated on the carton and sachet after EXP. The expiry

nditions.

es inwards and press them together. Return the used al patch.

r pharmacist how to throw away medicines you no ronment.

on

What Bupeaze contains

• The active substance is buprenorphine.

  Each 35 micrograms/h transdermal patch of 25 cm² co 35 micrograms of buprenorphine per hour. Each 52.5 micrograms/h transdermal patch of 37.5 cm 52.5 micrograms of buprenorphine per hour. Each 70 micrograms/h transdermal patch of 50 cm² co 70 micrograms of buprenorphine per hour.

• The other ingredients are:

  Adhesive matrix (containing buprenorphine): povidone

  acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-viny Adhesive matrix (without buprenorphine):

  Poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-co Separating foil between adhesive matrices with and w Backing foil: polyester

  Release liner: Polyethylene terephthalate film, siliconi Blue printing ink

  ntains 20 mg of buprenorphine and releases

  ² contains 30 mg of buprenorphine and releases

  ntains 40 mg of buprenorphine and releases

  K90, levulinic acid, oleyl oleate, Poly[acrylic lacetate] (5:15:75:5)

  -(2-hydroxyethyl)acrylate-co-vinylacetate] (68:0,15:5:27) ithout buprenorphine: Polyethylene terephthalate film

  sed

What Bupeaze looks like and contents of the pac

Each transdermal patch is rectangular beige coloured with patch) “Buprenorphin” and “35 μg/h”, (52.5 micrograms/h (70 micrograms/h patch) “Buprenorphin” and “70 μg/h”.

Each transdermal patch is sealed in one child-resistant sa 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, Bev

Manufacturer

betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg, 8

This leaflet was last revised in May 2021

k

rounded corners and is imprinted (35 micrograms/h patch) “Buprenorphin” and “52.5 μg/h” and

chet. The patches are available in packs containing 3, 4,

erley, East Yorkshire, HU17 0LD, United Kingdom

6156, Germany

Apply/change your patch in morning of Apply/change your

patch in evening of

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Thursday

Friday

Saturday

Sunday

Monday

Tuesday

Sunday Wednesday

DRXXXXXX

16181-90000-05

280 mm

280 mm

(Bupeaze) Buprenorphine

35,52.5, & 70 mcg/h

Transdermal Patch

25/05/2017

Process Black

Brand: Dr Reddy’s

N/A

UK

07 JUN 2021

Product Name:

Strength:

Form:

Pack Size:

Leaflet

Country:

Date Created:

Date Modified:

Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK

280 x 480 mm Dimensions:

Project:

CC1000059633 9pt