Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Butec 5 microgram/hour transdermal patch

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Buprenorphine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Buprenorphine

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for This medicine has been prescribed for you to relieve moderate, long-lasting pain that requires the use of a strong painkiller. It contains buprenorphine which belongs to a class of medicines called opioids, which are 'pain relievers'. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. Butec patches should not be used to relieve acute pain.

Butec patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.

What you need to know before you take it

e Butec patches Do not use Butec patches if you:

  • are allergic (hypersensitive) to buprenorphine or any of the other ingredients of this medicine (listed in section 6 of this leaflet), or you have previously experienced an allergic skin reaction to buprenorphine patches;
  • have a condition that is currently affecting or might affect your breathing. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
  • are addicted to drugs, or you are currently undergoing drug withdrawal. Butec patches must not be used to treat symptoms associated with drug withdrawal;
  • are taking a type of medicine used to treat depression known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks;
  • suffer from myasthenia gravis (a condition in which the muscles become weak);
  • have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping drinking alcohol. Warnings and precautions Talk to your doctor, pharmacist or nurse before using Butec patches: Tolerance, dependence, and addiction This medicine contains buprenorphine which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Butec can also lead to dependence, abuse, and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Butec if:  You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction").  You are a smoker.  You have ever had problems with your mood (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs whilst taking Butec, it could be a sign that you have become dependent or addicted,  You need to take the medicine for longer than advised by your doctor.  You need to take more than the recommended dose.  You might feel that you need to carry on taking your medicine, even when it doesn't help to relieve your pain.  You are using the medicine for reasons other than prescribed, for instance, 'to stay calm' or 'help you sleep'.  You have made repeated, unsuccessful attempts to quit or control the use of the medicine.  When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again ('withdrawal effects').

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, If you stop taking BuTrans). The use of these medicines together with Butec patches can lead to serotonin syndrome, a potentially life-threatening condition if (see 'Other medicines and Butec patches); • • • • • • • • • •

You suffer from seizures, fits or convulsions. You may experience these more frequently whilst using this medicine; You know you are suffering from a brain injury or tumour, or you have a head injury, severe headache or feel sick, as this may indicate that the pressure in your skull is increased. This is because the patches may make symptoms worse, or hide the extent of any head injury; You have pale, cold, clammy skin, dizziness or light-headedness, fast, shallow breathing, or sweating. These are symptoms of shock; You are feeling unusually light-headed or faint; You have severe liver problems; You have recently had an operation; You have a high temperature, as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal; You have severely impaired lung function. Symptoms may include breathlessness and coughing; You have a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea; You are currently suffering from constipation.

Using this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment. Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Sleep-related breathing disorders Butec patches can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen levels 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.

When using Butec patches you may experience mild to moderate skin reactions at the site where you have applied the patch. These include redness, swelling, itching, rash, small blisters and a pain or burning sensation at the application site, which in some cases may be severe. In some cases a reaction may only begin after several months of treatment. Applying the patches according to the instructions given in section 3 'How to use Butec patches' reduces the risk of experiencing these reactions. Do not use if you have pain which lasts only for a short period or pain after having an operation because of the increased risk of dependence and developing serious breathing problems If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital if you are currently treated with Butec transdermal patch to discuss your pain management. If you experience these symptoms you or your caregivers should remove the patch immediately and contact your doctor. Continued use of the patches after experiencing an allergic reaction can result in blistering of the skin, open wounds, bleeding, ulceration, infections, changes to the colour of the skin (hypo- and hyperpigmentation), and dry, thick, scaly, scar-like patches. Children and adolescents Do not give this medicine to children below 18 years. Other medicines and Butec patches Some medicines may increase the side effects of Butec patches and may sometimes cause very serious reactions. Do not take any other medicines whilst using Butec patches without first talking to your doctor. Using Butec patches at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include:

