Patient Leaflet Updated 24-Nov-2021 | Napp Pharmaceuticals Limited
BuTrans 5, 10, 15 and 20ug/h Transdermal Patch
Package leaflet: Information for the patient
BuTrans® 5 microgram/hour transdermal patches
BuTrans® 10 microgram/hour transdermal patches
BuTrans® 15 microgram/hour transdermal patches
BuTrans® 20 microgram/hour transdermal patches
buprenorphine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet:
1. What BuTrans patches are and what they are used for
2. What you need to know before you use BuTrans patches
3. How to use BuTrans patches
4. Possible side effects
5. How to store BuTrans patches
6. Contents of the pack and other information
1. What BuTrans patches are and what they are used for
BuTrans patches contain the active ingredient buprenorphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. They have been prescribed for you by your doctor to relieve moderate, long-lasting pain that requires the use of a strong painkiller.
BuTrans patches should not be used to relieve acute pain.
BuTrans patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.
2. What you need to know before you use BuTrans patches
Do not use BuTrans patches:
BuTrans patches must not be used to treat symptoms associated with drug withdrawal.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using BuTrans patches:
Sleep-related breathing disorders
BuTrans patches can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
This medicine may cause application site reactions which are usually presented by a mild or moderate skin inflammation, and their typical appearance may include redness, swelling, itching, rash, small blisters, and painful/burning sensation at the application site. Most commonly the cause is skin irritation, and these reactions stop after BuTrans patches are removed. More serious allergic reactions may occur such as blisters with discharge, which may spread outside the application site and may not resolve rapidly after BuTrans removal. Chronic allergic reactions may lead to open wounds, bleeding, ulcers, skin discoloration and infections. If you notice any of the above skin reactions, please contact your doctor.
This medicine may increase your sensitivity to pain particularly at high doses. Tell your doctor if this happens. A reduction in your dose or a change in your medicine may be necessary.
If you have recently had an operation, please speak to your doctor before using these patches.
Similar to other opioids, BuTrans patches may affect the normal production of hormones in the body, such as cortisol or sex hormones, particularly if you have taken high doses for long period of time.
Children and adolescents
Do not give this medicine to children below 18 years.
Other medicines and BuTrans patches
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may increase the side effects of BuTrans patches and may sometimes cause very serious reactions. Do not take any other medicines whilst taking BuTrans patches without first talking to your doctor, especially:
Using BuTrans 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 BuTrans patches. Drinking alcohol whilst using BuTrans patches may also affect your reaction time.
Pregnancy, breast-feeding and fertility
You should not use BuTrans patches if you are pregnant or are breast-feeding, think you may be pregnant or are planning to have a baby unless otherwise instructed by your doctor having carefully considered the benefits and risk to both the mother and the child.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
BuTrans 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 BuTrans patches, or for 24 hours after removing the patch.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
3. How to use BuTrans 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.
Different strengths of BuTrans patches are available. Your doctor will decide which strength of BuTrans patch will suit you best.
When people first start using BuTrans, they often experience some nausea and vomiting (see section 4). 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 BuTrans 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.
Adults and elderly patients
Unless your doctor has told you differently, attach one BuTrans patch (as described in detail below) and change it every seventh day, 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 BuTrans 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
BuTrans 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 BuTrans patch may be affected and your doctor will therefore check on you more closely.
Before applying the BuTrans patch
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. 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 BuTrans patches (see “Take special care” section 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
Duration of treatment
Your doctor will tell you how long you should be treated with the BuTrans 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 BuTrans patches” below).
If you feel that the effect of the BuTrans patch is too weak or too strong, talk to your doctor or pharmacist.
If you use more BuTrans 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 straight away. 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 BuTrans 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 BuTrans patches
If you stop using BuTrans patches too soon or you interrupt your treatment your pain may return. If you wish to stop treatment please consult your doctor. They will tell you what can be done and whether you can be treated with other medicines. Some people may have side effects when they have used strong painkillers for a long time and stop using them. The risk of having effects after stopping BuTrans patches is very low. However, if you feel agitated, anxious, nervous or shaky, if you are overactive, have difficulty sleeping or digestive problems, tell your doctor.
The pain relieving effect of BuTrans 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects that may be associated with BuTrans patches are similar to those seen with other strong painkillers and include difficulty in breathing and low blood pressure.
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.
As with all strong painkillers, there is a risk that you may become addicted or reliant on BuTrans patches.
In patients treated with BuTrans 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 BuTrans patches. This is important because BuTrans 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 1000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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.
5. How to store BuTrans patches
Keep this medicine out of the sight and reach of children.
Do not use BuTrans 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 BuTrans 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.
6. Contents of the pack and other information
What BuTrans patches contain
The active ingredient is buprenorphine.
BuTrans 5 microgram/hour transdermal patch
Each 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).
BuTrans 10 microgram/hour transdermal patch
Each 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).
BuTrans 15 microgram/hour transdermal patch
Each 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).
BuTrans 20 microgram/hour transdermal patch
Each 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:
What BuTrans patches look like and contents of the pack
Transdermal patch
Four sizes are available.
5 microgram/hour: square, beige coloured patch with rounded corners marked BuTrans 5 μg/h
10 microgram/hour: rectangular, beige coloured patch with rounded corners marked BuTrans 10 μg/h
15 microgram/hour: rectangular, beige coloured patch with rounded corners marked BuTrans 15 μg/h
20 microgram/hour: square, beige coloured patch with rounded corners marked BuTrans 20 μg/h
BuTrans patches are available in cartons containing 4 child resistant pouches each containing a single patch.
Marketing Authorisation Holder:
Manufacturers:
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Norspan®
Belgium Norspan®
Czech Republic Norspan®
Denmark Norspan®
Estonia Norspan®
Finland Norspan®
Germany Norspan®
Hungary Norspan®
Iceland Norspan®
Latvia Norspan®
Lithuania Norspan®
Luxembourg Norspan®
Netherlands BuTrans®
Norway Norspan®
Poland Norspan®
Portugal Norspan®
Republic of Ireland BuTrans®
Slovak Republic Norspan®
Sweden Norspan®
United Kingdom BuTrans®
For UK only:
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: BuTrans patches
Reference number: 16950/0136
This leaflet was last revised in September 2021
® NAPP and the ‘NAPP’ logo are registered trade marks of the Napp Pharmaceutical Group.
® BUTRANS is a registered trade mark of Mundipharma.
© 2007-2021 Napp Pharmaceuticals Ltd.
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