The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL40431/0027.
Butec 5, 10, 15 and 20 microgram/hour transdermal patch
Butec® 5 microgram/hour transdermal patches
Butec® 10 microgram/hour transdermal patches
Butec® 15 microgram/hour transdermal patches
Butec® 20 microgram/hour transdermal patches
1. What Butec patches are and what they are used for
2. What you need to know before you use Butec patches
3. How to use Butec patches
4. Possible side effects
5. How to store Butec patches
6. Contents of the pack and other information
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.
Talk to your doctor, pharmacist or nurse before using Butec patches if you:
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.
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.
Do not give this medicine to children below 18 years.
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:
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.
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.
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.
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:
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 follow-up 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.
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.
Butec patches should not be used in patients below the age of 18 years.
In patients with kidney disease, no change in dose is necessary.
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.
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.
Stick the patch on to the area of skin you have chosen and remove the remaining foil.
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.
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).
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.
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.
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.
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.
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.
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.
If you notice any of the following signs whilst using Butec patches, it could be a sign that you have become addicted.
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)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
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)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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.
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.
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.
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.
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.
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.
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 May 2021
® QDEM and the ‘Qdem pharmaceuticals’ logo are registered trade marks of Qdem Pharmaceuticals Limited.
® BUTEC is a registered trade mark of Mundipharma.
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