  • other medicines used to treat pain known as opioids (such as codeine or morphine);
  • medicines used to treat depression;
  • medicines used to treat allergies (antihistamines);
  • medicines used to make you feel sleepy (such as benzodiazepines);
  • medicines used to treat anxiety;
  • medicines used to treat psychiatric or mental disorders (such as phenothiazines);
  • anaesthetics (such as halothane);
  • medicines used to treat high blood pressure (such as clonidine);
  • a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not use Butec patches if you are currently taking this type of medicine, or have taken this medicine in the last two weeks.
  • Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
  • Medicines to treat depression.
  • Medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics).
  • Muscle relaxants.
  • Medicines to treat Parkinson's disease Because of this, your doctor will only prescribe Butec patches where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers

notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately. Talk to your doctor before taking anti-depressants such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepine, or trimipramine. These medicines may interact with Butec patches 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 you take some medicines such as phenobarbital or phenytoin (medicines commonly used to treat seizures, fits or convulsions), carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions), or rifampicin (a medicine to treat tuberculosis) the effects of Butec patches may be reduced. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Using Butec patches with food, drink and alcohol Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Butec patches. Drinking alcohol whilst using Butec patches may also affect your reaction time. Pregnancy, breast-feeding and fertility Do not take Butec patches if you are pregnant or think you may be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Butec patches during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Do not use Butec patches while you are breastfeeding as buprenorphine passes into breast milk and will affect your baby. Ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Butec patches may 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;
  • if you are taking medicines to treat anxiety or help you sleep;
  • if your dose is increased. If you are affected (e.g. feel dizzy, drowsy or have blurred vision), you should not drive or operate machinery whilst using Butec patches, or for 24 hours after removing the patch.
  • Do not drive while taking this medicine until you know how it affects you.
  • It is an offence to drive if this medicine affects your ability to drive.
  • However you would not be committing an offence if:
  • 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 or in the information provided with the medicine and It was not affecting your ability to drive safely.

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

How to take it

Butec patches Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using BuTec, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking BuTec). Different strengths of Butec patches are available. Your doctor will decide which strength of Butec patch will suit you best. When people first start using Butec, they often experience some nausea and vomiting (see section 4 of this leaflet). This usually passes after the first week of treatment. It's a good idea to book a followup appointment with your doctor a week or two after you first start using Butec patches to ensure that you are taking the correct dose and to manage any side effects. During treatment, your doctor may change the patch you use to a smaller or larger one if necessary, or tell you to use a combination of up to two patches. Do not cut or divide the patch or use a higher dose than recommended. You should not apply more than two patches at the same time, up to a maximum total dose of 40 micrograms/hour. Your prescriber should have discussed with you how long the course of patches will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Adults and elderly patients Unless your doctor has told you differently, attach one Butec patch (as described in detail below) and change it once per week on the same day each week, preferably at the same time of day. Your doctor may wish to adjust the dose after 3-7 days until the correct level of pain control has been found. If your doctor has advised you to take other painkillers in addition to the patch, strictly follow the doctor's instructions, otherwise you will not fully benefit from treatment with the Butec patch. The patch should be worn for 3 full days before increasing the dose; this is when the maximum effect of a given dose is established. Patients under 18 years of age Butec patches should not be used in patients below the age of 18 years. Patients with kidney disease/dialysis patients In patients with kidney disease, no change in dose is necessary. Patients with liver disease In patients with liver disease, the effects and period of action of the Butec patch may be affected and your doctor will therefore check on you more closely.

Before applying the Butec patch

  • Choose an area of non-irritated, intact skin on your upper arm, outer arm, upper chest, upper back or side of the chest. (See illustrations below). Ask for assistance if you cannot apply the patch yourself.

• • •

The Butec patch should be applied to a relatively hairless or nearly hairless skin site. If no suitable hair free sites are available the hairs should be cut 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, alcohol, oil, lotions 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 patch from sticking properly.

Applying the patch Step 1:

Each patch is sealed in a pouch. Just before use, cut the pouch along the dotted line with scissors. Be careful not to damage the transdermal patches with the scissors. Take out the patch. Do not use the patch if the pouch seal is broken. Step 2: The sticky side of the patch is covered with a silvery protective foil. Carefully peel off half the foil. Try not to touch the sticky part of the patch. Step 3:

Stick the patch on to the area of skin you have chosen and remove the remaining foil.

