• 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.

• 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.

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

• 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.

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
• 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”).

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.

Bupeaze can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and 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.

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.

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.
• 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 inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• antidepressants such as moclobemide, tranylcypromine, 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 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/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).

You should not drink alcohol while using Bupeaze. Alcohol may intensify certain side effects of the transdermal patch and you may feel unwell. Drinking grapefruit juice may intensify the effects of Bupeaze.

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 breast-feeding.

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.

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

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 while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).
• 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.
• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

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.

The following table shows you when to change your patch.

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

Monday Thursday

Tuesday Friday

Wednesday Saturday

Thursday Sunday

Friday Monday

Saturday Tuesday

Sunday Wednesday

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.

No dosage adjustment is needed for elderly patients.

In patients with kidney disease and in dialysis patients, no dosage adjustment is necessary.

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.

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.

Step 1: Each transdermal patch is sealed in a sachet. Cut the child-resistant sachet along the sealed edge with scissors. Be careful not to damage the transdermal patches.

Take out the transdermal patch.

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 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.

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).

• Take the old transdermal patch off.
• Fold it in half with 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 site (as described above). Wait at least one week before using the same site again.

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 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.

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 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 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 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 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.

• 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

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.