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Sevodyne 5, 10, 15 and 20 microgram/hour transdermal patch
Sevodyne 5 microgram/hour transdermal patch
Sevodyne 10 microgram/hour transdermal patch
Sevodyne 15 microgram/hour transdermal patch
Sevodyne 20 microgram/hour transdermal patch
This medicine contains buprenorphine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop using it suddenly.
1. What Sevodyne is and what it is used for
2. What you need to know before you use Sevodyne
3. How to use Sevodyne
4. Possible side effects
5. How to store Sevodyne
6. Contents of the pack and other information
This medicine has been prescribed for you for relieving 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 using it suddenly. Your prescriber should have explained how long you will be using it for, and when it is appropriate to stop, how to do this safely.
Sevodyne should not be used to relieve acute pain.
Sevodyne patches act through the skin. After application, buprenorphine passes through the skin into the blood. Each patch lasts for seven days.
Sevodyne must not be used to treat symptoms associated with drug withdrawal.
Talk to your prescriber before using this medicine 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 using 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 using 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 using 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. Using 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
Sevodyne 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, difficulty in maintaining 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 Sevodyne 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 Sevodyne removal. Chronic allergic reactions may lead to open wounds, bleeding, ulcers, skin discolouration 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.
Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Similar to other opioids, this medicine may affect the normal production of hormones in the body, such as cortisol or sex hormones, particularly if you have taken high doses for a long period of time.
Do not give this medicine to children and adolescents below 18 years.
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 Sevodyne and may sometimes cause very serious reactions. Do not take any other medicines whilst using Sevodyne without first talking to your doctor, especially:
Alcohol may make some of the side effects worse and you may feel unwell if you drink alcohol whilst wearing Sevodyne.
Drinking alcohol whilst using Sevodyne may also affect your reaction time.
Do not use Sevodyne if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, 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 Sevodyne during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not use Sevodyne while you are breast-feeding as buprenorphine passes into breast milk and will affect your baby.
Ask your doctor or pharmacist for advice before using this medicine.
Sevodyne 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 Sevodyne, or for 24 hours after removing the patch.
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
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 Sevodyne are available. Your doctor will decide which strength of Sevodyne will suit you best.
When people first start using Sevodyne, 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 Sevodyne 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.
If you feel that the effect of the Sevodyne is too weak or too strong, talk to your doctor or pharmacist.
Unless your doctor has told you differently, attach one Sevodyne 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 Sevodyne. 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.
In patients with kidney disease, no change in dose is necessary.
In patients with liver disease, the effects and period of action of Sevodyne may be affected and your doctor will therefore check on you more closely.
Sevodyne should not be used in patients below the age of 18 years.
Sevodyne transdermal patch is for transdermal use.
Sevodyne acts through the skin. After application, buprenorphine passes through the skin into the blood.
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 Sevodyne (see ‘Warnings and precautions’ 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 transdermal patch’ below).
Your prescriber should have discussed with you how long the course of treatment will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop using the medicine.
Do not stop treatment without consulting a doctor, because your pain may return and you may feel unwell (see also ‘If you stop using Sevodyne’ below).
If you feel that the effect of the Sevodyne 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 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.
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 using this medicine. If you want to stop using 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 using this medicine.
The pain relieving effect of Sevodyne 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, this medicine can cause side effects, although not everybody gets them.
Serious side effects that may be associated with Sevodyne 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 Sevodyne.
In patients treated with buprenorphine, 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 Sevodyne. This is important because Sevodyne 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):
When you stop using Sevodyne, 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 Sevodyne, 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects, you can help provide more information on the safety of this medicine.
Each transdermal patch contains 5mg of buprenorphine in a patch size of 6.25cm2 and releases 5 micrograms of buprenorphine per hour (over a period of 7 days).
Each transdermal patch contains 10mg of buprenorphine in a patch size of 12.5cm2 and releases 10 micrograms of buprenorphine per hour (over a period of 7 days).
Each transdermal patch contains 15mg of buprenorphine in a patch size of 18.75 cm2 and releases 15 micrograms of buprenorphine per hour (over a period of 7 days).
Each transdermal patch contains 20mg of buprenorphine in a patch size of 25cm2 and releases 20 micrograms of buprenorphine per hour (over a period of 7 days).
Adhesive matrix (containing buprenorphine): povidone K90, levulinic acid, oleyl oleate, poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5),
Adhesive matrix (without buprenorphine): poly[(2-ethylhexyl)acrylate-co-glycidylmethacrylate-co- (2-hydroxyethyl)acrylate-co-vinylacetate] (68:0,15:5:27),
Separating foil between adhesive matrices with and without buprenorphine: Polyethylene terephthalate film; Backing foil: Polyester; Release liner: Polyethylene terephthalate film, siliconised; Blue printing ink.
Four sizes are available.
Each transdermal patch is beige coloured with rounded corners and is imprinted with ‘Buprenorphin’ and ‘5μg/h’
Each transdermal patch is beige coloured with rounded corners and is imprinted with ‘Buprenorphin’ and ‘10μg/h’
Each transdermal patch is beige coloured with rounded corners and is imprinted with ‘Buprenorphin” and ‘15μg/h’
Each transdermal patch is beige coloured with rounded corners and is imprinted with ‘Buprenorphin’ and ‘20μg/h’
One transdermal patch is sealed in one child-resistant sachet. The patches are available in cartons containing 1, 2, 3, 4, 5, 8, 10 or 12 transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in 02/2023