Step 4: Press the patch against your skin with the palm of your hand and count slowly to 30. Make sure that the whole patch is in contact with your skin, especially at the edges. Wearing the patch You should wear the patch for seven days (one week). Provided that you have applied the patch correctly, there is little risk of it coming off. If the edges of the patch begin to peel off, they may be taped down with a suitable skin tape. You may shower, bathe or swim whilst wearing it. Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps, sauna, hot tubs, heated water beds, hot water bottle, etc) as this may lead to larger quantities of the active ingredient being absorbed into the blood than normal. External heat may also prevent the patch

from sticking properly. If you have a high temperature this may alter the effects of Butec patches (see section 2 'Warnings and precautions' above). In the unlikely event that your patch falls off before it needs changing, do not use the same patch again. Stick a new one on straight away (see 'Changing the patch' below). Changing the patch

  • Take the old patch off.
  • Fold it in half with the sticky side inwards.
  • Open and take out a new patch. Use the empty pouch to dispose of the old patch. Now discard the pouch safely.
  • Even used patches contain some active ingredient that may harm children or animals, so make sure your used patches are always kept out of the reach and sight of them.
  • Stick a new patch on a different appropriate skin site (as described above). You should not apply a new patch to the same site for 3-4 weeks.
  • Remember to change your patch at the same time of day. It is important that you make a note of the time of day. Duration of treatment Your doctor will tell you how long you should be treated with the Butec patch. Do not stop treatment without consulting a doctor, because your pain may return and you may feel unwell (see also 'If you stop using Butec patches' below). If you feel that the effect of the Butec patch is too weak or too strong, talk to your doctor or pharmacist. If you use more Butec patches than you should As soon as you discover that you have used more patches than you should, remove all patches and call your doctor or hospital immediately. People who have taken an overdose may feel very sleepy and sick. They may also have breathing difficulties or lose consciousness and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining patches with you to show to the doctor. If you forget to apply the Butec patch Stick a new patch on as soon as you remember. Also make a note of the date, as your usual day of changing may now be different. If you are very late changing your patch, your pain may return. In this case, please contact your doctor. Do not apply additional patches to make up for the forgotten application. If you stop using Butec patches Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine. If you stop using Butec patches too soon or you interrupt your treatment your pain may return.

The pain relieving effect of Butec patch is maintained for some time after removal of the patch. You should not start another opioid analgesic (strong painkiller) within 24 hours after removal of the patch. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Butec patches can cause side effects, although not everybody gets them. This medicine can cause allergic reactions, although serious allergic reactions are rare. Remove the patch and tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. These may be signs of a serious allergic reaction. You may also experience allergic skin reactions at the application site, the symptoms of which include rash, redness, itching, blisters, pain or a burning sensation, inflammation or swelling of the skin, which in some cases may be severe. If you experience these symptoms you or your caregivers should remove the patch and contact your doctor. The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 1,000 people and is more likely to occur when taking certain other medicines (see section 2 'Other medicines and Butec patches'). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms. Drug withdrawal When you stop taking Butec patches you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted? If you notice any of the following signs whilst using Butec patches, it could be a sign that you have become addicted.

  • You need to use the patches for longer than advised by your prescriber;
  • You feel you need to use more than the recommended dose;
  • You are using the medicine for reasons other than prescribed;
  • When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again. If you notice any of these signs it is important you talk to your prescriber. In patients treated with Butec patches, the following other side effects have been reported: Very common (may affect more than 1 in 10 people)
  • headache, dizziness, drowsiness;
  • constipation, feeling or being sick;
  • itchy skin;
  • rash, redness, itching, blisters, pain or a burning sensation, inflammation or swelling of the skin at the application site. Common (may affect up to 1 in 10 people)

• • • • • •

loss of appetite; confusion, depression, anxiety, difficulty in sleeping, nervousness, shaking (tremors); shortness of breath; abdominal pain or discomfort, diarrhoea, indigestion, dry mouth; sweating, rash, skin eruptions; tiredness, a feeling of unusual weakness, muscle weakness, swelling or puffiness of hands, ankles or feet.

