BuTrans patches (buprenorphine)

• BuTrans patches contain the active ingredient buprenorphine, which is a strong opioid painkiller related to morphine.

What are BuTrans patches used for?

• BuTrans patches are used to treat ongoing moderate pain that can't be relieved by weaker non-opioid painkillers, for example long-term pain caused by osteoarthritis.

How do BuTrans patches work?

• BuTrans patches contain the active ingredient buprenorphine, which is a type of medicine called an opioid painkiller.
• Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors.
• Buprenorphine mimicks the action of natural endorphins by stimulating the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt.
• BuTrans patches contain a reservoir of buprenorphine that passes slowly from the patch through the skin and into the bloodstream. The blood level of the medicine rises slowly in first three days after the first patch is put on, so the initial effect of the medicine is not rapid, but after this the blood level of the medicine remains steady. The patch should be changed every seven days to provide continuous pain relief.

How do I use BuTrans patches?

• It is important that you carefully follow the instructions you have been given with this medicine.
• The patches should not be divided, cut or damaged in any way.
• BuTrans patches should be applied to a clean, dry, non-hairy, non-irritated, non-broken area of skin, preferably on the upper outer arm, upper chest, upper back, or the side of the chest. Avoid areas with large scars. If you need to clean the skin before sticking on the patch use only water, not soap or other cleansers. If hair needs to be removed before applying the patch it should be cut with scissors, not shaved. Don't stick the patch on straight after a hot bath or shower, wait for the skin to cool down first, and don't use talc, creams or moisturisers before applying the patch as they may prevent it sticking. Stick the patch on straight after removing it from the sachet and press it firmly into place with the palm of the hand for 30 seconds.
• While you are wearing the patch you can swim, bathe and shower as normal, but you should avoid exposing the patch to excessive heat sources, such as hot water bottles, electric blankets, heat lamps, sunbeds, saunas or hot spa baths, as heat can increase the absorption of the active ingredient into the body, resulting in a greater risk of side effects. Tell your doctor if you get a fever (high temperature) while wearing the patch, as this might also increase the absorption of medicine through the skin.
• Each patch should be worn for seven days and then removed. You should always change your patch at the same time of day. New patches should be applied to a different area of skin, and you should avoid using the same area for the next three to four weeks.
• If a patch starts to peel off at the edges it can can be stuck back down at the edges with skin tape. If a patch falls off before it needs changing, stick a new one on straight away, and remember this replacement will need changing after seven days.
• Removed patches should be folded in half, sticky side innermost, and placed inside the open sachet or a piece of tin foil, for careful disposal away from children or animals. This is because used patches may still contain some active ingredient that may be harmful to children or animals.
• Don't use more than your doctor tells you to. No more than two patches should be worn at any one time.
• Important information about BuTrans patches
• This medicine may cause drowsiness and various other side effects that could impair your mental or physical ability to drive or operate machinery safely, particularly when you first start using the patches, or after any dose increases. You should be aware of how you react to this medicine before driving or operating machinery. When you first start using the patches, or after any dose increases, you should not drive or operate machinery while wearing a patch, or for at least 24 hours after removing the last patch.
• You should avoid drinking alcohol while using the patches as alcohol is likely to increase the risk of you feeling drowsy or dizzy.
• Buprenorphine is in the same class of medicines as some of the medicines on the list, which means it may be an offence to drive while you are using this medicine. The new law will allow police to use roadside drug tests to check for the presence of the prohibited drugs in a driver's saliva. There are very low limits for illegal drugs, but higher limits for prescribed medicines. This means most people using buprenorphine as prescribed will not be breaking the law, provided they are not driving dangerously. If you test positive for one of the medicines there is a medical defence if you are taking it as prescribed, as long as your driving is not impaired. If you are using a high dose of buprenorphine it may therefore be sensible to carry your prescription with you if you feel you are safe to drive, in case you are asked to take a test by the police. You should not drive if you think this medicine affects your ability to drive safely, for example if it makes you feel sleepy, dizzy, unable to concentrate or make decisions, or if you have blurred or double vision. If you are driving dangerously while using this medicine you will be breaking the law.
• This medicine has severe adverse reactions in an overdose. Do not use more patches than prescribed by your doctor. If you become very sleepy or have slow and/or shallow breathing while wearing a patch, remove it, contact your doctor immediately and call for emergency help.
• The effect of this medicine (including any side effects) can last for up to 30 hours after removing the last patch. If your doctor is changing you from this painkiller to another opioid painkiller, the new opioid, as a general rule, should not be started until 24 hours after removing the BuTrans patch.
• With prolonged use, the body may become dependent on this medicine. As a result, withdrawal symptoms such as diarrhoea, feeling agitated, anxious, nervous or shaky, or having difficulty sleeping, may occur after you stop using the medicine. This is rare, but tell your doctor if you experience any of these symptoms after stopping this medicine. If they occur, these effects usually begin a couple of days after stopping the medicine and disappear after a couple of weeks.
• Buprenorphine is a controlled drug. If you are planning to travel abroad with it you should check its legal status in the countries you are travelling through and to. There are legal limits on how much of this medicine you can take abroad with you. If you need to take more than this limit you will have to apply to the Home Office for a licence before you travel. Even if you don't need a licence, if you are taking this medicine abroad it is always a good idea to carry a letter from your doctor that confirms your need for the medicine. You should always carry the medicine in correctly labelled packaging, as dispensed by the pharmacy.

