Patient leaflet - BUPEAZE 35 MICROGRAMS / H TRANSDERMAL PATCHES
1. What Bupeaze is and what it is used for
2. What you need to know before you use Bupeazei
-
3. Howto 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
Ihe 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 paihkiIlers. Bupeaze acts through the skin. When the 'transdermal patch is applied to the skin, the active substance 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 thelbrain). The effect of the transdermal patch lasts for up to [four days. Bupeaze is not suitable for the treatment of acute (short-lasting) pain.
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2. what you need to know before you use bupeaze
Do not use Bupeaze
i* 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 thislype ofmedicine i n The lasttwo weed’s (see^Othermedicines 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)
i* if you are pregnant.
[Bupeaze must not be used to treat withdrawal symptom^ in drug-dependent persons.
480 mm
[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-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 i
- [ if you have difficulty breathing or are taking other medicines that may make you breathe more slowly or weakly
; (see „Other medicines and Bupeaze“)
i* “Tfyourtiver does not work properly—
- [ if you are inclined to abuse medicines or drugs
- [ if you have depression or other conditions that are treated with antidepressants
- [ The use of these medicines together with Bupeaze can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and| Bupeaze”).
lAlso, 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. 1
[Athletes should be aware that this medicine may cause positive reaction to sports doping control tests.
[Sleep-related breathing disorders
[Bupeaze camcause-sleep-relatedbreathing disorders-si|ch as-sleep^pnoea^breathing pauses during sleep) ancL^ sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during [sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the [day. If you or another person observe these symptoms, Contact your doctor. A dose reduction may be considered [by your doctor.
[The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider [decreasing your total opioid dosage if you experience central sleep apnea.
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
iTell 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.
! Thesesid e effects may be intensified if other medicih es that may produce the sam e 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.
- ! Concomitant use of Bupeaze and sedative medicines such as benzodiazepines or related drugs increases the
[ risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening.
[ Because of this, concomitant use should only be considered when other treatment options are not possible.
; However if your doctor does prescribe Bupeaze together with sedative medicines the dose and duration of
। concomitant treatment should be limited by your doctor.
[ Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose
[ recommendation closely. It could be helpful to infornji friends or relatives to be aware of the signs and
[ symptoms stated above. Contact your doctor when experiencing such symptoms.
i* antidepressants such as moclobemide, tranylcyproniiine, citalopram, escitalopram, fluoxetine, fluvoxamine,
[ paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may
[ interact with Bupeaze and you may experience symptoms such as involuntary, rhythmic contractions of
[ muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased ijnuscle 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/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, orphenytoin) ormedicines fortubercijrlosis (ergr rifampicin^
Bupeaze with food, drink and alcohol
You should not drink alcohol while using Bupeaze. Alcohol Imay intensify certain side effects of the transdermal patch and you may feel unwell. Drinking grapefruit juice may intensify the effects of Bupeaze.
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 not sufficient experience regarding the use of Bupeaze in pregnant women. Therefore, do not use Bupeaze if you are pregnant. |
Buprenorphine, the active substance contained in the transdermal patch, inhibits milk formation and passes into the breast milk. Therefore, do not use Bupeaze if you are tjreast-feeding.
Driving and using machines
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 1
- when your dose is changed
- when you switch to Bupeaze from another pain relieve|r
- if you also use other medicines that act on the brain
- if you drink alcohol. i
If you are affected, you should not drive or operate machineiy 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.
Discuss with your doctor or pharmacist if you are unsure about anything.
The medicine can affect your ability to drive as it may make Vou sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you.
- It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence
(called the ‘statutory defence’). I
- This defence applies when:
- 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 and in the information provided with the medicine._____________________________________________i__________________________________________________________
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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3. Howto use Bupeaze
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 of larger one if necessary.
The recommended dose is:
Adults -p
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, ^ou 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 I strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment with Bupeaze.
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 Thursday
Tuesday Friday
Wednesday Saturday
Thursday Sunday 1
Friday Monday
__ Saturday__ Juesda^ __ __ J__ __ __ __ __ __ __ __
Sunday Wednesday
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.
Elderly patients
No dosage adjustment is needed for elderly patients.
Patients with kidney disease I dialysis patients
In patients with kidney disease and in dialysis patients, no dqsage 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.
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 lof the back (see adjacent illustrations). Call assistance if you cannot apply the transdermal patch yourself.
Front
- If the chosen area has hairs, cut them off with a pair of scissors. Do not shave them off!
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 urind than normal)
- weariness
lotion, cream or ointment to the chosen area. This mjght prevent your transdermal patch from sticking properly.
Applying the transdermal patch
Step 1: Each transdermal patch is sealed in a sachet. (Lt the child-resistant sachet along the sealed edge with scissors. Be careful not to damage the transdermal patches. Take out the transdermal patch.
I
Step 3: Stick the transdermal patch onto the area of skin you have chosen and remove the remaining foil.
Step 2: The sticky side of the transdermal patch is covered with a transparent protective foil. Carefully peel off half the foil. Try not to touch the sticky part of the transdermal patch.
Step 4: Press the transdermal patch against your skin v|/ith 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.
“Rare (may affect up to 1 in T7UU0 people): j
- 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
- withdrawal symptoms (see below), administration site reactions
- serious allergic reactions (see below)
- dependence, mood swings
- muscle twitching, taste disorders
- pin-point pupils — — — — — -i— — — — — — —
- ear pain I
- abnormally rapid breathing, hiccups
- retching
- pustules, small blisters
- chest pain
Not known (Frequency cannot be estimated from the available data)
- dermatitis contact (skin rash with inflammation which pay include burning sensation), skin discolouration 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 pharmacistThis includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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 iTirThalfwith the sticky side inwards.
- Throw it away carefully, out of the sight and reach of children.
- Stick a new transdermal patch on a different skin si|e (as described above). Wait at least one week before using the same site again.
How long will you use the patch for
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.
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, nauslea, and vomiting. You may get pin-point pupils and breathing may become slow and weak. You may also get cardiovascular collapse.
As soon as you discover that you have used more transldermal patches than you should, remove the excess transdermal patches and talk to a doctor or pharmacist.
If you forget touse 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 notelof 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 sto() 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. — — —
5. How to store Bupeaze
- 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 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
Wiat 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): povidon^ KOO, 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 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 pg/h”, (52.5 micrograms/h patch) “Buprenorphin” and “52.5 pg/h” and (70 micrograms/h patch) “Buprenorphin” and “70 pg/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 OLD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg, 86156, Germany
This leaflet was last revised in May 2021
Artwork
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, anklei 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 i m med lately i 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: I
| Brand: | Dr Reddy’s |
| Product Name: | (Bupeaze) Buprenorphine |
| Strength: | 35,52.5, & 70 mcg/h |
| Form: | Transdermal Patch |
| Component: | Leaflet |
| Pack Size: | N/A |
| Country: | UK |
| Date Created: | 25/05/2017 |
| Date Modified: | 07 JUN 2021 |
| Version: | 3.2 |
Technical Information
| Die Cut | Guides | |
Very common (may affect more than 1 in 10 people): i* nausea (feeling sick)
- ! redness, itching
Min Font Size: 9pt
Printer: Teifenbacher
Dimensions: 280 × 480 mm
Project: CC1000059633
Colours
| | Process Black | | |
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