Uncommon (may affect up to 1 in 100 people)

  • allergic (hypersensitivity) reactions, including swelling of the face, lips or tongue, rash or itching;
  • loss of control of your mood, changes to your sleeping habits, restlessness, agitation, a feeling of extreme happiness, hallucinations, reduced sexual drive, nightmares, aggression;
  • feeling very drowsy, changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness;
  • loss of memory, migraine, fainting, problems with concentration or co-ordination;
  • dry eyes, blurred vision;
  • a ringing or buzzing sound in the ears, a feeling of dizziness or spinning (vertigo);
  • high or low blood pressure, chest pain, fast or irregular heartbeat, flushing of the skin;
  • cough, hiccups, wheezing;
  • wind;
  • weight loss;
  • dry skin, a raised, itchy rash (hives)
  • muscle spasms, aches and pains;
  • loss of bladder control, difficulty in beginning the flow of urine;
  • inability to fully empty the bladder;
  • fatigue, raised body temperature, sudden feeling of cold with a high temperature and sweating, water retention;
  • an increase in accidental injuries (e.g. falls);
  • withdrawal symptoms such as agitation, anxiousness, sweating or shaking upon stopping using Butec patches (see section 'Drug withdrawal'). If you need to have blood tests remind your doctor that you are using Butec patches. This is important because Butec patches may change the way your liver works and this could affect the results of some blood tests. Rare (may affect up to 1 in 1,000 people)
  • a severe allergic reaction (anaphylaxis), the symptoms of which include difficulty breathing, wheezing, severe swelling of the face, lips or tongue, rash or itching, and loss of consciousness (see above);
  • angina (chest pain associated with heart disease);
  • severe mental disorder causing loss of touch with reality (psychotic disorder);
  • difficulties with balance;
  • changes to your vision, swelling or puffiness of the eyelids or face, a reduction in size of the pupils in the eye;
  • difficulty in breathing, worsening of asthma, very fast breathing (hyperventilation);
  • a feeling of faintness, especially on standing up;
  • difficulty in swallowing, a condition where the bowel doesn't work properly (ileus);
  • swelling and irritation inside the nose;
  • decreased erection, sexual dysfunction;
  • a flu-like illness;

•

dehydration.

Very rare (may affect up to 1 in 10,000 people)

  • mood swings;
  • involuntary muscle twitching;
  • ear pain;
  • blisters. Not known (frequency cannot be estimated from the available data)
  • seizures, fits or convulsions;
  • inflammation of the bowel wall. Symptoms may include fever, vomiting and stomach pain or discomfort;
  • colicky abdominal pain or discomfort;
  • feeling detached from oneself;
  • an increased sensitivity to pain;
  • development of a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
  • a need to take increasingly higher doses to obtain the same level of pain relief (drug tolerance);
  • dependence and addiction (see section 'How do I know if I am addicted?').
  • dermatitis contact (skin rash with inflammation which may include burning sensation, skin discolouration. Long term use of Butec patches during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