Who should not use BuTrans patches?

• Children or adolescents under 18 years of age.
• People with acute (short-term) pain.
• People with severe breathing problems causing very slow, shallow breathing (respiratory depression).
• People who have or who are at risk of getting a blockage in the gut (paralytic ileus).
• People with a condition called myasthenia gravis, in which there is abnormal muscle weakness.
• People with a serious medical condition caused by withdrawal from alcohol (delirium tremens).
• People who have taken a monoamine-oxidase inhibitor (MAOI) in the last 14 days.
• People dependent on opioids.
• BuTrans patches are not licensed for substitution therapy in people having treatment for opioid dependence. Other brands of buprenorphine are used for this.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

BuTrans patches should be used with caution in

• Elderly, weak or debilitated people.
• People with decreased liver or kidney function.
• People with decreased lung function or breathing difficulties, for example asthma or chronic obstructive pulmonary disease (COPD).
• People with low blood pressure (hypotension) or low circulating blood volume (hypovolaemia).
• People with reduced production of natural steroid hormones by the adrenal glands (adrenocortical insufficiency).
• People with an underactive thyroid gland (hypothyroidism).
• People with difficulty passing urine, for example men with an enlarged prostate gland.
• People with disorders of the bile ducts.
• People with chronic constipation, inflammatory or obstructive bowel disease.
• People with a history of convulsions (fits), eg epilepsy.
• People with a head injury, brain tumour, or increased pressure in the brain (raised intracranial pressure).
• People with reduced levels of conciousness.
• People with a history of drug abuse or dependence.
• People with a high temperature.

Can I use BuTrans patches while pregnant or breastfeeding?

• This medicine should not be used during pregnancy, particularly in the third trimester. If used during labour it may cause breathing difficulties in the baby after the birth. Babies born to mothers who have been using buprenorphine for a long time may have withdrawal symptoms after the birth. Seek further medical advice from your doctor.
• Small amounts of this medicine may pass into breast milk. It should not be used in women who are breastfeeding because it can potentially cause problems in the nursing baby, such as breathing or feeding problems. Seek further medical advice from your doctor.

What are the possible side effects of BuTrans patches?

• Itching or other reaction of skin at patch application site.
• Headache.
• Dizziness.
• Drowsiness.
• Dry mouth.
• Constipation.
• Nausea and vomiting.
• Hot flushes.
• Itching.
• Feeling weak or tired.
• Loss of appetite.
• Confusion.
• Depression.
• Nervousness.
• Difficulty sleeping (insomnia).
• Pins and needles sensations.
• Shortness of breath.
• Abdominal pain or indigestion.
• Diarrhoea.
• Rash.
• Sweating.
• Retention of fluid causing swelling, eg of the ankles (peripheral oedema).
• Chest pain.

Talk to your doctor, nurse or pharmacist if you want any more information about the possible side effects of this medicine. 

Can I use other medicines with BuTrans patches?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to make sure that the combination is safe.

This medicine should not be used by people who are taking a monoamine oxidase inhibitor (MAOI), for example the antidepressants phenelzine, tranylcypromine, isocarboxacid or moclobemide, or by people who have taken one of these medicines in the last 14 days.

There may be an increased risk of side effects such as drowsiness, sedation and slow, shallow breathing, if this medicine is used with other medicines that have a sedative effect on the central nervous system. These include the following:

• alcohol
• antipsychotics, eg haloperidol, chlorpromazine
• barbiturates, eg phenobarbital, amobarbital
• benzodiazepines, eg diazepam, temazepam (these should not be taken while you are using BuTrans patches)
• general anaesthetics
• muscle relaxants, eg baclofen
• other opioid painkillers, eg morphine, codeine, dihydrocodeine
• sedating antihistamines, eg chlorphenamine, hydroxyzine
• sleeping tablets, eg zopiclone
• tricyclic antidepressants, eg amitriptyline.

The following medicines may increase the blood level of buprenorphine and you may need a lower dose if you are taking one of these:

• azole antifungals such as itraconazole, ketoconazole
• macrolide antibiotics such as erythromycin, clarithromycin
• protease inhibitors for HIV infection, such as ritonavir, indinavir, saquinavir.

The following medicines may decrease the blood level of buprenorphine and could make it less effective:

• carbamazepine
• phenobarbital
• phenytoin
• rifampicin
• the herbal remedy St John's wort (Hypericum perforatum).

References:

https://www.rxlist.com/butrans-side-effects-drug-center.htm

https://www.medicines.org.uk/emc/product/124/pil

https://butrans.com/patient/what-is-butrans.html

https://www.webmd.com/drugs/2/drug-155153/butrans-transdermal/details

https://www.medicines.ie/medicines/butrans-transdermal-patches-31508/patient-info