How to store it

Butec patches Keep this medicine out of the sight and reach of children. Do not use Butec patches after the expiry date which is stated on the carton and on the pouch. The expiry date refers to the last day of that month. After the expiry date, take any unused patches to a pharmacy. Do not store Butec patches above 25°C. Do not use the patch if the pouch seal is broken. Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them. Used patches must be folded over on themselves with the adhesive layer inwards, and discarded safely out of sight and reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Butec patches contain The active ingredient is buprenorphine. Each Butec 5 microgram/hour transdermal patch contains 5 mg of buprenorphine in a patch size of 6.25 cm2 and releases about 5 micrograms of buprenorphine per hour (over a period of 7 days). Each Butec 10 microgram/hour transdermal patch contains 10 mg of buprenorphine in a patch size of 12.5 cm2 and releases about 10 micrograms of buprenorphine per hour (over a period of 7 days). Each Butec 15 microgram/hour transdermal patch contains 15 mg of buprenorphine in a patch size of 18.75 cm2 and releases about 15 micrograms of buprenorphine per hour (over a period of 7 days). Each Butec 20 microgram/hour transdermal patch contains 20 mg of buprenorphine in a patch size of 25 cm2 and releases about 20 micrograms of buprenorphine per hour (over a period of 7 days). The other ingredients are polyacrylate (Durotak 387-2051 & 387-2054), levulinic acid, oleyl oleate, povidone, polyethyleneterephthalate. What Butec patches look like and contents of the pack Butec 5 microgram/hour transdermal patch is a square, beige coloured patch with rounded corners marked Butec 5 μg/h. Butec 10 microgram/hour transdermal patch is a rectangular, beige coloured patch with rounded corners marked Butec 10 μg/h. Butec 15 microgram/hour transdermal patch is a rectangular, beige coloured patch with rounded corners marked Butec 15 μg/h. Butec 20 microgram/hour transdermal patch is a square, beige coloured patch with rounded corners marked Butec 20 μg/h. Butec patches are available in cartons containing 4 child resistant pouches, each containing a single patch. Marketing Authorisation Holder Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. Manufacturer Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK. This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on: 0800 198 5000 You will need to give details of the product name and reference number. These are as follows: Product name: Butec patches Reference number: 40431/0024 This leaflet was last revised in March 2025 ® QDEM and the 'Qdem pharmaceuticals' logo are registered trade marks of Qdem Pharmaceuticals Limited. ® BUTEC is a registered trade mark of Mundipharma. © 2015-2025 Qdem Pharmaceuticals Limited.

Frequently asked questions about Butec 5 microgram/hour transdermal patch

How do I take Butec 5 microgram/hour transdermal patch?

Butec 5 microgram/hour transdermal patch comes as patch containing 5mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Butec 5 microgram/hour transdermal patch?

The active substance in Butec 5 microgram/hour transdermal patch is buprenorphine.

Are there equivalent medicines to Butec 5 microgram/hour transdermal patch?

Medicines with the same active substance, strength and form include: BuTrans 5 microgram/hour transdermal patch, Bunov 5 microgram/h transdermal patch, Panitaz 5 micrograms/h Transdermal Patches. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Butec 5 microgram/hour transdermal patch, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Butec 5 microgram/hour transdermal patch without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Buprenorphine (42 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia

Butec is not suitable for the treatment of acute pain.

Butec is indicated in adults.

4.2. Posology and method of administration

Posology

Butec should be administered once per week on the same day each week.

Patients aged 18 years and over:

The lowest Butec dose (Butec 5 microgram/hour transdermal patch) should be used as the initial dose. Consideration should be given to the previous opioid history of the patient (see section 4.5) as well as to the current general condition and medical status of the patient.

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Titration:

During initiation of treatment with Butec, short-acting supplemental analgesics may be required as needed until analgesic efficacy with Butec is attained.

The dose of Butec may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour. A new patch should not be applied to the same skin site for the subsequent 3-4 weeks (see section 5.2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.

Conversion from opioids:

Butec can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose (Butec 5 microgram/hour transdermal patch) and continue taking short-acting supplemental analgesics during titration, as required.

Paediatric population:

The safety and efficacy of Butec in children below 18 years of age has not been established. No data are available.

Elderly:

No dosage adjustment of Butec is required in elderly patients.

Renal impairment:

No special dose adjustment of Butec is necessary in patients with renal impairment.

Hepatic impairment:

Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore patients with hepatic insufficiency should be carefully monitored during treatment with Butec.

Patients with severe hepatic impairment may accumulate buprenorphine during Butec treatment. Consideration of alternate therapy should be considered, and Butec should be used with caution, if at all, in such patients.

Method of administration

Route of administration:

Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces.

Patch application:

In order to ensure effective analgesia of buprenorphine and to minimise the potential for skin reactions (see section 4.4.) the following directions of use should be followed.

Butec should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars. Butec should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven.

If the application site must be cleaned, it should be done with clean water only. Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. Butec should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges. If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear. The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch. If a patch falls off, a new one should be applied and worn for 7 days.

Duration of administration:

Butec should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Butec is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.

Treatment goals and Discontinuation:

Before initiating treatment with Butec, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Butec, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4).

After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Butec is to be followed by other opioids. As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. At present, only limited information is available on the starting dose of other opioids administered after discontinuation of the transdermal patch (see section 4.5).

Patients with fever or exposed to external heat:

While wearing the patch, patients should be advised to avoid exposing the application site to external heat sources, such as heating pads, electric blankets, hot water bottles, heat lamps, sauna, hot tubs, and heated water beds, etc., as an increase in absorption of buprenorphine may occur.

When treating febrile patients, one should be aware that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and thereby increased risk of opioid reactions.

Duration of treatment

Butec should not be used longer than necessary.

4.3. Contraindications

Butec is contra-indicated in:

- patients with known hypersensitivity to the active substance buprenorphine or to any of the excipients, including previous history of application site reactions suggestive of allergic contact dermatitis with buprenorphine transdermal patches (see section 6.1)

- opioid dependent patients and for narcotic withdrawal treatment

- conditions in which the respiratory centre and function are severely impaired or may become so

- patients who are receiving MAO inhibitors or have taken them within the last two weeks (see section 4.5)

- patients suffering from myasthenia gravis

- patients suffering from delirium tremens.

4.4. Special warnings and precautions for use

Butec should be used with particular caution in patients with severely impaired respiratory function, sleep apnoea, acute alcohol intoxication, head injury, shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, severe hepatic impairment (see section 4.2) or constipation.

The primary risk of opioid excess is respiratory depression.

Sleep-related breathing disorders

Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.

Concomitant use of Butec and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Butec concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route. A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported.

Serotonin syndrome

Concomitant administration of Butec and other serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).

If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms.

If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

Skin reactions at application site

Application site reactions usually present as a mild to moderate skin inflammation (contact dermatitis) with erythema, oedema, pruritis, rash, vesicles and pain or a burning sensation at the application site. The reaction typically resolves spontaneously following removal of the Butec patch. Adherence to the method of administration given in section 4.2 reduces the risk of skin reactions at the application site.

Butec patches may also cause skin sensitisation and subsequent immune-mediated, type IV hypersensitivity reaction allergic contact dermatitis. Allergic contact dermatitis may develop with a significant delay of up to several months following initiation of treatment with Butec patches. This may manifest either with symptoms similar to irritant contact dermatitis or with more severe symptoms, including burn-like lesions with bullae and discharge which spread beyond the application site and may not resolve rapidly following removal of the patch. Patients and caregivers should be instructed to monitor the application site for such reactions.

If allergic contact dermatitis is suspected, relevant diagnostic procedures should be performed to determine whether sensitisation has occurred and is caused by the patches. If allergic contact dermatitis is confirmed treatment should be discontinued (see section 4.3). Continued treatment with Butec patches in patients experiencing allergic contact dermatitis may lead to complications, including blistering of the skin, open wound, bleeding, ulceration and subsequent infections. Mechanical injuries during patch removal, such as laceration, are also possible in patients with fragile skin. Chronic inflammation may lead to long-lasting sequelae such as post-inflammatory hyper- and hypopigmentation, as well as dry and thick scaly lesions which may closely resemble scars.

Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder.

Since CYP3A4 inhibitors may increase concentrations of buprenorphine (see section 4.5), patients already treated with CYP3A4 inhibitors should have their dose of Butec carefully titrated since a reduced dosage might be sufficient in these patients.

Butec is not recommended for analgesia in the immediate post-operative period or in other situations characterised by a narrow therapeutic index or a rapidly varying analgesic requirement. Prolonged release opioids should not be used for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).​

Tolerance and opioid use disorder (abuse and dependence)

Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Butec. Repeated use of Butec can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Butec may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders).

Before initiating treatment with Butec and during the treatment, treatment goals and a discontinuation plan should be agreed with the patient (see section 4.2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.

Patients will require monitoring for signs of drug-seeking behavior (e.g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

Drug withdrawal syndrome

Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with buprenorphine.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

Withdrawal syndrome, when it occurs, is generally mild, begins after 2 days and may last up to 2 weeks. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia

Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

Butec should not be used at higher doses than recommended.

4.5. Interaction with other medicinal products and other forms of interaction

Butec must not be used concomitantly with MAOIs or in patients who have received MAOIs within the previous two weeks (see section 4.3).

Butec should be used cautiously when co-administered with serotonergic medicinal products, such as selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).

Effect of other active substances on the pharmacokinetics of buprenorphine:

Buprenorphine is primarily metabolised by glucuronidation and to a lesser extent (about 30%) by CYP3A4. Concomitant treatment with CYP3A4 inhibitors may lead to elevated plasma concentrations with intensified efficacy of buprenorphine. Studies with the CYP3A4 inhibitor ketoconazole did not produce clinically relevant increases in mean maximum (Cmax) or total (AUC) buprenorphine exposure following Butec with ketoconazole as compared to Butec alone.

The interaction between buprenorphine and CYP3A4 enzyme inducers has not been studied. Co-administration of Butec and enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin and rifampicin) could lead to increased clearance which might result in reduced efficacy.

Reductions in hepatic blood flow induced by some general anaesthetics (e.g. halothane) and other medicinal products may result in a decreased rate of hepatic elimination of buprenorphine.

Pharmacodynamic interactions:

Butec should be used cautiously with other central nervous system depressants such as other opioid derivatives (analgesics and antitussives containing e.g. morphine, codeine or dextromethorphan), certain antidepressants, sedative H1-receptor antagonists, alcohol, anxiolytics, neuroleptics, clonidine and related substances. These combinations increase the CNS depressant activity.

The concomitant use of Butec with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4).

Concomitant administration of buprenorphine with anticholinergics or medications with anticholinergic activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may results in increased anticholinergic adverse effects.

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no data from the use of Butec in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Therefore Butec should not be used during pregnancy and in women of childbearing potential who are not using effective contraception.

Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration.

Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available.

Breastfeeding

Administration to nursing women is not recommended as buprenorphine is secreted in breast milk and may cause respiratory depression in the infant.

Studies in rats have shown that buprenorphine may inhibit lactation. Available pharmacodynamic/ toxicological data in animals has shown excretion of buprenorphine into the milk (see section 5.3). Therefore the use of Butec during lactation should be avoided.

Fertility

No human data on the effect of buprenorphine on fertility are available. In a fertility and early embryonic development study, no effects on reproductive parameters were observed in male or female rats (see section 5.3).

4.7. Effects on ability to drive and use machines

Butec has a major influence on the ability to drive and use machines. Even when used according to instructions, Butec may affect the patient's reactions to such an extent that road safety and the ability to operate machinery may be impaired. This applies particularly in the beginning of treatment and in conjunction with other centrally acting substances including alcohol, tranquillisers, sedatives and hypnotics. An individual recommendation should be given by the physician. A general restriction is not necessary in cases where a stable dose is used.

Patients who are affected and experience side effects (e.g. dizziness, drowsiness, blurred vision) during treatment initiation or titration to a higher dose should not drive or use machines, nor for at least 24 hours after the patch has been removed.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive.

• Do not drive until you know how the medicine 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

4.8. Undesirable effects

Serious adverse reactions that may be associated with Butec therapy in clinical use are similar to those observed with other opioid analgesics, including respiratory depression (especially when used with other CNS depressants) (see section 4.4).

The following frequency categories form the basis for classification of the undesirable effects:

Term

Frequency

Very common

≥ 1/10

Common

≥ 1/100 to <1/10

Uncommon

≥ 1/1,000 to <1/100

Rare

≥1/10,000 to <1/1,000

Very rare

<1/10,000

Frequency not known

Cannot be estimated from the available data

Immune system disorders:

Uncommon: hypersensitivity.

Rare: anaphylactic reaction.

Frequency not known: anaphylactoid reaction.

Metabolism and nutrition disorders:

Common: anorexia.

Rare: dehydration.

Psychiatric disorders:

Common: confusion, depression, insomnia, nervousness, anxiety.

Uncommon: affect lability, sleep disorder, restlessness, agitation, euphoric mood, hallucinations, decreased libido, nightmares, aggression.

Rare: psychotic disorder.

Very rare: mood swings.

Frequency not known: drug dependence (see section 4.4), depersonalisation.

Nervous system disorders:

Very common: headache, dizziness, somnolence.

Common: tremor.

Uncommon: sedation, dysgeusia, dysarthria, hypoaesthesia, memory impairment, migraine, syncope, abnormal co-ordination, disturbance in attention, paraesthesia.

Rare: balance disorder, speech disorder.

Very rare: involuntary muscle contractions.

Frequency not known: seizure, hyperalgesia, sleep apnoea syndrome.

Eye disorders:

Uncommon: dry eye, blurred vision.

Rare: visual disturbance, eyelid oedema, miosis.

Ear and labyrinth disorders:

Uncommon: tinnitus, vertigo.

Very rare: ear pain.

Cardiac disorders:

Uncommon: palpitations, tachycardia

Rare: angina pectoris.

Vascular disorders:

Uncommon: hypotension, circulatory collapse, hypertension, flushing.

Rare: vasodilation, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders:

Common: dyspnoea.

Uncommon: cough, wheezing, hiccups.

Rare: respiratory depression, respiratory failure, asthma aggravated, hyperventilation, rhinitis.

Gastrointestinal disorders:

Very common: constipation, nausea, vomiting.

Common: abdominal pain, diarrhoea, dyspepsia, dry mouth.

Uncommon: flatulence.

Rare: dysphagia, ileus.

Frequency not known: diverticulitis.

Hepatobiliary disorders:

Frequency not known: biliary colic.

Skin and subcutaneous tissue disorders:

Very common: pruritis, erythema.

Common: rash, sweating, exanthema.

Uncommon: dry skin, urticaria.

Rare: face oedema.

Very rare: pustules, vesicles.

Frequency not known: Dermatitis contact, skin discolouration.

Musculoskeletal and connective tissue disorders:

Common: muscular weakness.

Uncommon: myalgia, muscle spasms.

Renal and urinary disorders:

Uncommon: urinary incontinence, urinary retention, urinary hesitation.

Reproductive system and breast disorders:

Rare: erectile dysfunction, sexual dysfunction.

General disorders and administration site conditions:

Very common: application site skin reactions*.

Common: tiredness, asthenic conditions, peripheral oedema.

Uncommon: fatigue, pyrexia, rigors, oedema, drug withdrawal syndrome, chest pain.

Rare: influenza-like illness.

Frequency not known: neonatal drug withdrawal syndrome, drug tolerance.

* Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritis, rash, vesicles and pain/burning sensation at the application site. In some cases late onset allergic contact dermatitis has occurred with marked signs of inflammation. In such cases treatment with Butec patches should be terminated.

Investigations:

Uncommon: alanine aminotransferase increased, weight decreased.

Injury, poisoning and procedural complications:

Uncommon: accidental injury, fall

Drug dependence

Repeated use of Butec can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment (see section 4.4).

After discontinuation of Butec, withdrawal symptoms are uncommon. This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9. Overdose

Symptoms

Symptoms similar to those of other centrally acting analgesics are to be expected. These include respiratory depression, sedation, drowsiness, nausea, vomiting, cardiovascular collapse and marked miosis.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Treatment

Remove any patches from the patient's skin. Establish and maintain a patent airway, assist or control respiration as indicated and maintain adequate body temperature and fluid balance. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

A specific opioid antagonist such as naloxone may reverse the effects of buprenorphine, although naloxone may be less effective in reversing the effects of buprenorphine than other mu-opioid agonists. Treatment with continuous intravenous naloxone should begin with the usual doses but high doses may be required.

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